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pdfMatose, Takunda (NIH/OD) [C]
From:
To:
Cc:
Subject:
Attachments:
OHSR (NIH/DDIR)
Sampson, Annie (NIH/NCI) [E]
Grant, Nicole (NIH/NCI) [E]
Determination for OHSRP 12414
Request for Amendment OHSRP #____
Dear Dr. Sampson,
Attached is the OHSRP determination of Excluded from IRB Review per 45 CFR 46 and NIH policy for your
project NCI Advocate Database. You may proceed with the project.
Please retain this documentation as you would other research records. Amendments and or changes to the
research must be submitted to OHSRP for review as changes may affect the determination. Please refer to
OHSRP #12414 for future amendments to this activity. To request future amendments, please use the
attached email template modified to meet the specific changes needed for your project. If you have any
questions or need further assistance, please feel free to contact us.
Best,
Takunda Matose
OHSRP ‐ National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301‐402‐3444
Office Fax: 301‐402‐3443
From: OHSR (NIH/DDIR)
Sent: Friday, May 09, 2014 12:51 PM
To: Sampson, Annie (NIH/NCI) [E]
Subject: Req for Determination Rec'd_OHSRP 12414
Good afternoon Ms. Sampson,
This email is to verify that OHSR has received your Request for Determination and it is currently being processed as
OHSRP #12414. Please use this number in any future correspondence regarding this study. We will contact you via
email if any additional information is needed. Please note that due to ongoing project deadlines, determinations are
taking longer than normal to process.
Protocol Title: NCI Advocate Database
Thank you.
Sincerely,
Chris Brentin
OHSRP ‐ National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301‐402‐3444
1
OHSRP #12414
REQUEST FORM: OHSRP DETERMINATION FORSURVEVS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
Date of Request: 4/29/2013
Requestor's name: Nichole Sorhaindo
e-mail: nichole.sorhaindo@nih.gov
Role: _Administrative support X Investigator
_Other, explain: _ _ _ _ _ __
Name of NIH Senior Investigator: Annie Sampson
(The investigator must be an NIH employee)
IC: National Cancer Institute Laboratory/Branch: Office of Advocacy Relations
Building & Room No. 10A28D
Tel. No. 301-594-6831
FAX No. 301-480-7558
Is the NIH Senior Investigator an NIH employee(FTE)? X Yes
No
e 11nvestigator who will conduct research)
~, .......,____.._,
Supervisor Signature:
(Signature of official for IC, e.g., Lab/Branch Chief)
Name of NIH investigator conducting research if not the NIH Senior Investigator: (i.e,
junior investigator, contractor investigator, fellow, student)
Please provide the name and e-mail of any others who should receive a copy of the
OHSRP determination: Kelley Landy kelley.landy@nih.gov; Kelli Marciel
kelli.marciel@nih.gov; Annie Sampson annie.sampson@nih.gov
1. What role will the NIH investigator(s) have in this research project? (check all that
apply)
_Conduct research activity
_Analyze samples/data only
_Consultant/advisor to collaborator(s)
_Author on publication(s)/manuscript(s) pertaining to this research
X Other, please describe: Pull information from database
2. Title: NCI Advocate Database
{Provide a short title to distinguish this activity from other projects that you may have)
3. Describe in lay terms the research activity that will be performed:
Central to OAR's identity is both matching qualified research advocates to engage in
research activities within NCI and engaging with a variety of advocacy organizations at
the organization level. These activities rely on a robust database to store and retrieve
Page 1 of3
REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
information about the advocates, organizations and research activities. A custom OAR
application for these purposes was developed by CBIIT (accessible at
http://oar.nci.nih.gov/oar).
•
The purpose of the database, as it long has been, is to track interactions between both
individual volunteer research advocates and NCI's Office of Advocacy Relations, and
advocacy organizations and OAR. Another purpose for this database is tracking and
evaluating the process and outcomes of engaging advocates in research in support of
the NCI mission. The database is programmatic in nature.
The NCI Advocate Database stores and retrieves information about advocates,
organizations and NIH research activities in which research advocates have participated.
All information is entered into the database by OAR staff, with two exceptions; requests
for research advocate activity participation from may be submitted via online form by
an investigator and individual research advocates may edit their profiles through an
online form. The use to which this information will be put is for OAR staff to be able to
respond to internal requests from investigators to identify and match qualified research
advocates with research advocacy opportunities at NCI and across NIH.
The NCI Advocate Database is being slightly revised from its previous iteration,
architected in 2005; this revision includes updates to fields where information is
collected from participants and it also includes functionality and design changes to the
backside dashboard where OAR staff can view and search for records.
4. Proposed start date 7/1/2013
Proposed completion date: n/a
5. Specify the nature of the data: (select all that apply)
_Interview procedure
_Survey
_Educational Testing
Educational Research
_Research on public benefit or service programs
X Other, describe: Research advocate profile information for potential involvement in
NCI research activities
6. What kind of human data (e.g., private information, responses to questionnaires,
test results, recordings) will be collected in your research?
7. Will human data be? (select all that apply)
Collected
Yes_ No X
Received
Yes NoX
Sent
Yes_ No X
Page 2 of3
REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
8. If receiving or sending, list the collaborating investigator(s):
lnstitution/IC
Address/e-mail
Name
FWA number*
9. Where are the subjects of this research activity located? (Provide a general
description or complete the institutional information below)
Nationwide
Institution: n/a
Contact Name: n/a
Address: n/a
Phone: n/a
10. Will NIH investigator(s) have direct contact or intervention with the subjects of
the study? (For example, by interviewing, surveying or recording the subjects?)
Yes X No_
If yes, what is the age range of subjects involved in the research?
_Children aged< 18 years
X Adults aged~ 18 years
11. Who will collect the data or information?
(a) X NIH Investigator
(b)_ non-NIH Collaborator
(c)_ NIH Contractor
(d) X Other, specify: respondents input information onto online database themselves
If b or c, will an Honest Broker or data use agreement be used? Yes_ No_
If yes, complete and attach the Honest Broker Assurance or data-use agreement to
this submission; e-mail ohsr nih ddir@od.nih.qov to request a form.
12. Select the best description that applies to the human data or information:
_ Data or information will not contain any identifiable information, nor can it be
linked to individual subjects by you or your collaborators.
X Data or information will be recorded in such a manner that subjects can be
identified directly or through identifiers linked to
th~
subjects
13. Per NIH guidance, are all conflicts of interest by NIH employees (sender or
receiver), if any, resolved? _ _Yes X No**
Page 3 of3
OHSR (NIH/DDIR)
From:
Sent:
To:
Subject:
Attachments:
Bridge, Heather (NIH/OD) [E]
Friday, April 11, 2014 7:08 AM
Sampson, Annie (NIH/NCI) [E]; Matose, Takunda (NIH/OD) [C]; Brentin, Christine
(NIH/OD) [E]; Brown, Kristan (NIH/OD) [E]
FW: Office of Advocacy Relations
1833_001.pdf
Importance:
High
Follow Up Flag:
Flag Status:
Follow up
Flagged
Categories:
Red Category, Yellow Category
Hi Annie,
I no longer process these requests but have cc’d my colleagues for you. We had some technical issues w/our inbox that
may have caused a delay.
Folks please make sure this determination request is processed.
Best,
Heather Bridge
Office of Human Subjects Research Protections
Office of Intramural Research
National Institutes of Health
10 Center Drive,
Bldg. 10, Room 2C146
Bethesda, MD 20892
Direct line: 301‐402‐4504
BB: 240‐281‐9015
Office Main: 301‐402‐3444
Fax: 301‐402‐3443
E‐mail: bridgeh@od.nih.gov
OHSRP website: https://federation.nih.gov/ohsr/nih/index.php (NIH login required)
From: Sampson, Annie (NIH/NCI) [E]
Sent: Thursday, April 10, 2014 4:03 PM
To: Bridge, Heather (NIH/OD) [E]
Subject: Office of Advocacy Relations
Hi Heather,
I put this request in awhile ago, you have probably reviewed it and made a recommendation, however I do not have the
final signature page. Can you please send me your final determination?
Thank you,
Annie
Annie Sampson, MSc
NIH/National Cancer Institute
Office of Advocacy Relations
1
31 Center Drive, MSC 2580
Bethesda, MD 20892
Phone: (301) 594.6831
sampsona@mail.nih.gov
2
OHSR (NIH/DDIR)
From:
Sent:
To:
Subject:
OHSR (NIH/DDIR)
Friday, June 21, 2013 10:43 AM
OHSR (NIH/DDIR); Sampson, Annie (NIH/NCI) [E]
FW: Cannot Process RE: OAR Advocate Database -- Request for Determination
Follow Up Flag:
Flag Status:
Follow up
Flagged
Categories:
Red Category, Yellow Category
Hi Annie,
I am forwarding your question to Takunda Matose, who reviews the requests.
Chris
From: Sampson, Annie (NIH/NCI) [E]
Sent: Friday, June 21, 2013 10:31 AM
To: OHSR (NIH/DDIR)
Subject: RE: Cannot Process RE: OAR Advocate Database -- Request for Determination
Honestly, I’m not sure what this is. should I check with our Administrative Office?
From: OHSR (NIH/DDIR)
Sent: Friday, June 21, 2013 10:30 AM
To: Sampson, Annie (NIH/NCI) [E]
Subject: RE: Cannot Process RE: OAR Advocate Database -- Request for Determination
Hi Annie,
Will an Honest Broker or data use agreement be used?
Thank you.
Chris
Sincerely,
OHSRP ‐ National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301‐402‐3444
Office Fax: 301‐402‐3443
The NIH is committed to maintaining the highest standards for the protection of human
subjects.
Please consider the environment before printing this e-mail
From: Sampson, Annie (NIH/NCI) [E]
Sent: Thursday, June 20, 2013 9:17 AM
1
To: OHSR (NIH/DDIR)
Subject: RE: Cannot Process RE: OAR Advocate Database -- Request for Determination
I apologize, I thought I had responded. The answer is A. I will be the NIH investigator.
Does that answer the outstanding question?
Please let me know if you need anything else.
Thank you,
Annie
From: OHSR (NIH/DDIR)
Sent: Thursday, June 20, 2013 9:14 AM
To: Sampson, Annie (NIH/NCI) [E]
Subject: Cannot Process RE: OAR Advocate Database -- Request for Determination
Importance: High
Hi Annie,
I wanted to follow up with this request. OHSRP has not yet received your response to the email below. Please let me
know if you would like to continue this request.
Thanks very much.
Sincerely,
Chris Brentin
OHSRP
From: OHSR (NIH/DDIR)
Sent: Monday, May 20, 2013 2:10 PM
To: Sampson, Annie (NIH/NCI) [E]
Subject: Cannot Process RE: OAR Advocate Database -- Request for Determination
Importance: High
Hi Annie,
I apologize that we omitted a correction that OHSRP needs in order to process your request. The current form has a
typo in #11. It should read: “if A or c, will an Honest Broker or data use agreement be used?”
11. Who will collect the data or information?
(a) X NIH Investigator
(b)_ non-NIH Collaborator
(c)_ NIH Contractor
(d) X Other, specify: respondents input information onto online database themselves
If b(A) or c, will an Honest Broker or data use agreement be used? Yes_ No_
If yes, complete and attach the Honest Broker Assurance or data-use agreement
Please answer this question in a response email. You do not have to resend the form. I have attached an Honest Broker
form if you do need it. Once I receive your response, I will enter it into our system for review.
Please contact OHSRP with any questions.
Thank you.
Sincerely,
Chris Brentin
OHSRP ‐ National Institutes of Health
2
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301‐402‐3444
Office Fax: 301‐402‐3443
The NIH is committed to maintaining the highest standards for the protection of human
subjects.
Please consider the environment before printing this e-mail
From: Sampson, Annie (NIH/NCI) [E]
Sent: Thursday, May 16, 2013 9:12 AM
To: OHSR (NIH/DDIR)
Cc: Sorhaindo, Nichole (NIH/NCI) [C]; Sampson, Annie (NIH/NCI) [E]
Subject: RE: OAR Advocate Database -- Request for Determination
Good morning,
I have attached the adjusted form here.
Thank you,
Annie
From: OHSR (NIH/DDIR)
Sent: Monday, May 06, 2013 4:31 PM
To: Sampson, Annie (NIH/NCI) [E]
Cc: Sorhaindo, Nichole (NIH/NCI) [C]
Subject: RE: OAR Advocate Database -- Request for Determination
Good afternoon Dr. Sampson.
While reviewing this request I found that question #4 – Proposed completion dates was not completed. If you expect
the study to continue past 5 years, enter 7/1/2018 as the proposed date. Send an amendment request via email to
extend the date as it gets closer to 2018. Question #7 – Will human data be collected, received or sent (check all that
apply) was answered no. I assume you will be collecting? Question #13 – Are all conflicts resolved was answered
no. This question has to be answered Yes before we can process your submission.
Please let me know if you have any questions.
Kristan Brown
OHSRP ‐ National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301‐402‐3444
Office Fax: 301‐402‐3443
The NIH is committed to maintaining the highest standards for the protection of human
subjects.
Please consider the environment before printing this e-mail
3
From: Sorhaindo, Nichole (NIH/NCI) [C]
Sent: Monday, May 06, 2013 11:52 AM
To: OHSR (NIH/DDIR)
Cc: Bridge, Heather (NIH/OD) [E]; Sampson, Annie (NIH/NCI) [E]; Landy, Kelley (NIH/NCI) [E]
Subject: OAR Advocate Database -- Request for Determination
Importance: High
Hello,
I would like to submit the attached OHSRP Determination Request Form on behalf of the NCI’s Office of Advocacy
Relations (OAR) for OAR’s Advocate Database. If you have any questions, please feel free to contact me at
nichole.sorhaindo@nih.gov or the PI, Annie Sampson, at annie.sampson@nih.gov.
Thanks,
Nichole Sorhaindo, MPH
Contractor
Palldian Partners, Inc.
Office of Advocacy Relations (OAR)
National Cancer Institute (NIH)
Building 31, Room 10A28E
31 Center Drive, MSC 2580, Bethesda, MD 20892‐2580
Phone: 301‐594‐3194
Email: sorhaindond@mail.nih.gov
4
OHSR (NIH/DDIR)
From:
Sent:
To:
Subject:
OHSR (NIH/DDIR)
Friday, May 09, 2014 12:51 PM
Sampson, Annie (NIH/NCI) [E]
Req for Determination Rec'd_OHSRP 12414
Good afternoon Ms. Sampson,
This email is to verify that OHSR has received your Request for Determination and it is currently being processed as
OHSRP #12414. Please use this number in any future correspondence regarding this study. We will contact you via
email if any additional information is needed. Please note that due to ongoing project deadlines, determinations are
taking longer than normal to process.
Protocol Title: NCI Advocate Database
Thank you.
Sincerely,
Chris Brentin
OHSRP ‐ National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301‐402‐3444
Office Fax: 301‐402‐3443
The NIH is committed to maintaining the highest standards for the protection of human
subjects.
Please consider the environment before printing this e-mail
1
File Type | application/pdf |
File Modified | 2014-05-23 |
File Created | 2013-04-29 |