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pdfInstitutional Review Board - Federalwide Assurance #00002988
Cincinnati Childrens Hospital Med Ctr
Date:
Friday, January 25, 2013
From:
IRB Committee
To:
Principal Investigator: Lawrence Dolan
Endocrinology
Re:
Study ID: 2011-0407
Study Title: SEARCH for Diabetes in Youth
The above referenced protocol and all applicable additional documentation provided to the IRB
were reviewed and RE-APPROVED using an EXPEDITED review procedure set forth in 45
CFR 46.110(b)(1), Category(ies)(see below) on 1/24/2013.
This study will be due for continuing review at least 30 days before 1/23/2014.
Study Documents
Atrium approval - expires 12/22/12
BCMH (OH Dept. of Health) approval - expires 1/20/13
Birthday card
Brochure - 2012
Brochure - follow-up
CES-D
CES-D - Spanish
Christ approval - expires 1/1/13
Cohort description 10-17 years
Cohort description 5-10 years
Cohort description adult
Cohort instructions
Cohort instructions - Spanish
Cohort intro letter
Cohort reminder letter
Cohort reminder letter - Spanish
Consent for 2012 visits
Consent for 2012 visits - Spanish
Consent for Single Follow-up Visit
Consent for single follow-up visit - Spanish
Consent for volunteers
Contact information
Contact information - Spanish
DVD cover
DVD disk label
Eating Problems
Eating problems - Spanish
Eye Vision
Facebook page
Family conflict
Family conflict - Spanish
Family medical history
Food Frequency
Food frequency - Spanish
Fort Hamilton Hughes waiver approval - no expiration
Health Questionnaire
Health Questionnaire - Spanish
IPS
IPS - Spanish
IPS letter
IPS letter - Spanish
IPS thank you letter
IPS thank you letter - Spanish
IPS Voucher - Spanish
Lab results description
Lab results description - Spanish
Letter - recruitment, registry visit
Letter - recruitment, registry visit - Spanish
Link to recruitment video
Link to study-wide public website
Low blood sugar
Low Blood Sugar - Spanish
McCullough-Hyde approval - expires 11/17/12
Medical record review
Medical Record Validation
Medication inventory
Medication inventory - Spanish
Mercy/Jewish approval - expires 12/20/12
MNSI
MNSI - Spanish
Newsletter - winter 2012
PDQ
PDQ - Spanish
PedsQL - diabetes-specific
PedsQL - diabetes-specific - Spanish
PedsQL - generic
PedsQL - generic - Spanish
Permission to text
Postcard - airplanes
Postcard - airplanes - Spanish
Postcard - hands
Postcard - hands - Spanish
Poster
Poster - Spanish
Protocol - version 4
Quality of Care
Quality of Care - Spanish
Referral - business size card
Referral card - depression - CCHMC pt.
Referral card - depression - non-CCHMC pt.
Refrigerator magnet
Registry description
Registry description - Spanish
Registry instructions
Registry lab result description
Registry reminder letter
Result letter - participant
Result letter - participant - Spanish
Result letter - provider
Retinal photo result letter
Script for completing forms prior to visit
Spanish translation certification - 2012 Visits Consent & recruitment documents
Spanish translation certification - consent, reminder letter, visit instructions
Spanish translation certification - Contact info.
Spanish translation certification - explanation of labs and urine instructions
Spanish translation certification - Food Freq. and QOC
Spanish translation certification - IPS
Spanish translation certification - lab results description
Spanish translation certification - Med Inventory
Spanish translation certification - MNSI
Continuing Review Documents:
Registry consent
Cohort consent
Please note the following requirements:
AMENDMENTS: The principal investigator is responsible for notifying the IRB of any
changes in the protocol, participating investigators, procedures, recruitment, consent
forms, FDA status, or conflicts of interest. Approval is based on the information as
submitted. New procedures cannot be initiated until IRB approval has been given. If you wish to
change any aspect of this study, please submit an Amendment via ePAS to the IRB, providing a
justification for each requested change.
CONTINUING REVIEW: The investigator is responsible for submitting a Continuing Review
via ePAS to the IRB at least 30 days prior to the expiration date listed above. Please note that
study procedures may only continue into the next cycle if the IRB has reviewed and granted reapproval prior to the expiration date.
UNANTICIPATED PROBLEMS: The investigator is responsible for reporting unanticipated
problems promptly to the IRB via ePAS according to current reporting policies.
STUDY COMPLETION: The investigator is responsible for notifying the IRB by submitting a
Request to Close via ePAS when the research, including data analysis, has completed.
Research Categories
4. Collection of data through noninvasive procedures (not involving general anesthesia or
sedation) routinely employed in clinical practice, excluding procedures involving x-rays or
microwaves. Where medical devices are employed, they must be cleared/approved for
marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are
not generally eligible for expedited review, including studies of cleared medical devices for new
indications.) Examples: (a) physical sensors that are applied either to the surface of the body or
at a distance and do not involve input of significant amounts of energy into the subject or an
invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance
imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally
occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler
blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body
composition assessment, and flexibility testing where appropriate given the age, weight, and
health of the individual.
5. Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for nonresearch purposes (such as medical treatment or
diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for
the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that
is not exempt.)
Please note: This approval is through the IRB only. You may be responsible for reporting to other
regulatory officials (e.g. VA Research and Development Office, UC Health - University Hospital). Please
check with your institution and department to ensure you have met all reporting requirements.
Statement regarding International conference on Harmonization and Good Clinical Practices: The
Institutional Review Board is duly constituted (fulfilling FDA requirements for diversity), has written
procedures for initial and continuing review of clinical trials; prepares written minutes of convened
meetings, and retains records pertaining to the review and approval process; all in compliance with
requirements defined in 21 CFR Parts 50, 56 and 312 Code of Federal Regulations. This institution is in
compliance with the ICH GCP as adopted by FDA/DHHS.
Thank you for your cooperation during the review process.
Greetings Dr. Dabalea, Principal Investigator,
This is official notification your NNR-01.106 Annual Report, Revised Consent
Forms and your request for continuation was approved this 28th Day of
January. The Continuation for period covering January 28, 2013 to January
28th with all Standard Conditions and acceptance of the Annual Report and
Revised Consent Forms. .
Your Annual Report was well done and included all research related activities
and information. Your protocol NNR-02.106 will be on the NNHRRB Agenda so
there is an official record of action taken and you will receive your letter of
notification and approval after that meeting.
I will be mailing your revised Consent Forms to the Shipock office on January
29, 2013 and you can begin utilizing the revised Consents. If you have any
questions please do not hesitate to contact me.
Thank you for your cooperation and understanding these trying times
regarding the research office, we will keep you updated on activities as they
occur. There is no February IRV NNHRRB meeting.
Beverly Becenti-Pigman, Chairperson
Navajo Nation Human Research Review Board
The Navajo Nation
Window Rock, Arizona 86515
OFFICE OF HUMAN RESEARCH ETHICS
Medical School Building 52
Mason Farm Road
CB #7097
Chapel Hill, NC 27599-7097
(919) 966-3113
Web site: ohre.unc.edu
Federalwide Assurance (FWA) #4801
To: Elizabeth Mayer-Davis
Nutrition
From: Non-Biomedical IRB
Approval Date: 4/01/2013
Expiration Date of Approval: 3/11/2014
RE: Notice of IRB Approval by Full Board Review
Submission Type: Renewal
Study #: 10-2341
Study Title: SEARCH for Diabetes in Youth: Carolina Site (SEARCH 3)
Sponsors: Centers for Disease Control and Prevention (CDC)
National Institute of Diabetes, Digestive and Kidney Diseases
National Institutes of Health (NIH)
This submission has been approved by the IRB for the period indicated.
Study Description:
This application includes two distinct aspects of SEARCH 3
Purpose: SEARCH for Diabetes in Youth is a multi-center study designed with a two-fold purpose
of: (1) developing a uniform population based approach to finding and understanding rates and types
of diabetes mellitus in youth including the development of a sustainable surveillance effort.
(Registry study) and (2) Monitoring development of complications of diabetes in youth that were
previously identified and participated in a SEARCH study baseline visit (Cohort Study).
Participants: Children and youth from 0-19 years of age with newly diagnosed diabetes living in
South Carolina (Registry study) and individuals diagnosed with diabetes between 2002 and 2008
that previously completed a SEARCH study baseline visit and have had diabetes for at least five
years(Cohort study).
Submission Description:
1. Revise introductory participant letter: Remove phone number for provider's office, replace with
phone number for local SEARCH subsite.
2. Add new forms, per SEARCH Coordinating Center: Cohort Visit Employment and Economics
Questionnaire; Cohort Visit Household Food Security and Food Assistance Form; Registry Visit
Household Food Security Survey and Food Assistance Form (English and Spanish Versions);
3. Add revised form: Registry Visit Extended Core Form.
page 1 of 2
3. Add recruitment method: Text messaging (samples of messages included)
4. Add staff member to study: Jaime Hughes
5. Removed study team members (no longer at UNC): Megan Demaria, Jennifer Anderson,
Whitney Franz, and Fran Urbina
Regulatory and other findings:
This research, which involves children, meets criteria at 45 CFR 46.404 and/or 21 CFR 50.51
(research involving no greater than minimal risk). Permission of one parent or guardian is sufficient.
The surveys do not ask sensitive information and the blood draw and eye photography present
minimal risk.
This research meets criteria for a waiver of written (signed) consent according to 45 CFR
46.117(c)(2) for completion of the IPS survey and for the collection of the overnight urine sample.
Written consent will be collected before the urine is given to the research staff the next day.
This research meets criteria for waiver of informed consent for research [45 CFR 46.116(d)] and
waiver of HIPAA authorization [45 CFR 164.512(i)(2)(ii)] for the case ascertainment and validation
portion of the study.
This approval includes a limited waiver of HIPAA authorization to identify potential subjects for
recruitment into this research study (Registry Study only), as allowed under 45 CFR 164.512. This
temporary waiver provides access to protected health information (PHI) to confirm eligibility and
facilitate initial contact, after which consent and HIPAA authorization will be sought. Access and
use is limited to the minimum amount of PHI necessary to review eligibility criteria and to contact
potential subjects.
Investigator’s Responsibilities:
Federal regulations require that all research be reviewed at least annually. It is the Principal
Investigator’s responsibility to submit for renewal and obtain approval before the expiration date.
You may not continue any research activity beyond the expiration date without IRB approval.
Failure to receive approval for continuation before the expiration date will result in automatic
termination of the approval for this study on the expiration date.
Your approved consent forms and other documents are available online at
http://apps.research.unc.edu/irb/irb_event.cfm?actn=info&irbid=10-2341.
You are required to obtain IRB approval for any changes to any aspect of this study before they can
be implemented. Any unanticipated problem involving risks to subjects or others (including adverse
events reportable under UNC-Chapel Hill policy) should be reported to the IRB using the web portal
at http://irbis.unc.edu.
This study was reviewed in accordance with federal regulations governing human subjects research,
including those found at 45 CFR 46 (Common Rule), 45 CFR 164 (HIPAA), 21 CFR 50 & 56
(FDA), and 40 CFR 26 (EPA), where applicable.
CC:
Joan Thomas, Nutrition
page 2 of 2
May 22, 2013
James Amrhein, MD
Atten: Joan Thomas
Children’s Hospital
200 Patewood Drive
Greenville, SC 29605
RE: IRB File # Pro00010812
Study Title:
SEARCH For Diabetes in Youth-Carolina Center, Phase 3
Items Submitted for IRB Review:
Study Protocol and Consent Form Reapproval
Dear Dr. Amrhein:
On May 22, 2013, the Institutional Review Board/Committee-B (IRB) of the Greenville Hospital System reviewed your
research study. Full committee approval of the above-mentioned items was given for one year.
Your study will expire on May 21, 2014. It is the investigator’s responsibility to make sure the proper
reapproval information is submitted to the IRB. This information must be submitted to the IRB in April 2014.
The same requirements as previously outlined for you by the IRB remain in effect as long as the study is ongoing.
These requirements are as follows:
1.
2.
3.
4.
5.
6.
7.
8.
9.
All participants must sign a copy of the attached IRB-stamped “approved” consent form before they can be
enrolled in this study. Please use this stamped “approved” consent form to make copies for each
participant.
Only the principal investigator or co-investigator can obtain consent from the participant.
The participant must sign and date the consent form in the presence of a witness.
A report to the IRB is required at the end of the approved time period giving the results of the participants
involved in the study, the status of the study and whether or not renewed approval is desired.
Immediate notification must be sent to the IRB of any advertisements, modification of the Form 1572, as
well as all revisions, changes, or amendments to the protocol or consent form.
Notification must be sent to the IRB within five (5) working days of any serious and/or unexpected adverse
event that occurs locally. Notification of all non-locally occurring serious and/or unexpected adverse events
must be sent to the IRB as soon as they are received from the sponsor.
The investigator must be sure that all consent forms are signed, dated and witnessed and placed in the
participant's study record prior to study participation. The original should be retained in the participant’s
study record at the clinical research site. Case histories (patient charts/records) will also document that
Informed Consent was obtained prior to the subject’s participation in the study.
A signed copy of the consent form must be given to the person signing the form and a copy placed in the
medical record if the study involves any type of hospital stay.
Please remember to use the GHS Study Drug Request Form for all participants entered in this study, when
applicable. Your cooperation in this helps the pharmacy to better serve you. This form can purchased from
the Supply and Distribution Center (Karen Corwin at 455-7819), Form Number A23914.
James Amrhein, MD
May 22, 2013
Page 2
Thank you for your assistance in this matter. If you have any questions, please feel free to call the IRB Office at 4554360.
Sincerely,
James W. Hayes, MD, Medical Director
Institutional Review Board/Committee-B
900 West Faris Road
Greenville, SC 29605
JWH:gh
MHS IRB Use Only
IRB Study Number
IRB Notification
Approval
20-271
June 18, 2013
Catherine Pihoker, M.D.
Department of Endocrinology 7G-1
4800 Sand Point Way NE
Seattle, WA 98105
RE: Your follow-up submission of 6/17/2013 regarding study number 20-271: SEARCH for Diabetes in Youth of
the Puget Sound (CDC, NIDDK)
Dear Dr. Pihoker:
Thank you for your response to requests from a prior review of your continuing review application for the study
listed above. This type of response qualifies for expedited review under FDA and DHHS (OHRP) regulations.
This is to confirm that your application for continuation of your study is approved. The requested modifications
have been approved. Your withdrawal of a request to conduct remote questionnaire-only cohort visits without using
a consent form or a consent waiver has been accepted and approved. Thus, all interviews will be conducted onsite
using your normal consenting process. The protocol is now approved through Phase 3 version dated 9/2012. The
consent form(s) as submitted (6/3/2013) has been approved. You must obtain signed written consent from all
subjects.
You are granted permission to continue your study as described effective immediately. Enclosed is the current “MHS
IRB Approved” stamped consent form to be used when consenting patients. The study is next subject to continuing
review on or before 6/2/2014, unless closed before that date.
As with the initial approval, changes to the study must be promptly reported and approved. Contact Kristina O'Brien
(253-403-3877; fax 253-403-1112; email: kristina.o'brien@multicare.org) if you have any questions or require further
information.
Sincerely,
H. Lester Reed, MD, FACP
Co-chair, MHS Institutional Review Board
MultiCare Health System Institutional Review Board
Approval
Page 1 of 1
IRB STATUS REPORT
Submit 1 copy electronically to irb@seattlechildrens.org.
IRB Number
12074
Study Title
SEARCH for Diabetes in Youth
Principal Investigator
Catherine Pihoker, MD
PI Email
catherine.pihoker@seattlechildrens.org
Study Contact
Beth Loots, MPH MSW
Contact Email
beth.loots@seattlechildrens.org
Principal Investigator Assurance
I acknowledge that the information provided in this status report is an accurate and complete description of the research study. I
acknowledge that I have provided the IRB the information necessary for its complete review of this continuing research activity. I
acknowledge that I am responsible for reporting any emergent problems, serious or unanticipated adverse events, or proposed
changes to the research study. I acknowledge that any proposed changes described in this status report will not be put into effect until
I receive IRB approval to continue this research.
I also certify that to the best of my knowledge, all current investigators have an up to date SFI disclosure on file with the Office of
Research Compliance. For information on how to submit SFI disclosures, please visit the Office of Research Compliance web page on
CHILD or seattlechildrens.org. For questions about SFI, contact the Office of Research Compliance.
8/7/13
__________________________________________________________________________________
Signature of Principal Investigator
Date
(Signature optional if submitted from PI’s email account)
IRB Determinations
Study Status:
Approved; any contingencies met on: _______________
Disapproved
Closed
46.404
Category of Research: _________________________
9
Category of Expedited Review (if applicable): _______________
consent 18+; one parent permission; assent 7+; waivers for
participants who turn 18 unless researcher has further interactions
Parental Permission/Consent/ Assent Requirements: ____________________________________________________________
IRB Chairperson/Subcommittee: ___________________________________________
8-20-13
Date: _______________
IRB Approval Valid Through: _______________
8-19-14
IRB APPROVAL VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED
IRB Status Report – Revised 1.14.13
1
1. CURRENT STATUS
A. Check the appropriate box (double-click on the box and select “checked”):
i.
Continued IRB approval required because:
Enrollment still in progress
Enrollment closed, but participants still active in the research
Enrolment closed, all research interventions complete, and study active for long term follow-up only - list
remaining procedures (e.g., following standard of care, completing quality of life surveys):
Participant involvement complete; remaining activities limited to analysis of identifiable data or publication
Enrollment not started at SCH
ii.
IRB approval no longer required because:
Study completed at SCH and no further use/analysis of identifiable data at this time (complete this form)
Study never started
iii. IRB approval has lapsed and requesting study be re-opened:
Indicate above the study status once re-opened and explain the following: (1) why the lapse occurred; (2)
whether any research activities occurred after the lapse; and (3) what corrective actions will be taken to
prevent future lapses:
2. RESEARCH PARTICIPANTS
A. Enrollment
i. Please complete the enrollment table for participants enrolled (consent/assent obtained) under SCH’s IRB
approval (include sites relying on SCH IRB) and participants enrolled at all other sites (if a multi-site study):
Label each participant group in each row (e.g. cases,
controls, parents, family members, nurses, or teachers)
1. Total # approved for entire study
2. Total # enrolled to date (since study initiated)
3. Total # enrolled during the current approval period
4. Total # currently active participants
ii.
SCH’s IRB Approval
All Sites
(SCH, UW, etc.)
(Multi-site trials only)
Estimated 5,500
This is a population
based study, so we
and other sites aim to
enroll all youth with
newly diagnosed
diabetes in the
defined geographic
areas and time
frames.
5,025
22,911
238
820
4,570
N/A
Is the overall enrollment proceeding as expected?
Yes
No, please explain if this will affect the ability to answer study questions and what steps will be taken to
improve enrollment:
iii. Have you received any complaints from participants or others during the current approval period?
No
Yes, please summarize:
iv. Have any participants withdrawn or been withdrawn from the study during the current approval period?
No (N/A)
Yes, please list the number and summarize the reasons for the withdrawals:
IRB Status Report – Revised 1.14.13
2
B. Consent/Parental Permission/Assent Process
i. Have any active participants reached 18 years of age during the current approval period? An active
participant is any participant that for the purposes of this study you continue to have interactions with or
whose identifiable data you continue to use, study, or analyze.
No
Yes, please indicate whether these participants have been or will be re-consented:
th
All participants are re-approached after their 18 birthday
IRB has previously approved a waiver for participants who turn 18 during the research
If you are unable to re-approach and do not currently have waivers of consent/HIPAA, please
explain why it is not practicable/feasible to re-approach these participants:
3. STUDY PROGRESS
A. Progress Report
i. Please provide a brief progress report. Your report must have sufficient detail to demonstrate the study is
being conducted consistent with your IRB approval. If you have not yet enrolled research participants, please
explain why:
SEARCH for Diabetes in Youth is an ongoing, multi-center, CDC/DDT and NIH/NIDDK funded observational
study of childhood diabetes that provides the most comprehensive data on a large cohort of youth with diabetes
ever established. SEARCH 3 includes registry and cohort components, as well as approved ancillary studies.
The study is currently funded until September 29, 2015.
Study Activities
Registry
SEARCH for Diabetes in Youth is continuing to ascertain newly diagnosed incident diabetes cases in youth age
<20 years across five geographically dispersed study centers, in order to assess temporal trends in diabetes by
age, sex, race/ethnicity, and diabetes type. At the WA site, the geographic area for the study includes King,
Kitsap, Pierce, Snohomish, and Thurston counties. The study is identifying incident cases from 2010 – 2015, and
is periodically re-ascertaining cases from earlier years. We are finding that we are averaging about 270 incident
cases per year, based on incident 2010 (n=256), incident 2011 (n=317), incident 2012 (n=288), and incident 2013
(n=95) cases. 2011 – 2013 case ascertainment is in process.
Participants with newly diagnosed diabetes are being asked to complete an Initial Participant Survey (IPS). We
are currently averaging about a 75% response rate to the IPS. A portion of those who are diagnosed in 2012 are
also being asked to complete a ‘registry’ visit. We have completed 80 registry visits to date at our site, out of an
estimated 145 total projected visits. We are continuing to collaborate closely with our local partners on case
ascertainment and IPS efforts.
Study investigators are providing consultation and support to inform the development of low-cost sustainable
public health surveillance systems of childhood diabetes in the U.S. SEARCH is also assessing total and causespecific mortality among 2002 – 2008 incident cases for the period from the date of diabetes diagnosis through
December 31, 2010.
Cohort
SEARCH is conducting an in-person ‘cohort’ visit with SEARCH participants who were incident in 2002 or later,
have a duration of diabetes about > 5 years, and have data from a baseline study visit (n=3,743 across 5 sites;
n=638 in WA). Data gathered at these visits will help investigators assess the prevalence and incidence of, and
risk factors for, chronic microvascular complications, selected markers of macrovascular complications, and
serious acute complications of diabetes. It will help determine the degree to which barriers to care, quality of
care, and the process of transition from pediatric to adult care impact disease factors, including dimensions of
diabetes type and diabetes-related outcomes. This data will also be used to maintain and supplement the
SEARCH repository for biological specimens, and promote access to SEARCH for conduct of scientifically and
logistically appropriate ancillary studies. We have completed 278 cohort visits to date at our site, which is 44% of
our target population. We are scheduling visits at times and locations that work well for participants and their
families. We are also completing a medical record review on a subset of this group.
Ongoing
We are continually updating contact information for study participants via contact information mailings, newsletter
mailings, LexisNexis, searching medical records, and contacting participants via phone or email.
IRB Status Report – Revised 1.14.13
3
Study-wide Activities
The WA Principal Investigator, Dr. Pihoker, is a member of the SEARCH Study Group and participates in the
oversight of the national study. Other local Investigators and staff are active in the SEARCH Study Group and in
a number of additional committees. Investigators and staff also participate in a number of writing groups.
Ancillary Studies
SEARCH Air
The SEARCH Air study is an ancillary study of SEARCH and is the first study to comprehensively evaluate the
role of air pollution on inflammatory and subclinical CVD markers in a diverse racial/ethnic and geographic
population of youth with Type 1 diabetes. Understanding the role of these environmental pollutants on this
vulnerable population has the potential to have a marked impact on treatment approaches and behavioral
recommendations. The study approach is utilizing rich existing SEARCH data, combined with new assays of
stored plasma, to examine inflammatory markers and subclinical measures of cardiovascular function and
structure in conjunction with air pollution exposures, estimated with state of the art spatio-temporal models.
Participants for the study are being drawn from five SEARCH sites. Incident cases from 2002 to 2005 are being
included as well as prevalent cases beginning in 2001. Existing plasma samples of 2 aliquots or more taken at
baseline and follow-up visits will be analyzed for participants without existing inflammatory marker data.
Recorded residential addresses are being geocoded for the baseline and follow-up visits when 1) existing
inflammatory or subclinical CVD markers were assessed and 2) when blood was drawn for inflammatory markers
to be analyzed by this study. Acute and chronic exposures to ambient pollution and traffic-related pollution will be
modeled using spatio-temporal statistical models. These exposures will be assigned to each geocoded address
for each participant. This study is in the data analysis stage.
SNAS
The SEARCH Nutrition Ancillary Study (SNAS) is an ancillary study of SEARCH funded by the National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK) and designed to substantially expand the nutrition
component of SEARCH, using both cross-sectional and longitudinal designs. The overall goal of SNAS is to
examine associations of nutritional factors with 1) the progression of insulin secretion defects, and 2) the
presence of CVD risk factors in youth with T1DM. After clinical diagnosis of autoimmune mediated DM, patients
can retain some capacity to secrete insulin for several weeks, months, or longer. Preservation of β-cell function
has been associated with lower risk for hypoglycemic events as well as lower HbA1c values and less frequent
microvascular complications. Moreover, children and adolescents with T1DM are at increased risk for
cardiovascular disease in later life. The premise of the work is that preservation of β-cell function and
development of CVD risk factors in youth with T1DM are impacted by nutritional factors. Identification of these
nutritional determinants may provide fruitful approaches to improving the long-term health of these young people.
This study is in the data analysis and manuscript writing stage.
Monogenic
The SEARCH Monogenic Ancillary Study was funded by the Juvenile Diabetes Research Foundation to extend
the observations made in SEARCH. Monogenic diabetes is caused by a single mutation in genes that control
either the production or release of insulin. There are two major classifications of monogenic diabetes, Maturity
Onset Diabetes of the Young (MODY) and Permanent Neonatal Diabetes Mellitus (PNDM). Individuals at highest
risk for MODY are those with non-autoimmune diabetes. Individuals at highest risk for PNDM are those
diagnosed with diabetes at less than 12 months of age. Little is known about the frequency of either MODY or
PNDM. SEARCH performed genetic analysis in the groups at high risk for monogenic diabetes. The goal of this
ancillary study is to extend the observations made in the SEARCH study by performing genetic analyses for the
three most common types of MODY (MODY3, MODY1, MODY2) in all SEARCH participants with nonautoimmune diabetes; performing genetic analyses for all known types of PNDM, including Kir6.2, SUR1, insulin
gene, EIF2AK3 (Wolcott-Rallison syndrome), FOXP3 (IPEX syndrome), homozygous GCK, IPF1, HNF-1β, GLIS3
and PTF1A, in all SEARCH participants diagnosed with diabetes in infancy; assessing the impact of establishing
a diagnosis of monogenic diabetes on clinical care; and performing genetic analysis for monogenic diabetes in
selected first degree relatives of SEARCH probands to establish a link between the MODY or PNDM mutations
and the presence of diabetes within these families.
IRB Status
We have continuing approval at 4 Institutional Review Boards (IRBs), including: Seattle Children’s, MultiCare
Health Systems, Virginia Mason, and Swedish Medical Center. Group Health Cooperative ceded review to Seattle
Children’s. We are continuing to submit revisions and renewals through these IRBs as appropriate.
IRB Status Report – Revised 1.14.13
4
Future Directions
Seattle Children’s continues to be a key contributor to the national study. Our site benefits from an extensive
local network that includes enthusiastic study participants, investigators with extensive diabetes expertise, and
regular contact with youth with diabetes. Collaborating institutions include the Benaroya Research Institute, the
R.H. Williams Laboratory for Diabetes Research, the Diabetes Endocrinology Research Center, the University of
Washington Diabetes Care Center, Group Health Cooperative, MultiCare Health Systems (Mary Bridge Children’s
Hospital), and others throughout the Puget Sound region.
B. Adverse Events, Incidents, and Unanticipated Problems
i.
Has the overall frequency and severity of adverse events been consistent with the research protocol, the
informed consent, and the investigator brochure (as applicable)?
Yes
No, please summarize the events and what actions have or will be taken (e.g., changes to protocol,
consent form):
ii.
Are there any unexpected adverse events (nature, severity, or frequency) that have not been previously
reported? Please note a report is only required for participants enrolled under SCH’s IRB approval.
No
Yes, please complete and attach the Seattle Children’s Adverse Event Reporting Form.
iii. Are there any incidents, protocol deviations, or potential unanticipated problems that have not been
previously reported? Please note a report is only required for participants enrolled under SCH’s IRB
approval.
No
Yes, please complete and attach the Seattle Children’s Incident Report Form.
C. Data & Safety Monitoring
i.
Does this study have a Data Safety Monitoring Board or Data Safety Monitoring Committee?
No
Yes, please attach the most recent correspondence from the Board/Committee.
ii.
Has the study been reviewed by a monitor (e.g., SCH compliance officer or CRO), sponsor, or agency (e.g.,
FDA, OHRP) during the current IRB approval period?
No
Yes, please attach the report or any other available information.
D. New Information
i.
Is there any new information that may be relevant to participants, whether published or unpublished? New
information includes FDA warnings, off-site SAEs, suspensions in enrollment, and scientific literature/findings
(including new risks).
No
Yes, please summarize the information:
ii.
If there is relevant new information, will you inform previously-enrolled participants?
No (N/A)
Yes, please submit a modification request describing how participants will be informed of the new
information (e.g., letter to participants, verbal discussion at next visit, re-consenting/assenting in-person
or by mail):
IRB Status Report – Revised 1.14.13
5
4. ATTACHMENT CHECKLIST
Please indicate the applicable attachments (completion of this section is mandatory). Submit 1 copy electronically to
irb@seattlechildrens.org.
Adverse Event Report Form
Incident Report Form
Data & Safety Monitoring Report
Monitor, Sponsor, or Agency Report
Consent/Parental Permission Form(s)
(most recently approved version, unstamped)
Assent Form(s)
(most recently approved version, unstamped)
Translations of Consents/Assents
Information Sheet(s)
(waiver of documentation of consent)
HIPAA Form(s)
(including other languages, if applicable)
Modification Request Form*
Yes
N/A, no new AEs to report
Yes
N/A, no new incidents to report
Yes
N/A, no data/safety monitor
Yes
N/A, no new monitoring reports
Yes, participants still enrolling or
forms needed to re-approach at 18
N/A or no longer enrolling
Yes, participants still enrolling
N/A
Yes, translations are current
N/A We will translate and submit these
to the IRB as the need arises.
Yes, participants still enrolling
N/A
Yes, participants still enrolling
HIPAA does not apply
Yes
N/A, no changes
*If you wish to make changes at the time of renewal (e.g., revisions to consent/assent/HIPAA forms to reflect updated
template information), you must complete the Modification Request Form and submit it with the status report.
IRB Status Report – Revised 1.14.13
6
Routing Instruction:
1 electronic copy to
irb@seattlechildrens.org
Institutional Review Board
Modification Request Form
For Office Use Only
A. Study Information
IRB Study #: 12074
Project/Study Title: SEARCH for Diabetes in Youth
Principal Investigator: Catherine Pihoker, MD
Department, Division: Pediatrics, Endocrinology
IRB Contact Person: Beth Loots, MPH MSW
Form Information:
Form #: N/A
Form Owner: Laurie Bolton
Owning Dept: HSPP
Revision Date: 08/12
46.404
46.405
46.406
Date: 8/7/13
Phone: 206-987-5037
Center Affiliation: CCTR
Phone: 206-884-4488
B. Modifications Proposed – Please check all categories that apply and supply requested information as applicable.
1.
Change in Research Personnel
Name
Richard Mauseth, MD
Add or
Remove
Remove
Role on Project & Title
Co-Investigator
**SCH
Workforce?
No
Human
Subjects
Training Date &
Type/Location
Will s/he
obtain
consent?
Phone
206-987n/a
n/a
2540
Angela Badaru, MD
Remove
Co-Investigator
206-987No
n/a
n/a
2540
Rebecca O’Connor, RN
Remove
Clinical Research
206-987No
n/a
n/a
Coordinator
2540
Emil Buscaino, BS BA
Remove
Clinical Research
206-987No
n/a
n/a
Associate
2540
Patricia D’Alessandro
Add
Clinical Research
206-987Yes
8/6/13, CITI
yes
Associate
2540
*REMINDER: Before participating in research, all added investigators must have an up to date SFI disclosure on file with the Office of
Research Compliance . For information on how to submit SFI disclosures, please visit the Office of Research Compliance web page
on CHILD or seattlechildrens.org. For questions about SFI, contact the Office of Research Compliance.
* *Seattle Children’s workforce: employees of Seattle Children’s, Children’s University Medical Group (CUMG) members, and
residents and fellows working at Seattle Children’s.
2.
Changes in Research Design and Methods
Treatment regimen
Research procedures
Drug used in the research
(e.g. dosage change)
Device/s used in the research
Visit schedule
Data collection methods or
instruments (e.g. if adding)
Randomization methods
Duration of follow-up
Specimen collection/use
Other (describe):
* REMINDER (If Any Boxes in Section 2 are checked): By virtue of submitting this form, the PI attests that both the FRA and Study
Manager data for this study will be updated accordingly.
3.
Changes Pertaining to Research Participants
Sample size change
Addition of a new cohort or
sample
Eligibility/exclusion criteria
Recruitment/approach
Consent/assent process
Methods for documenting
consent
Risks and benefits
(e.g. new treatment side effects;
radiation requiring safety committee
review--attach relevant documents)
Privacy of research participants
Confidentiality of research
participants’ data
Research Site/Location
(attach relevant letters of
cooperation)
Other (describe):
4.
Materials Revised/Amended: Check all documents being revised or amended at this time. Submit revised documents in
electronic form with tracked changes and clean versions to facilitate IRB review.
Protocol, Version:
Investigator’s Brochure, Version:
© Seattle Children’s Research Institute
Consent, Version:
Assent, Version:
Recruitment materials* (e.g.
flyer)
Page 1 of 3
Routing Instruction:
1 electronic copy to
irb@seattlechildrens.org
Institutional Review Board
Modification Request Form
Data collection form
HIPAA/Oath of Confidentiality
Translated study documents (must
include Affidavit; see IRB Policy 021)
Form Information:
Form #: N/A
Form Owner: Laurie Bolton
Owning Dept: HSPP
Revision Date: 08/12
Other (describe):
Questionnaire/Survey, Please List:
*See following link re information & templates for recruitment materials: http://research.seattlechildrens.org/rss/irb/advertising.asp
5.
Funding Information (Funded Awards Only) **Please submit an electronic copy of the funded proposal. If this proposal applies to
more than one IRB application, please submit a modification form for each study separately.
Title of Funding Proposal:
Type of Funding Proposal:
Grant
Name of PI on Funding Proposal:
Contract
Subcontract
Supplement
Other (Please explain)
If Subcontract, name of main PI
Sponsor Grant Identification Number (if known; eg.
R010123456-01A1):
Fred Hutchinson
Other (Please explain)
Name of Funding Agency:
Funding based at?
Seattle Children’s
UW
Proposed Funding Period (dates XX/YY/ZZ-XX/YY/ZZ):
Are research activities described in this funding proposal consistent with the current IRB application? :
Yes
No, If No,
Please explain which aims of this study apply.
Please provide rationale for the differences between the grant and the IRB application.
Are there future aims without current IRB approval? :
Yes
No If Yes, please explain your plans to obtain approval.
C. Modification Summary and Rationale: Please address ALL of the following, use additional pages if needed:
a) Describe each change/revision in sufficient detail:
Dr. Mauseth has been removed as he has retired; Dr. Badaru has been removed as she has relocated; Rebecca
O’Connor has been removed as she is no longer a Seattle Children’s employee; and Emil Buscaino will be leaving
employment at Seattle Children’s on August 9, 2013. Patricia D’Alessandro has been added as she is a new research
team member. Sharla Semana has earned a MSW degree.
b) Provide the rationale for the proposed changes:
To update the study consents and assents to reflect current research personnel.
c) Explain whether these changes add new risks or increase the current risks of study participation:
They do not.
D. Signatures and Approvals
PI Signature: ___
___________________________________________________
Date: __08/07/13_________
(Optional Signature if submitted from PI’s e-mail account.)
IRB Approval
Approve
Disapprove
Noted
Reviewed via expedited procedures, 45 CFR 46.110(b)(2)
8-20-13
IRB Chairperson/Subcommittee Signature:
Date Approved:
Subject to the conditions/contingencies detailed in IRB correspondence dated: ___________
Conditions/contingencies met on: ___________
© Seattle Children’s Research Institute
Page 2 of 3
Routing Instruction:
1 electronic copy to
irb@seattlechildrens.org
Institutional Review Board
Modification Request Form
Form Information:
Form #: N/A
Form Owner: Laurie Bolton
Owning Dept: HSPP
Revision Date: 08/12
VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED
© Seattle Children’s Research Institute
Page 3 of 3
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
PARENTAL PERMISSION FORM
CONSENT FORM: Ages 18 and up
ASSENT FORM: Ages 14-17
8-20-13
COHORT VISIT
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
The Research Team:
Name/Degree
Title
Department
Catherine Pihoker, MD
Lenna Liu, MD MPH
Maryam Afkarian, MD
Irl Hirsch, MD
Carolyn Paris, MD
Joyce Yi-Frazier, PhD
Principal Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Carla Greenbaum, MD
Co-Investigator
Martin Goldsmith, MD
Beth Babler, ARNP
Patricia Fechner, MD
Christian Roth, MD
Ildi Koves, MD
Craig Taplin, MD
Kate Ness, MD
Carolina DiBlasi, MD
Roja Motaghedi, MD
Erin Alving, ARNP
Karen Aitken, ARNP
Joanie Warner, ARNP
Sara Benitez, PA
Gwyn Recupero, PA
Beth Loots, MPH MSW
Sue Kearns, RN
Mary Klingsheim, RN, BSN
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Research Manager
Study Coordinator
Study Coordinator
Endocrinology
Pediatrics
Nephrology
Medicine
Emergency
Endocrinology
Benaroya Res
Instit
Peds Northwest
Mary Bridge
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Consent, Assent and Parental Permission Form
Phone
Number
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206-987-2540
206 987-2540
206 987-2540
Template Version: 8/20/2013
Page 1 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Name/Degree
Title
Department
Jessica Fosse, MPH, RN,
BSN
Katherine Cochrane, BS
Sharla Semana, MSW
Patricia D’Alessandro, MA
Study Coordinator
Endocrinology
Phone
Number
206 987-2540
Clinical Research Associate
Clinical Research Associate
Clinical Research Associate
Endocrinology
Endocrinology
Endocrinology
206 987-2540
206 987-2540
206 987-2540
Clinical Research Center: (206) 987-3897
If you have questions about your rights as a research study participant, you can call the
Institutional Review Board at (206) 987-7804.
24 hour Emergency Contact Number: 206 987-2000 Ask for the Endocrinologist on call
1. Researchers’ Statement:
You have the option to take part in a research study. The goals of this form are to give
you information about what would happen in the study if you choose to take part and to
help you decide if you want to be in the study.
Feel free to take notes, write questions or highlight any part of this form.
Potential Participants 18 years and older: This is a consent form. It provides a summary of
the information the research team will discuss with you. If you decide that you would like to take
part in this research study, you would sign this form to confirm your decision. If you sign this
form, you will receive a signed copy of this form for your records.
Potential Teen Participants: This form also serves as an assent form. That means that if you
choose to take part in this research study, you would sign this form to confirm your choice. Your
parent or guardian would also need to give their permission and sign this form for you to join the
study.
Parents/Guardians: You have the option of having your child or teen join a research study.
This is a parental permission form. It provides a summary of the information the research team
will discuss with you. If you decide that your child can take part in this study, you would sign
this form to confirm your decision. If you sign this form, you will receive a signed copy for your
records.
The word “you” in this form refers to your child/teen.
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 2 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
2. What you should know about this study:
•
•
•
•
•
•
•
•
This form explains what would happen if you join this research study.
Please read it carefully. Take as much time as you need.
Please ask the research team questions about anything that is not clear.
You can ask questions about the study any time.
If you choose not to be in the study, it will not affect your care at Seattle Children’s.
If you say ‘Yes’ now, you can still change your mind later.
You can quit the study at anytime.
You would not lose benefits or be penalized if you decide not to take part in the study or to
quit the study later.
3. What is the goal of this study?
Diabetes is the third most common chronic or ongoing disease in individuals under 20 years of
age. The total number of cases of diabetes in this age group is increasing, and types of
diabetes that have not been seen in young people are now being seen. These changes have
resulted in gaps in our knowledge about the total number of cases and types of diabetes in the
United States, the type of care young people with diabetes receive, the complications they
experience, and the effect diabetes has on their lives.
The goal of any research study is to answer questions. We (the research team listed on the
front of this form and our staff) are doing this research study to answer the following questions:
•
•
•
How common are long-term complications related to diabetes, including: retinopathy
(damage to back of the eye), nephropathy (kidney damage), neuropathy (nerve
damage), and damage to the heart and blood vessels?
How common are short-term complications, including hypoglycemia (low blood sugar)
and diabetic ketoacidosis (DKA)?
What type of medical care are young people with diabetes receiving, and how does
diabetes affect the lives of these individuals?
4. Why do I have the option of joining the study?
You have the option to take part in this research study because you have completed a SEARCH
baseline in-person visit and have had diabetes for (about) 5 years or more.
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 3 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
5. How many people will take part in the study?
We think that about 610 people will take part in the SEARCH cohort visit at Seattle Children’s.
A total of about 3,900 people will take part in the cohort visit at hospitals and clinics around the
country.
6. If I agree to join this study, what would I need to do?
The cohort study visit includes:
• Blood draw
• Urine collections
• Brief physical exam
• Questionnaires
• Nerve tests
• Blood vessel test
• Eye test
• Medical record review
• Follow up contact
Blood Draw and Urine Collection
You/your child would be scheduled for an in-person study visit(s) at the Clinical Research
Center at Seattle Children’s or at another SEARCH outreach clinic. We would work with you to
schedule 1 or 2 visits to complete the cohort study measurements at time(s) that are convenient
for you. At least one of these visits would be a "fasting" visit, which means that no food or
fluids, other than water, could be consumed for at least 8 hours before coming to your visit.
You/your child would be asked not to take insulin or other diabetes medications the morning
before the test, except for basal insulin, which should be taken as usual. If you come to the visit
nonfasting, we might ask you to return another day to redraw all or part of the blood sample.
Before your scheduled appointment, you would receive a container with detailed instructions to
collect one urine sample at home the morning of your visit. We will ask that you collect the urine
from the first time you urinate in the morning. You would be asked to bring this urine sample
with you to your visit. Your urine would be tested for microalbumin (small particles of protein) to
see how well your kidneys are working.
When you arrive at your appointment, we would review the consent/assent form(s). This would
take about 20 – 30 minutes. If you/your child would like a numbing agent for the blood draw,
this part may take about an additional 30 minutes.
A blood sample would be drawn from your/your child's arm to measure blood sugar, hemoglobin
A1c (a test measuring your/your child’s average blood glucose level over the past 3 months), Cpeptide (a measure of your/your child's own insulin production), different types of cholesterol
(fat), islet cell antibodies (markers in the blood for type 1 diabetes), and several blood markers
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 4 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
associated with risk for developing heart disease or stroke. Based on age and size, the amount
of blood that would be needed for this would be between 1 teaspoon and 3 tablespoons.
If possible, we would collect all blood samples at the same time that a routine blood draw would
be done. If you/your child take part in more than one research study at the same visit, we would
try to combine tests and results when we can.
A urine sample would also be obtained during the visit and tested for several markers
associated with the risk of diabetes complications, such as heart disease and stroke. The
SEARCH study would like to keep some of the blood and urine that would be collected during
the study but is not used for other tests. Should we have questions about some of tests, the
storage sample would allow us to repeat the tests without needing to ask for a second blood
draw from you/your child. In addition, we would like to collect another sample of blood for
storage for future research.
We will also ask your permission to obtain and store a sample of blood to look at DNA, the
genetic material that is found in all of your cells. Researchers may look at specific genes, or
they may look at all of your genes together. If researchers were to look at specific genes, you
have the option of receiving the results of this testing if it would effect your clinical care.
However, if they were to look at all of your genes together, you would not receive the results.
The information researchers find about your DNA would be sent to a national storage center
called dbGaP (part of the National Institutes of Health) to help researchers better understand
how genes affect the risk of developing diseases such as asthma, cancer, diabetes, and heart
disease. When your DNA and clinical information would be sent to the storage center, no
personal information would be included, such as your name, date of birth, or address. Thus,
researchers would not be able to link this information back to you. The research that would be
done with your blood and urine samples would not be designed to specifically help you. It might
help people who have diabetes and other diseases in the future.
The total amount of blood that would be needed for the storage sample would be 1 teaspoon for
young children and up to 2 tablespoons for older children, dependent on age and weight. This
part of the visit would take 10 – 20 minutes.
The total volume of blood for this visit would be up to approximately 3 tablespoons.
After the fasting blood and urine samples are collected, a snack and/or meal or meal voucher
would be provided and you/your child would also take your routine medication.
Physical Exam
A trained member of the research team would perform a brief physical examination including:
height, weight, waist measurements, blood pressure, and examination of the skin of the neck.
The time to complete this exam would be about 20 minutes.
Nerve Tests
The purpose of these tests is to learn more about nerve damage in people with diabetes. We
would ask you not to exercise heavily the day before the tests. If you get sick or get very upset
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 5 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
in the day or two before the tests, or you eat or drink things that may affect the tests, we may
ask you to reschedule these tests.
These are the nerve tests:
1) MNSI, or Michigan Neuropathy Screening Instrument, is a 1-page survey and a brief foot
exam.
You would fill out the survey yourself; it has 15 “yes or no” questions about pain, numbness, and
temperature sensitivity in your legs and feet.
The foot exam is short and tests for your vibration sense, your reflexes, and your sensitivity to
monofilaments. Monofilaments are just small pieces of lightweight plastic, much like fishing
lines. The study coordinator would first test your vibration sense by placing a vibrating
instrument on your big toe. They would then use a rubber “hammer” to test the reflexes in your
ankle. These tests are not painful, and your regular doctor has probably used them with you
before. Finally, the study coordinator would place a monofilament on your toe to test your
sense of touch. These small pieces of plastic are not painful. The study coordinator would just
ask you if you could feel them on your toe or not.
The MNSI would take about 10 minutes to complete.
2) HRV, or Heart Rate Variability, would find out the health of your heart nerves. The test uses
an ECG, or electrocardiogram. This is a test that doctors regularly use to study the heart, and
your doctor may have used it with you before. The study coordinator would apply three
electrode stickers (special stickers that help transmit information) on your wrists and left
ankle/leg. These pads would be attached to wires and would record your heartbeat. During the
test, you would simply breathe normally for ten minutes while the ECG records your heartbeat.
The Heart Rate Variability test would take about 20 minutes to complete.
Blood Vessel Test
We would perform a test to measure how your blood vessels function. This test is called an
arterial stiffness test. You/your child would be asked to remove your outer clothing and to put
on a patient gown if you are not wearing loose-fitting shorts. A trained study coordinator would
check your pulse on your upper, inner thigh (groin), but would not expose private parts. A
chaperone would be present during these procedures.
The following test would then be performed:
The study coordinator would measure the distance from your neck to the top of your sternum
(breast bone), from your neck to your wrist, from your sternum to your belly button, from your
belly button to your groin, and from your groin to your foot. The electrode pads would be left in
place on your wrists and leg during this part of the test.
Your wrist would be touched with a small instrument shaped like a pen; and the stiffness of your
blood vessels would be measured. This instrument detects pressure changes with a tiny,
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 6 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
highly-sensitive pressure sensor in the flat end of the device that is shaped like a pencil eraser.
It does not use radiation (X-rays), sound waves (ultrasound), or needles. This test would be
repeated 3 times.
Then the same pen-shaped instrument would be touched on the side of your neck, your groin,
and your foot to measure the speed of your pulse. This test would be repeated 3 times.
The blood vessel test would take about one hour. After the test you would receive a meal or
meal voucher.
Eye Test
You/your child would be asked about your eyes and your eye doctor if you have one.
We would take 2 pictures of each of your/your child’s eyes. You/your child would be asked to sit
in front of a special camera and place your chin in a chin rest. The study coordinator would
darken the room so that your pupils would dilate (open) and we could align and focus the
camera on your retina (the back of your eye). No drops would be put in your eyes, and the
camera would not touch your eye. The study coordinator would sit on the other side of the
camera to record information into a computer and prepare the camera. While we do this, you
would see some small red bars and a multi-colored “x” in the camera lens. We would ask you to
look at the “x”. Just before we take the pictures, we would ask you to blink your eyes and then
open them really wide. The camera would flash a light from within the camera lens as the
picture is taken. This flash does not hurt the eye. Just after the picture is taken, you may see a
blue or red circular spot in front of your eye. This spot would not harm you and would go away
in about 5 to 7 minutes. We would wait a little while until your eyes dilate (open) again, and
then we would take another picture of this eye. We would then take 2 pictures of your other
eye. We might need to take extra pictures if the first ones don’t come out OK.
These pictures would be sent to the Ocular Epidemiology Reading Center in Madison,
Wisconsin to be read by trained eye specialists who would study the blood vessels and look for
any unusual changes.
Doing the eye test would take about 30 minutes.
Questionnaires
You/your child would answer questions about the effects of diabetes on your/your child's lives,
including current medications, personal and family medical history, financial information, the
type of diabetes education available, health insurance, diabetes self-care habits, diet, your/your
child’s self-report on stage of puberty, and information about your/your child's medical care.
If you/your child is 10 years of age or older, you/your child would also be asked to answer
additional questions about physical activity, smoking, alcohol, eating, and depression. Some of
the questions may be sensitive, for example, there are questions about mood, how well
you/your child get along in school, how you/your child gets along with family, friends, and
others.
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 7 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
You/your child are free to not answer any questions you don't want to answer, and may stop the
interview at any time. If you/your child decide not to answer any of the questions, you can still
take part in the rest of the research study.
One of the questionnaires assesses risk for depression, and it would be scored while you are at
your/your child’s appointment. If you/your child scores in a range at risk for depression that
result would be shared with your parent/you and a referral list would be shared with you if you
need it.
These questionnaires would take 45 – 60 minutes to complete.
Medical Records Review
We ask your permission for the researchers involved in this study to review your/your child's
medical record. Any information obtained from the medical charts is for use in this research
study only. It may be necessary to review your diabetes-related inpatient and outpatient
medical records. These records may include, but are not limited to visit notes, progress notes,
discharge summaries, consultation notes, medication records, history and physical, emergency
room records, and lab and other test reports.
Follow up
We will send you requests to update your contact information about every year. Part of this
update includes a question about your/your child’s social security number, which we will use to
track mortality among SEARCH study participants. If this study is expanded, or if other diabetes
studies are developed, we may contact you/your child in the future to ask if you/your child want
to participate further. As with this study, taking part in any future study is voluntary.
7. How long would I be in the study?
The study is currently funded through September 2015.
The total time to complete the cohort visit would be about 3 ½ to 4 hours. You may complete
the visit on one or two days, based on your preference and the research staff’s availability. You
may be able to complete some of the questionnaires at home or over the phone to shorten the
length of the in-person visit.
If you join the study, you can decide to stop at any time for any reason. Please discuss your
decision to stop with Dr. Pihoker or the research team.
If you would like your/your child’s stored samples removed from storage, we would send a
request to the central laboratory. They would then destroy the sample, and send us a letter
certifying that the sample has been destroyed. We would send you a copy of this letter.
The research study doctor could also decide to take you out of this study. This might happen if
we find out that it is not safe for you to stay in the study. Or it might happen if you cannot
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 8 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
complete to enough of the study elements. If we ask you to leave the study, we would always
explain why.
8. What are the potential harms or risks if I join this study?
If you feel uncomfortable at any time during any of these tests, just tell the study coordinator and
they would immediately stop the tests. All reasonable precautions would be taken to reduce
risks.
When taking a blood sample, there may be brief discomfort, and a bruise may form where the
needle poke occurs. To reduce the possibility of these risks, a local anesthetic (numbing cream
or liquid) may be applied to the skin before blood is taken.
The blood tests require that you/your child not have any food or fluids overnight, other than
water. In order to prevent low or high blood sugars, you/your child’s blood sugar would be
checked by finger-stick and your diabetes medication would be given as needed to control
your/your child’s blood sugar.
Some of the tests would look for the presence of health problems associated with diabetes,
such as high cholesterol. If researchers find signs of these health problems, it may cause
you/your child some anxiety or concern. If this happens, you/your child would be referred to the
appropriate local health professionals for evaluation and treatment.
There are no majors risks associated with the MNSI foot exam. All of the devices used (a reflex
hammer, a tuning fork, and a monofilament) are used daily in doctors’ offices; your doctor has
probably used them with you before. The tests are not painful, but some people may be slightly
anxious or uncomfortable when these instruments are used.
There are no major risks associated with the Heart Rate Variability nerve test. ECGs are used
daily in hospitals; you may have had one before. No electrical current is sent through the body,
so there is no risk of electrical shock. Application of the patches may feel cold, and in very rare
cases, a patient may develop a skin rash or irritation where the patches were applied. Some
people become slightly anxious when this test is done.
You may feel some pressure for a few seconds when the arterial stiffness blood vessel device is
placed on your skin.
There are no known risks associated with taking these pictures of the eye. People who are
light-sensitive may see a blue or red spot after the camera flashes, but this would not hurt the
eye, and it would go away within a few minutes.
If you find out that you have eye damage it could make you worried. We would share the
results with your provider, and would refer you to your provider or another doctor for appropriate
treatment. We would also be available to explain the results to you to help reduce your worry.
Consent, Assent and Parental Permission Form
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Page 9 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
There could be harms associated with sharing your genetic information despite our safety
measures to protect your genetic information. They include:
• Someone could break into the computer system. They could then find the code that links
your genetic and medical information to you. This is very unlikely, but is possible.
• Find a way to link your genetic or medical information in a database back to you. Your
genetic information is unique to you. But you do share some genetic information with
your children, parents, brothers, sisters and other blood relatives. So it might be possible
for someone to use genetic information from your relatives to help figure out who you
are. That person would need to be able to access the database. They would also need
genetic information from you or one of your relatives. Again, it is unlikely this would
happen.
• Since some genetic information may predict health problems you or your relatives could
have in the future. This information might be of interest to health providers, life insurance
companies and others. There are state and federal laws that protect against genetic
discrimination. There is a new federal law called the Genetic Information
Nondiscrimination Act (GINA). This law makes it illegal for health insurance companies,
group health plans and most employers to discriminate against you based on your
genetic information. However, it does not completely protect you from discrimination.
• Genetic information could also be used by law enforcement agencies to identify a person
or his/her blood relatives.
• There could be privacy risks we don’t know about.
As with any research study, there may be additional risks that are unknown or unexpected.
9. What are the potential benefits if I join this study?
Potential Benefits for You:
You/your child may not directly benefit from participating in this research study. However, this
study may more clearly tell us about your/your child’s type of diabetes and whether you/your
child has any of the complication of diabetes.
You would receive results of your/your child’s blood and urine tests usually within 6-8 weeks of
the study visit. These results would include the Hemoglobin A1C, lipid profile (cholesterol), and
urine microalbumin (urine protein). These are standard tests. The report you receive would
explain the results to you. Your/your child’s doctor would also receive these standard test
results, plus results of the research laboratory tests that are being studied to determine the type
of diabetes.
You/your child and your/your child’s diabetes provider may receive the results of genetic tests
done for research purposes while taking part in this research study if it is determined that the
results of such tests could impact clinical care.
Consent, Assent and Parental Permission Form
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Page 10 of 17
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
We would give you information about any eye problems that we find. If something is found that
needs urgent attention, we would phone/contact you and your health care provider as soon as
we receive these results (usually within 2 – 3 days). This eye test does not take the place of a
visit to your own personal doctor nor does it replace your regular dilated comprehensive eye
examinations. It is not a test of your/your child’s vision.
You would not receive any results or feedback on the nerve tests or blood vessel test as part of
this study. These tests are for research purposes only and do not replace the normal care
provided to you by your regular health care provider.
Potential Benefits for Others:
We hope that the information learned in this research study will benefit young people with
diabetes in the future. This is a large research study being carried out at five major medical
centers across the United States. The information we learn in this research study will improve
our understanding of how education, diagnosis, and the costs of having diabetes can affect the
people who live with this disease every day. The tests we do may help us better understand the
short and long term effects of diabetes. This may help improve diabetes-related care in the
future.
10. What other options do I have?
Taking part in research is voluntary. You/your child may choose not to take part in this study or
in parts of the study.
11. How would you keep my information confidential?
All information gathered during this study would be held in strict confidence. Any publication
resulting from participation in this study would not identify you/your child by name. A one of a
kind number, called a research study number, would be assigned to you/your child. No other
identifying information would be used. The research study number would be used to identify
only the test and interview information that was collected during the research study. The
research number assigned to you/your child, and not your child’s name, would be sent to the
study Coordinating Center at Wake Forest University in order to study the information. The list
containing the research study number assigned to you/your child would be kept in a locked file
in the research office of Dr. Pihoker, the research study's Principal Investigator. No one other
than Dr. Pihoker and her research team would be able to connect any of research study
information to you/your child.
Any stored samples would be kept in a central laboratory and stored for upcoming studies of
diabetes. The central laboratory is at the University of Washington. The samples would be
banked with a code, with no information at the laboratory that could link the samples to you/your
child. Dr. Pihoker and the study coordinators on this project would be the only people with
Consent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
access to the code. The banked samples would be stored indefinitely, although would likely be
used within 7 years. When there is another researcher who wants to do a diabetes study and
use the stored samples, he/she would need to talk to Dr. Pihoker. If the study seems to be
important and reasonable, an Institutional Review Board (IRB) would review the study, and
samples can be used only after the study is approved. The IRB is a committee responsible for
protecting the rights of persons taking part in research.
The nerve test results would be sent to the University of Michigan and the SEARCH
Coordinating Center. The eye test results would be sent to the Ocular Epidemiology Reading
Center (OERC) at the University of Wisconsin – Madison and the SEARCH Coordinating center.
Investigators would analyze these results along with other data collected in the SEARCH study.
All answers that you/your child give and other information gathered about you/your child during
this study would be kept private. This is so because this study has been given a Certificate of
Confidentiality. This means that anything you/your child tells us or information we learn about
you/your child would not have to be given out to anyone, even if a court orders us to do so,
unless you say it’s OK. But under the law, we must report to the state suspected cases of child
abuse or if you/your child tell us he/she is planning to cause serious harm to self or others.
If you take part, we would make every effort to keep your information confidential.
If you join this study, we may put information about this study in your medical record. We do
this because the research study involves patient care.
Information collected about you during the study would be kept until all information has been
studied and results have been published. Future funding may allow the study to continue for a
longer period of time, however, the information about you would be destroyed as soon as it is no
longer necessary for the conduct of the research study.
12. Would it cost me money to be in the study?
If you take part in this study, there would be no cost to you and no cost to your
insurance company.
13. What if I were injured because I joined the study?
If you were injured as the direct result of this research study, Seattle Children's Hospital
would provide treatment. We would refer you for treatment if needed.
You would NOT need to pay for this treatment and neither would your insurance
company. This is the only compensation offered for study-related injuries. It is
important that you tell the Principal Researcher Catherine Pihoker, if you think that you
have been injured as a result of taking part in this study. You can call her at 206-9875037.
Consent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
14. Would I be paid if I join this study?
If needed, we may be able to offer some assistance with travel costs, dependent on availability
of study funds. Important: You would need to give us receipts that clearly show your costs.
Once you complete all of the study procedures, we would give you/your child $120 in gift cards.
You would be paid a smaller amount if you complete only part of the study procedures. In the
rare circumstance that a blood redraw is necessary, you would receive an additional $20 gift
card.
We will be asking a small number of study participants to repeat the Heart Rate Variability
and/or Blood Vessel tests in order to assess the research team’s quality control. If you are
asked to participate in these repeat measurements, you would be given an additional gift card if
you agreed to participate. You would receive a $10 gift card if you were asked to repeat some
of these measurements, or a $20 gift card if you were asked to repeat all of them. If you are
fasting for the visit, we will provide a snack after you complete the blood draw and/or a $6 meal
or meal voucher after the blood vessel tests.
The IRS has certain rules about paying people who take part in research studies. If you
took part in this study, we would ask you to provide your name, mailing address, and
social security number so we could pay you.
You can be in this study even if you do not give us this information. If you decide not to
give us this information, you could receive a gift card or no payment.
The payments you would receive for being in this study might be taxable. Seattle
Children’s is required to report to the IRS study payments of $600 or more made to
anyone in any year.
Your samples could be used to make new products, tests or findings. These may have value
and may be developed and owned by the research team and/or others. If this happens, there
are no plans to provide any money to you.
Consent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
15. Who do I call if I have problems or questions?
If I have questions or
would like to know about …
• Emergencies
• General study
questions
• Research-related
injuries
• Any research concerns
or complaints
• Emergencies
• General study
questions
• Research-related
injuries
• Any research concerns
or complaints
•
Your rights as a
research participant
•
Assistance with figuring
out what questions to
ask the research team
Help understanding the
research process
•
You can call …
At …
Catherine Pihoker, MD or
Endocrinologist on call
Phone: 206-987-2000
Diabetes Research Team
Phone: 206-987-2540
Institutional Review Board
This is a group of scientists
and community members
who make sure research
meet legal and ethical
standards.
Research and Family
Liaison
A person who works with
families to ensure they
receive the information they
need to make an informed
decision about taking part in
a research study.
Phone: (206) 987-7804
Phone: (206) 884-7858
Pager: (206) 469-3983
16. If I join the study, can I stop?
Yes. Taking part in research is always a choice. If you decide to be in the study, you can
change your mind at any time. We ask that you tell the study team. You can contact this
person by calling 206-987-2540.
If you choose to leave the study, it will not affect your care at Seattle Children’s. You will
not lose any benefits or be penalized if you choose to leave the study.
Consent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
17. What would my signature on this form mean?
Your signature on this form would mean:
• The research study was explained to you.
• You had a chance to ask all the questions you have at this time. All your questions have
been answered in a way that is clear.
• You understand that the persons listed on this form will answer any other questions you
may have about the study or your rights as a research study participant.
• You have rights as a research participant. We will tell you about new information or
changes to the study that may affect your health or your willingness to stay in the
study.
• By signing this consent form, you do not give up any of your legal rights. The
researcher(s) or sponsor(s) are not relieved of any liability they may have.
o You agree to take part in the research study.
o If the person reading this form is a parent/guardian, you agree to have your child take
part in this research study.
Please Note: If the person taking part in this research study is a foster child or a ward of the
state, then please tell the researcher or their staff.
___________________________________
Printed Name of Research Participant
______________________________________
Signature of Research Participant (required if 14 years or older)
Date/Time
______________________________________
Printed Name of Parent or Legal Guardian
______________________________________
Signature of Parent or Legal Guardian
Date/Time
Permissions:
Storage of Blood and Urine Samples
Do you give permission to have your/your child’s blood and urine samples saved and used in
current and future research??
Yes, I give my permission
No, I do not give permission
Consent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Storage of DNA Samples (looking at specific genes)
Do you give permission to have your/your child’s DNA saved and used in current and future
research?
Yes, I give my permission
No, I do not give permission
Genetic Test Results (looking at specific genes)
If researchers determine that genetic results could impact clinical care, would you like the
results of genetic tests sent to you and your/your child’s diabetes provider?
Yes, I give my permission
No, I do not give permission
Full Gene Analysis (looking at all of your genes) and the National Storage Center
(NIH/dbGaP)
Do you give permission to have your/your child’s DNA analyzed to identify a complete picture of
your genetic makeup? This information would be sent to a national storage center to help
researchers better understand how genes affect the risk of developing diseases. When your
DNA and clinical information is sent to the storage center, no personal information would be
included, such as your name, date of birth, or address. Thus, researchers would not be able to
link this information back to you.
Yes, I give my permission
No, I do not give permission
Medical Record Review
Do you give permission to have your/your child’s medical chart reviewed by research study
members, as described above?
Yes, I give my permission
No, I do not give permission
Future contact
Do you give permission for researchers to contact you/your child in the future, to ask if you/your
child are interested in participating in new research studies that are developed? As with this
research study, taking part in any future studies is voluntary. Participation in this present study
does not mean that you/your child are automatically volunteering to take part in any future
Consent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
studies. You/your child would be asked to sign a consent form for any future research studies in
which you/your child agree to participate.
Yes, I give my permission
No, I do not give permission
18. Researcher’s Signature
I have fully explained the research study described by this form. I have answered the
participant and/or parent/guardians questions and will answer any future questions to the best of
my ability. I will tell the family and/or the person taking part in this research of any changes in
the procedures or in the possible harms/possible benefits of the study that may affect their
health or their willingness to stay in the study.
_________________________________
Printed Name of Researcher Obtaining Parental Permission or Consent
_______________________________
Signature of Researcher Obtaining Parental Permission or Consent
Date/Time
19. Interpreter Information
_____________________________________
Printed Name of Interpreter during initial presentation of study
Date/Time
______________________________________
Printed Name of Interpreter when translated form is presented (if applicable)
Date/Time
Original form to:
Research Team File
Copies to:
Participant
Parents/Guardians (if applicable)
Medical Records (if applicable)
Consent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
PARENTAL PERMISSION FORM
CONSENT FORM: Ages 18 and up
ASSENT FORM: Ages 14-17
8-20-13
REGISTRY VISIT (2012 cohort)
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
The Research Team:
Name/Degree
Title
Department
Catherine Pihoker, MD
Lenna Liu, MD MPH
Maryam Afkarian, MD
Irl Hirsch, MD
Carolyn Paris, MD
Joyce Yi-Frazier, PhD
Principal Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Carla Greenbaum, MD
Co-Investigator
Martin Goldsmith, MD
Beth Babler, ARNP
Patricia Fechner, MD
Christian Roth, MD
Ildi Koves, MD
Craig Taplin, MD
Kate Ness, MD
Carolina DiBlasi, MD
Roja Motaghedi, MD
Erin Alving, ARNP
Karen Aitken, ARNP
Joanie Warner, ARNP
Sara Benitez, PA
Gwyn Recupero, PA
Beth Loots, MPH MSW
Sue Kearns, RN
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Research Manager
Study Coordinator
Endocrinology
Pediatrics
Nephrology
Medicine
Emergency
Endocrinology
Benaroya Res
Instit
Peds Northwest
Mary Bridge
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Consent, Assent and Parental Permission Form
Phone
Number
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206-987-2540
206 987-2540
Template Version: 8/20/2013
Page 1 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Name/Degree
Title
Department
Mary Klingsheim, RN, BSN
Jessica Fosse, MPH, RN,
BSN
Katherine Cochrane, BS
Sharla Semana, MSW
Patricia D’Alessandro, MA
Study Coordinator
Study Coordinator
Endocrinology
Endocrinology
Phone
Number
206 987-2540
206 987-2540
Clinical Research Associate
Clinical Research Associate
Clinical Research Associate
Endocrinology
Endocrinology
Endocrinology
206 987-2540
206 987-2540
206 987-2540
Clinical Research Center: (206) 987-3897
If you have questions about your rights as a research study participant, you can call the
Institutional Review Board at (206) 987-7804.
24 hour Emergency Contact Number(s): 206 987-2000 Ask for the Endocrinologist on call
1. Researchers’ Statement:
You have the option to take part in a research study. The goals of this form are to give
you information about what would happen in the study if you choose to take part and to
help you decide if you want to be in the study.
Feel free to take notes, write questions or highlight any part of this form.
Potential Participants 18 years and older: This is a consent form. It provides a summary of
the information the research team will discuss with you. If you decide that you would like to take
part in this research study, you would sign this form to confirm your decision. If you sign this
form, you will receive a signed copy of this form for your records.
Potential Teen Participants: This form also serves as an assent form. That means that if you
choose to take part in this research study, you would sign this form to confirm your choice. Your
parent or guardian would also need to give their permission and sign this form for you to join the
study.
Parents/Guardians: You have the option of having your child or teen join a research study.
This is a parental permission form. It provides a summary of the information the research team
will discuss with you. If you decide that your child can take part in this study, you would sign
this form to confirm your decision. If you sign this form, you will receive a signed copy for your
records.
The word “you” in this form refers to your child/teen.
Consent, Assent and Parental Permission Form
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Page 2 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
2. What you should know about this study:
•
•
•
•
•
•
•
•
This form explains what would happen if you join this research study.
Please read it carefully. Take as much time as you need.
Please ask the research team questions about anything that is not clear.
You can ask questions about the study any time.
If you choose not to be in the study, it will not affect your care at Seattle Children’s.
If you say ‘Yes’ now, you can still change your mind later.
You can quit the study at anytime.
You would not lose benefits or be penalized if you decide not to take part in the study or to
quit the study later.
3. What is the goal of this study?
Diabetes is the third most common chronic or ongoing disease in individuals under 20 years of
age. The total number of cases of diabetes in this age group is increasing, and types of
diabetes that have not been seen in young people are now being seen. These changes have
resulted in gaps in our knowledge about the total number of cases and types of diabetes in the
United States, the type of care young people with diabetes receive, the complications they
experience, and the effect diabetes has on their lives.
The goal of any research study is to answer questions. We (the research team listed on the
front of this form and our staff) are doing this research study to answer the following questions:
•
•
•
•
How many cases of diabetes there are in the United States among youth;
What are the characteristics of each type of diabetes;
What medical care is being given to young people who have different forms of diabetes;
How is diabetes affecting the lives of young people with diabetes.
4. Why do I have the option of joining the study?
You have the option to take part in this research study because you have any type of diabetes,
were diagnosed under the age of 20 in 2012, and lived in King, Kitsap, Pierce, Snohomish, or
Thurston county in 2012.
Consent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
5. How many people will take part in the study?
We think that about 1,220 people will take part in the SEARCH registry study at Seattle
Children’s. About 225 people at this site will complete a registry visit. A total of about 6,440
people will take part in the registry study at hospitals and clinics around the country.
6. If I agree to join this study, what would I need to do?
The registry study includes:
• Written questionnaires
• Blood draw
• Urine collections
• Brief physical exam
• Medical record review
• Follow up contact
Written Questionnaires
Prior to your visit, you/your child will have been asked to answer a short series of questions – in
person, via mail, online, or on the telephone – about the effects of diabetes on your/your child's
lives, your family’s education and income level, and general medical care. That survey will have
taken about 20 minutes. During your visit, we will ask you to complete an additional brief survey
about the medications that you/your child takes.
Blood Draw and Urine Collection
You/your child would be scheduled for an in-person study visit at the Clinical Research Center
at Seattle Children’s or at another SEARCH outreach clinic that is convenient to you. This
would be a "fasting" visit, which means that no food or fluids, other than water, could be
consumed for at least 8 hours before coming to your visit. You/your child would be asked not to
take insulin or other diabetes medications the morning before the test, except for basal insulin,
which should be taken as usual. If you come to the visit nonfasting, we might ask you to return
another day to redraw all or part of the blood sample.
Before your scheduled appointment, you would receive a container with detailed instructions to
collect one urine sample at home the morning of your visit. We will ask that you collect the urine
from the first time you urinate in the morning. You would be asked to bring this urine sample
with you to your visit. Your urine would be tested for microalbumin (small particles of protein) to
see how well your kidneys are working.
When you arrive at your appointment, we would review the consent/assent form(s). This would
take about 20 – 30 minutes. If you/your child would like a numbing agent for the blood draw,
this part may take about an additional 30 minutes.
A blood sample would be drawn from your/your child's arm to measure blood sugar, hemoglobin
A1c (a test measuring your/your child’s average blood glucose level over the past 3 months), CConsent, Assent and Parental Permission Form
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IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
peptide (a measure of your/your child's own insulin production), different types of cholesterol
(fat), islet cell antibodies (markers in the blood for type 1 diabetes), and genetic markers for
diabetes. Based on age and size, the total amount of blood that would be needed would be
between 1 teaspoon and 3 tablespoons.
If possible, we would collect all blood samples at the same time that a routine blood draw would
be done. If you/your child take part in more than one research study at the same visit, we would
try to combine tests and results when we can.
A urine sample would also be obtained during the visit and tested for several markers
associated with the risk of diabetes complications, such as heart disease and stroke.
The SEARCH study would like to keep some of the blood and urine that would be collected
during the study but is not used for other tests. Should we have questions about some of tests,
the storage sample would allow us to repeat the tests without needing to ask for a second blood
draw from you/your child. In addition, we would like to collect another sample of blood for
storage for future research.
We will also ask your permission to obtain and store a sample of blood to look at DNA, the
genetic material that is found in all of your cells. Researchers may look at specific genes, or
they may look at all of your genes together. If researchers were to look at specific genes, you
have the option of receiving the results of this testing if it would effect your clinical care.
However, if they were to look at all of your genes together, you would not receive the results.
The information researchers find about your DNA would be sent to a national storage center
called dbGaP (part of the National Institutes of Health) to help researchers better understand
how genes affect the risk of developing diseases such as asthma, cancer, diabetes, and heart
disease. When your DNA and clinical information would be sent to the storage center, no
personal information would be included, such as your name, date of birth, or address. Thus,
researchers would not be able to link this information back to you. The research that would be
done with your blood and urine samples would not be designed to specifically help you. It might
help people who have diabetes and other diseases in the future.
The total amount of blood that would be needed for the storage sample would be 1 teaspoon for
young children and up to 2 tablespoons for older children, dependent on age and weight. This
part of the visit would take 10 – 20 minutes.
The total volume of blood for this visit would be up to approximately 3 tablespoons.
After the fasting blood and urine samples are collected, a free breakfast or meal voucher would
be provided and you/your child would take your routine medication.
Physical Exam
A trained member of the research team would perform a brief physical examination including:
height, weight, waist measurements, blood pressure, and examination of the skin of the neck.
The time to complete this exam would be about 20 minutes.
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 5 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Follow up
We will send you requests to update your contact information about every year. Part of this
update includes a question about your/your child’s social security number, which we will use to
track mortality among SEARCH study participants. If this study is expanded, or if other diabetes
studies are developed, we may contact you/your child in the future to ask if you/your child want
to participate further. As with this study, taking part in any future study is voluntary.
7. How long would I be in the study?
The study is currently funded through September 2015.
The time to complete the registry visit would be about 1 hour.
If you join the study, you can decide to stop at anytime for any reason. Please discuss your
decision to stop with Dr. Pihoker or the research team.
If you would like your/your child’s stored samples removed from storage, we would send a
request to the central laboratory. They would then destroy the sample, and send us a letter
certifying that the sample has been destroyed. We would send you a copy of this letter.
The research study doctor could also decide to take you out of this study. This might happen if
we find out that it is not safe for you to stay in the study. Or it might happen if you cannot
complete to enough of the study elements. If we ask you to leave the study, we would always
explain why.
8. What are the potential harms or risks if I join this study?
If you feel uncomfortable at any time during any of these tests, just tell the study coordinator and
they would immediately stop the tests. All reasonable precautions would be taken to reduce
risks.
When taking a blood sample, there may be brief discomfort, and a bruise may form where the
needle poke occurs. To reduce the possibility of these risks, a local anesthetic (numbing cream
or liquid) may be applied to the skin before blood is taken.
The blood tests require that you/your child not have any food or fluids overnight, other than
water. In order to prevent low or high blood sugars, you/your child’s blood sugar would be
checked by finger-stick and your diabetes medication would be given as needed to control
your/your child’s blood sugar.
Some of the tests would look for the presence of health problems associated with diabetes,
such as high cholesterol. If researchers find signs of these health problems, it may cause
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 6 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
you/your child some anxiety or concern. If this happens, you/your child would be referred to the
appropriate local health professionals for evaluation and treatment.
There could be harms associated with sharing your genetic information despite our safety
measures to protect your genetic information. They include:
• Someone could break into the computer system. They could then find the code that links
your genetic and medical information to you. This is very unlikely, but is possible.
• Find a way to link your genetic or medical information in a database back to you. Your
genetic information is unique to you. But you do share some genetic information with
your children, parents, brothers, sisters and other blood relatives. So it might be possible
for someone to use genetic information from your relatives to help figure out who you
are. That person would need to be able to access the database. They would also need
genetic information from you or one of your relatives. Again, it is unlikely this would
happen.
• Since some genetic information may predict health problems you or your relatives could
have in the future. This information might be of interest to health providers, life insurance
companies and others. There are state and federal laws that protect against genetic
discrimination. There is a new federal law called the Genetic Information
Nondiscrimination Act (GINA). This law makes it illegal for health insurance companies,
group health plans and most employers to discriminate against you based on your
genetic information. However, it does not completely protect you from discrimination.
• Genetic information could also be used by law enforcement agencies to identify a person
or his/her blood relatives.
• There could be privacy risks we don’t know about.
As with any research study, there may be additional risks that are unknown or unexpected.
9. What are the potential benefits if I join this study?
Potential Benefits for You:
You/your child may not directly benefit from participating in this research study. However, this
study may more clearly tell us about your/your child’s type of diabetes and whether you/your
child has complication of diabetes.
You would receive results of your/your child’s blood and urine tests usually within 6-8 weeks of
the study visit. These results would include Hemoglobin A1C, lipid profile (cholesterol), and
urine microalbumin (urine protein). These are standard tests. The report you receive would
explain the results to you. Your/your child’s doctor would also receive these standard test
results, plus results of the research laboratory tests that are being studied to determine the type
of diabetes.
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 7 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
You/your child and your/your child’s diabetes provider may receive the results of genetic tests
done for research purposes while taking part in this research study if it is determined that the
results of such tests could impact clinical care.
Potential Benefits for Others:
We hope that the information learned in this research study will benefit young people with
diabetes in the future. This is a large research study being carried out at five major medical
centers across the United States. The information we learn in this research study will improve
our understanding of how education, diagnosis, and the costs of having diabetes can affect the
people who live with this disease every day.
10. What other options do I have?
Taking part in research is voluntary. You/your child may choose not to take part in this study or
in parts of the study.
11. How would you keep my information confidential?
All information gathered during this study would be held in strict confidence. Any publication
resulting from participation in this study would not identify you/your child by name. A one of a
kind number, called a research study number, would be assigned to you/your child. No other
identifying information would be used. The research study number would be used to identify
only the tests and interview information that was collected during the research study. The
research number assigned to you/your child, and not your child’s name, would be sent to the
study Coordinating Center at Wake Forest University in order to study the information. The list
containing the research study number assigned to you/your child would be kept in a locked file
in the research office of Dr. Pihoker, the research study's Principal Investigator. No one other
than Dr. Pihoker and her research team would be able to connect any of research study
information to you/your child.
Any stored samples would be kept in a central laboratory and stored for upcoming studies of
diabetes. The central laboratory is at the University of Washington. The samples would be
banked with a code, with no information at the laboratory that could link the samples to you/your
child. Dr. Pihoker and the study coordinators on this project would be the only people with
access to the code. The banked samples would be stored indefinitely, although would likely be
used within 7 years. When there is another researcher who wants to do a diabetes study and
use the stored samples, he/she would need to talk to Dr. Pihoker. If the study seems to be
important and reasonable, an Institutional Review Board (IRB) would review the study, and
samples could be used only after the study is approved. The IRB is a committee responsible for
protecting the rights of persons taking part in research.
All answers that you/your child give and other information gathered about you/your child during
this study would be kept private. This is so because this study has been given a Certificate of
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 8 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Confidentiality. This means that anything you/your child tells us or information we learn about
you/your child would not have to be given out to anyone, even if a court orders us to do so,
unless you say it’s OK. But under the law, we must report to the state suspected cases of child
abuse or if you/your child tell us he/she is planning to cause serious harm to self or others.
If you take part, we would make every effort to keep your information confidential.
If you join this study, we may put information about this study in your medical record. We do
this because the research study involves patient care.
Information collected about you during the study would be kept until all information has been
studied and results have been published. Future funding may allow the study to continue for a
longer period of time, however, the information about you would be destroyed as soon as it is no
longer necessary for the conduct of the research study.
12. Would it cost me money to be in the study?
If you take part in this study, there would be no cost to you and no cost to your
insurance company.
13. What if I were injured because I joined the study?
If you were injured as the direct result of this research study, Seattle Children's Hospital
would provide treatment. We would refer you for treatment if needed.
You would NOT need to pay for this treatment and neither would your insurance
company. This is the only compensation offered for study-related injuries. It is
important that you tell the Principal Researcher Catherine Pihoker, if you think that you
have been injured as a result of taking part in this study. You can call her at 206-9875037.
14. Would I be paid if I join this study?
If needed, we may be able to offer some assistance with travel costs, dependent on availability
of study funds. Important: You would need to give us receipts that clearly show your costs.
To thank you for taking part in the study we would give you/your child a $10 gift card for
completion of the Initial Participant Survey, and an $80 gift card for completion of the visit. In
the rare circumstance that a blood redraw is necessary, you would receive an additional $20 gift
card. If you are fasting for the visit, we will provide a $6 breakfast voucher, or breakfast, after
you complete the blood draw.
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 9 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
The IRS has certain rules about paying people who take part in research studies. If you
took part in this study, we would ask you to provide your name, mailing address, and
social security number so we could pay you.
You can be in this study even if you do not give us this information. If you decide not to
give us this information, you could receive a gift card or no payment.
The payments you would receive for being in this study might be taxable. Seattle
Children’s is required to report to the IRS study payments of $600 or more made to
anyone in any year.
Your samples could be used to make new products, tests or findings. These may have value
and may be developed and owned by the research team and/or others. If this happens, there
are no plans to provide any money to you.
15. Who do I call if I have problems or questions?
If I have questions or
would like to know about …
• Emergencies
• General study
questions
• Research-related
injuries
• Any research concerns
or complaints
• Emergencies
• General study
questions
• Research-related
injuries
• Any research concerns
or complaints
•
Your rights as a
research participant
You can call …
At …
Catherine Pihoker, MD or
Endocrinologist on call
Phone: 206-987-2000
Diabetes Research Team
Phone: 206-987-2540
Institutional Review Board
This is a group of scientists
and community members
who make sure research
meet legal and ethical
standards.
Phone: (206) 987-7804
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 10 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
If I have questions or
would like to know about …
•
•
Assistance with figuring
out what questions to
ask the research team
Help understanding the
research process
You can call …
Research and Family
Liaison
A person who works with
families to ensure they
receive the information they
need to make an informed
decision about taking part in
a research study.
At …
Phone: (206) 884-7858
Pager: (206) 469-3983
16. If I join the study, can I stop?
Yes. Taking part in research is always a choice. If you decide to be in the study, you can
change your mind at any time. We ask that you tell the study team at 206-987-2540.
If you choose to leave the study, it will not affect your care at Seattle Children’s. You will
not lose any benefits or be penalized if you choose to leave the study.
17. What would my signature on this form mean?
Your signature on this form would mean:
• The research study was explained to you.
• You had a chance to ask all the questions you have at this time. All your questions have
been answered in a way that is clear.
• You understand that the persons listed on this form will answer any other questions you
may have about the study or your rights as a research study participant.
• You have rights as a research participant. We will tell you about new information or
changes to the study that may affect your health or your willingness to stay in the
study.
• By signing this consent form, you do not give up any of your legal rights. The
researcher(s) or sponsor(s) are not relieved of any liability they may have.
o You agree to take part in the research study.
o If the person reading this form is a parent/guardian, you agree to have your child take
part in this research study.
Please Note: If the person taking part in this research study is a foster child or a ward of the
state, then please tell the researcher or their staff.
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 11 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
___________________________________
Printed Name of Research Participant
______________________________________
Signature of Research Participant (required if 14 years or older)
Date/Time
______________________________________
Printed Name of Parent or Legal Guardian
______________________________________
Signature of Parent or Legal Guardian
Date/Time
Permissions:
Storage of Blood and Urine Samples
Do you give permission to have your/your child’s blood and urine samples saved and used in
current and future research?
Yes, I give my permission
No, I do not give permission
Storage of DNA Samples (looking at specific genes)
Do you give permission to have your/your child’s DNA saved and used in current and future
research?
Yes, I give my permission
No, I do not give permission
Genetic Test Results (looking at specific genes)
If researchers determine that genetic results could impact clinical care, could you like the results
of genetic tests sent to you and your/your child’s diabetes provider?
Yes, I give my permission
No, I do not give permission
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 12 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Full Gene Analysis (looking at all of your genes) and the National Storage Center
Do you give permission to have your/your child’s DNA analyzed to identify a complete picture of
your genetic makeup? This information would be sent to a national storage center to help
researchers better understand how genes affect the risk of developing diseases. When your
DNA and clinical information is sent to the storage center, no personal information would be
included, such as your name, date of birth, or address. Thus, researchers would not be able to
link this information back to you.
Yes, I give my permission
No, I do not give permission
Future contact
Do you give permission for researchers to contact you/your child in the future, to ask if you/your
child are interested in participating in new research studies that are developed? As with this
research study, taking part in any future studies is voluntary. Participation in this present study
does not mean that you/your child are automatically volunteering to take part in any future
studies. You/your child would be asked to sign a consent form for any future research studies in
which you/your child agree to participate.
Yes, I give my permission
No, I do not give permission
18. Researcher’s Signature
I have fully explained the research study described by this form. I have answered the
participant and/or parent/guardians questions and will answer any future questions to the best of
my ability. I will tell the family and/or the person taking part in this research of any changes in
the procedures or in the possible harms/possible benefits of the study that may affect their
health or their willingness to stay in the study.
_________________________________
Printed Name of Researcher Obtaining Parental Permission or Consent
_______________________________
Signature of Researcher Obtaining Parental Permission or Consent
Consent, Assent and Parental Permission Form
Date/Time
Template Version: 8/20/2013
Page 13 of 14
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
19. Interpreter Information
_____________________________________
Printed Name of Interpreter during initial presentation of study
Date/Time
______________________________________
Printed Name of Interpreter when translated form is presented (if applicable)
Date/Time
Original form to:
Research Team File
Copies to:
Participant
Parents/Guardians (if applicable)
Medical Records (if applicable)
Consent, Assent and Parental Permission Form
Template Version: 8/20/2013
Page 14 of 14
8-20-13
SEATTLE CHILDREN’S
UNIVERSITY OF WASHINGTON
SEARCH for Diabetes in Youth
Monogenic Ancillary Study
Consent Form: Initial Genetic Testing
To be signed by participants age 18 and older, cosigned by participants ages 14 to 17,
and signed by parent/guardian of participants under age 18
Principal investigator:
Co-investigators:
Catherine Pihoker, MD, Department of Endocrinology, 206/987-5037
Lenna L. Liu, MD, MPH, Department of Pediatrics, 206/987-5037
Maryam Afkarian, MD, Department of Nephrology, 206/987-5037
Irl Hirsch, MD, Department of Medicine, 206/987-5037
Carolyn Paris, MD, Department of Emergency Medicine, 206/987-5037
Joyce Yi-Frazier, PhD, Department of Endocrinology, 206/987-5037
Carla Greenbaum, MD, Clinical Research Center, 206/987-5037
Martin Goldsmith, MD, Pediatrics Northwest, 206/987-5037
Beth Babler, ARNP, Mary Bridge, 206/987-5037
Patricia Fechner, MD, Department of Endocrinology, 206/987-5037
Christian Roth, MD, Department of Endocrinology, 206/987-5037
Ildi Koves, MD, Department of Endocrinology, 206/987-5037
Craig Taplin, MD, Department of Endocrinology, 206/987-5037
Kate Ness, MD, Department of Endocrinology, 206/987-5037
Carolina DiBlasi, MD, Department of Endocrinology, 206/987-5037
Roja Motaghedi, MD, Department of Endocrinology, 206/987-5037
Erin Alving, ARNP, Department of Endocrinology, 206/987-5037
Karen Aitken, ARNP, Department of Endocrinology, 206/987-5037
Joanie Warner, ARNP, Department of Endocrinology, 206/987-5037
Sara Benitez, PA, Department of Endocrinology, 206/987-5037
Gwyn Recupero, PA, Department of Endocrinology, 206/987-5037
Study Coordinators:
Beth Loots, MPH, MSW, Department of Endocrinology, 206/987-2540
Sue Kearns, RN, Department of Endocrinology, 206/987-2540
Mary Klingsheim RN BSN, Department of Endocrinology, 206/987-2540
Jessica Fosse, MPH RN BSN, Department of Endocrinology, 206/987-2540
Katherine Cochrane, BS, Department of Endocrinology, 206/987-2540
Sharla Semana, MSW, Department of Endocrinology, 206/987-2540
Patricia D’Alessandro, MA, Department of Endocrinology, 206/987-2540
24-hour emergency telephone number:
Catherine Pihoker, MD, or Pediatric Endocrinologist on call: 206/987-2000
Page 1 of 6. Seattle Children’s Monogenic Study, Initial Genetic Testing Consent. 08 2013
Researcher's Statement
You/your child are being asked to give permission for you/your child to take part in a research
study. Taking part in research is voluntary. Please take time to make your decision, and discuss it
with family and friends. If you/your child decide to participate, but then later want to drop out of the
research study, you are free to do so without loss of any benefits, treatment, or services to which
you are otherwise entitled.
This form provides a summary of the information the researchers will discuss with you. If you/your
child takes part in this research study, you will keep a copy of this form. Be sure to ask any
questions you have about the research study.
You/your child are being asked to take part in a research study because you/your child were
diagnosed with diabetes at <1 year of age. Because of this, you/your child may have a genetic
form of diabetes called Permanent Neonatal Diabetes Mellitus (PNDM). As part of the SEARCH
study, we are currently testing people diagnosed with diabetes at <1 year of age for mutations in
the genes that cause these inherited forms of diabetes.
Purpose
We have learned from recent research that many infants who are diagnosed with diabetes at less
that one year of age have an inherited form of diabetes. The reason that it is very important to
test for these mutations in people who develop diabetes as infants is because, in some cases, it
can dramatically affect the treatment. It is possible that some people may receive treatment for
diabetes that does not include the use of insulin.
The purpose of this research study is to:
a. Learn how many patients with PNDM there are in the United States
b. Learn more about patients with PNDM
c. Offer genetic testing for PNDM at no charge
Benefits
If you/your child agree to take part in this study, there may or may not be direct medical benefits to
you/your child. If we find an abnormal test result for PNDM, this could affect your/your child’s
treatment. It is possible that some people with PNDM may receive treatment for diabetes that
does not include the use of insulin, and it is also possible that the diabetes control will improve with
a different form of treatment. However, it is also possible, even if your/your child’s results are
abnormal, that the diabetes treatment will not change. In addition, the information we learn in this
research study may benefit other children by improving our understanding of who needs to be
tested for PNDM, and whether testing for PNDM improves the lives of patients in whom mutations
are found.
Procedures
This study consists of 2 parts:
1) We will obtain a blood or saliva sample in order to perform the genetic testing
2) You will fill out questionnaires about diabetes in your family and the effects that diabetes has
on your/your child's life
Page 2 of 6. Seattle Children’s Monogenic Study, Initial Genetic Testing Consent. 08 2013
Sample Collection for Genetic Testing
You/your child will be scheduled for an in-person study visit in the Clinical Research Center at
Seattle Children’s Hospital and Regional Medical Center or another SEARCH outreach clinic. This
may be scheduled at the same time as a SEARCH study visit. A blood sample will be drawn from
your/your child's arm. DNA will be removed from the blood and used to test for mutations in one of
several genes that may cause PNDM. The total amount of blood needed for this sample is 2
teaspoons. If your child weighs less than 11 pounds at the time of the blood draw, a smaller
amount of blood will be drawn; we will follow guidelines that tell us what is a safe amount of blood
to take. This part of the visit will take 10 – 20 minutes. If you/your child needs a numbing cream
for the blood draw, this part will take at least 30 minutes.
If you/your child are not able to come for an in-person visit, you can have blood drawn by your
local doctor and then send the blood sample to us in the mail.
If we can not get a blood sample, we can instead collect a saliva (spit) sample. We are not able to
get as much DNA from saliva as we can from blood, so we may not be able to test for all the genes
that may cause PNDM. For the saliva collection, you/your child will spit about 2 teaspoons (10
milliliters) of saliva into a container. If we are collecting this sample from your baby, we will rub
some soft sponges in your baby’s mouth to collect the saliva. If you are not able to come to the
study center, you may be able to collect the saliva sample at home and send the container to us in
the mail.
Written Questionnaires
After completing the blood draw or saliva collection, you/your child will answer some questions
about diabetes in your family, the effects of diabetes on your/your child's life, and other aspects of
your/your child’s medical history. You/your child are free to not answer any questions you don't
want to answer, and you may stop the interview at any time. If you/your child decide not to answer
any of the questions, you can still take part in the rest of the research study. This part of the study
visit will take about 20-30 minutes.
Research Data and Specimens
Blood and saliva samples will be sent to a central laboratory located at the University of
Washington and some DNA from these samples will be sent to a laboratory that specializes in
these genetic studies (Molecular Genetics Laboratory, Royal Devon and Exeter NHS Healthcare
Trust, Exeter, U.K.). The remaining DNA will be stored for upcoming studies of diabetes. The
samples are banked with a code, with no information at either laboratory that could link the
samples to you/your child. Some information about your/your child’s health and about diabetes in
your family may be sent to the U.K. laboratory to guide further testing in case the initial tests are
negative. This information will also be sent with a code, so that it cannot be linked to you/your
child. Dr. Pihoker and the study coordinators on this project will be the only people with access to
the code. The banked samples will be stored indefinitely, although will likely be used within 7
years. When there is another researcher who wants to do a diabetes study and use the stored
samples, he/she will need to talk to Dr. Pihoker. If the study seems to be important and
reasonable, an Institutional Review Board (IRB) will review the study, and samples can be used
only after the study is approved. The IRB is a committee responsible for protecting the rights of
persons taking part in research.
You may choose to withdraw from the study at any time. If you would like your/your child’s stored
samples removed from storage, we will send a request to the central laboratory. They will then
Page 3 of 6. Seattle Children’s Monogenic Study, Initial Genetic Testing Consent. 08 2013
destroy the sample, and send us a letter certifying that the sample has been destroyed. We will
send you a copy of this letter.
Risks, Stress or Discomfort
When taking a blood sample, there may be brief discomfort, and a bruise may form where the
needle poke occurs. To reduce the pain associated with the blood draw, a local anesthetic
(numbing cream) may be applied to the skin before blood is taken.
Knowing that you/your child have a genetic form of diabetes may cause you to have more
questions. We will answer any questions you may have to the best of our abilities. If needed,
you/your child will be referred to an appropriate local health professional for further evaluation and
treatment.
You might worry about whether results of this genetic test will lead to discrimination, for example
denial of health insurance or employment. Laws exist to protect against genetic discrimination, and
these vary from state to state. While it is theoretically possible that genetic information about
you/your child could lead to this sort of discrimination, this is very unlikely. Information about
you/your child will not be given to insurance companies, employers, or other parties without your
permission. Results of this genetic testing will be reported to your health care provider with your
permission (as indicated at the end of this form), and will therefore go into your medical record.
Test results
Test results will be mailed to you approximately 6 months after the blood is collected. If you have a
positive test result, someone from the study will also call you to explain the results to you before
you receive the letter in the mail. Your/your child’s diabetes provider will also receive the results, if
you have given your permission.
Privacy and Confidentiality
All information gathered during this study will be held in strict confidence. Any publication resulting
from participation in this study will not identify you/your child by name.
Once you/your child decide to join the research study, a one of a kind number, called a research
study number, will be assigned to you/your child. No other identifying information will be used.
The research study number will be used to identify only the test and interview information that was
collected during the research study. The research number assigned to you/your child will be kept
in a locked file in the research office of Dr. Pihoker, the research study's Principal Investigator. No
one other than Dr. Pihoker and her research team will be able to connect any of research study
information to you/your child.
All answers that you/your child give and other information gathered about you/your child during this
study will be kept private. This is so because this study has been given a Certificate of
Confidentiality. This means that anything you/your child tells us or information we learn about
you/your child will not have to be given out to anyone, even if a court orders us to do so, unless
you say it’s ok. But, under the law we must report to the state suspected cases of child abuse or if
you/your child tell us he/she is planning to cause serious harm to self or others’.
Taking Part in Research is Voluntary
Taking part in research is voluntary. You/your child may choose not to take part. If you/your child
do take part, you/your child may withdraw from this study at any time. If you/your child drop out of
the research study you can request that all blood or DNA samples that have been collected be
Page 4 of 6. Seattle Children’s Monogenic Study, Initial Genetic Testing Consent. 08 2013
destroyed. Withdrawal from this research study will have no effect on access to medical care nor
will it have any effect on the standard of care your/your child’s health care professionals are
providing.
Compensation
For the in-person visit, you/your child will receive a $20 gift card.
If you or your child is injured as the direct result of this research study, we (Seattle Children’s) will
treat you or your child. If appropriate, we will refer you or your child for treatment. You or your
insurance company will be billed for the cost of this treatment. Please call Catherine Pihoker at
206-987-2540 if you believe you or your child have been injured as a result of this study.
Questions
For questions about the research, please call Dr. Catherine Pihoker at 206/987-2540. For
questions about your/your child’s rights as a research participant, contact Seattle Children’s
Institutional Review Board (IRB) at 206-987-7804. The IRB is a committee that reviews the
research and is responsible for protecting the rights and welfare of children and families taking part
in research.
________________________________
Signature of Researcher
Date/Time
Permissions:
Storage of DNA Samples
Do you give permission to have your/your child’s DNA stored and used in future research studies,
to find better ways to diagnose the different types of diabetes, and to study the health risks
associated with this disease, such as insulin not working and obesity?
Yes, I give my permission
No, I do not give permission
Communication of Genetic Test Results
Do you give permission to have the results of these genetic tests communicated to your/your
child’s diabetes provider?
Yes, I give my permission
No, I do not give permission
Page 5 of 6. Seattle Children’s Monogenic Study, Initial Genetic Testing Consent. 08 2013
Participant’s Statement:
The study described above has been explained to me, and I voluntarily consent to participate (or
have my child participate) in this study. I have had the opportunity to ask questions and
understand future questions I may have about the research study or about research participants’
rights will be answered by the investigators listed above.
_____________________________________________
Signature of Participant
Date/Time
_____________________________________________
Signature of Parent/Legal Guardian*
Date/Time
*If the child to be involved in this research study is a foster child or a ward of the state, please
notify the researcher or their staff who is obtaining your consent.
Copies to: Participant/parent, Medical Record (when appropriate), Investigator’s file
Page 6 of 6. Seattle Children’s Monogenic Study, Initial Genetic Testing Consent. 08 2013
8-20-13
SEATTLE CHILDREN’S
UNIVERSITY OF WASHINGTON
SEARCH for Diabetes in Youth
Monogenic Ancillary Study
Consent Form: Confirmation of Positive Result
To be signed by participants age 18 and older, cosigned by participants ages 14 to 17,
and signed by parent/guardian of participants under age 18
Principal investigator:
Co-investigators:
Catherine Pihoker, MD, Department of Endocrinology, 206/987-5037
Lenna L. Liu, MD, MPH, Department of Pediatrics, 206/987-5037
Maryam Afkarian, MD, Department of Nephrology, 206/987-5037
Irl Hirsch, MD, Department of Medicine, 206/987-5037
Carolyn Paris, MD, Department of Emergency Medicine, 206/987-5037
Joyce Yi-Frazier, PhD, Department of Endocrinology, 206/987-5037
Carla Greenbaum, MD, Clinical Research Center, 206/987-5037
Martin Goldsmith, MD, Pediatrics Northwest, 206/987-5037
Beth Babler, ARNP, Mary Bridge, 206/987-5037
Patricia Fechner, MD, Department of Endocrinology, 206/987-5037
Christian Roth, MD, Department of Endocrinology, 206/987-5037
Ildi Koves, MD, Department of Endocrinology, 206/987-5037
Craig Taplin, MD, Department of Endocrinology, 206/987-5037
Kate Ness, MD, Department of Endocrinology, 206/987-5037
Carolina DiBlasi, MD, Department of Endocrinology, 206/987-5037
Roja Motaghedi, MD, Department of Endocrinology, 206/987-5037
Erin Alving, ARNP, Department of Endocrinology, 206/987-5037
Karen Aitken, ARNP, Department of Endocrinology, 206/987-5037
Joanie Warner, ARNP, Department of Endocrinology, 206/987-5037
Sara Benitez, PA, Department of Endocrinology, 206/987-5037
Gwyn Recupero, PA, Department of Endocrinology, 206/987-5037
Study Coordinators:
Beth Loots, MPH, MSW, Department of Endocrinology, 206/987-2540
Sue Kearns, RN, Department of Endocrinology, 206/987-2540
Mary Klingsheim RN BSN, Department of Endocrinology, 206/987-2540
Jessica Fosse, MPH RN BSN, Department of Endocrinology, 206/987-2540
Katherine Cochrane, BS, Department of Endocrinology, 206/987-2540
Sharla Semana, MSW, Department of Endocrinology, 206/987-2540
Patricia D’Alessandro, MA, Department of Endocrinology, 206/987-2540
24-hour emergency telephone number:
Catherine Pihoker, MD, or Pediatric Endocrinologist on call: 206/987-2000
Page 1 of 6. Seattle Children’s Monogenic Study, Confirmatory Testing Consent. 08 2013
Researcher's Statement
You/your child are being asked to give permission for you/your child to take part in a research
study. Taking part in research is voluntary. Please take time to make your decision, and discuss it
with family and friends. If you/your child decide to participate, but then later want to drop out of the
research study, you are free to do so without loss of any benefits, treatment, or services to which
you are otherwise entitled.
This form provides a summary of the information the researchers will discuss with you. If you/your
child takes part in this research study, you will keep a copy of this form. Be sure to ask any
questions you have about the research study.
You/your child are being asked to take part in a research study because through your/your child’s
participation in the SEARCH Study for Diabetes in Youth, we have found that you/your child had
a positive test for an inherited form of diabetes.
Purpose
There are a few rare inherited forms of diabetes. You/your child had a positive test in the SEARCH
study for either Permanent Neonatal Diabetes Mellitus (PNDM) or Maturity Onset Diabetes of
the Young (MODY). The study coordinator will tell you which one you have.
In infants who are diagnosed with diabetes at <6 months of age, very recent research studies have
shown that an inherited cause of diabetes (PNDM) is extremely common (about half of cases).
Diabetes may also be caused by inherited forms of diabetes in infants diagnosed between 6
months and 1 year of age, although not as frequently as in the younger age group. The reason that
it is very important to test for these mutations in people who develop diabetes as infants is
because, in some cases, it can dramatically affect the treatment. It is possible that some people
may receive treatment for diabetes that does not include the use of insulin.
MODY are a set of diabetes types that affect about 1-2% of people with diabetes. MODY usually
runs in families because of a change in a single gene that is passed on by parents to their children.
The usual course of MODY is different than the usual course of type 1 diabetes. Generally the
progression to needing treatment is more gradual. Some patients do not require insulin but rather
can be effectively treated with a certain oral medication (sulfonylurea). However, it is often not
possible to tell MODY from Type 1 or Type 2 diabetes when the diabetes is first diagnosed without
special testing. By finding out which type of diabetes a person has, the most appropriate treatment
for them can be determined.
The purpose of this research study is to:
a. Learn how many patients with PNDM and MODY there are in the United States
b. Learn more about patients with PNDM and MODY
c. Offer genetic testing for PNDM or MODY at no charge
Benefits
Although much care is taken when handling the research samples and performing the research
tests, it is still important to make sure the result is verified following the usual procedures for
medical tests. If we confirm an abnormal test result for PNDM or MODY, this could affect your/your
Page 2 of 6. Seattle Children’s Monogenic Study, Confirmatory Testing Consent. 08 2013
child’s treatment. It is possible that some people may receive treatment for diabetes that does not
include the use of insulin, and it is also possible that the diabetes control will improve with a
different form of treatment. However, it is also possible, even if your/your child’s results are
abnormal, that your/your child’s treatment will not change.
In addition, while this research study may not benefit you directly, the information we learn may
benefit other people by improving our understanding of who needs to be tested for these genetic
forms of diabetes, and whether testing improves the lives of patients in whom mutations are found.
Procedures
This study consists of 3 parts:
1) We will obtain a blood or saliva sample in order to perform the confirmatory genetic testing
2) If you have not already done this, you will fill out questionnaires about diabetes in your family,
the effects that diabetes has on your/your child's life, and the effects that participating in this
research study has had on your/your child’s life
3) We will review your/your child's medical records to get complete information for the research
study
Sample Collection for Genetic Testing
You/your child will be scheduled for an in-person study visit in the Clinical Research Center at
Seattle Children’s Hospital and Regional Medical Center or another SEARCH outreach clinic. This
may be scheduled at the same time as a SEARCH study visit. A blood sample will be drawn from
your/your child's arm. DNA will be removed from the blood and used to confirm the abnormal test
result, by rechecking to be sure that you have a mutation in a gene that causes PNDM or MODY.
The total amount of blood needed for this sample is 2 teaspoons. If your child weighs less than 11
pounds at the time of the blood draw, a smaller amount of blood will be drawn; we will follow
guidelines that tell us what is a safe amount of blood to take. This part of the visit will take 10 – 20
minutes. If you/your child needs a numbing cream for the blood draw, this part will take at least 30
minutes.
If you/your child are not able to come to the study center for an in-person visit, you can have blood
drawn by your local doctor and then send the blood sample to us in the mail.
If we can not get a blood sample, we will instead collect a saliva (spit) sample. For the saliva
collection, you/your child will spit about 2 teaspoons (10 milliliters) of saliva into a container. If we
are collecting this sample from your baby, we will rub some soft sponges in your baby’s mouth to
collect the saliva. If you are not able to come to the study center, you may be able to collect the
saliva sample at home and send the container to us in the mail.
Written Questionnaires
After completing the blood draw or saliva collection, you/your child will answer some questions
about diabetes in your family, the effects of diabetes on your/your child's life, other aspects of
you/your child’s medical history, and the effects that participating in this research study has had on
you/your child’s life. You/your child are free to not answer any questions you don't want to answer,
and may stop the interview at any time. If you/your child decide not to answer any of the
questions, you can still take part in the rest of the research study. This part of the study visit will
take about 20 – 30 minutes.
Page 3 of 6. Seattle Children’s Monogenic Study, Confirmatory Testing Consent. 08 2013
Medical Records Review
We will ask your permission for the researchers involved in this study to review your/your child's
medical record. Any information obtained from the medical charts is for use in this research study
only. Researchers will gather information on the current status and treatment of your/your child's
diabetes. This information will include medications used to treat your diabetes and recent results
of laboratory tests. The medical records review will take place approximately one year after the
confirmatory test results are reported to you and your healthcare provider and will go back to the
period of time beginning 6 months before you received this test result.
Research Data and Specimens
Blood and/or saliva samples will be labeled with your/your child’s name and date of birth and sent
directly to the laboratory where the testing will be performed (Molecular Genetics Laboratory, Royal
Devon and Exeter NHS Healthcare Trust, Exeter, U.K.). Some health information and information
about diabetes in your family will also be sent to the lab in the U.K. in order to aid in the
interpretation of the genetic test result. This information will be linked with your name and date of
birth. After the blood/saliva sample has been tested, the rest of the sample will be destroyed. All
other study data obtained at this study visit (written questionnaires, documentation from medical
records review) will be labeled with a code, with no information that could link the data to you/your
child. Dr. Pihoker and the study coordinators on this project will be the only people with access to
the code.
You may choose to withdraw from the study at any time.
Risks, Stress or Discomfort
When taking a blood sample, there may be brief discomfort, and a bruise may form where the
needle poke occurs. To reduce the pain associated with the blood draw, a local anesthetic
(numbing cream) may be applied to the skin before blood is taken.
Knowing that you/your child have a genetic form of diabetes may cause you to have more
questions. We will answer any questions you may have to the best of our abilities. If needed,
you/your child will be referred to an appropriate local health professional for further evaluation and
treatment.
You might worry about whether results of this genetic test will lead to discrimination, for example
denial of health insurance or employment. Laws exist to protect against genetic discrimination, and
these vary from state to state. While it is theoretically possible that genetic information about
you/your child could lead to this sort of discrimination, this is very unlikely. Information about
you/your child will not be given to insurance companies, employers, or other parties without your
permission. Results of this genetic testing will be reported to your health care provider with your
permission (as indicated at the end of this form), and will therefore go into your medical record.
Test results
As the test results from this research study become available, you/your child will receive the
results. Results will be mailed to you approximately 1 month after the blood is collected. Someone
from the study will also call you to explain the results to you before you receive the letter in the
mail. Your/your child’s diabetes provider will also receive the results, if you have given your
permission.
Page 4 of 6. Seattle Children’s Monogenic Study, Confirmatory Testing Consent. 08 2013
Privacy and Confidentiality
All information gathered during this study will be held in strict confidence. Any publication resulting
from participation in this study will not identify you/your child by name.
A one of a kind number, called a research study number, will be used to label all data obtained as
a part of this study visit. No other identifying information will be used. The research number
assigned to you/your child will be kept in a locked file in the research office of Dr. Pihoker, the
research study's Principal Investigator. No one other than Dr. Pihoker and her research team will
be able to connect any of the research study information to you/your child.
Because results of the genetic tests may be used to change the type of treatment you/your child
are receiving for your diabetes, the blood or saliva sample needs to be sent with your name and
birth date so we can be sure that the sample belongs to you. The sample will be destroyed after
the testing has been completed, to protect your privacy.
All answers that you/your child give and other information gathered about you/your child during this
study will be kept private. This is so because this study has been given a Certificate of
Confidentiality. This means that anything you/your child tells us or information we learn about
you/your child will not have to be given out to anyone, even if a court orders us to do so, unless
you say it’s ok. But, under the law we must report to the state suspected cases of child abuse or if
you/your child tell us he/she is planning to cause serious harm to self or others.
Taking Part in Research is Voluntary
Taking part in research is voluntary. You/your child may choose not to take part. If you/your child
do take part, you/your child may withdraw from this study at any time. If you/your child drop out of
the research study you can request that all blood or DNA samples that have been collected be
destroyed. Withdrawal from this research study will have no effect on access to medical care nor
will it have any effect on the standard of care your/your child’s health care professionals are
providing.
Compensation
For the in-person visit, you/your child will receive a $20 gift card.
If you or your child is injured as the direct result of this research study, we (Seattle Childrens) will
treat you or your child. If appropriate, we will refer you or your child for treatment. You or your
insurance company will be billed for the cost of this treatment. Please call Catherine Pihoker at
206-987-2540 if you believe you or your child have been injured as a result of this study.
Questions
For questions about the research, please call Dr. Catherine Pihoker at 206/987-2540. For
questions about your/your child’s rights as a research participant, contact the Seattle Children’s
Institutional Review Board (IRB) at 206-987-7804. The IRB is a committee that reviews the
research and is responsible for protecting the rights and welfare of children and families taking part
in research.
________________________________
Signature of Researcher
Date/Time
Page 5 of 6. Seattle Children’s Monogenic Study, Confirmatory Testing Consent. 08 2013
Permissions:
Medical Record Review
Do you give permission to have your/your child’s medical chart(s), reviewed by research study
members, as described above?
Yes, I give my permission
No, I do not give permission
Communication of Genetic Test Results
Do you give permission to have the results of these genetic tests communicated to your/your
child’s diabetes provider?
Yes, I give my permission
No, I do not give permission
Participant’s Statement:
The study described above has been explained to me, and I voluntarily consent to participate (or
have my child participate) in this study. I have had the opportunity to ask questions and
understand future questions I may have about the research study or about research participants’
rights will be answered by the investigators listed above.
_____________________________________________
Signature of Participant
Date/Time
_____________________________________________
Signature of Parent/Legal Guardian*
Date/Time
*If the child to be involved in this research study is a foster child or a ward of the state, please
notify the researcher or their staff who is obtaining your consent.
Copies to: Participant/parent, Medical Record (when appropriate), Investigator’s file
Page 6 of 6. Seattle Children’s Monogenic Study, Confirmatory Testing Consent. 08 2013
8-20-13
SEATTLE CHILDREN’S
UNIVERSITY OF WASHINGTON
SEARCH for Diabetes in Youth
Monogenic Ancillary Study
Consent Form: Family Members
To be signed by participants age 18 and older, cosigned by participants ages 14 to 17,
and signed by parent/guardian of participants under age 18
Principal investigator:
Co-investigators:
Study Coordinators:
Catherine Pihoker, MD, Department of Endocrinology, 206/987-5037
Lenna L. Liu, MD, MPH, Department of Pediatrics, 206/987-5037
Maryam Afkarian, MD, Department of Nephrology, 206/987-5037
Irl Hirsch, MD, Department of Medicine, 206/987-5037
Carolyn Paris, MD, Department of Emergency Medicine, 206/987-5037
Joyce Yi-Frazier, PhD, Department of Endocrinology, 206/987-5037
Carla Greenbaum, MD, Clinical Research Center, 206/987-5037
Martin Goldsmith, MD, Pediatrics Northwest, 206/987-5037
Beth Babler, ARNP, Mary Bridge, 206/987-5037
Patricia Fechner, MD, Department of Endocrinology, 206/987-5037
Christian Roth, MD, Department of Endocrinology, 206/987-5037Ildi
Koves, MD, Department of Endocrinology, 206/987-5037
Craig Taplin, MD, Department of Endocrinology, 206/987-5037
Kate Ness, MD, Department of Endocrinology, 206/987-5037
Carolina DiBlasi, MD, Department of Endocrinology, 206/987-5037
Roja Motaghedi, MD, Department of Endocrinology, 206/987-5037
Erin Alving, ARNP, Department of Endocrinology, 206/987-5037
Karen Aitken, ARNP, Department of Endocrinology, 206/987-5037
Joanie Warner, ARNP, Department of Endocrinology, 206/987-5037
Sara Benitez, PA, Department of Endocrinology, 206/987-5037
Gwyn Recupero, PA, Department of Endocrinology, 206/987-5037
Beth Loots, MPH, MSW, Department of Endocrinology, 206/987-2540
Sue Kearns, RN, Department of Endocrinology, 206/987-2540
Mary Klingsheim RN BSN, Department of Endocrinology, 206/987-2540
Jessica Fosse, MPH RN BSN, Department of Endocrinology, 206/987-2540
Katherine Cochrane, BS, Department of Endocrinology, 206/987-2540
Sharla Semana, MSW, Department of Endocrinology, 206/987-2540
Patricia D’Alessandro, MA, Department of Endocrinology, 206/987-2540
24-hour emergency telephone number:
Catherine Pihoker, MD, or Pediatric Endocrinologist on call: 206/987-2000
Page 1 of 7. Seattle Children’s Monogenic Study, Family Members Consent. 08 2013
Researcher's Statement
You/your child are being asked to give permission for you/your child to take part in a research
study. Taking part in research is voluntary. Please take time to make your decision, and discuss it
with family and friends. If you/your child decide to participate, but then later want to drop out of the
research study, you are free to do so without loss of any benefits, treatment, or services to which
you are otherwise entitled.
This form provides a summary of the information the researchers will discuss with you. If you/your
child takes part in this research study, you will keep a copy of this form. Be sure to ask any
questions you have about the research study.
You/your child are being asked to take part in a research study because as part of the SEARCH
study, we have found that one of your/your child’s family members (your child, sister, or
brother) had a positive test for an inherited form of diabetes.
Purpose
There are a few rare inherited forms of diabetes. Your family member had a positive test in the
SEARCH study for either Permanent Neonatal Diabetes Mellitus (PNDM) or Maturity Onset
Diabetes of the Young (MODY). The study coordinator will tell you which one your family
member has.
In infants who are diagnosed with diabetes at <6 months of age, very recent research studies have
shown that an inherited cause of diabetes (PNDM) is extremely common (about half of cases).
Diabetes may also be caused by inherited forms of diabetes in infants diagnosed between 6
months and 1 year of age, although not as frequently as in the younger age group. The reason that
it is very important to test for these mutations in children who develop diabetes as infants is
because, in some cases, it can dramatically affect the treatment. It is possible that some children
may receive treatment for diabetes that does not include the use of insulin.
MODY are a set of diabetes types that affect about 1-2% of people with diabetes. MODY usually
runs in families because of a change in a single gene that is passed on by affected parents to their
children. The usual course of MODY is different than the usual course of type 1 diabetes.
Generally the progression to needing treatment is more gradual. Some patients do not require
insulin but rather can be effectively treated with a certain oral medication (sulfonylurea). However,
it is often not possible to tell MODY from Type 1 or Type 2 diabetes when the diabetes is first
diagnosed without special testing. By finding out which type of diabetes a person has, the most
appropriate treatment for them can be determined.
The purpose of this research study is to:
a. Learn whether the genetic mutation found in your/your child’s family member is likely to be
causing his/her diabetes
b. Offer genetic testing and testing for diabetes at no charge
c. Determine whether you are likely to pass this condition on to any future children.
Benefits
If you/your child have diabetes and are found to have the same abnormal test result, it could affect
your/your child’s treatment. It is possible that some people may receive treatment for diabetes that
Page 2 of 7. Seattle Children’s Monogenic Study, Family Members Consent. 08 2013
does not include the use of insulin, and it is also possible that the diabetes control will improve with
a different form of treatment. However, it is also possible, even if you/your child’s results are
abnormal, that you/your child’s treatment will not change.
If you/your child do not have diabetes, we may find by testing that you do have diabetes. You may
benefit from this because treating diabetes early can prevent complications from developing.
In addition, while this research study may not benefit you directly, the information we learn may
benefit other people by improving our understanding of who needs to be tested for these genetic
forms of diabetes, and whether testing improves the lives of patients in whom mutations are found.
Procedures
This study consists of 4 parts:
1) We will obtain a blood or saliva sample in order to look for the same abnormal test result that
was found in your/your child’s family member
2) If you do not have diabetes, we will test to see whether you have diabetes
3) We will ask you to fill out questionnaires about diabetes in your family, the effects that diabetes
has on your/your child's life, and the effects that participating in this research study has had
on your/your child’s life
4) If you/your child have diabetes or are found to have diabetes, we will review your/your child's
medical records to get complete information for the research study
Sample Collection for Genetic Testing
You/your child will be scheduled for an in-person study visit in the Clinical Research Center at
Seattle Children’s Hospital and Regional Medical Center or another SEARCH outreach clinic. A
blood sample will be drawn from your/your child's arm. DNA will be removed from the blood and
used to repeat the test for the gene(s) for which your family member had an abnormal test result.
The total amount of blood needed for this sample is 2 teaspoons. If your child weighs less than 11
pounds at the time of the blood draw, a smaller amount of blood will be drawn; we will follow
guidelines that tell us what is a safe amount of blood to take. This part of the visit will take 10 – 20
minutes. If you/your child needs a numbing cream for the blood draw, this part will take at least 30
minutes.
If you/your child are not able to come to the study center for an in-person visit, you can have blood
drawn by your local doctor and then send the blood sample to us in the mail.
If we can not get a blood sample, we will instead collect a saliva (spit) sample. For the saliva
collection, you/your child will spit about 2 teaspoons (10 milliliters) of saliva into a container. If we
are collecting this sample from your baby, we will rub some soft sponges in your baby’s mouth to
collect the saliva. If you are not able to come to the study center, you may be able to collect the
saliva sample at home and send the container to us in the mail.
Testing for Diabetes
If you/your child do NOT have diagnosed diabetes, we will also perform a test to determine
whether you have diabetes that has not been diagnosed. A member of the research team will set
up an early morning appointment. You/your child will come for a “fasting” visit, which means that
you will eat no food or fluids, other than water, for 8–10 hours prior to the visit.
A small plastic needle will be placed in your/your child’s forearm. You/your child will rest for 10
minutes and then 2-3 teaspoons of blood will be drawn through the plastic needle. You/your child
Page 3 of 7. Seattle Children’s Monogenic Study, Family Members Consent. 08 2013
will then drink a liquid meal. A final ½ teaspoon of blood will be drawn 2 hours after the first blood
draw. The needle will be removed after the last blood sample is obtained. Upon completion of the
test, you/your child will be given a free breakfast or meal voucher.
Written Questionnaires
After completing the blood draw or saliva collection, you/your child will answer some questions
about diabetes in your family, the effects of diabetes on your/your child's life, other aspects of
you/your child’s medical history, and the effects that participating in this research study has had on
you/your child’s life. You/your child are free to not answer any questions you don't want to answer,
and may stop the interview at any time. If you/your child decide not to answer any of the
questions, you can still take part in the rest of the research study. This part of the study visit will
take about 20 – 30 minutes.
Medical Records Review
If you have diabetes or are found to have diabetes, we will ask your permission for the researchers
involved in this study to review your/your child's medical record. Any information obtained from the
medical charts is for use in this research study only. Researchers will gather information on the
current status and treatment of your/your child's diabetes. This information will include
medications used to treat your diabetes and recent results of laboratory tests. The medical records
review will take place approximately one year after the confirmatory test results are reported to you
and your healthcare provider and will go back to the period of time beginning 6 months before you
received this test result.
Research Data and Specimens
Blood and/or saliva samples will be labeled with your/your child’s name and date of birth and sent
directly to the laboratory where the testing will be performed (Molecular Genetics Laboratory, Royal
Devon and Exeter NHS Healthcare Trust, Exeter, U.K.). After the blood/saliva sample has been
tested, the rest of the sample will be destroyed. Some health information and information about
diabetes in your family will also be sent to the lab in the U.K. in order to aid in the interpretation of
the genetic test result. This information will be linked with your name and date of birth. All other
study data obtained at this study visit (written questionnaires, documentation from medical records
review) will be labeled with a code, with no information that could link the data to you/your child.
Dr. Pihoker and the study coordinators on this project will be the only people with access to the
code.
You may choose to withdraw from the study at any time. If you would like your/your child’s stored
samples removed from storage, we will send a request to the central laboratory. They will then
destroy the sample, and send us a letter certifying that the sample has been destroyed. We will
send you a copy of this letter.
Risks, Stress or Discomfort
When taking a blood sample, there may be brief discomfort, and a bruise may form where the
needle poke occurs. To reduce the pain associated with the blood draw, a local anesthetic
(numbing cream) may be applied to the skin before blood is taken.
Knowing that you/your child have a genetic form of diabetes may cause you to have more
questions. We will answer any questions you may have to the best of our abilities. If needed,
you/your child will be referred to an appropriate local health professional for further evaluation and
treatment.
Page 4 of 7. Seattle Children’s Monogenic Study, Family Members Consent. 08 2013
You might worry about whether results of this genetic test will lead to discrimination, for example
denial of health insurance or employment. Laws exist to protect against genetic discrimination, and
these vary from state to state. While it is theoretically possible that genetic information about
you/your child could lead to this sort of discrimination, this is very unlikely. Information about
you/your child will not be given to insurance companies, employers, or other parties without your
permission. Results of this genetic testing will be reported to your health care provider with your
permission, and will therefore go into your medical record.
If you do not have diabetes and agree to participate, it is possible that we will diagnose you with
diabetes as a part of this study. Again, you might worry about whether results of this testing will
lead to discrimination, for example denial of health insurance or employment. It is possible that a
new diagnosis of diabetes could lead to this sort of discrimination. If you do not want to potentially
discover that you have diabetes, you should not participate in this research study.
Test results
As the test results from this research study become available, you/your child will receive results of
the tests. Genetic test results will be mailed to you approximately 1 month after the blood is
collected. Someone from the study will also call you to explain the results to you before you
receive the letter in the mail. Your/your child’s diabetes provider will also receive the results, if you
have given your permission. If you/your child do not have diabetes, you will also receive results of
the diabetes testing. These results will be available approximately 2 weeks after the blood is
collected. If we discover that you do have diabetes, you will be referred to a health care provider
who can help you to treat your diabetes.
Privacy and Confidentiality
All information gathered during this study will be held in strict confidence. Any publication resulting
from participation in this study will not identify you/your child by name.
Once you/your child decide to join the research study, a one of a kind number, called a research
study number, will be assigned to you/your child. No other identifying information will be used. The
research study number will be used to identify study data (written questionnaires, documentation
from medical records review) that was collected during the research study. The research number
assigned to you/your child will be kept in a locked file in the research office of Dr. Pihoker, the
research study's Principal Investigator. No one other than Dr. Pihoker and her research team will
be able to connect any of the research study information to you/your child.
Because results of the genetic tests may be used to change the type of treatment you/your child
are receiving for your diabetes, the blood or saliva sample needs to be sent with your name and
birth date so we can be sure that the sample belongs to you. In addition, because results of the
diabetes testing may be important for your medical care, these blood samples will also be sent with
your name and birth date. The samples will be destroyed after the testing has been completed, to
protect your privacy.
All answers that you/your child give and other information gathered about you/your child during this
study will be kept private. This is so because this study has been given a Certificate of
Confidentiality. This means that anything you/your child tells us or information we learn about
you/your child will not have to be given out to anyone, even if a court orders us to do so, unless
you say it’s ok. But, under the law we must report to the state suspected cases of child abuse or if
you/your child tell us he/she is planning to cause serious harm to self or others.
Page 5 of 7. Seattle Children’s Monogenic Study, Family Members Consent. 08 2013
Taking Part in Research is Voluntary
Taking part in research is voluntary. You/your child may choose not to take part. If you/your child
do take part, you/your child may withdraw from this study at any time. If you/your child drop out of
the research study you can request that all blood or DNA samples that have been collected be
destroyed. Withdrawal from this research study will have no effect on access to medical care nor
will it have any effect on the standard of care your/your child’s health care professionals are
providing.
Compensation
For the in-person visit, you/your child will receive a $20 gift card.
If you or your child is injured as the direct result of this research study, we (Seattle Children’s) will
treat you or your child. If appropriate, we will refer you or your child for treatment. You or your
insurance company will be billed for the cost of this treatment. Please call Catherine Pihoker at
206-987-2540 if you believe you or your child have been injured as a result of this study.
Questions
For questions about the research, please call Dr. Catherine Pihoker at 206-987-2540. For
questions about your/your child’s rights as a research participant, contact the Seattle Children’s
Institutional Review Board (IRB) at 206-987-7804. The IRB is a committee that reviews the
research and is responsible for protecting the rights and welfare of children and families taking part
in research.
________________________________
Signature of Researcher
Date/Time
Permissions:
Medical Record Review
Do you give permission to have your/your child’s medical chart, reviewed by research study
members, as described above?
Yes, I give my permission
No, I do not give permission
Communication of Genetic Test Results
Do you give permission to have the results of these diabetes and genetic tests communicated to
your/your child’s healthcare and/or diabetes provider?
Yes, I give my permission
No, I do not give permission
Page 6 of 7. Seattle Children’s Monogenic Study, Family Members Consent. 08 2013
Participant’s Statement:
The study described above has been explained to me, and I voluntarily consent to participate (or
have my child participate) in this study. I have had the opportunity to ask questions and
understand future questions I may have about the research study or about research participants’
rights will be answered by the investigators listed above.
_____________________________________________
Signature of Participant
Date/Time
_____________________________________________
Signature of Parent/Legal Guardian*
Date/Time
*If the child to be involved in this research study is a foster child or a ward of the state, please
notify the researcher or their staff who is obtaining your consent.
Copies to: Participant/parent, Medical Record (when appropriate), Investigator’s file
Page 7 of 7. Seattle Children’s Monogenic Study, Family Members Consent. 08 2013
SEATTLE CHILDREN’S
UNIVERSITY OF WASHINGTON
SEARCH for Diabetes in Youth
Consent Form: Genetic Testing for Group Health Cooperative (GHC) participants
Complete at Registry Visit for 2012 Incident Cases
To be signed by participants age 18 and older, cosigned by participants ages 14 to 17,
and signed by parent/guardian of participants under age 18
Principal investigator:
Co-investigators:
8-20-13
Study Coordinators:
Catherine Pihoker, MD, 206/987-2540
Department of Endocrinology A-5902
Seattle Children’s
4800 Sand Point Way NE
Seattle, WA 98105
Lenna L. Liu, MD, MPH, Department of Pediatrics, 206/987-5037
Maryam Afkarian, MD, Department of Nephrology, 206/987-5037
Irl Hirsch, MD, Department of Medicine, 206/987-5037
Carolyn Paris, MD, Department of Emergency Medicine, 206/987-5037
Joyce Yi-Frazier, PhD, Department of Endocrinology, 206/987-5037
Carla Greenbaum, MD, Clinical Research Center, 206/987-5037
Martin Goldsmith, MD, Pediatrics Northwest, 206/987-5037
Beth Babler, ARNP, Mary Bridge, 206/987-5037
Patricia Fechner, MD, Department of Endocrinology, 206/987-5037
Christian Roth, MD, Department of Endocrinology, 206/987-5037
Ildi Koves, MD, Department of Endocrinology, 206/987-5037
Craig Taplin, MD, Department of Endocrinology, 206/987-5037
Kate Ness, MD, Department of Endocrinology, 206/987-5037
Carolina DiBlasi, Department of Endocrinology, 206/987-5037
Roja Motaghedi, MD, Department of Endocrinology, 206/987-5037
Erin Alving, ARNP, CDE, Department of Endocrinology, 206/987-5037
Karen Aitken, ARNP, Department of Endocrinology, 206/987-5037
Joanie Warner, ARNP, Department of Endocrinology, 206/987-5037
Sara Benitez, PA, Department of Endocrinology, 206/987-5037
Gwyn Recupero, ARNP, Department of Endocrinology, 206/987-5037
Beth Loots, MPH, MSW, Department of Endocrinology, 206/987-2540
Sue Kearns, RN, Department of Endocrinology, 206/987-2540
Mary Klingsheim RN BSN, Department of Endocrinology, 206/987-2540
Jessica Fosse, MPH RN BSN, Department of Endocrinology, 206/987-2540
Katherine Cochrane, BS, Department of Endocrinology, 206/987-2540
Sharla Semana, MSW, Department of Endocrinology, 206/987-2540
Patricia D’Alessandro, MA, Department of Endocrinology, 206/987-2540
24-hour emergency telephone number: Catherine Pihoker, MD, or Pediatric Endocrinologist on
call: 206/987-2000
Page 1 of 4. Seattle Children’s (FOR Group Health Pts. ONLY) Genetic Testing Consent 08 2013
Researcher's Statement
You/your child are taking part in a research study because you/your child have diabetes. Taking
part in research is voluntary. This form provides a summary of information on genetic tests
performed as part of this study. Please read this consent form carefully, and ask questions about
anything that is not clear to you. Take enough time to make your decision, and discuss it with
family and friends. If you/your child decide to consent to genetic testing, but then later want to
withdraw this consent, you are free to do so without loss of any benefits, treatment or services to
which you are otherwise entitled.
Purpose
One of the goals of this research study is to examine the different types of diabetes that occur in
children and adolescents. Genetic testing tells us about traits that run in families, such as brown
eyes. A very small fraction of children with diabetes may have one of several rare, inherited forms
of diabetes. In the past few years, new research discoveries have been made related to these rare
forms of diabetes.
Benefits
Researchers hope to gather more information on these different types of diabetes by conducting
tests on stored samples in this research study.
Procedures
Genetic testing will be done on samples stored as part of this research study. No additional
procedures are needed. Prior to the visit, we will talk with you/your child about when genetic test
results might be shared and the pros and cons of receiving these genetic test results. You/your
child and your/your child’s diabetes provider may receive the results of genetic tests done for
research purposes while taking part in this research study if there is a consensus among doctors
that the results of such tests could affect your medical care.
Research Data and Specimens
The blood samples are kept in a central laboratory at the University of Washington. The samples
are banked with a code, with no information at the laboratory that could link the samples to
you/your child. Dr. Pihoker and her research staff are the only people with access to the code.
Risks, Stress or Discomfort
If, in the future, it is determined that the results of genetic tests could affect your/your child’s
medical care, your/your child’s medical insurance may not pay for the costs of tests to confirm the
research results or for the costs of genetic counseling. If the results indicate that you/your child
might have one of these rare types of diabetes, it might cause you/your child anxiety or concern. If
this happens, Dr. Pihoker will be available to answer questions, and if appropriate, you/your child
will be referred to the appropriate local health professionals for evaluation and treatment. Genetic
testing has risks, including the potential for inaccurate results, unknown meaning of results, or
misuse of results by others. If genetic test results are sent to your/your child’s physician, they
would become part of your medical record, which could affect future employment or insurance
availability.
Test results
If it is determined that the results of these tests could impact your medical care, researchers would
give you/your child and your/your child’s provider any positive results along with information on
follow-up testing to confirm the research results. As a result of follow-up testing, treatment
changes might be recommended. It is possible some children may receive treatment for diabetes
Page 2 of 4. Seattle Children’s (FOR Group Health Pts. ONLY) Genetic Testing Consent 08 2013
that does not include the use of insulin. It would be very important that you not make any changes
in your/your child’s therapy without confirmation testing and consulting with your/your child’s
provider. Confirmation testing would need to be done in a CLIA-certified lab. You may need to
pay for confirmation testing
Privacy and Confidentiality
All information gathered during this study will be held in strict confidence. Any publication resulting
from participation in this study will not identify you/your child by name. Once you/your child decide
to join the research study, a one of a kind number, called a research study number, will be
assigned to you/your child. No other identifying information will be used. The research study
number will be used to identify only the test and interview information that was collected during the
research study. The research number assigned to you/your child, and not your child’s name, will
be sent to the study Coordinating Center at Wake Forest University in order to study the
information. The list containing the research study number assigned to you/your child will be kept
in a locked file in the research office of Dr. Pihoker, the research study's Principal Investigator. No
one other than Dr. Pihoker and her research team will be able to connect any of research study
information to you/your child.
All answers that you/your child give and other information gathered about you/your child during this
study will be kept private. This is so because this study has been given a Certificate of
Confidentiality. This means that anything you/your child tells us or information we learn about
you/your child will not have to be given out to anyone, even if a court orders us to do so, unless
you say it’s OK. But under the law, we must report to the state suspected cases of child abuse or if
you/your child tell us he/she is planning to cause serious harm to self or others.
There is a risk that if people other than the researchers obtain genetic information, they could
misuse it. Because the genetic test results are kept with a code number, not your name, we think
the chance of this happening is very small.
Taking Part in Research is Voluntary
Taking part in research is voluntary. You/your child may choose not to take part. If you/your child
do take part, you/your child may withdraw from this study at any time. If you/your child drop out of
the research study you can request that all blood or DNA samples that have been stored be
destroyed. Withdrawal from this research study will have no effect on access to medical care nor
will it have any effect on the standard of care your/your child’s health care professionals are
providing.
Compensation
You/your child will not receive any additional compensation for this part of the study.
Questions
For questions about the research or feel you have been harmed, please call Dr. Catherine Pihoker
at 206/987-2540. For questions about your/your child’s rights as a research participant, contact
the Seattle Children’s Institutional Review Board (IRB) at 206-987-7804. This committee reviews
the research and is responsible for protecting the rights and welfare of children and families taking
part in research.
________________________________
Signature of Researcher
Date/Time
Page 3 of 4. Seattle Children’s (FOR Group Health Pts. ONLY) Genetic Testing Consent 08 2013
Permissions:
Genetic Test Results
Do you give permission to have the results of genetic tests done for research purposes
communicated to you and your/your child’s diabetes provider, if it is determined that the results of
such tests could impact clinical care?
Yes, I give my permission
No, I do not give permission
Results to Participant/Parent or Guardian of Participant
Do you give permission to researchers to send these results to you/your child?
Yes, I give my permission
No, I do not give permission
Results to Your/Your Child’s Provider
Do you give permission to researchers to send these results to your/your child’s provider?
Yes, I give my permission
No, I do not give permission
Participant’s Statement
The study described above has been explained to me, and I voluntarily consent to genetic testing
of my/my child’s samples stored in this study. I have had the opportunity to ask questions and
understand future questions I may have about the research study or about research participants’
rights will be answered by the investigators listed above.
Please Note: If the person taking part in this research study is a foster child or a ward of the state,
then please tell the researcher or their staff.
_____________________________________________
Signature of Participant
Date/Time
_____________________________________________
Signature of Parent/Legal Guardian
Date/Time
Copies to: Participant/parent, Medical Record (when appropriate), Investigator’s file
Page 4 of 4. Seattle Children’s (FOR Group Health Pts. ONLY) Genetic Testing Consent 08 2013
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
ASSENT FORM
For Participants 7 - 13 Years of Age
8-20-13
COHORT VISIT
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
The Research Team:
Name/Degree
Title
Department
Catherine Pihoker, MD
Lenna Liu, MD MPH
Maryam Afkarian, MD
Irl Hirsch, MD
Carolyn Paris, MD
Joyce Yi-Frazier, PhD
Carla Greenbaum, MD
Martin Goldsmith, MD
Beth Babler, ARNP
Patricia Fechner, MD
Christian Roth, MD
Ildi Koves, MD
Craig Taplin, MD
Kate Ness, MD
Carolina DiBlasi, MD
Roja Motaghedi, MD
Erin Alving, ARNP
Karen Aitken, ARNP
Joanie Warner, ARNP
Sara Benitez, PA
Gwyn Recupero, PA
Beth Loots, MPH MSW
Sue Kearns, RN
Mary Klingsheim, RN, BSN
Jessica Fosse, MPH, RN,
BSN
Principal Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Research Manager
Study Coordinator
Study Coordinator
Study Coordinator
Endocrinology
Pediatrics
Nephrology
Medicine
Emergency
Endocrinology
Benaroya Res Instit
Peds Northwest
Mary Bridge
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Assent Form Template
Phone
Number
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206-987-2540
206 987-2540
206 987-2540
206 987-2540
8/20/2013
Page 1 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Name/Degree
Katherine Cochrane, BS
Sharla Semana, MSW
Patricia D’Alessandro, MA
Title
Department
Clinical Research
Associate
Clinical Research
Associate
Clinical Research
Associate
Endocrinology
Phone
Number
206 987-2540
Endocrinology
206 987-2540
Endocrinology
206 987-2540
Clinical Research Center: (206) 987-3897
If you have questions about your rights as a research study participant, you can call the
Institutional Review Board at (206) 987-7804.
24 hour Emergency Contact Number: 206 987-2000 Ask for the Endocrinologist on call
What is research?
Research studies help us learn new things. We can test new ideas. First, we ask a question.
Then we try to find the answer.
This paper talks about our research study. We want you to ask us any questions that you have.
You can ask questions anytime.
There are a few things you should know about the study:
• You get to decide if you want to be in the study.
• You can say ‘No’ or you can say ‘Yes’.
• Whatever you decide is OK.
• If you say ‘Yes’, you can always say ‘No’ later.
• No one will be upset if you say ‘No’.
• We will still take good care of you no matter what you decide.
Assent Form Template
8/20/2013
Page 2 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Why are we doing this research study?
We want to talk to you about this study because you have diabetes.
In this study we want to find out more about your health, and how diabetes affects you and your
family. We are trying to understand how children, teenagers, and young adults with diabetes
might develop nerve, heart, or eye damage.
What would happen if I join this study?
If you decide to be in the study:
•
•
•
•
•
•
•
•
We want to take some blood from your arm with a needle so we can do some tests on
the blood that tell us about your diabetes. This would take 10 – 20 minutes.
We want to look at some of the genes that we know have something to do with diabetes.
A sample from this blood will be kept in a freezer until we do tests on it.
We want to take some samples of your urine. This collection would take a few minutes.
We would give you a snack and/or a meal or meal voucher after the blood and urine are
collected.
We want to measure your height, weight, blood pressure, and waist. This will be a lot
like the measurements you get at your doctor’s office. This would take about 20
minutes.
We want to ask you some questions about feelings in your legs and feet. We want to
also test how well your feet can feel things using tools a lot like your doctor uses. This
would take about 10 minutes.
We want to place stickers on your wrists and left leg so that we can measure your
heartbeat. We would ask you to breathe normally for ten minutes. We would then check
your pulse on your thigh, and take your blood pressure again. We would touch your
wrist, neck, leg, and foot with a pen-shaped device. These tests will not hurt. They will
take about an hour and a half.
We want to ask you questions about your eyes and your eye doctor if you have one. We
would take pictures of the backs of your eyes using a special camera. This would take
about 30 minutes.
Assent Form Template
8/20/2013
Page 3 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
•
We want to ask you questions about how you take care of your diabetes. You and your
parents/caretakers will answer the questions. If you are over 8 years old, you will be
asked to fill out a self-report on your stage of puberty. If you are over 10 years old, you
will have some extra questions to answer about exercise, the foods you eat, smoking,
alcohol, and your sleeping habits. This would take about one hour.
•
We want to look in your medical record for information that is needed for the study.
•
We want to keep in contact with you in the future.
Could bad things happen if I join this research?
The researcher would need to test some of your blood. These pokes can hurt. Sometimes the
needle can leave a bruise on the skin. We can put a cream on your skin before we take blood.
This cream would help so it won’t hurt as much.
The researcher would need to ask you some questions. They might be hard to answer.
If I join the study would it help me?
We think being in this study would possibly help you because we will let you know what we
learn about your diabetes after the tests are done.
We hope to learn something from this study. And someday we hope it will help other kids who
have diabetes like you do.
What else should I know about this research?
Being in the study is your choice. You can say ‘Yes’ or ‘No’. Either way is OK.
It is also OK to say yes and change your mind later. You can stop being in the research at any
time. If you want to stop, please tell the research doctors.
Assent Form Template
8/20/2013
Page 4 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Your information:
We don’t plan to share your information. Or tell anyone if you join this study. But, there are a
few reasons we would tell someone:
• If we found out you were in serious danger.
• If we found out someone else was in serious danger.
Here are some examples of when we would tell someone:
• If you told us you were being abused.
• If you told us you were going to hurt yourself or someone else.
We would tell to protect you or someone else from being hurt.
Can I do something else instead?
If you don’t want to be in the study, you don’t have to be.
Would I be paid if I do research?
Once you finish the study, we would give you $120 in gift cards. You would get less if you did
only some of the study. We will ask some children to repeat some of the tests, and if we ask
you to do this we will give you an extra $10 gift card. You should talk with your parents about
how you would like to use these gift cards.
If I have questions who do I ask?
You can talk to Dr. Pihoker or the study team at 206-987-2540. Ask us any questions you have.
You can ask questions any time. Take the time you need to make your choice.
Assent Form Template
8/20/2013
Page 5 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Child’s/Adolescent’s Statement
The researchers have told me about the research. I had a chance to ask questions. I know I
can ask questions any time. I want to be in the research.
Remember - being in the research is up to you. No one will be upset if you don’t sign this paper
or if you change your mind later.
Name of Child/Adolescent
____________________________________
Signature of Child/Adolescent
Date
__________________
Name of Researcher
___________________________
Signature of Researcher
Date/Time
____________________________________
_______________________________
____________________
Interpreter Information Section:
Note: The researcher only writes the interpreter’s name if the assent is documented via a
corresponding translated assent form.
______________________________________
Printed Name of Interpreter (if interpreter is used)
Date/Time
______________________________________
Printed Name of Interpreter (if interpreter is used)
Date/Time
Original form to:
Research Team File
Copies to:
Participant
Parents/Guardians
Medical Records (if appropriate)
Assent Form Template
8/20/2013
Page 6 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
ASSENT FORM
For Participants 7 - 13 Years of Age
8-20-13
REGISTRY VISIT (2012 Cohort)
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
The Research Team:
Name/Degree
Title
Department
Catherine Pihoker, MD
Lenna Liu, MD MPH
Maryam Afkarian, MD
Irl Hirsch, MD
Carolyn Paris, MD
Joyce Yi-Frazier, PhD
Principal Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Carla Greenbaum, MD
Co-Investigator
Martin Goldsmith, MD
Beth Babler, ARNP
Patricia Fechner, MD
Christian Roth, MD
Ildi Koves, MD
Craig Taplin, MD
Kate Ness, MD
Carolina DiBlasi, MD
Roja Motaghedi, MD
Erin Alving, ARNP
Karen Aitken, ARNP
Joanie Warner, ARNP
Sara Benitez, PA
Gwyn Recupero, PA
Beth Loots, MPH MSW
Sue Kearns, RN
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Research Manager
Study Coordinator
Endocrinology
Pediatrics
Nephrology
Medicine
Emergency
Endocrinology
Benaroya Res
Instit
Peds Northwest
Mary Bridge
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Assent Form Template
Phone
Number
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206-987-2540
206 987-2540
8/20/2013
Page 1 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Name/Degree
Title
Department
Mary Klingsheim, RN, BSN
Jessica Fosse, MPH, RN,
BSN
Katherine Cochrane, BS
Sharla Semana, MSW
Patricia D’Alessandro, MA
Study Coordinator
Study Coordinator
Endocrinology
Endocrinology
Phone
Number
206 987-2540
206 987-2540
Clinical Research Associate
Clinical Research Associate
Clinical Research Associate
Endocrinology
Endocrinology
Endocrinology
206 987-2540
206 987-2540
206 987-2540
Clinical Research Center: (206) 987-3897
If you have questions about your rights as a research study participant, you can call the
Institutional Review Board at (206) 987-7804.
24 hour Emergency Contact Number: 206 987-2000 Ask for the Endocrinologist on call
What is research?
Research studies help us learn new things. We can test new ideas. First, we ask a question.
Then we try to find the answer.
This paper talks about our research study. We want you to ask us any questions that you have.
You can ask questions anytime.
There are a few things you should know about the study:
• You get to decide if you want to be in the study.
• You can say ‘No’ or you can say ‘Yes’.
• Whatever you decide is OK.
• If you say ‘Yes’, you can always say ‘No’ later.
• No one will be upset if you say ‘No’.
• We will still take good care of you no matter what you decide.
Assent Form Template
8/20/2013
Page 2 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Why are we doing this research study?
We want to talk to you about this study because you have diabetes.
In this study we want to find out about the types of diabetes children and teenagers have. We
also want to find out how many children and teenagers who live around your area have
diabetes. We also want to learn more about your health, and how diabetes affects you and
your family.
What would happen if I join this study?
If you decide to be in the study:
•
•
•
•
•
•
•
We want to take some blood from your arm with a needle so we can do some tests on
the blood that tell us about your diabetes. This would take 10 – 20 minutes.
We want to look at some of the genes that we know have something to do with diabetes.
A sample from this blood will be kept in a freezer until we do tests on it.
We want to take some samples of your urine. This collection would take a few minutes.
We would give you a free breakfast or meal voucher after the blood and urine are
collected.
We want to measure your height, weight, blood pressure, and waist. This will be a lot
like the measurements you get at your doctor’s office. This would take about 20
minutes.
We want to ask you questions about the medications you take. You and your
parents/caretakers will answer the questions. This would take about 20 minutes.
We want to keep in contact with you in the future.
Assent Form Template
8/20/2013
Page 3 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Could bad things happen if I join this research?
The researcher would need to test some of your blood. These pokes can hurt. Sometimes the
needle can leave a bruise on the skin. We can put a cream on your skin before we take blood.
This cream would help so it won’t hurt as much.
The researcher would need to ask you some questions. They might be hard to answer.
If I join the study would it help me?
We think being in this study would possibly help you because we will let you know what we
learn about your diabetes after the tests are done.
We hope to learn something from this study. And someday we hope it will help other kids who
have diabetes like you do.
What else should I know about this research?
Being in the study is your choice. You can say ‘Yes’ or ‘No’. Either way is OK.
It is also OK to say yes and change your mind later. You can stop being in the research at any
time. If you want to stop, please tell the research doctors.
Your information:
We don’t plan to share your information. Or tell anyone if you join this study. But, there are a
few reasons we would tell someone:
• If we found out you were in serious danger.
• If we found out someone else was in serious danger.
Here are some examples of when we would tell someone:
• If you told us you were being abused.
• If you told us you were going to hurt yourself or someone else.
• If you or your parent told us you did not have enough to eat.
We would tell to protect you or someone else from being hurt.
Assent Form Template
8/20/2013
Page 4 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Can I do something else instead?
If you don’t want to be in the study, you don’t have to be.
Would I be paid if I do research?
To thank you for completing the visit, we would give you $80 in gift cards. You should talk with
your parents about how you would like to use these gift cards.
If I have questions who do I ask?
You can talk to Dr. Pihoker or the study team at 206-987-2540. Ask us any questions you have.
You can ask questions any time. Take the time you need to make your choice.
Child’s/Adolescent’s Statement
The researchers have told me about the research. I had a chance to ask questions. I know I
can ask questions any time. I want to be in the research.
Remember - being in the research is up to you. No one will be upset if you don’t sign this paper
or if you change your mind later.
Name of Child/Adolescent
____________________________________
Signature of Child/Adolescent
Date
____________________________________
__________________
Assent Form Template
8/20/2013
Page 5 of 6
IRB #: 12074
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: August 2013
Protocol Version: December 2010
Name of Researcher
___________________________
Signature of Researcher
Date/Time
_______________________________
____________________
Interpreter Information Section:
Note: The researcher only writes the interpreter’s name if the assent is documented via a
corresponding translated assent form.
______________________________________
Printed Name of Interpreter (if interpreter is used)
______________________________________
Printed Name of Interpreter (if interpreter is used)
Date/Time
Date/Time
Original form to:
Research Team File
Copies to:
Participant
Parents/Guardians
Medical Records (if appropriate)
Assent Form Template
8/20/2013
Page 6 of 6
SEATTLE CHILDREN’S
UNIVERSITY OF WASHINGTON
SEARCH for Diabetes in Youth
Monogenic Ancillary Study
Assent Form: Initial Genetic Testing
To be read to children younger than age 7, and read and signed by children ages 7 to 13
Principal investigator:
Co-investigators:
8-20-13
Study Coordinators:
Catherine Pihoker, MD, Department of Endocrinology, 206/987-5037
Lenna L. Liu, MD, MPH, Department of Pediatrics, 206/987-5037
Maryam Afkarian, MD, Department of Nephrology, 206/987-5037
Irl Hirsch, MD, Department of Medicine, 206/987-5037
Carolyn Paris, MD, Department of Emergency Medicine, 206/987-5037
Joyce Yi-Frazier, PhD, Department of Endocrinology, 206/987-5037
Carla Greenbaum, MD, Clinical Research Center, 206/987-5037
Martin Goldsmith, MD, Pediatrics Northwest, 206/987-5037
Beth Babler, ARNP, Mary Bridge, 206/987-5037
Patricia Fechner, MD, Department of Endocrinology, 206/987-5037
Christian Roth, MD, Department of Endocrinology, 206/987-5037
Ildi Koves, MD, Department of Endocrinology, 206/987-5037
Craig Taplin, MD, Department of Endocrinology, 206/987-5037
Kate Ness, MD, Department of Endocrinology, 206/987-5037
Carolina DiBlasi, MD, Department of Endocrinology, 206/987-5037
Roja Motaghedi, MD, Department of Endocrinology, 206/987-5037
Erin Alving, ARNP, Department of Endocrinology, 206/987-5037
Karen Aitken, ARNP, Department of Endocrinology, 206/987-5037
Joanie Warner, ARNP, Department of Endocrinology, 206/987-5037
Sara Benitez, PA, Department of Endocrinology, 206/987-5037
Gwyn Recupero, PA, Department of Endocrinology, 206/987-5037
Beth Loots, MPH, MSW, Department of Endocrinology, 206/987-2540
Sue Kearns, RN, Department of Endocrinology, 206/987-2540
Mary Klingsheim RN BSN, Department of Endocrinology, 206/987-2540
Jessica Fosse, MPH RN BSN, Department of Endocrinology, 206/987-2540
Katherine Cochrane, BS, Department of Endocrinology, 206/987-2540
Sharla Semana, MSW, Department of Endocrinology, 206/987-2540
Patricia D’Alessandro, MA, Department of Endocrinology, 206/987-2540
24-hour emergency telephone number:
Catherine Pihoker, MD, or Pediatric Endocrinologist on call: 206/987-2000
There are different kinds of diabetes. Children who get diabetes when they are very little may
have a special kind of diabetes caused by one of the genes in the body. These special kinds of
diabetes may run in the family. The treatment for these special kinds of diabetes may be different.
We want to find out if you have one of these special kinds of diabetes. We also want to learn more
about your health, and how diabetes affects you and your family.
We will ask you to do the things that have a check √ in the box:
Page 1 of 2. Seattle Children’s Monogenic Study, Initial Genetic Testing Assent. 08 2013
We will take some blood from your arm with a needle.
The needle poke may hurt a little, but
the nurse can apply a numbing cream to the area so it will not hurt as much. You may have
a bruise on your arm but this should not last long. A sample from this blood will be kept in a
freezer until we do tests on it. We will then test for some of the changed genes that we see
in children who get diabetes when they are very little. This will help us to find out if you
have a special kind of diabetes.
We will take a saliva (spit) sample. You will spit about 2 teaspoons of saliva into a container.
This will take between 10 and 20 minutes. We will then test for some of the changed genes
that we see in children who develop diabetes when they are very little. This will help us to
find out if you have a special kind of diabetes.
We want to ask you questions about your health and how you take care of your diabetes.
We also want to ask you questions about who else in your family has diabetes. You and
your parents/caretakers will answer the questions. This will take about 20 minutes.
We will give you a $20 gift card for doing these blood tests, giving these spit samples, or
answering these questions.
If you don’t want to do something, tell us and we will stop.
You don’t have to be in this study if you don’t want to. It is OK to say No. If you do say yes, you
can stop any time. We’ll answer all of your questions any time.
___________________________________
Researcher’s signature
_______________
Date/Time
Child’s Statement
The doctor has told me about this study. I want to be in it.
____________________________________
Child’s signature
_______________
Date
__________________________________
Parent or Legal Guardian’s signature
_______________
Date/Time
Copies to: Child/Parent, Medical Record (when appropriate), Investigators file
Page 2 of 2. Seattle Children’s Monogenic Study, Initial Genetic Testing Assent. 08 2013
SEATTLE CHILDREN’S
UNIVERSITY OF WASHINGTON
SEARCH for Diabetes in Youth
Monogenic Ancillary Study
Assent Form: Confirmation of Positive Result
To be read to children younger than age 7, and read and signed by children ages 7 to 13
Principal investigator:
Co-investigators:
8-20-13
Study Coordinators:
Catherine Pihoker, MD, Department of Endocrinology, 206/987-5037
Lenna L. Liu, MD, MPH, Department of Pediatrics, 206/987-5037
Maryam Afkarian, MD, Department of Nephrology, 206/987-5037
Irl Hirsch, MD, Department of Medicine, 206/987-5037
Carolyn Paris, MD, Department of Emergency Medicine, 206/987-5037
Joyce Yi-Frazier, PhD, Department of Endocrinology, 206/987-5037
Carla Greenbaum, MD, Clinical Research Center, 206/987-5037
Martin Goldsmith, MD, Pediatrics Northwest, 206/987-5037
Beth Babler, ARNP, Mary Bridge, 206/987-5037
Patricia Fechner, MD, Department of Endocrinology, 206/987-5037
Christian Roth, MD, Department of Endocrinology, 206/987-5037
Ildi Koves, MD, Department of Endocrinology, 206/987-5037
Craig Taplin, MD, Department of Endocrinology, 206/987-5037
Kate Ness, MD, Department of Endocrinology, 206/987-5037
Carolina DiBlasi, MD, Department of Endocrinology, 206/987-5037
Roja Motaghedi, MD, Department of Endocrinology, 206/987-5037
Erin Alving, ARNP, Department of Endocrinology, 206/987-5037
Karen Aitken, ARNP, Department of Endocrinology, 206/987-5037
Joanie Warner, ARNP, Department of Endocrinology, 206/987-5037
Sara Benitez, PA, Department of Endocrinology, 206/987-5037
Gwyn Recupero, PA, Department of Endocrinology, 206/987-5037
Beth Loots, MPH, MSW, Department of Endocrinology, 206/987-2540
Sue Kearns, RN, Department of Endocrinology, 206/987-2540
Mary Klingsheim RN BSN, Department of Endocrinology, 206/987-2540
Jessica Fosse, MPH RN BSN, Department of Endocrinology, 206/987-2540
Katherine Cochrane, BS, Department of Endocrinology, 206/987-2540
Sharla Semana, MSW, Department of Endocrinology, 206/987-2540
Patricia D’Alessandro, MA, Department of Endocrinology, 206/987-2540
24-hour emergency telephone number:
Catherine Pihoker, MD, or Pediatric Endocrinologist on call: 206/987-2000
There are different kinds of diabetes. Some kinds of diabetes are caused by a change in one of
the genes in the body. These special kinds of diabetes may run in the family. The treatment for
these special kinds of diabetes may be different. A while ago, you gave a blood and/or spit sample
as part of the SEARCH study. This sample was tested for changes in genes that cause diabetes.
Your test came back positive. We want to make sure that this positive test is right. This might help
your doctor in taking care of you. We also want to find out how many children have this special
kind of diabetes that you probably have. We want to learn more about this special kind of diabetes
so that we can help other children.
Page 1 of 2. Seattle Childrens Monogenic Study, Confirmatory Testing Assent. 08 2013
We will ask you to do the things that have a check √ in the box:
We will take some blood from your arm with a needle.
The needle poke may hurt a little, but
the nurse can apply a numbing cream to the area so it will not hurt as much. You may have
a bruise on your arm but this should not last long. A sample from this blood will be kept in a
freezer until we do tests on it. We will then test for some of the changed genes that we see
in children who develop diabetes when they are very little. This will help us to find out if you
have a special kind of diabetes.
We will take a saliva (spit) sample. You will spit about 2 teaspoons of saliva into a container.
We will then test for some of the changed genes that we see in children who develop
diabetes when they are very little. This will help us to find out if you have a special kind of
diabetes. This will take between 10 and 20 minutes.
We want to ask you questions about your health and how you take care of your diabetes.
We also want to ask you questions about who else in your family has diabetes. You and
your parents/caretakers will answer the questions. This will take about 20 minutes.
We will give you a $20 gift card for doing these blood tests, giving these spit samples, or
answering these questions.
If you don’t want to do something, tell us and we will stop.
You don’t have to be in this study if you don’t want to. It is OK to say No. If you do say yes, you
can stop any time. We’ll answer all of your questions any time.
___________________________________
Researcher’s signature
_______________
Date/Time
Child’s Statement
The doctor has told me about this study. I want to be in it.
____________________________________
Child’s signature
_______________
Date
__________________________________
Parent or Legal Guardian’s signature
_______________
Date/Time
Copies to: Child/Parent, Medical Record (when appropriate), Investigators file
Page 2 of 2. Seattle Childrens Monogenic Study, Confirmatory Testing Assent. 08 2013
SEATTLE CHILDREN’S
UNIVERSITY OF WASHINGTON
SEARCH for Diabetes in Youth
Monogenic Ancillary Study
Assent Form: Family Members
To be read to children younger than age 7, and read and signed by children ages 7 to 13
Principal investigator:
Co-investigators:
8-20-13
Study Coordinators:
Catherine Pihoker, MD, Department of Endocrinology, 206/987-5037
Lenna L. Liu, MD, MPH, Department of Pediatrics, 206/987-5037
Maryam Afkarian, MD, Department of Nephrology, 206/987-5037
Irl Hirsch, MD, Department of Medicine, 206/987-5037
Carolyn Paris, MD, Department of Emergency Medicine, 206/987-5037
Joyce Yi-Frazier, PhD, Department of Endocrinology, 206/987-5037
Carla Greenbaum, MD, Clinical Research Center, 206/987-5037
Martin Goldsmith, MD, Pediatrics Northwest, 206/987-5037
Beth Babler, ARNP, Mary Bridge, 206/987-5037
Patricia Fechner, MD, Department of Endocrinology, 206/987-5037
Christian Roth, MD, Department of Endocrinology, 206/987-5037
Ildi Koves, MD, Department of Endocrinology, 206/987-5037
Craig Taplin, MD, Department of Endocrinology, 206/987-5037
Kate Ness, MD, Department of Endocrinology, 206/987-5037
Carolina DiBlasi, MD, Department of Endocrinology, 206/987-5037
Roja Motaghedi, MD, Department of Endocrinology, 206/987 5037
Erin Alving, ARNP, Department of Endocrinology, 206/987-5037
Karen Aitken, ARNP, Department of Endocrinology, 206/987-5037
Joanie Warner, ARNP, Department of Endocrinology, 206/987-5037
Sara Benitez, PA, Department of Endocrinology, 206/987-5037
Gwyn Recupero, PA, Department of Endocrinology, 206/987-5037
Beth Loots, MPH, MSW, Department of Endocrinology, 206/987-2540
Sue Kearns, RN, Department of Endocrinology, 206/987-2540
Mary Klingsheim RN BSN, Department of Endocrinology, 206/987-2540
Jessica Fosse, MPH RN BSN, Department of Endocrinology, 206/987-2540
Katherine Cochrane, BS, Department of Endocrinology, 206/987-2540
Sharla Semana, MSW, Department of Endocrinology, 206/987-2540
Patricia D’Alessandro, MA, Department of Endocrinology, 206/987-2540
24-hour emergency telephone number:
Catherine Pihoker, MD, or Pediatric Endocrinologist on call: 206/987-2000
There are different kinds of diabetes. Some kinds of diabetes are caused by a change in one of
the genes in the body. These special kinds of diabetes may run in the family. The treatment for
these special kinds of diabetes may be different. A while ago, your sister or brother was tested for
changes in genes that can cause diabetes. The test was positive. We want to find out if you also
have a change in the same gene. This will help us to understand if the changed gene is causing
your sister or brother’s diabetes. If you do not have diabetes and you are 10 years old or older, we
may test you for diabetes by measuring how much insulin is made after you eat.
Page 1 of 3. Seattle Children’s Monogenic Study, Family Members Assent. 08 2013
We will ask you to do the things that have a check √ in the box:
We will take some blood from your arm with a needle.
The needle poke may hurt a little, but
the nurse can apply a numbing cream to the area so it will not hurt as much. You may have
a bruise on your arm but this should not last long. A sample from this blood will be kept in a
freezer until we do tests on it. We will then test for the same changed gene(s) that we found
in your sister or brother.
We will take a saliva (spit) sample. You will spit about 2 teaspoons of saliva into a container.
We will then test for the same changed gene that we found in your sister or brother. This
will take between 10 and 20 minutes.
We will test to see if you have diabetes. You cannot eat any food, or drink anything except
water, the morning of the test. You might feel hungry before the test is done. We will put a
small tube called a catheter in a vein in your arm. The nurse will apply a numbing cream to
the area so it will not hurt as much. The needle-poke when we put the tube in your arm
may still hurt a little. Once the needle is in your arm, drawing the blood should not hurt you
at all. First we will take some blood from your arm. Then you will drink a milkshake-like
drink over a short period of time. After 2 hours, we will take some more blood from the
catheter that is in your arm. You may have a small bruise from where the needle was in
your arm, but this should not last a long time. After the test is done, you can eat breakfast.
A total of 2 blood samples will be drawn and the whole test should take about 2 to 2 ½
hours. We will let you know what we learn after the tests are done.
We want to ask you questions about your health and, if you have diabetes, how you take
care of your diabetes. We also want to ask you questions about who else in your family has
diabetes. You and your parents/caretakers will answer the questions. This will take about
20 minutes.
We will give you a $20 gift card for doing these blood tests, giving these spit samples, taking the
diabetes milkshake test, or answering these questions.
If you don’t want to do something, tell us and we will stop.
You don’t have to be in this study if you don’t want to. It is OK to say No. If you do say yes, you
can stop any time. We’ll answer all of your questions any time.
___________________________________
Researcher’s signature
_______________
Date/Time
Page 2 of 3. Seattle Children’s Monogenic Study, Family Members Assent. 08 2013
Child’s Statement
The doctor has told me about this study. I want to be in it.
____________________________________
Child’s signature
_______________
Date
__________________________________
Parent or Legal Guardian’s signature
_______________
Date/Time
Copies to: Child/Parent, Medical Record (when appropriate), Investigators file
Page 3 of 3. Seattle Children’s Monogenic Study, Family Members Assent. 08 2013
Permission to Use, Create and Share Health Information for Research
Research Study Title: SEARCH for Diabetes in Youth
IRB Study #: 12074
The federal Privacy Rule protects your/your child’s health information. The Privacy Rule is part of
the Health Insurance Portability and Accountability Act (HIPAA).
If you/your child agree to take part in this research study (named above), the researchers may use,
create or share your/your child’s health information as part of the research. The researchers will do
so only if you give permission to use, create or share your/your child’s health information as part of
the research. This form gives you information to help you decide if you will give such permission.
Please read this form carefully. After reading this form, you can refuse to sign this form.
What does “health information” include? It includes:
Name
Address
Social Security Number
Medical and/or birth history
Demographic information
Results of physical exams
Results of laboratory and/or radiology tests
Interview and/or focus group data
Survey and/or questionnaire data
Results of behavioral tests
Information related to your health condition
Information in your medical record relevant to this study
Other (please specify) *
* If using a translated HIPAA Form, this information must also be translated
What the researchers may do with health information
Researchers may create new health information about you/your child during the study. Researchers
may use health information in your/your child’s records.
Researchers may also share health information about you/your child collected during the study with
the following:
1. The sponsor of this study and its representatives. Sponsor Name: Centers for Disease
Control/National Institute of Digestive & Kidney Diseases/JDRF
2. Researchers at other centers taking part in this research study.
Name(s) of other center(s): Cincinnati Children’s Hospital Medical Center,
University of Colorado, Pacific Health Research Institute (HI), University of North
Carolina, University of South Carolina, Southern California Kaiser Permanente,
Wake Forest University, Northwest Lipid Research Labs, University of
Washington; and the Molecular Genetics Laboratory, Royal Devon and Exeter
NHS Healthcare Trust, Exeter, U.K., Ocular Epidemiology Reading Center at the
University of Wisconsin – Madison, and the University of Michigan
Permission to Use, Create and Share Health Information on Research
Form Version 04/11/13
Page 1 of 4
3. Government agencies, ethics review boards, data and safety monitoring boards, and
others responsible for watching over the safety, effectiveness, and conduct of the
research.
4. Your health care insurance company if it is paying for care provided as part of the
research study.
5. Other health care providers involved in your/your child’s care.
6. National Institutes of Health and its grantholders for the purpose of research
administrative activities (e.g., tracking overall research activity).
7. Others, as provided by law.
The Privacy Rule applies to doctors, hospitals and other health care providers. Some of the
groups listed above are not required to follow the Privacy Rule and may share your/your child’s
information with others, if other laws allow. However, other privacy protections may still apply.
Research Records
You may look at or copy the information that may be used or disclosed. However, for certain types
of research studies, some of the research records may not be available to you/your child while the
study is going on. This does not affect your right to see what is in your/your child’s medical
(hospital) records.
The researchers may publish or present the research findings. You/your child will not be identified
in any findings that are published or presented.
The federal Privacy Rule does not apply to health information that is not identified in any way. The
researchers may decide to remove any information that could identify you/your child. If they do
this, the information may be used and shared by the researchers and the sponsor as the law allows.
This may include use in other research studies.
Permissions to Take Part in Research
If you agree to take part or allow your child to take part in the research, you will be asked to sign a
research consent form. The research consent form gives you details about the research. The
consent form describes the risks and benefits of the research. It explains the purpose of the study,
what will happen and other important information for you to know.
To be in this research study, you must also sign this permission form (Permission to Use, Create
and Share Health Information for Research). If you do not want to sign this permission form, this
will not affect the care and treatment you or your child receive.
How Long does the Permission Last? What if You Change Your Mind?
This permission will not expire, but you may cancel it at any time.
If you change your mind and want to cancel your permission, please let us know in writing. Write
to Principal Investigator (PI)/Researcher:
[Name and Address of PI]. Catherine Pihoker, MD, Seattle Children’s, 4800 Sand Point Way
NE/OC.7.820, Seattle, WA 98105-0371
Permission to Use, Create and Share Health Information on Research
Form Version 04/11/13
Page 2 of 4
If you cancel your permission and you/your child are a patient at Children’s, please send a
copy of your letter to:
Director of Health Information and Privacy, Health Information Management, M/S OC.6.820,
Seattle Children’s, 4800 Sand Point Way NE, Seattle, WA 98105-0371.
If you cancel your permission, no other health information about you/your child will be collected
for this research. However, the health information that was received with your permission may be
shared or used. For example, researchers may need to use or share this information:
• for safety reasons;
• to verify the research data;
• if required by law.
If you agree to take part or allow your child to take part, you will be given a copy of this permission
form after you have signed it.
Permission
I agree to the use, creation, and sharing of my or my child’s health information for purposes of this
research study (named on page 1). For Children’s patients, your medical record # will be recorded
on this form and used to place a copy of this form in your medical record.
_____________________________
_______________________________
Printed Name of Participant
Signature of Participant (if 18 years or Older)
_______________
_____________
Date
Time
_____________________________
Printed Name of Participant’s Parent or
Legal Representative
_______________
_______________________________
Signature of Research Participant’s Parent or
Legal Representative (if younger than18 years)
_____________
Date
Time
Researcher Obtaining Authorization
__________________________________
Printed Name of Research Team Member*
_________________________________
Signature of Research Team Member
___________
_____________
Date
Time
Permission to Use, Create and Share Health Information on Research
Form Version 04/11/13
Page 3 of 4
*INSTRUCTIONS TO RESEARCHER
1. File signed original of this form in Research File
2. Provide copy of signed form to Research Participant/Parent
For Children’s Patients
3. Complete or attach patient label:
Participant’s Medical Record # __________________
Participant’s Date of Birth
_____/______/______
4. Send copy of the signed form to Health Information Filing: Mailstop OC.6.820
Permission to Use, Create and Share Health Information on Research
Form Version 04/11/13
Page 4 of 4
Permiso para utilizar, crear y compartir información para fines de investigación
Título del estudio de investigación: SEARCH for Diabetes in Youth
N.º de estudio del IRB: 12074
La Regla de privacidad federal protege su información/la información de salud de su hijo. La Regla
de privacidad es parte de la Ley de Responsabilidad y Portabilidad del Seguro de Salud (Health
Insurance Portability and Accountability Act, “HIPAA”).
Si usted/su hijo acepta participar en este estudio de investigación (nombrado arriba), los
investigadores podrán usar, crear o compartir su información de salud/la información de salud de su
hijo como parte de la investigación. Los investigadores lo harán únicamente si usted da permiso
para utilizar, crear o divulgar su información de salud/la información de salud de su hijo como parte
de la investigación. En este formulario se le proporciona información para ayudarle a decidir si
dará ese permiso. Lea este formulario con atención. Después de leer el formulario, puede
rehusarse a firmarlo.
¿Qué incluye la “información de salud”? Incluye:
Nombre
Name
Dirección
Address
Núm. Seguro Social
Social Security Number
Antecedentes médicos y/o de nacimiento
Medical and/or birth history
Información demográfica
Demographic information
Resultados de los exámenes médicos
Results of physical exams
Resultados de análisis y/o estudios radiográficos
Results of laboratory and/or radiology tests
Datos de entrevistas y/o grupos de enfoque
Interview and/or focus group data
Datos de encuestas y/o cuestionarios
Survey and/or questionnaire data
Resultados de pruebas conductuales
Results of behavioral tests
Información relacionada con su problema médico
Information related to your health condition
Información de su expediente médico pertinente a este estudio
Information in your medical record relevant to this study
Otra (explique)*
Other (please specify)*
* Si está usando un formulario HIPAA traducido, esta información también tiene que estar traducida.
* If using a translated HIPAA Form, this information must also be translated
Lo que los investigadores pueden hacer con información de salud
Los investigadores pueden crear nueva información de salud acerca de usted/su hijo durante el
estudio. Los investigadores pueden utilizar la información de salud que se encuentra en su
expediente clínico/en el expediente clínico de su hijo.
También puede ser necesario que los investigadores compartan información de salud sobre usted/su
hijo obtenida durante el estudio con las siguientes personas o entidades:
Permission to Use, Create and Share Health Information on Research / Spanish
Form Version 04/11/13
Página 1 de 5
1. El patrocinador de este estudio y sus representantes. Nombre del patrocinador:
2.
3.
4.
5.
6.
7.
Centers for Disease Control/National Institute of Digestive & Kidney
Diseases/JDRF
Investigadores en otros centros que están participando en este estudio de investigación.
Nombres de los otros centros: Cincinnati Children’s Hospital Medical Center,
University of Colorado, Pacific Health Research Institute (HI), University of North
Carolina, University of South Carolina, Southern California Kaiser Permanente,
Wake Forest University, Northwest Lipid Research Labs, University of
Washington; and the Molecular Genetics Laboratory, Royal Devon and Exeter
NHS Healthcare Trust, Exeter, U.K., Ocular Epidemiology Reading Center at the
University of Wisconsin – Madison, and the University of Michigan
Dependencias del gobierno, comités de ética, consejos que supervisan los datos y la
seguridad, y otros responsables por velar por la seguridad, la eficacia y la conducta de la
investigación.
Su compañía de seguro médico, si ellos están pagando por la atención facilitada como
parte del estudio de investigación.
Otros proveedores de atención de la salud que participan en la atención de usted/de su
hijo.
National Institutes of Health y los cesionarios de sus subvenciones para fines de
actividades administrativas de la investigación (p. ej. para llevar seguimiento de toda
actividad de la investigación).
Otras entidades o personas según lo disponga la ley.
La Regla de privacidad corresponde a médicos, hospitales y otros proveedores atención de la
salud. Algunos de los grupos enumerados más arriba no tienen obligación de observar la Regla de
privacidad y podrán divulgar su información de salud/la información de salud de su hijo a otras
personas o entidades, si otras leyes lo permiten. No obstante, podrían corresponder aún otras
protecciones de la privacidad.
Expedientes de la investigación
Usted puede ver o copiar la información que podría usarse o divulgarse. Sin embargo, en ciertos
tipos de estudios de investigación es posible que parte de los expedientes de la investigación no
estén a su disposición en el transcurso del estudio. Eso no afecta su derecho de ver lo que se
encuentra en su expediente clínico/el expediente clínico de su hijo.
Los investigadores podrían publicar o presentar los resultados de sus investigaciones. Usted/su hijo
no serán identificados en ningunos resultados que sean publicados o presentados.
La Regla de privacidad federal no corresponde a información de salud que no está identificada de
manera alguna. Es posible que los investigadores decidan retirar cualquier información que pudiera
identificar a usted/su hijo. Si lo hacen, la información podrá ser utilizada y compartida entre los
investigadores y el patrocinador según lo permita la ley. Eso podría incluir el uso en otros estudios
investigación.
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Form Version 04/11/13
Página 2 de 5
Permiso para participar en la investigación
Si usted acepta participar o permite que su hijo participe en la investigación, se le pedirá que firme
un formulario de consentimiento. El formulario de consentimiento para investigación proporciona
los detalles sobre la investigación. En el formulario de consentimiento se describen los riesgos y
beneficios de la investigación. En él se explica el propósito del estudio, lo que ocurrirá y otra
información importante que usted necesita saber.
Para poder participar en este estudio de investigación, usted también deberá firmar este
formulario de permiso (Permiso para utilizar, crear y compartir información para fines de
investigación). Si usted no desea firmar este formulario de autorización, eso no tendrá ningún
efecto sobre la atención y el tratamiento que usted o su hijo reciba.
¿Cuánto tiempo dura el permiso? ¿Qué ocurrirá si cambia de parecer?
Este permiso no tiene vencimiento, pero lo puede cancelar en cualquier momento.
Si cambia de parecer y desea cancelar su permiso, por favor avísenos por escrito. Envíe su
correspondencia al investigador principal:
[Nombre y dirección del IP] Catherine Pihoker, MD, Seattle Children’s, 4800 Sand Point Way
NE/OC.7.820, Seattle, WA 98105-0371
[Name and Address of PI]
Si cancela su permiso y usted/su hijo es un paciente de Children’s, sírvase enviar una copia de
su correspondencia a:
Director of Health Information and Privacy, Health Information Management, OC.6.820, Seattle
Children’s, 4800 Sand Point Way NE, Seattle, WA 98105-0371.
Si cancela su permiso, no se recolectará ninguna otra información de salud sobre usted/su hijo para
esta investigación. Sin embargo, la información de salud que haya sido obtenida con su permiso
podrá ser divulgada o utilizada. Por ejemplo, podría ser necesario que los investigadores utilicen o
divulguen esta información:
• por motivos de seguridad;
• para verificar los datos de la investigación;
• si la ley lo dispone.
Si usted acepta participar o permitir que su hijo participe, le entregarán una copia de este formulario
de permiso después de que lo firme.
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Form Version 04/11/13
Página 3 de 5
Permiso
Yo convengo al uso, creación y divulgación de mi información de salud/la información de salud de
mi hijo para los fines de este estudio de investigación (nombrado en la página 1). Para los pacientes
de Children’s, su número de expediente clínico se anotará en este formulario y se utilizará para
incluir una copia de este formulario en su expediente clínico.
__________________________________
_____________________________
Nombre del participante
(en letra de imprenta)
Firma del participante
(si es mayor de 18 años)
Printed Name of Participant
Signature of Participant (if 18 years or Older)
_______________
_______________
Fecha
Date
Hora
Time
__________________________________
_____________________________
Nombre impreso del padre, madre o tutor
legal del participante
Firma del padre, madre o tutor legal del
participante de la investigación
(si es menor de 18 años)
Printed Name of Participant’s Parent or
Legal Representative
Signature of Research Participant’s Parent or
Legal Representative (if younger than18 years)
_______________
_______________
Fecha
Date
Hora
Time
Investigador que obtuvo la autorización
__________________________________
_____________________________
Nombre del miembro del equipo de la
investigación (en letra de imprenta)*
Firma del miembro del equipo de la
investigación
Printed Name of Research Team Member*
Signature of Research Team Member
_______________
_______________
Fecha
Date
Hora
Time
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Form Version 04/11/13
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*INSTRUCCIONES PARA EL INVESTIGADOR
*INSTRUCTIONS TO RESEARCHER
1. Archive el original firmado de este formulario en el archivo de la investigación
File signed original of this form in Research File
2. Proporcione una copia del formulario firmado al participante/padre/madre
Provide copy of signed form to Research Participant/Parent
Para pacientes del Children’s (For Children’s Patients)
3. Complete o adjunte la etiqueta del paciente:
Complete or attach patient label:
No. de expediente médico del participante _______________
Participant’s Medical Record #
Fecha de nacimiento del participante _____/______/______
Participant’s Date of Birth
4. Envíe una copia del formulario firmado a Health Information Filing: Mailstop OC.6.820
Send copy of the signed form to Health Information Filing: Mailstop OC.6.820
Permission to Use, Create and Share Health Information on Research / Spanish
Form Version 04/11/13
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Tso Cai los Siv, Tsim thiab Qhia Lus Txog Kev Mob rau Kev Tshawb Xyuas
Lub Npe Rau Kev Tshawb Xyuas:
Kev Kawm IRB #:
Txoj cai ntawm tebchaw hu ua Privacy Rule (tsab cai tsis pub qhia) tiv thaiv koj/koj tus menyuam
cov lus qhia txog kev mob. Txoj cai Privacy Rule yog ib qho ntawm qhov Health Insurance
Portability and Accountability Act (HIPAA; txoj cai saib xyuas cov kev pov hwm kho mob).
Yog koj/koj tus menyuam pom zoo los koom nrog qhov kev kawm tshawb xyuas no (lub npe nyob
rau saum toj sauv), cov neeg tshawb xyuas yuav siv, tsim lossis qhia tau koj/koj tus menyuam cov
lus qhia txog kev mob thaum ua txoj kev tshawb xyuas. Cov neeg tshawb xyuas tsuas ua li no
thaum koj tso cai tag kom los siv, tsim lossis qhia koj/koj tus menyuam cov lus qhia txog kev mob
rau txoj kev tshawb xyuas. Daim ntawv sau no yuav muab lus qhia los pab koj txiav txim siab seb
koj puas tso cai. Thov ua zoo nyeem daim ntawv sau no. Thaum koj nyeem daim ntawv sau no
tag, koj tsis kam xees daim ntawv no los tau.
Cov “lus qhia txog kev mob” yog muaj dabtsi hauv? Nws muaj:
Npe
Name
Chaw nyob
Lej Xaus Saus
Keebkwm mob thiab/lossis kev yug
Address
Social Security Number Medical and/or birth history
Qhov tshwm sim ntawm kev kuaj ib ce
Results of physical exams
Lus qhia seb yog neeg dabtsi
Demographic information
Qhov tshwm sim ntawm chaw kuaj sim thiab/lossis cov kev xoos faisfab
Results of laboratory and/or radiology tests
Lus khaws los ntawm kev sib tham thiab/lossis sib tham ua ib pab
Interview and/or focus group data
Lus khaws ntawm kev ntsuam xyuas thiab/lossis lus nug
Survey and/or questionnaire data
Qhov tshwm sim ntawm kev sim cwj pwm
Results of behavioral tests
Lus qhia txog koj qhov kev mob
Information related to your health condition
Lus qhia txog koj cov ntawv sau txog kev mob uas phim rau txoj kev tshawb xyuas no
Information in your medical record relevant to this study
Lwm yam (thov qhia) *
Other (please specify)*
* Yog koj siv daim ntawv HIPAA uas tau muab txhais, cov lus ntawm no yuav tsum muab txhais thiab
* If using a translated HIPAA Form, this information must also be translated
Tej yam cov neeg tshawb xyuas yuav ua nrog cov lus qhia txog cov kev mob
Tejzaum cov neeg tshawb xyuas yuav tsim cov lus qhia tshiab txog cov kev mob rau koj/koj tus
menyuam thaum ua kev kawm no. Tejzaum cov neeg tshawb xyuas yuav siv cov lus qhia txog mob
hauv koj/koj tus menyuam cov ntawv sau tseg txog cov kev mob.
Cov neeg tshawb xyuas tejzaum yuav qhia lwm tus txog kev mob ntawm koj/koj tus menyuam uas
tau khaws thaum ua qhov kev kawm no nrog rau cov nram qab no:
1. Tus txhawb nqa qhov kev kawm no thiab tus sawv cev rau nws. Tus Txhawb Nqa Lub
Npe:
Permission to Use, Create and Share Health Information on Research / Hmong
Form Version 04/11/13
Nplooj 1 ntawm 5
2. Lwm cov neeg tshawb xyuas ntawm lwm qhov chaw uas koom kawm tshawb xyuas
nrog qhov no.
Lwm qhov (cov) chaw kawm lub npe (cov npe):
3. Kooshaum nom tswv, pab pawg neeg saib kom ncaj, pab pawg neeg saib lus khaws tseg
thiab kev nyab xeeb, thiab lwm cov uas muaj lub haujlwm los saib kev nyab xeeb, kev
ua kom raug, thiab kev coj rau qhov tshawb xyuas.
4. Koj lub khw pov hwm kev mob yog lawv them rau kev tu xyuas uas yog ib qho ntawm
qhov kev kawm tshawb xyuas no.
5. Lwm cov muab kev tu mob ua nrog koj/koj tus menyuam.
6. Lub National Institutes of Health (kooshaum tebchaws txog kev mob) thiab nws cov
neeg muab nyiaj txhawb rau yam ua los tswj kev tshawb xyuas (xws li, taug raws kev
tshawb xyuas tag nrho).
7. Lwm cov, raws txoj cai.
Txoj cai Privacy Rule yuav raug rau cov kws kho mob, tsev kho mob thiab lwm cov muab kev
tu xyuas mob. Ib txhia ntawm cov saum toj no yuav tsis raug ua kom raws li txoj cai Privacy Rule
thiab yuav qhia tau koj/koj tus menyuam cov lus rau lwm tus, yog lwm cov cai pub ua. Txawm li
cas los, tejzaum nws yeej muaj lwm cov cai tswj kom tsis pub qhia uas yuav tiv thaiv tau thiab.
Ntawv Tshawb Xyuas Sau Tseg
Koj saib tau lossis luam tseg cov lus uas tejzaum yuav muab siv lossis qhia tawm. Txawm li cas
los, rau tej hom kev kawm tshawb xyuas, tej cov ntawv tshawb xyuas sau tseg yuav tsis muaj rau
koj/koj tus menyuam thaum qhov kev kawm tseem tab tom khiav. Qhov no yuav tsis raug koj txoj
cai los pom seb muaj dabtsi nyob hauv koj/koj tus menyuam cov ntawv sau tseg txog kev mob (tsev
kho mob loj).
Cov neeg tshawb xyuas yuav luam tawm lossis muab qhia qhov tshwm sim ntawv kev tshawb
xyuas tau. Peb yuav tsis qhia tias koj/koj tus menyuam yog leej twg ntawm qhov tshwm sim ntawd
thaum tau muab luam tawm lossis muab nthuav qhia.
Txoj cai Privacy Rule ntawm tebchaw yuav tsis raug txog cov lus qhia txog mob uas tsis qhia tseeb
tias yog dabtsi kiag. Tejzaum cov neeg tshawb xyuas yuav txiav txim siab los tshem cov lus uas
qhia tau tias yog koj/koj tus menyuam. Yog lawv ua li no lawm, cov lus qhia no yuav muab siv
thiab pub qhia tau rau cov neeg tshawb xyuas thiab lawv cov txhawb nqa lawv raws li txoj cai pub.
Qhov no tejzaum yuav pub siv rau lwm txoj kev kawm tshawb xyuas.
Tso Cai los Koom Nrog Kev Tshawb Xyuas
Yog koj pom zoo los koom lossis pub koj tus menyuam los koom nrog qhov kev tshawb xyuas,
lawv yuav nug koj los xees npe rau daim ntawv tso cai rau kev tshawb xyuas. Daim ntawv tso cai
rau kev tshawb xyuas yuav qhia txog qhov kev tshawb xyuas. Daim ntawv tso cai yuav piav txog
tej yam uas yuav muaj feem raug rau koj thiab qhov yuav pab los ntawm qhov kev tshawb xyuas.
Nws yuav qhia lub hom phiaj ntawm qhov kev kawm, seb yuav muaj licas thiab lwm yam lus tseem
ceeb kom koj paub.
Yuav kom koj koom tau nrog qhov kev tshawb xyuas no, koj yuav tsum xees daim ntawv tso
cai no thiab (Tso Cai los Siv, Tsim thiab Qhia Lus Txog Kev Mob rau Kev Tshawb Xyuas). Yog
koj tsis xav xees daim ntawv tso cai no, qhov no yuav tsis hloov txoj kev tu xyuas thiab kev kho
mob uas koj lossis koj tus menyuam txais.
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Nplooj 2 ntawm 5
Qhov Kev Tso Cai No Kav Hov Ntev? Yuav Ua Li Cas Yog Koj Ho Pauv Siab?
Qhov kev tso cai no tsis txawj tag sijhawm, tiamsis koj yuav muab ncua tseg thaum twg los tau.
Yog tias koj loov tswv yim thiab tsis kam tso cai lawm, thov sau ntawv tuaj qhia rau peb. Sau ntawv
rau tus Principal Investigator (PI)/Researcher:
[Npe thiab Chaw Nyob ntawm Tus PI].
[Name and Address of PI].
Yog koj tsis kam tso cai thiab koj/koj tus menyuam yog ib tug neeg mob tom Children’s, thov
xa ib tsab ntawv luam ntawm koj daim ntawv mus rau:
Director of Health Information and Privacy, Health Information Management, M/S OC.6.820,
Seattle Children’s, 4800 Sand Point Way NE, Seattle, WA 98105-0371.
Yog koj tsis kam tso cai lawm, peb yuav tsis nrhiav lwm cov lus qhia kev mob txog koj/koj tus
menyuam rau qhov kev tshawb xyuas no ntxiv lawm. Txawm li cas los, cov lus qhia txog mob uas
twb tau txais nrog koj lo lus tso cai tejzaum tseem yuav muab pub qhia lossis siv. Piv txwv, cov
neeg tshawb xyuas tejzaum yuav xav siv lossis pub qhia cov lus no vim:
• kev nyab xeeb;
• los saib seb cov ntawv khaws tseg txog qhov kev tshawb xyuas puas muaj tseeb;
• yog txoj cai hais tias yuav tsum ua.
Yog koj pom zoo los koom lossis pub koj tus menyuam los koom, peb mam muab ib tsab ntawv
luam ntawm daim ntawv tso cai no rau koj thaum koj xees tag.
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Nplooj 3 ntawm 5
Tso Cai
Kuv pom zoo rau txoj kev siv, tsim, thiab pub qhia kuv cov lossis kuv tus menyuam cov lus qhia
txog kev mob rau txoj kev kawm tshawb xyuas no (muaj npe rau nplooj 1). Rau Children’s cov
neeg mob, koj cov ntawv khaws tseg txog mob tus # yuav muab sau rau daim ntawv no thiab siv los
tso ib tsab luam ntawm daim no rau koj cov ntawv khaws tseg txog mob.
_____________________________
_______________________________
Sau Tus Mob Lub Npe Kom Nyeem Tau
Printed Name of Participant
Tes Xees Ntawm Tus Tuaj Koom (yog tias18 xyoo
lossis Luas Tshaj)
Signature of Participant (if 18 years or Older)
_______________
_____________
Hnub Tim
Date
Sijhawm
Time
_____________________________
_______________________________
Sau Tus Tuaj Koom Niam Txiv Lub Npe
lossis Tus Sawv Cev Raws Cai Kom Nyeem Tau
Printed Name of Participant’s Parent or
Legal Representative
Tes Xees Ntawm Tus Tuaj Koom Kev Tshawb
Xyuas Tus Niam Txiv lossis Tus Sawv Cev Raws
Cai (yog hluas dua 18 xyoo)
Signature of Research Participant’s Parent or
Legal Representative (if younger than18 years)
_______________
_____________
Hnub Tim
Date
Sijhawm
Time
Tus Neeg Tshawb Xyuas Muab Kev Tso Cai
__________________________________
Sau Lub Npe Ntawm Tus Neeg Ua Nrog Pab Neeg Tshawb
Xyuas Kom Nyeem Tau*
Printed Name of Research Team Member*
_________________________________
Tes Xees Ntawm tus Neeg Ua Nrog Pab Neeg Tshawb
Xyuas
Signature of Research Team Member
_______________
_____________
Hnub Tim
Date
Sijhawm
Time
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*KEV QHIA RAU TUS NEEG TSHAWB XYUAS
*INSTRUCTIONS TO RESEARCHER
1. Muab daim tseem ntawm daim no uas tau xees tag tso hauv phau Research File
File signed original of this form in Research File
2. Muab ib daim luam ntawm daim ntawv tau xees rau tus
Tuaj Koom Kev Tshawb Xyuas/Niam Txiv
Provide copy of signed form to Research Participant/Parent
Rau Cov Neeg Mob Uas Yog Menyuam Yaus (For Children’s Patients)
3. Sau kom tiav lossis lo daim ntawv rau tus mob:
Complete or attach patient label:
Tus Tuaj Koom Tus Lej Ntawm Cov Ntawv Mob
Khaws Tseg # ____________________________
Participant’s Medical Record #
Tus Tuaj Koom Lub Hnub Yug
_____/______/______
Participant’s Date of Birth
4. Xa ib tsab luam ntawm daim tau xees mus rau
Health Information Filing: Mailstop OC.6.820
Send copy of the signed form to Health Information Filing: Mailstop OC.6.820
Permission to Use, Create and Share Health Information on Research / Hmong
Form Version 04/11/13
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Разрешение на использование, создание и передачу сведений медицинского характера
для исследовательских целей
Название исследовательского проекта: SEARCH for Diabetes in Youth
IRB-номер проекта: 12074
Федеральное Правило неприкосновенности личной жизни охраняет доступ к медицинской
информации, как Вашей, так и Вашего ребенка. Правило неприкосновенности личной жизни
содержится в Законе о соблюдении принципов преемственности и ответственности при
страховании здоровья (HIPAA).
Если Вы или Ваш ребенок дадите согласие на участие в вышеназванном научном
исследовании, это даст право научным работникам в рамках данного исследования
использовать, создавать или передавать третьим лицам сведения медицинского характера о Вас
или Вашем ребенке. При этом научные работники вправе делать это только при наличии
Вашего согласия на использование, создание или передачу сведений медицинского характера о
Вас или Вашем ребенке в рамках указанной научной работы. Этот формуляр содержит
информацию, которая поможет Вам принять решение о предоставлении такого разрешения.
Просим внимательно ознакомиться с ним. Прочитав этот формуляр, вы можете отказаться
подписывать его.
Что входит в состав «информации медицинского характера»? Она включает:
Имя и фамилия
Name
Адрес
Address
Номер соц. обесп.
Social Security Number
История болезни и/или рождения
Medical and/or birth history
Демографич. информация
Demographic information
Результаты медицинских осмотров
Results of physical exams
Результаты лабораторных и/или рентгеновских обследований
Results of laboratory and/or radiology tests
Данные из бесед и/или целевых групп
Interview and/or focus group data
Данные из анкет и/или опросов
Survey and/or questionnaire data
Результаты поведенческих тестов
Results of behavioral tests
Сведения, касающиеся состояния вашего здоровья
Information related to your health condition
Сведения из вашей мед. карточки, касающиеся данного исследования
Information in your medical record relevant to this study
Прочее (укажите)*
Other (please specify)*
* Если используется переведенный формуляр HIPAA, эта информация тоже должна быть переведена.
* If using a translated HIPAA Form, this information must also be translated
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Как исследователи могут поступать с медицинской информацией
Исследователи могут создавать новую информацию медицинского характера о Вас или Вашем
ребенке в процессе научной работы. Научные работники могут использовать информацию
медицинского характера, содержащуюся в Вашей медкарте или медкарте Вашего ребенка.
В ходе работы исследователям, возможно, потребуется передать информацию медицинского
характера о Вас или Вашем ребенке, собранную в процессе исследований, третьим лицам,
таким как:
1. Спонсору данного исследования и его представителям. Фамилия/наименование
спонсора: Centers for Disease Control/National Institute of Digestive & Kidney
Diseases/JDRF
2. Исследователям из других организаций, принимающим участие в данном проекте.
Наименование организаций: Cincinnati Children’s Hospital Medical Center,
University of Colorado, Pacific Health Research Institute (HI), University of North
Carolina, University of South Carolina, Southern California Kaiser Permanente,
Wake Forest University, Northwest Lipid Research Labs, University of Washington;
and the Molecular Genetics Laboratory, Royal Devon and Exeter NHS Healthcare
Trust, Exeter, U.K., Ocular Epidemiology Reading Center at the University of
Wisconsin – Madison, and the University of Michigan
3. Государственным учреждениям, комиссиям по этике, контрольным органам по
вопросам информации и безопасности и другим структурам, отвечающим за
соблюдение безопасности, эффективности и организации научно-исследовательских
работ.
4. Вашей медицинской страховой компании, если она оплачивает Ваше лечение или
лечение Вашего ребенка в рамках проводящегося исследования.
5. Другим лечебным учреждениям, предоставляющим медицинские услуги Вам или
Вашему ребенку.
6. Национальному институту здравоохранения и получателям его субсидий для целей
администрирования исследований (например, отслеживания исследовательской
деятельности в целом).
7. Другим организациям в соответствии с законом.
Правило неприкосновенности личной жизни является обязательным для врачей, больниц
и других лечебных учреждений. Некоторые из вышеприведенных структур не обязаны
соблюдать Правило неприкосновенности личной жизни и вправе передавать третьим лицам
информацию медицинского характера о Вас или Вашем ребенке в соответствии с другими
законами. При этом, однако, могут применяться и иные средства правовой защиты
неприкосновенности личной жизни.
Научно-исследовательская документация
Вы имеете право читать или копировать сведения, которые разрешается использовать или
разглашать. Однако во время проведения некоторых видов исследований некоторые из
исследовательских документов могут быть недоступны Вам/Вашему ребенку. Это не относится
к Вашему праву на ознакомление с Вашей медкартой или медкартой Вашего ребенка.
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Исследователи вправе публиковать или представлять на конференциях результаты своих
исследований. В публикуемых или представляемых результатах не указываются Ваши личные
данные.
Федеральное Правило неприкосновенности личной жизни не распространяется на
обезличенные сведения медицинского характера. Исследователи могут исключить из
документации любую информацию, которая может помочь идентифицировать Вас или Вашего
ребенка. В этом случае такая информация может использоваться и передаваться другим
исследователям и заказчику проекта в установленном порядке. Это положение может
распространяться и на использование ее в других исследованиях.
Согласие на участие в научных исследованиях
Если Вы не возражаете против Вашего личного участия или участия Вашего ребенка в данном
научном исследовании, Вам предложат подписать согласие на участие в исследовательском
проекте по установленной форме. В этом документе изложены необходимые сведения о
данной исследовательской работе. В нем также описаны все риски и польза от указанного
исследования. Разъясняется также цель исследования, предполагаемые результаты и дается
другая важная информация для Вашего сведения.
Для того, чтобы принять участие в этом научном исследовании, Вам необходимо также
подписать настоящее разрешение (на использование, создание и передачу третьим лицам
сведений медицинского характера для научных целей). Если Вы не желаете подписывать
настоящее согласие, то это не отразится на лечении и медицинском обслуживании,
предоставляемом Вам или Вашему ребенку.
Каков срок действия данного разрешения? Что произойдет, если Вы передумаете?
Срок действия разрешения не истекает, но вы имеете право отменить его в любое время.
Если вы передумаете и пожелаете отменить свое разрешение, просим сообщить нам об этом
письменно. Направьте письмо на имя руководителя темы (РТ)/научного работника:
[Имя, фамилия и адрес РТ]
Catherine Pihoker, MD, Seattle Children’s, 4800 Sand Point Way
NE/OC.7.820, Seattle, WA 98105-0371
[Name and Address of PI].
Если Вы решили отменить разрешение, а Вы или Ваш ребенок являетесь пациентами
клиники Children’s, просим направить копию письма начальнику отдела медицинской
информации и неприкосновенности личной жизни клиники Children's:
Director of Health Information and Privacy, Health Information Management, OC.6.820, Seattle
Children’s, 4800 Sand Point Way NE, Seattle, WA 98105-0371.
Если Вы аннулировали свое разрешение, то сбор медицинских данных о Вас или Вашем
ребенке для данного исследования прекращается. Однако информация, полученная в период
действия Вашего разрешения, может использоваться или передаваться третьим лицам.
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Например, исследователям, возможно, потребуется использовать или передать эту информацию
по следующим причинам:
• в целях обеспечения безопасности;
• для проверки данных, полученных в ходе исследования;
• на основании закона.
Если Вы дадите согласие на Ваше участие или участие Вашего ребенка в данном научном
исследовании, Вам будет выдан второй экземпляр настоящего разрешения с Вашей подписью.
Разрешение
Я даю согласие на использование, создание и передачу третьим лицам информации
медицинского характера обо мне или о моем ребенке для целей данного научного исследования
(название которого указано на стр. 1). Вниманию пациентов Children’s: № вашей медицинской
карточки будет написан на этом формуляре и использован для включения копии этого
формуляра в вашу медицинскую карточку.
__________________________________
Печатными буквами имя и фамилия
участника исследования
Printed Name of Participant
_________________________________
Подпись участника исследования (если
возраст участника 18 лет или старше)
Signature of Participant (if 18 years or Older)
_______________
_______________
Date
Time
__________________________________
Печатными буквами имя и фамилия
родителя или законного представителя
участника исследования
_________________________________
Подпись родителя или законного
представителя участника исследования
(если участник младше 18 лет)
Дата
Printed Name of Participant’s Parent or
Legal Representative
_______________
Дата
Date
Время
Signature of Research Participant’s Parent or
Legal Representative (if younger than18 years)
_______________
Время
Time
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Исследователь, получающий разрешение
__________________________________
Печатными буквами имя и фамилия члена
исследовательского коллектива*
_________________________________
Подпись члена исследовательского
коллектива
Printed Name of Research Team Member*
Signature of Research Team Member
_______________
_______________
Date
Time
Дата
Время
*УКАЗАНИЯ ДЛЯ ИССЛЕДОВАТЕЛЯ
*INSTRUCTIONS TO RESEARCHER
1. Внести подписанный оригинал данного формуляра в Исследовательское дело
File signed original of this form in Research File
2. Передать копию подписанного формуляра участнику исследования/его родителю
Provide copy of signed form to Research Participant/Parent
Для пациентов больницы Children’s (For Children’s Patients)
3. Заполнить или прикрепить ярлык пациента:
Complete or attach patient label:
Номер медкарты участника:
__________________
Participant’s Medical Record #
Дата рождения участника:
_____/______/______
Participant’s Date of Birth
4. Отправить копию подписанного формуляра в отдел регистрации медицинской
информации (Health Information Filing): Mailstop OC.6.820
Send copy of the signed form to Health Information Filing: Mailstop OC.6.820
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Ogolaansho U Helid Isticmaalka, Samaynta, Iyo La Qaybsiga Warka Caafimaadka ee Cilmi Baadhida
Cinwaanka Cilmi Baadhida: SEARCH for Diabetes in Youth
Tirsiga Daraasada IRB#: 12074
Dawlada sharcigeeda qarsoodiga ama khaaska ah ayaa ilaalineysa warka caafimaadkaaga/ka canugaaga.
Sharcigan khaaska ah wuxuu ka mid yahay caymiska caafimaadka qaadasho karida
Iyo masuul noqosho karida sharciga (HIPAA).
Hadii adiga/canugaaga ogolaataan inaad ka qayb qaadataan cilmi baadhistan barashada (kor ku
magacaaban), cilmi baadhayaasha waxaa laga yaabaa iney isticmaalaan, sameeyaan ama la qaybsadaan
warka caafimaadkaaga/ka canugaaga oo ka mid ah cilmi baadhistan. Cilmi baadhayaashu waxay samayn
doonaan sidaas oo kale keliya hadii aad ogolaansho u siisid isticmaalka, samaynta ama la qaybsashada
adiga/canugaaga warkiina caafimaad oo ka mid ah cilmi baashista. Foomkani wuxuu ku siinayaa war kaa
caawinaaya inaad go’aan ka gaadhid hadii aad siin doontid ogolaanshahan oo kale. Fadlan, u akhri
foomkan si taxadir ah. Kadib, marka aad aakhridid foomkan, waxaad karaysa in aad diidid in saxeexdid
foomkan.
Maxaa "maclumaadka cafimaadka" ka mid ah? waxaa ka mid ah:
Magac
Name
Cinwaan
Address
Tirsiga Badbaadada Bulshada
Social Security Number
Taariikh Cafimaad iyo/ama dhalasho
Medical and/or birth history
Maclumaadka guud ee geedi socodka isbadadalada qofka
Demographic information
Natiijada baadhista Jidhka
Results of physical exams
Natiijada Sheybaadhka iyo/ama baadhista raajada
Results of laboratory and/or radiology tests
Wareysiga iyo/ama maclumaadka kooxda ahmiyada u leh
Interview and/or focus group data
Daraasad iyo/ama maclumaadka suaalaha laga Jawaabayo
Survey and/or questionnaire data
Natiijada imitixaanada hab dhaqanka
Results of behavioral tests
Maclumaad la xidhiidha cafimaadkaaga
Information related to your health condition
Maclumaad la xidhiidha xaaladaada xaaladaada cafimaad ee waafaqsan cilmibaadhistan
Information in your medical record relevant to this study
Waxyaabo kale (tilmaam gaar ah ka bixi)*
Other (please specify)*
*Haddii aad isticmaaleysid foom turjuuman oo ah HIPAA, waa in sido kale maclumaadkan turjumaada lagu sameeyo
* If using a translated HIPAA Form, this information must also be translated
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Maxay cilmi baadhayaashu ku samayn karayaan maclumaadka caafimaadka
Cilmi baadhayaashu waxaa surtagal ah in ay soo saaraan maclumaad cusub oo la xidhiidha cafimaadkaaga
adiga/ ilmahaaga inta lagu gudo jiro daraasada. Cilmi baadhayaashu waxaa isticmaali karaan maclumaadka
dhinaca cafimaadka ee ku xusan diwaankaaga adiga /ilmahaaga.
Cilmi baadhayaashu waxaa sido kale laga yaaba in ay ku wadaagaan macluumaadka la xidhiidha
cafimaadkaaga/ka ilmahaaga ee lasoo ururiyay inti lagu gudo jiray daraasada iyada oo loo marayo
marxaladahan hoosta ku qeexan:
1. kafaalasho qaataha daraasaddan iyo wakiilkiisa. Magaca kafaalasho qaataha: Centers for
Disease Control/National Institute of Digestive & Kidney Diseases/JDRF
2. Cilmi baadhayaasha xarumaha kale ee cilmi baadhistan ka qayb qaadanaya. Magaca /Magacyada
xarumaha kale/Magaca xarumaha kale: Cincinnati Children’s Hospital Medical Center,
University of Colorado, Pacific Health Research Institute (HI), University of North
Carolina, University of South Carolina, Southern California Kaiser Permanente,
Wake Forest University, Northwest Lipid Research Labs, University of
Washington; and the Molecular Genetics Laboratory, Royal Devon and Exeter
NHS Healthcare Trust, Exeter, U.K., Ocular Epidemiology Reading Center at the
University of Wisconsin – Madison, and the University of Michigan
3. Hayadaha dowlada, gudiyada dibu eegista anshaxa, gudiyada dabagalka diwaanada qoraalada
iyo amniiga, iyo kuwo kale oo ka masuul ah ilaalinta amniga, wax tarida, iyo nidaamka cilmi
baadhista.
4. Kambanigaaga caymiska ee caafimaadka hadii ay dhiibayaan xanaaneynta lagu siiyey ay qeyb
ka tahay barashada cilmi baadhistu.
5. Caafimaad bixiyayaasha kale ee ku jira adiga/canugaaga xanaanadiina.
6. Xarumaha Cafimaadka Qaranka iyo deeq hayayaashiisa ku shaqada leh arrimaha cilmi
baadhiista hawlaha maamulka (tusaale; lasocodka dhamaan hawlaha cilmi baadhiista)
7. Kuwo kale, oo sida uu sharcigu dhigayo ah.
Sharciga khaaska ah wuxuu khusaynayaa dhakhtarada, cisbitaalada iyo kuwo kale oo caafimaadka
bixiya. Mida ururada kor ku xusan lagama rabo inay raacaan sharcigii khaaska ahaa iyo laga yaabee
adiga/canugaaga iney idin la qabsadaan warar kuwo kale, Hadii sharciyo kale ogol yihiin. Si kasta, kuwo
kale oo ilaalin khaas ah waa laga yaabaa iney weli khuseeyaan.
Diwaanada Cilmi baadhista
Waxaa surtagal ah in aad daawatid ama aad nuqulka ka sameeysatid maclumaadka la isticmaali doono ama la
shaaciin doono, Haseyeeshe, cilmi baadhiisyo khaas ah oo cayiman, ayaa waxaa laga yaaba in aydaan qaar
ka mid ah qoraalada cilmi baadhiste helin adigu iyo lmahaaguba inta ay socto cilmi baadhiistu Amuurtani
wax uma dhimeyso xuquuqdaada gaarka ah adigu lmahaaguba aad ku eegi laheydeen diwaanadiina dhinaca
cafimaadka (isbitaalka). Tani waxba uma dhimeyso xaqaaqa inaad aragtid waxa ku jira canugaaga
diiwaanada caafimaadkiisa (isbitaalka).
Cilmi baadhayaashu waxa laga yaabaa iney daabacaan ama soo bandhigaan cilmi baadhida wixii laga helay.
Adiga/canugaaga laydiin ma sheegayo ama laydin ma muujinaayo aqoonsigiina wixii la helay midnaba oo la
daabacay ama la soo bandhigey.
Dowladii sharcigeeda qarsoodiga ama khaaska ahaa ee aan khusaynin warka caafimaadka si kastaba kaas oo
muujineyn aqoonsasho. Cilmi baadhayaashu wax laga yaabaa iney go’aansadaan in war kasta laga saaro
adiga ku muujinaayo aqoonsigaaga/canugaaga. Hadii ay sameeyaan sidan, warkaa waxaa laga yaabaa in loo
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adeegsado iyo in lala wadaago cilmi baadhayaashu iyo kafaalo qaadida sida sharcigu ogolyahay. Tan waxaa
laga yaabaa oo ku jira in loo isticmaalo dersid cilmi baadhisyo kale.
Ogolaanshaha Ka Qayb Qaadashada Cilmi Baadhista
Hadii aad ogolaatid inaad ka qayb qaadato ama u ogolaato canugaaga ka qayb galka cilmi baadhista, waxaa
lagu weydiin doonaa inaad saxiixdid foomka ogolaanshaha cilmi baadhista. Cilmi baadhista wuxuu ku
siinayaa faahfaahinta ku saabsan cilmi baadhista. Foomkii cilmi baadhistu wuxuu sharaxayaa khatarta iyo
faa’iidada cilmi baadhista. Waxay kuu sharaxeysaa ula jeedada barashada, wixii dhici doona iyo warka
muhiimka kuu ah inaad ogaatid.
Si aad ugu jirtid barashada cilmi baadhistan, waa inaad saxiixdid foomkan ogolaanshahan
(Ogolaansho aad ku isticmaasho, ku samaysid iyo kula qaybsatid warka caafimaadka ee cilmi baadhista).
Hadii aadan rabin inaad saxiixdid foomka ogolaanshaha, tani ma joojinayso xanaaneynta iyo daaweynta
adiga ama cunugaaga aad helaysaan.
Muddo inte leeg ayaa uu ku eeg yahay ogolaanshahan? Maxaase dhacaya haddii aad goaankaaga
badashid?
Ogolaanshahan waqtigiisa ma dhamaanayo,laakiin mar waliba waad iska joojin kartaa.
Haddii is bedeshid aadna rabto ogolaanshahan, fadlan inoogu soo sheeg Isagoo qoraal ah.
U soo qor warqada Principal Investigator (PI)/Researcher:
[Magaca iyo Cinwaanka Baadhaha sare] Catherine Pihoker, MD, Seattle Children’s, 4800 Sand
Point Way NE/OC.7.820, Seattle, WA 98105-0371
[Name and Address of PI].
Hadii aad joojisid ogolaanshahaagii hore/kii canugaaga aadna tihiin bukaan socodtada Xarunta
Children’s, fadlan usoo dir nuquulka warqadaada:
Director of Health Information and Privacy, Health Information Management, OC.6.820, Seattle
Children’s, 4800 Sand Point Way NE, Seattle, WA 98105-0371.
Hadii aad joojisid ogolaanshaha, war ku saabsan caafimaadkaga/ka canugaaga looma ururin doono cilmi
baadhistan. Si kastaba, warka caafimaadkan ee lagu helay ogolaanshahaaga waxaa laga yaabaa in la
qeybsado ama la isticmaalo. Tusaale ahaan, cilmi baadhayaashu waxaa laga yaabaa iney u baahdaan iney
isticmaalaan ama la qeybsadaan wararkan:
• Amaanka sababihiisa;
• Hubinta macluumaadka cilmi baadhista;
• Hadii sharcigu u baahan yahay.
Hadii aad ogolaato inaad ka qeyb qaadato ama u ogolaato canugaaga inuu ka qeyb qaato, waxaa lagu siin
doonaa koobi foomka ogolaanshaha markaad sixiixdid ka dib.
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Ogolaansho
Waan ogolahay inaan isticmaalo, abuurida, iyo la qaybsiga canugayga maclumaadka caafimaadka oo ah ula
jeedada cilmi baadhista waxbarasho (lagu magacaabey boga 1). Carrurta bukaanka ah, diwaankaaga
cafimaadka waxaa lagu diwaangalinaya foomkan kaas oo loo adeegsan doono in lagu dhigo
nuquulka foomkan diwaankaaga cafimaadka.
_______________________________________
Magaca Kaqeybgalaha
Cilmi baadhista oo Daabacan
_________________________________
Saxeexa kaqeybgalaha Cilmi baadhisla
(haddii 18 Jir u yahay ama ka weyn yahay)
Printed Name of Participant
Signature of Participant (if 18 years or Older)
_______________
_____________
Taariikhda
Date
Wakhtiga
Time
_______________________________________
Magaca Waalidka ama Wakiilka
Cilmi baadhista oo Daabacan
Sharciyeesan ee Kaqeybgalaha
Printed Name of Participant’s Parent or
Legal Representative
___________________________________
Saxeexa waalidka ama wakiilka
(haddii uu ka yar yahay 18 Jirka)
Cilmi baadhista
Sharciyeesan ee Kaqeybgalaha
Signature of Research Participant’s Parent or
Legal Representative (if younger than18 years)
_______________
_____________
Taariikhda
Date
Wakhtiga
Time
Ogolaanshaha helida Cilmi baadhaha
_______________________________________
Magaca Xubinka Kooxda
Cilmi baadhista oo Daabacan
_________________________________
Cilmi baadhista
Saxeexa Xubinka Kooxda
Printed Name of Research Team Member*
Signature of Research Team Member
_____________
_____________
Taariikhda
Date
Wakhtiga
Time
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*TILMAAMAHA LOOGU TALO GALAY CILMI BAADHAHA
*INSTRUCTIONS TO RESEARCHER
1. Sii nuqulka foomkan oo saxeexan Waalidka/Kaqeybgadaha cilmi baadhista
File signed original of this form in Research File
2. Ku xaree nuqulka asalka ee foomkan oo saxeexan fagyilka cilmi baadhista
Provide copy of signed form to Research Participant/Parent
Carrurta Bukaanka Ah (For Children’s Patients)
3. Dhameystir ama ku lifaaq heerka bukaanka:
Complete or attach patient label:
Diwaanka Cafimaadka Kaqeybgalaha # __________________
Participant’s Medical Record #
Taariikhda Dhalashada Kaqeybgalaha _____/______/______
Participant’s Date of Birth
4. Dir nuqulka foomkan oo saxeexan Faayilka Maclumaadka Cafimaadka: Mailstop OC.6.820
Send copy of the signed form to Health Information Filing: Mailstop OC.6.820
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同意在研究專案中使用、建立和共享健康資料
專題研究題目: SEARCH for Diabetes in Youth
IRB 研究號碼: 12074
聯邦「隱私條例」保護您本人/您的子女的健康資料。「隱私條例」是「健康保險便利及責任法案」
（HIPAA）的一部份。
如果您本人/您的子女同意參加此項專題研究（上述名稱），研究人員可將您本人/您的子女的健康資
料作為研究的一部份而使用、建立或共享。研究人員僅在您同意將您本人/您的子女的健康資料作為
研究的一部份使用、建立或共享時才會這樣做。本表格提供必要的資訊以幫助您決定是否給予此種
同意。請仔細閱讀本表格。讀完後您可以拒絕在本表格簽名。
「健康資料」包括什麼？「健康資料」包括：
姓名
Name
地址
Address
社會安全號碼
Social Security Number
醫療及/或出生史
Medical and/or birth history
統計資訊
Demographic information
體檢結果
Results of physical exams
化驗及/或放射線測試結果
Results of laboratory and/or radiology tests
面談及/或專題小組資料
Interview and/or focus group data
調查問卷資料
Survey and/or questionnaire data
行為測試結果
Results of behavioral tests
與您的健康狀況相關的資訊
Information related to your health condition
您的醫療記錄中與本項研究相關的資訊
Information in your medical record relevant to this study
其他（請說明）*
Other (please specify)*
* 如果使用翻譯的 HIPAA 表格，此處的資訊也必須翻譯。
* If using a translated HIPAA Form, this information must also be translated
研究人員如何使用健康資料
研究人員在研究中可以建立有關您本人/您的子女新的健康資料。研究人員可以使用您本人/您的子女
醫療記錄中的健康資料。
研究人員也可能需要與下列各方共享在研究中收集的有關您本人/您的子女的健康資料：
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1. 此項研究的贊助方及其代表。贊助方名稱：
Centers for Disease Control/National
Institute of Digestive & Kidney Diseases/JDRF
2. 參加此項專題研究的其他中心的研究人員。
其他中心名稱：Cincinnati Children’s Hospital Medical Center, University of
Colorado, Pacific Health Research Institute (HI), University of North Carolina,
University of South Carolina, Southern California Kaiser Permanente, Wake
Forest University, Northwest Lipid Research Labs, University of Washington; and
the Molecular Genetics Laboratory, Royal Devon and Exeter NHS Healthcare
Trust, Exeter, U.K., Ocular Epidemiology Reading Center at the University of
Wisconsin – Madison, and the University of Michigan
3. 政府機構、倫理審查委員會、資料及安全監督委員會，以及其他負責監督研究之安全
性、有效性及行為的部門。
4. 您的醫療保險公司——如果他們支付專題研究中部份醫療的費用。
5. 其他參與您本人/您的子女保健的醫療提供者。
6. 美國衛生院及其撥款持有人從事研究管理活動（例如，追蹤總體研究活動）。
7. 法律規定的其他方。
「隱私條例」適用於醫生、醫院和其他醫療提供者。在上述團體中，有一些未被要求遵守《隱私條
例》，而且若有其他法律允許，可與其他人共享您本人/您的子女的資料。但其他隱私保護規定仍可
適用。
研究記錄
您可以查閱或複印可能使用或披露的信息。但是，對於某些類型的研究，您/您的子女可能無法在研
究進行時獲得研究記錄。但這不會影響您查看您/您的子女的醫療（醫院）記錄的權利。
研究人員可以發表或展示研究結果。在任何發表或展示的研究結果中都不會辨識您本人/您的子女的
身份。
聯邦「隱私條例」不適用於無法以任何方式辨識身份的健康資料。研究人員可決定去除任何可能辨
識出您本人/您的子女身份的資訊。在這種情況下，研究人員和贊助方可依法使用和共享資料，包括
用於其他專題研究。
參加研究的同意書
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如果您同意參加或允許子女參加研究，您會被要求簽署一份研究同意書。這份研究同意書提供有關
此研究的詳細情況，描述研究的風險和利益，說明這項研究的目的、將發生什麼以及其他您需要知
道的重要資訊。
要參加這項專題研究，您還必須在這份同意書上簽字（「同意在研究專案中使用」、「建立和共享
健康資料」）。如果您不想簽署這份同意書，並不會影響您本人/您的子女接受的護理和治療。
這份同意書的時效有多久？您如果改變主意該怎麼辦？
本同意書不會失效，但是您可以在任何時候取消。
如果您改變主意，想撤消您的同意書，請書面通知我們。請致函首席研究員﹙PI﹚/研究人員：
Catherine Pihoker, MD, Seattle Children’s, 4800 Sand Point
Way NE/OC.7.820, Seattle, WA 98105-0371
[首席研究員的姓名及地址]
[Name and Address of PI]
如果您撤消同意書，而且您本人/您的子女是 Children’s 醫院的患者，請將一份信函的副本寄至：
Director of Health Information and Privacy, Health Information Management, OC.6.820, Seattle
Children’s, 4800 Sand Point Way NE, Seattle, WA 98105-0371.
如果您撤消同意書，我們將不再為此項研究收集有關您本人/您的子女的健康資料，但仍可共享或使
用以前在您同意下收到的健康資料。例如，研究人員可能因以下原因需要使用或共享這些資料：
•
安全原因；
•
證實研究資料；
•
遵照法律要求。
如果您同意參加或允許子女參加，您會在簽署同意書後收到一份同意書副本。
同意書
我同意為此項專題研究（姓名列於第一頁）之目的而使用、建立及共享我或子女的健康資料。對於
子女的父母，您的醫療記錄號碼將在本表中記錄，並被用於將本表的一份副本存入您的醫療記錄。
______________________________
參加研究者姓名（正楷）
__________________________
參加研究者簽名（如果年滿 18 歲或以上）
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Printed Name of Participant
Signature of Participant (if 18 years or Older)
_______________
日期
_______________
時間
Date
Time
______________________________
___________________________________
參加研究者的父母或法定代表姓名
參加研究者的父母或法定代表簽名
（正楷）
（如果參加研究者的年齡未滿 18 歲）
Printed Name of Participant’s Parent or
Legal Representative
Signature of Research Participant’s Parent or
Legal Representative (if younger than18 years)
_______________
日期
_______________
時間
Date
Time
徵求授權的研究人員
_______________________________
________________________________
研究團隊成員姓名（正楷）*
研究團隊成員簽名
Printed Name of Research Team Member*
Signature of Research Team Member
_______________
日期
_______________
時間
Date
Time
* 供研究人員使用的說明
*INSTRUCTIONS TO RESEARCHER
Permission to Use, Create and Share Health Information on Research / Traditional Chinese
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1. 將本表的簽名原件在研究文件中存檔
File signed original of this form in Research File
2. 將簽名表格的副本交給參加研究者/父母
Provide copy of signed form to Research Participant/Parent
供 Children’s 病人使用 (For Children’s Patients)
3. 填寫或隨附病人標籤：
Complete or attach patient label:
參加者的醫療記錄號碼 __________________
Participant’s Medical Record #
參加者的出生日期
_____/______/______
Participant’s Date of Birth
4. 將簽名表格的副本送交至健康資訊檔案部：Mailstop OC.6.820
Send copy of the signed form to Health Information Filing: Mailstop OC.6.820
Permission to Use, Create and Share Health Information on Research / Traditional Chinese
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Giaáy Cho Pheùp Söû Duïng, Taïo Laäp, Vaø Chia Seû Thoâng Tin Y Teá Cho Muïc Ñích
Nghieân Cöùu
Ñeà Taøi Nghieân Cöùu: SEARCH for Diabetes in Youth
Soá Nghieân Cöùu IRB: 12074
Quy Ñònh veà Quyeàn Rieâng Tö cuûa Chính Quyeàn Lieân Bang baûo veä caùc thoâng tin y teá cuûa quyù
vò/con quyù vò. Quy Ñònh veà Quyeàn Rieâng Tö naèm trong Ñaïo Luaät veà Traùch Nhieäm vaø Quyeàn
Chuyeån Ñoåi Chöông Trình Baûo Hieåm Söùc Khoûe (tieáng Anh goïi taét laø HIPAA).
Neáu quyù vò/con quyù vò ñoàng yù tham gia vaøo cuoäc nghieân cöùu naøy (xem teân ñeà taøi ñöôïc ghi
treân ñaây), nhöõng ngöôøi nghieân cöùu coù theå söû duïng, taïo laäp, hay chia seû caùc thoâng tin y teá
cuûa quyù vò/con quyù vò trong quaù trình nghieân cöùu. Nhöõng ngöôøi nghieân cöùu chæ ñöôïc pheùp
laøm nhöõng ñieàu naøy neáu quyù vò cho pheùp hoï söû duïng, taïo laäp, hay chia seû caùc thoâng tin y teá
cuûa quyù vò/con quyù vò trong quaù trình nghieân cöùu. Maãu ñôn naøy cung caáp thoâng tin ñeå giuùp
quyù vò suy nghó xem coù neân kyù vaøo giaáy pheùp naøy hay khoâng. Xin ñoïc kyõ maãu naøy. Sau khi
ñoïc xong, quyù vò coù theå töø choái kyù maãu naøy.
Töø “thoâng tin y teá” bao haøm nhöõng gì? Töø naøy bao haøm:
Teân Hoï
Name
Ñòa Chæ
Address
Soá An Sinh Xaõ Hoäi
Social Security Number
Beänh söû vaø/hoaëc quaù trình sinh haï
Medical and/or birth history
Thoâng tin nhaân khaåu hoïc
Demographic information
Keát quaû cuûa caùc cuoäc khaùm söùc khoûe toång quaùt
Results of physical exams
Keát quaû xeùt nghieäm trong phoøng thí nghieäm va/hoaëc quang tuyeán
Results of laboratory and/or radiology tests
Döõ lieäu töø caùc cuoäc phoûng vaán vaø/hoaëc nhoùm taäp trung
Interview and/or focus group data
Döõ lieäu töø caùc cuoäc khaûo saùt vaø/hoaëc baûng hoûi
Keát quaû xeùt nghieäm veà haønh vi
Survey and/or questionnaire data
Results of behavioral tests
Thoâng tin lieân quan ñeán tình traïng söùc khoûe cuûa quyù vò
Information related to your health condition
Thoâng tin trong hoà sô y teá coù lieân quan ñeán cuoäc nghieân cöùu naøy
Information in your medical record relevant to this study
Khaùc (cho bieát cuï theå) *
Other (please specify)*
* Neáu söû duïng maãu HIPAA ñöôïc dòch saün, thoâng tin naøy cuõng phaûi ñöôïc chuyeån ngöõ
* If using a translated HIPAA Form, this information must also be translated
Nhöõng ngöôøi nghieân cöùu coù theå söû duïng thoâng tin y teá nhö theá naøo?
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Nhöõng ngöôøi nghieân cöùu coù theå taïo laäp thoâng tin y teá môùi veà quyù vò/con quyù vò trong quaù
trình nghieân cöùu. Hoï cuõng coù theå söû duïng caùc thoâng tin y teá saün coù trong hoà sô y teá cuûa
quyù vò/con quyù vò.
Nhöõng ngöôøi nghieân cöùu cuõng coù theå caàn chia seû thoâng tin y teá veà quyù vò/con quyù vò ñöôïc
thu thaäp trong quaù trình nghieân cöùu vôùi nhöõng ngöôøi/toå chöùc sau ñaây:
1. Nhaø taøi trôï cuoäc nghieân cöùu naøy vaø caùc ñaïi dieän. Teân cuûa Nhaø Taøi Trôï laø:
Centers for Disease Control/National Institute of Digestive & Kidney
Diseases/JDRF
2. Nhöõng ngöôøi nghieân cöùu taïi nhöõng trung taâm khaùc cuõng tham gia vaøo cuoäc nghieân
cöùu naøy.
Teân cuûa caùc trung taâm khaùc laø: Cincinnati Children’s Hospital Medical Center,
University of Colorado, Pacific Health Research Institute (HI), University of North
Carolina, University of South Carolina, Southern California Kaiser Permanente,
Wake Forest University, Northwest Lipid Research Labs, University of
Washington; and the Molecular Genetics Laboratory, Royal Devon and Exeter
NHS Healthcare Trust, Exeter, U.K., Ocular Epidemiology Reading Center at the
University of Wisconsin – Madison, and the University of Michigan
3. Caùc cô quan nhaø nöôùc, uûy ban xem xeùt veà tính hôïp ñaïo ñöùc, hoäi ñoøng quan saùt söï
an toaøn vaø döõ lieäu, vaø caùc toå chöùc khaùc coù traùch nhieäm theo doõi söï an toaøn,
hieäu quaû vaø quaù trình thöïc hieän caùc cuoäc nghieân cöùu.
4. Coâng ty baûo hieåm söùc khoûe cuûa quyù vò, neáu coâng ty bao traû cho caùc dòch vuï chaêm
soùc ñöôïc cung caáp trong cuoäc nghieân cöùu naøy.
5. Caùc nhaø cung caáp dòch vuï y teá khaùc lieân heä ñeán vieäc chaêm soùc söùc khoûe cho quyù
vò/con quyù vò.
6. Vieän Y Teá Quoác Gia vaø caùc toå chöùc ñöôïc caáp quyõ cho caùc hoaït ñoäng quaûn lyù
nghieân cöùu (ví duï, theo doõi toång quaùt caùc hoaït ñoäng nghieân cöùu).
7. Nhöõng ngöôøi/toå chöùc khaùc ñöôïc quy ñònh bôûi luaät phaùp.
Quy Ñònh veà Quyeàn Rieâng Tö ñöôïc aùp duïng cho caùc baùc só, beänh vieän, vaø caùc nhaø cung
caáp dòch vuï y teá khaùc. Moät soá trong nhöõng nhoùm keå treân khoâng baét buoäc phaûi theo Quy
Ñònh veà Quyeàn Rieâng Tö, do ñoù hoï coù theå chia seû thoâng tin veà quyù vò/con quyù vò vôùi ngöôøi
khaùc neáu luaät phaùp cho pheùp. Tuy nhieân, caùc quy ñònh khaùc veà vieäc baûo veä quyeàn rieâng tö
vaãn coù theå ñöôïc aùp duïng.
Hoà Sô Nghieân Cöùu
Quyù vò coù quyeàn xem vaø chuïp baûn sao caùc thoâng tin coù theå ñöôïc söû duïng hay tieát loä. Tuy
nhieân, trong moät soá loaïi nghieân cöùu, coù theå quyù vò/con quyù vò seõ khoâng ñöôïc pheùp xem vaøi
hoà sô nghieân cöùu trong khi cuoäc nghieân cöùu ñang ñöôïc tieán haønh. Ñieàu naøy khoâng aûnh höôûng
ñeán quyeàn cuûa quyù vò ñeå xem hoà sô y teá (hoà sô beänh vieän) cuûa quyù vò/con quyù vò.
Nhöõng ngöôøi nghieân cöùu coù theå xuaát baûn hay trình baøy caùc keát quaû nghieân cöùu. Danh taùnh
cuûa quyù vò/con quyù vò seõ khoâng ñöôïc tieát loä khi xuaát baûn hay trình baøy nhöõng keát quaû naøy.
Quy Ñònh veà Quyeàn Rieâng Tö cuûa Lieân Bang khoâng aùp duïng cho caùc thoâng tin y teá naøo ñöôïc
xoùa boû taát caû caùc chi tieát coù theå söï duïng ñeå nhaän bieát danh taùnh cuûa beänh nhaân. Nhöõng
ngöôøi nghieân cöùu coù theå quyeát ñònh xoùa boû taát caû caùc chi tieát nhaän dieän quyù vò/con quyù
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vò. Baèng caùch naøy, ngöôøi nghieân cöùu vaø nhaø taøi trôï coù theå töï do söû duïng vaø chia seû thoâng
tin naøy trong phaïm vi luaät phaùp cho pheùp, keå caû söû duïng thoâng tin trong caùc cuoäc nghieân cöùu
khaùc.
Thuû Tuïc Cho Pheùp Tham Gia Nghieân Cöùu
Neáu quyù vò ñoàng yù tham gia hay cho pheùp con mình tham gia vaøo cuoäc nghieân cöùu naøy, quyù vò
seõ ñöôïc yeâu caàu kyù teân vaøo maãu öng thuaän tham gia nghieân cöùu. Maãu öng thuaän tham gia
nghieân cöùu cho bieát thoâng tin chi tieát vaø giaûi thích caùc nguy cô vaø lôïi ích cuûa cuoäc nghieân
cöùu. Maãu naøy cuõng giaûi thích veà muïc ñích nghieân cöùu, nhöõng gì seõ xaûy ra trong khi tham gia,
vaø caùc thoâng tin quan troïng khaùc quyù vò caàn bieát.
Muoán tham gia vaøo cuoäc nghieân cöùu, quyù vò cuõng phaûi kyù teân vaøo giaáy cho pheùp naøy
(Giaáy Cho Pheùp Söû Duïng, Taïo Laäp, Vaø Chia Seû Caùc Thoâng Tin Y Teá Cho Muïc Ñích Nghieân
Cöùu). Neáu quyù vò khoâng muoán kyù giaáy pheùp naøy, caùc dòch vuï chaêm soùc vaø ñieàu trò ñöôïc
caáp cho quyù vò hay con cuûa quyù vò seõ khoâng bò aûnh höôûng.
Giaáy Cho Pheùp Naøy Seõ Coù Hieäu Löïc Trong Bao Laâu? Neáu Quyù Vò Ñoåi YÙ Thì Sao?
Giaáy cho pheùp naøy seõ khoâng bao giôø heát hieäu löïc, nhöng quyù vò coù theå huûy boû noù vaøo baát
cöù luùc naøo.
Neáu quyù vò ñoåi yù vaø muoán huûy boû giaáy cho pheùp naøy, xin vieát thö baùo cho chuùng toâi bieát.
Vieát thö cho Ngöôøi Nghieân Cöùu Chính (tieáng Anh vieát taét laø PI):
[Teân vaø Ñòa Chæ cuûa PI] Catherine Pihoker, MD, Seattle Children’s, 4800 Sand Point Way
NE/OC.7.820, Seattle, WA 98105-0371
[Name and Address of PI].
Neáu quyù vò huûy boû giaáy cho pheùp naøy vaø quyù vò/con quyù vò laø beänh nhaân taïi Beänh
Vieän Nhi Ñoàng xin gôûi moät baûn sao cuûa thö baùo huûy boû ñeán:
Director of Health Information and Privacy, Health Information Management, OC.6.820, Seattle Children's,
4800 Sand Point Way NE, Seattle, WA 98105-0371.
Neáu quyù vò huûy boû giaáy cho pheùp naøy, chuùng toâi seõ khoâng thu thaäp theâm thoâng tin y teá veà
quyù vò/con quyù vò nöõa ñeå söû duïng trong cuoäc nghieân cöùu. Tuy nhieân, caùc thoâng tin y teá ñaõ
thu thaäp ñöôïc trong khi quyù vò coøn cho pheùp thì vaãn coù theå ñöôïc chia seû hay söû duïng. Thí duï,
nhöõng ngöôøi nghieân cöùu coù theå caàn söû duïng hay chia seû thoâng tin:
• vì lyù do an toaøn;
• ñeå kieåm laïi caùc döõ lieäu trong cuoäc nghieân cöùu;
• theo quy ñònh cuûa luaät phaùp.
Neáu quyù vò ñoàng yù tham gia hay cho con quyù vò tham gia, quyù vò seõ ñöôïc giao moät baûn sao cuûa
giaáy cho pheùp naøy sau khi kyù xong.
Permission to Use, Create and Share Health Information on Research / Vietnamese
Form Version 04/11/13
Page 3 of 5
Lôøi Cho Pheùp
Toâi ñoàng yù cho pheùp söû duïng, taïo laäp, vaø chia seû caùc thoâng tin y teá cuûa toâi/con toâi cho muïc
ñích thöïc hieän cuoäc nghieân cöùu naøy (xem teân ñeà taøi ôû trang 1). Ñoái vôùi beänh nhaân cuûa Beänh
Vieän Nhi Ñoàng, soá hoà sô y teá seõ ñöôïc ghi treân maãu naøy ñeå coù theå ñöa baûn sao cuûa maãu naøy
vaøo hoà sô y teá cuûa beänh nhaân.
_____________________________
_______________________________
Teân Hoï (In Hoa) cuûa Ngöôøi Tham Gia Nghieân
Cöùu
Chöõ Kyù cuûa Ngöôøi Tham Gia Nghieân Cöùu
(neáu ngöôøi tham gia töø 18 tuoåi trôû leân)
Signature of Participant (if 18 years or Older)
Printed Name of Participant
_____________
_______________
Giôø
Time
Ngaøy
Date
_____________________________
_______________________________
Teân Hoï (In Hoa) cuûa Phuï Huynh hay Ñaïi Dieän
Hôïp Phaùp cuûa Ngöôøi Tham Gia Nghieân Cöùu
Printed Name of Participant’s Parent or
Legal Representative
Chöõ Kyù cuûa Phuï Huynh hay Ñaïi Dieän Hôïp
Phaùp cuûa Ngöôøi Tham Gia Nghieân Cöùu
(neáu ngöôøi tham gia döôùi 18 tuoåi)
Signature of Research Participant’s Parent or
Legal Representative (if younger than18 years)
_______________
_____________
Ngaøy
Date
Giôø
Time
Ngöôøi Nghieân Cöùu Laøm Thuû Tuïc Xin Pheùp
_____________________________
_______________________________
Teân Hoï (In Hoa) cuûa Thaønh Vieân Nhoùm Nghieân
Cöùu*
Printed Name of Research Team Member*
Chöõ Kyù cuûa Thaønh Vieân
Nhoùm Nghieân Cöùu
Signature of Research Team Member
_____________
_______________
Ngaøy
Date
Giôø
Time
Permission to Use, Create and Share Health Information on Research / Vietnamese
Form Version 04/11/13
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*PHAÀN HÖÔÙNG DAÃN DAØNH CHO NGÖÔØI NGHIEÂN CÖÙU
*INSTRUCTIONS TO RESEARCHER
1. Löu baûn goác coù chöõ kyù cuûa giaáy naøy vaøo Hoà Sô Nghieân Cöùu
File signed original of this form in Research File
2. Ñöa baûn sao cuûa giaáy coù chöõ kyù cho Ngöôøi Tham Gia Nghieân Cöùu/Phuï Huynh
Provide copy of signed form to Research Participant/Parent
Daønh Cho Beänh Nhaân Taïi Beänh Vieän Nhi Ñoàng (For Children’s Patients)
3. Ñieàn vaøo hay daùn nhaõn ghi thoâng tin cuûa beänh nhaân:
Complete or attach patient label:
Soá Hoà Sô Y Teá cuûa Ngöôøi Tham Gia Nghieân Cöùu __________________
Participant’s Medical Record #
Ngaøy Sinh cuûa Ngöôøi Tham Gia Nghieân Cöùu
_____/______/______
Participant’s Date of Birth
4. Göûi baûn sao cuûa giaáy coù chöõ kyù ñeán Phoøng Löu Tröõ Hoà Sô Y Teá: Mailstop OC.6.820
Send copy of the signed form to Health Information Filing: Mailstop OC.6.820
Permission to Use, Create and Share Health Information on Research / Vietnamese
Form Version 04/11/13
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| File Type | application/pdf |
| Author | Gena Hargis |
| File Modified | 2013-11-12 |
| File Created | 2013-11-12 |