Download:
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pdfHOPS SITE 1012
Dupont Circle Physicians Group
• This site defers to the CDC IRB, and therefore does not have a yearly local IRB
approval
• English language consent
OMB Control Number: 0920-1080
Expiration date: 02/29/2024
HOPS Informed Consent Forms
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
The following information is being presented to help you decide whether or not you want to participate
in a research study. Please read it carefully. If there is anything you do not understand, ask the doctor.
Study Title:“The HIV Outpatient Study (HOPS)”
Study Site: Dupont Circle Physicians Group
Principal Investigator: Jessicamarie Fox, NP-C
Address: 1145 19th St NW, Washington, DC 20036
Phone: (202) 745-0201
Study Sponsor: Centers for Disease Control and Prevention (CDC) and Cerner Corporation
Study funded by: Centers for Disease Control and Prevention (CDC)
PURPOSE: You are being invited to participate in this research study because you are a patient at our
clinic and you are HIV-positive. Our clinic works collaboratively with the Centers for Disease Control
and Prevention (CDC) and Cerner Corporation. Cerner collects information on patients with HIV
infection from medical clinics in the United States for a research study to better understand HIV disease
and treatments. Data gathered by Cerner are shared with the CDC. The data may also be used for other
purposes permitted by law, including comparative data analysis and the development, marketing and
distribution of products and services.
We are asking you to allow us to use information gathered as a result of your treatment at this
clinic. Your information will be included in the Cerner’s database with data from over 9,000 HIVpositive patients seen at several clinics around the country. This database has already been existence for
many years.
PROCEDURE: Data for this project will be gathered from your medical record; this will not require
any effort from you. The database includes demographic information, diagnoses, laboratory results,
symptoms, treatments, and hospitalizations. Information in the database is handled with the same strict
privacy as your medical record.
In addition we may occasionally ask you to participate in surveys or questionnaires on various topics.
These may include personal questions about sex, drug use, medication adherence, or other topics. These
surveys or questionnaires may be done on paper, by computer, or by an automated telephone
system. You may refuse to participate in these special studies and still be in the main study.
This study will not require extra office visits or extra lab tests. It will cost you nothing to be in this
study.
RISKS: There are no known health risks to you from participating in this study.
There is a risk of loss of privacy, meaning that information collected about you could become known to
others outside of the study. To minimize the risk of this happening, your data in the database is
identified only by a code number.
The additional surveys or questionnaires that you may be asked to participate in may include questions
about sexual practices, illegal drug use, or similar topics. Although these surveys are private, questions
about these topics may cause some discomfort or anxiety.
BENEFITS: There is no direct benefit to you from participating in this study. The information gathered
in this study, however, may result in a better understanding of HIV disease and treatments, which may
ultimately benefit persons with HIV infection.
Privacy: Your personal identifying information (including your name, date of birth, and possibly your
medical record number) will be entered and kept in a private and secure database, separately from your
medical information. Your personal identifying information cannot be seen by anyone outside of this
clinic. Cerner and CDC study staff will see your medical information in the database only with your
secure HOPS study participant number, not your name.
Your medical records and the consent form you sign may be inspected by authorized research
investigators or the CDC to make sure the study follows federal and state regulations. From time to time,
Cerner or CDC staff may review your medical records and survey data to check that your information in
the database is correct. Because of this need, we cannot guarantee absolute privacy. However, CDC and
Cerner staff are held to the same rules of privacy as office and study staff.
If the results of this research are published in a medical journal or presented at a conference they will not
include your name or any other information that may identify you.
This research project has a Certificate of Confidentiality from the Centers for Disease Control and
Prevention (CDC). Unless you say it is okay, researchers cannot release information that may identify
you for a legal action, a lawsuit or as evidence. This protection applies to requests from federal, state or
local civil, criminal, administrative, legislative, or other proceedings. As an example, the Certificate
would protect your information from a court subpoena.
There are some important things you need to know. The Certificate DOES NOT protect your
information if federal, state or local law says it must be reported. For example, some laws require
reporting of abuse, communicable diseases, and threats of harm to yourself or others. The Certificate
CANNOT BE USED to stop a federal or state government agency from checking records or evaluating
programs. The Certificate DOES NOT stop reporting required by the U.S. Food and Drug
Administration (FDA). The Certificate also DOES NOT stop your information from being used for other
research if allowed by federal regulations.
Researchers may release your information when you say it is okay. For example, you may give them
permission to release information to insurers, your doctors, or any other person not connected with the
research. The Certificate of Confidentiality does not stop you from releasing your own information. It
also does not stop you from getting copies of your own information.
The Certificate of Confidentiality will not be used to stop sharing your information for any purpose you
have consented to in this informed consent document, such as data collected from your medical records
for this research.
PAYMENT FOR STUDY PARTICIPATION: You will not be paid to participate in this study.
VOLUNTEERING TO BE PART OF THIS RESEARCH STUDY: Your participation in this study
is voluntary. You may refuse to participate or you may quit at any time. If you decide to stop taking part
in this study, tell the study doctor and your data will stop being added to the study database. Any of your
information already in the database at the time you quit the study may be still used for research.
If you stop participating in this study, this will not affect your medical care, benefits to which you are
otherwise entitled, or ability to take part in future research studies.
TERMINATION: We do not know when this study will end. It will go on until it is stopped for some
reason, or until funds are gone. The investigator or the sponsor may terminate your participation in this
study without your consent.
QUESTIONS AND CONTACTS:
If you have any questions or problems related to this research you may call Jessicamarie Fox,
Investigator, at (202) 745-0201.
If you have questions about your rights as a person who is taking part in a research study, you may
contact a member of the CDC’s Human Research Protection at 1-800-584-8814.
CONSENT STATEMENT
By signing this form, I confirm that
•
•
•
•
•
I have fully read (or someone has read and explained to me) this informed consent form
describing a research study.
I was given the opportunity ask questions and my questions have been answered to my
satisfaction.
I understand the risks and benefits, and I freely give my consent to participate in the research
project outlined in this form.
I understand that I am not giving up any of my legal rights.
I have been offered a copy of this informed consent form, which is mine to keep.
*___________________________
Signature of Participant
______________________________
Printed Name of Participant
_______
Date
___________________________
Signature of Witness
(if appropriate)
______________________________
Printed Name of Witness
_______
Date
INVESTIGATOR STATEMENT:
The subject signing this consent form has had the study fully and carefully explained to him or her. I
hereby certify that, to the best of my knowledge, the subject signing this consent form understands the
nature, demands, risks and benefits involved in participating in this study
_______________________________
Signature of Investigator
______________________________
Printed Name of Investigator
________
Date
_______________________________
Signature of Person Obtaining Consent
If Other than Investigator
______________________________
Printed Name
________
Date
The research project/study and informed consent form were reviewed and approved by the CDC Human
Research Protection Institutional Review Board. The board may be contacted at 1-800-584-8814.
HOPS SITE 1021/1025
Vivent Health
• English language consent
Form Approved
OMB No. 0920-1080
Expiration Date: 02/29/2024
VIVENT HEALTH
CYNTHIA S. FIRNHABER, MD
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
The following information is being presented to help you decide whether or not you want
to participate in a research study. Please read it carefully. If there is anything you do not
understand, ask the doctor.
Study Title: The HIV Outpatient Study (HOPS)
Study Site: Vivent Health
Principal Investigator: Cynthia S. Firnhaber, MD
Address: 5250 Leetsdale Drive, Suite #300, Denver, Colorado 80246
Phone: (303) 393-8050
Study Sponsor: Centers for Disease Control and Prevention & Cerner Corporation
PURPOSE: Our office works with Cerner Corporation. Cerner Corporation collects and
shares information on the course of and changes in the disease, symptoms, and
treatments of HIV infection. Data gathered by Cerner Corporation will be shared with the
Centers for Disease Control and Prevention (CDC). Your participation in this study is
voluntary and you may decide to withdraw at any time.
We are asking you to allow us to use information given by you or gathered as a result of
your treatment at this clinic. This data will be used to create a database of clinical findings.
The data may also be used for other purposes permitted by law, including without
limitation, comparative data analysis and the development, marketing and distribution of
other products and services. Your data will be grouped with data gathered on over 10,000
patients around the country. This database will span many years of treatment.
PROCEDURE: Data for Cerner Corporation is gathered from your medical record, and
will not require any effort from you. The database includes demographic information,
diagnoses, laboratory results, symptoms, treatments, and hospitalizations. Data in the
database is handled with the same strict confidentiality as your medical record. There is
no end date for this study. It will go on until it is stopped for some reason, or until funds
are gone.
In addition, we may occasionally ask you to participate in surveys or questionnaires on
various topics. These may include personal questions about sex, drug use, medication
adherence, or other topics. These surveys or questionnaires may be done on paper, by
Version: Mar 06, 2023
Page 1 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 02/29/2024
computer, or by an automated telephone system. You may refuse to participate in these
special studies and still be in the main study.
This study will not require extra office visits or extra lab tests. It will cost you nothing to be
in this study.
RISKS: There are no known health risks to you from participating in this study.
There is a risk of loss of confidentiality, meaning that information collected about you
could become known to others outside of the study. To minimize the risk of this
happening, your data in the database is identified only by a code number.
The additional surveys or questionnaires that you may be asked to participate in may
include questions about sexual practices, illegal drug use, or similar topics. Although
these surveys are confidential, questions about these topics may cause some discomfort
or anxiety.
BENEFITS: There may be no direct benefit to you from your participation in this
study. The information gathered in this study, however, may result in a better
understanding of HIV disease and treatments, which may ultimately benefit persons with
HIV infection.
FINANCIAL RESPONSIBILITY: This study will not require extra clinic visits or extra lab
tests. It will cost you nothing to be in this study. You will not receive extra care if you agree
to be in this study, and the cost of your health care will not change.
COMPENSATION: There will be no compensation to you for participation in this study.
ALTERNATIVES: The only other option to being in this study is to not be in this study.
CONFIDENTIALITY: Your personal identifying information (including your name, date of
birth, and possibly your medical record number) will be entered and kept in a confidential
and secure database, separately from your medical information. Your
personal identifying information cannot be seen by anyone outside of this clinic. Cerner
and CDC study staff will see your medical information in the database only with your
secure HOPS study participant number, not your name.
Your medical records and the consent form you sign may be inspected by authorized
research investigators or the CDC to make sure the study follows federal and state
regulations. From time to time, Cerner or CDC staff may review your medical records and
survey data to check that your information in the database is correct. Because of this
need, we cannot guarantee absolute confidentiality. However, CDC and Cerner staff are
held to the same rules of confidentiality as office and study staff.
Version: Mar 06, 2023
Page 2 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 02/29/2024
If the results of this research are published in a medical journal or presented at a
conference, they will not include your name or any other information that may identify
you.
This research project has a Certificate of Confidentiality from the Centers for Disease
Control and Prevention (CDC). Unless you say it is okay, researchers cannot release
information that may identify you for a legal action, a lawsuit or as evidence. This
protection applies to requests from federal, state or local civil, criminal, administrative,
legislative, or other proceedings. As an example, the Certificate would protect your
information from a court subpoena.
There are some important things you need to know. The Certificate DOES NOT protect
your information if federal, state or local law says it must be reported. For example, some
laws require reporting of abuse, communicable diseases, and threats of harm to yourself
or others. The Certificate CANNOT BE USED to stop a federal or state government
agency from checking records or evaluating programs. The Certificate DOES NOT stop
reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also
DOES NOT stop your information from being used for other research if allowed by federal
regulations.
Researchers may release your information when you say it is okay. For example, you
may give them permission to release information to insurers, your doctors, or any other
person not connected with the research. The Certificate of Confidentiality does not stop
you from releasing your own information. It also does not stop you from getting copies of
your own information.
The Certificate of Confidentiality will not be used to stop sharing your information for any
purpose you have consented to in this informed consent document, such as data
collected from your medical records for this research.
COMPENSATION FOR INJURY: If you are harmed as a result of joining this study, there
are no plans to compensate you or pay for medical costs not covered by your insurance
plan. Neither the CDC, Cerner Corporation, nor Vivent Health will assume any such
responsibility. The above does not prevent you from seeking such compensation.
PATIENT’S RIGHTS: As a research study patient, you have the right to ask questions.
You should not agree to be in this study until all your questions have been answered. You
have the right to withdraw from this study at any time. If you chose to withdraw from this
study, your care will not change. If you have questions about your rights as a person who
is taking part in a research study, you may contact a member of the CDC’s Human
Research Protection at 1-800-584-8814.
If you have any questions or problems related to this research study, or if you wish to
withdraw from this study, you may call Dr. Cynthia (Cindy) Firnhaber at 303-393-8050.
Version: Mar 06, 2023
Page 3 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 02/29/2024
CONSENT:
I, ____________________________, hereby authorize Dr._______________________
and Cerner Corporation to use any information given by me, or by my doctors as a result
of my treatment. I know that this information will be used by members of Cerner
Corporation and the Centers for Disease Control and Prevention for studies on the causes
of illness, treatments, and outcomes of patients with HIV.
I have been given the chance to ask questions, and am satisfied with the answers I have
received. I know that I will be given a copy of this consent form. I know that I may withdraw
from this study at any time, and that withdrawing will not affect my treatment. I have been
given the name and number of a contact person for questions, concerns, or to call if I
wish to withdraw.
By signing this consent form, I have not waived any of the legal rights which I otherwise
would have as a patient or a participant in a research study.
______________________________________________________________________
Patient Name
Patient Signature
Date
______________________________________________________________________
Name of Witness
Witness Signature
Date
(if appropriate)
INVESTIGATOR STATEMENT:
The subject signing this consent form has had the study fully and carefully explained to
him or her. I hereby certify that, to the best of my knowledge, the subject signing this
consent form understands the nature, demands, risks and benefits involved in
participating in this study.
______________________________________________________________________
Signature of Investigator
Printed Name
Date
______________________________________________________________________
Signature of Person Obtaining
Printed Name
Date
Consent if Other than Investigator
Version: Mar 06, 2023
Page 4 of 4
HOPS SITE 1040
Northwestern University
• English language consent
IRB #: STU00028271 Approved by NU IRB for use on or after 4/19/2019
Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above
OMB Control Number: 0920-1080
Expiration Date: 09/29/2024
Title of Research Study:
HIV Outpatient Study (HOPS)
Investigator:
Frank Palella, MD
Supported By:
This research is supported by Cerner Corporation and Centers for Disease Control
(CDC)
Financial Interest Disclosure:
The following disclosure is made to give you an opportunity to decide if this relationship will affect your
willingness to participate in this research study:
If your doctor is also the person responsible for this research study, please note that he is interested in both your
clinical care and the conduct of this research study. You have the right to discuss this study with another person
who is not part of the research team before deciding whether to participate in the research.
Key Information:
The first few pages of this document include a summary of this study to help you decide whether or not to
participate. Detailed information is provided after the summary.
Why am I being asked to take part in this research study?
We are asking you to take part in this research study because you are HIV positive and will be receiving
treatment at our clinic for your disease.
What should I know about a research study?
•
Someone will explain this research study to you.
•
Whether or not you take part is up to you.
•
You can choose not to take part.
•
You can agree to take part and later change your mind.
•
Your decision will not be held against you.
•
You can ask all the questions you want before you decide.
Why is this research being done?
The purpose of this research study is to collect and share information on the course and changes in the diseases,
symptoms, and treatments of HIV infection. Data gathered by Cerner will be shared with the Centers for
Disease Control and Prevention (CDC). This database will be used for research to better understand HIV and to
improve treatment of HIV.
You are being asked to allow us to use the information given by you or gathered as a result of your treatment at
this clinic. This data will be used to create a database of clinical findings. This database will span many years of
treatment.
Page 1 of 6
Version Date: February 28, 2019
IRB #: STU00028271 Approved by NU IRB for use on or after 4/19/2019
Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above
How long will the research last and what will I need to do?
We expect that you will be in this research study for as long as your receive treatment at this clinic.
More detailed information about the study procedures can be found under the section What happens if I say
“Yes, I want to be in this research”?
Is there any way being in this study could be bad for me?
Your participation in this study does not involve any physical risk to you.
Will being in this study help me anyway?
There may be no direct benefit to you by your participation in this research study. We cannot promise any
benefits to you or others from you taking part in this research. However, possible benefits include helping
people who research HIV disease to better understand the disease.
What happens if I do not want to be in this research?
Participation in research is completely voluntary. You decide whether or not to participate. If you choose to not
participate, there will be no penalty to you or loss of benefit to which are entitled.
Detailed Information:
The rest of this document includes detailed information about this study (in addition to the information
listed above).
Whom can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research team at
(312) 926-8358.
This research has been reviewed and approved by an Institutional Review Board (IRB). You may talk to them at
(312) 503-9338 or irb@northwestern.edu if:
• Your questions, concerns, or complaints are not being answered by the research team.
• You cannot reach the research team.
• You want to talk to someone besides the research team.
• You have questions about your rights as a research participant.
• You want to get information or provide input about this research.
Page 2 of 6
Version Date: February 28, 2019
IRB #: STU00028271 Approved by NU IRB for use on or after 4/19/2019
Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above
How many people will be studied?
Your data will be grouped with data gathered on over 10,000 subjects around the country.
What happens if I say “Yes, I want to be in this research”?
Data for Cerner is gathered from your medical record, and will not require any effort from you.
Data in the database is handled with the same strict confidentiality as your medical record. There is no end date
for this study. During your participation in this study, you may be approached to participate in special studies
through which extra data will be gathered by surveys on topics that might be of interest at that time. Some of
these surveys could ask personal questions about sex, drug use, payment for medical care, or medication
adherence. You will not have to be in any of the extra studies just because you are a part of this study. You may
refuse to participate in these special studies and still be in the main study.
What happens if I say “Yes”, but I change my mind later?
You can leave the research at any time; it will not be held against you.
Choosing not to be in this study or to stop being in this study will not result in any penalty to you or loss of
benefit to which you are entitled. Specifically, your choice not to be in this study will not negatively affect your
right to any present or future medical treatment.
If you stop being in the research, already collected data may not be removed from the study database. You will
be asked whether the investigator can collect data from your routine medical care.
Detailed Risks: Is there any way being in this study could be bad for me?
This study involves the use of your identifiable, personal information and there is a chance that a loss of
confidentiality could occur. The researchers have procedures in place to lessen the possibility of this happening.
See the section below titled: “What happens to the information collected for the research?”
Will it cost me anything to participate in this research study?
Taking part in this research study will not lead to any costs to you.
What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of your personal information, including research study and
medical records, to people who have a need to review this information. We cannot promise complete secrecy.
Organizations that may inspect and copy your information include the Cerner Corporation, the Centers for
Disease Control (CDC), the IRB and other representatives of this institution.
Page 3 of 6
Version Date: February 28, 2019
IRB #: STU00028271 Approved by NU IRB for use on or after 4/19/2019
Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above
This data may be used for other purposes permitted by law, including without limitations, comparative data
analysis and the development, marketing and distribution of other products and services. No personal
identifying information will be collected such as name, address, phone number, medical record number, or
social security number for Cerner Corporation or the CDC. Allowing your data to be used for these purposes is
not considered optional, unless you decline to participate in the study.
Data Sharing
De-identified data from this study may be shared with the research community at large to advance science and
health. We will remove or code any personal information that could identify you before files are shared with
other researchers to ensure that, by current scientific standards and known methods, no one will be able to
identify you from the information we share. Despite these measures, we cannot guarantee anonymity of your
personal data.
HIPAA Authorization
We are committed to respect your privacy and to keep your personal information confidential. When choosing
to take part in this study, you are giving us the permission to use your personal health information that includes
health information in your medical records and information that can identify you. For example, personal health
information may include your name, address, phone number or social security number. Your health information
we may collect and use for this research includes:
•
•
•
•
•
•
•
•
•
All information in a medical record
Results of physical examinations
Medical history
Lab tests, or certain health information indicating or relating to a particular condition as well as diaries
and questionnaires
Records about study medication or drugs
Records about study devices
HIV Testing Results
Substance abuse information, such as alcohol and drug use
Mental Health information, such as any diagnosis listed in your medical record, as well as treatment on
antidepressants, etc.
You have the right to inspect and copy the mental health and developmental disabilities records that will be
collected as part of this study.
The following clinical providers may give the researchers information about you: all current and previous
health care providers, including but not limited to the Shirley Ryan Ability Lab (SRALAB), Northwestern
Medical Group (NMG), Northwestern Memorial Hospital (NMH), and Northwestern Lake Forest Hospital
(NLFH).
Page 4 of 6
Version Date: February 28, 2019
IRB #: STU00028271 Approved by NU IRB for use on or after 4/19/2019
Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above
Once we have the health information listed above, we may share some of this information with the following
offices or entities outside of Northwestern University and its clinical partners (or affiliates): the Northwestern
University Institutional Review Board Office and Office for Research Integrity; the US Office of Research
Integrity; the US Office for Human Research Protections; the US Food and Drug Administration.
Any research information shared with outside entities will not contain your name, address, telephone or social
security number or any other personal identifier unless disclosure of the identifier is necessary for review by
such parties or is required by law or University policy [except that such information may be viewed by the
Study sponsor and its partners or contractors at the Principal Investigator’s office].
The following entities may receive your health information:
• Authorized members of the Northwestern University workforce, who may need to see your
information, such as administrative staff members from the Office for Research, Office for
Research and members of the Institutional Review Board.
• Clinical affiliates, including but not limited to the Shirley Ryan Ability Lab (SRALAB),
Northwestern Medical Group (NMG), Northwestern Memorial Hospital (NMH), Northwestern
Lake Forest Hospital (NLFH), and the Ann & Robert H. Lurie Children’s Hospital of Chicago
(Lurie Children’s). Your participation in this clinical trial may be tracked in an electronic
database and may be seen by investigators running other trials that you are enrolled in and by
your healthcare providers.
• Other University research centers and University contractors who are also working on the study.
• Study monitors and auditors who make sure that the study is being done properly.
• Cerner Corporation and CDC, who is sponsoring the study, and that company’s contractors and partners.
• Government agencies and public health authorities, such as the Food and Drug Administration (FDA)
and the Department of Health and Human Services (DHHS).
Those persons who get your health information may not be required by Federal privacy laws (such as the
Privacy Rule) to protect it. Some of those persons may be able to share your information with others without
your separate permission.
However, Illinois law does not allow the re-release of HIV/AIDS, genetic testing, mental health and
developmental disabilities information by the receivers of the information except in precise situations
allowed by law.
Also, Federal Confidentiality Rules, 42 CFR Part 2, prohibit making any further disclosure of substance use
disorder information unless further disclosure of this information is expressly permitted by written consent
of the person to whom it pertains or as otherwise permitted by 42 CFR Part 2.
The results of this study may also be used for teaching, publications, or for presentation at scientific
meetings.
Unless you revoke your consent, it will expire at the end of research study.
Page 5 of 6
Version Date: February 28, 2019
IRB #: STU00028271 Approved by NU IRB for use on or after 4/19/2019
Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above
Although you may revoke consent to participation in this research at any time and in any format, you must
revoke authorization for use or disclosure of your health information in writing. To revoke your
authorization, write to
PI’s Name: Frank J. Palella, Jr., MD
Institution: Northwestern University
Division of Infectious Disease
Address: 645 N. Michigan Ave., Suite 900, Chicago, IL 60611
You do not have to authorize the use or disclosure of your health information; however, you will not be allowed
to take part in this research study. If you do not authorize the use or disclosure of your health information, it
will not affect your treatment by health care providers, or the payment or enrollment in any health plans, or
affect your eligibility for benefits.
A copy of this signed consent document, information about this study, and the results of any test or procedure
done may be included in your medical records and may be seen by your insurance company.
Your signature documents your permission to take part in this research. You will be provided a copy of this
signed document.
Signature of Participant
Date
Printed Name of Participant
Signature of Person Obtaining Consent
Date
Printed Name of Person Obtaining Consent
Page 6 of 6
Version Date: February 28, 2019
HOPS SITE 1041
SUNY-Stonybrook
• English language consent
HOPS SITE 1057
Temple University
• English language consent
• Spanish language consent
Permission to Take Part in a Human Research Study
Page 1 of 8
OMB Control Number: 0920-1080 expiration date: 02/29/2024
Temple IRB Approved
02/28/2023
Title of research study: #3156 HIV Outpatient Study (HOPS)
Investigator and Department: Ellen M. Tedaldi, M.D., General Internal Medicine
Why you are being invited to take part in a research study:
We invite you to take part in a research study because you have HIV infection and we are
collecting information about the course of and changes in treatments, diseases and outcomes
of persons living with HIV in the United States. We are working with a health database that is
run by Cerner Corporation in cooperation with the Centers for Disease Control and
Prevention (CDC). The database will have the same information gathered in 8 other clinics
around the country.
What you should know about a research study:
•
•
•
•
•
•
•
Someone will explain this research study to you.
You volunteer to be in a research study.
Whether you take part is up to you.
You can choose not to take part in the research study.
You can agree to take part now and later change your mind.
Whatever you decide, it will not affect your care.
Feel free to ask all the questions you want before and after you decide.
Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, contact
the research team at : Dr. Ellen Tedaldi, MD, General Internal Medicine, 1316 W. Ontario
Street, Philadelphia, PA 19140, Phone: 215-707-1800
This research has been reviewed and approved by an Institutional Review Board. You may
talk to them at (215) 707-3390 or e-mail them at: irb@temple.edu for any of the following:
•
Your questions, concerns, or complaints are not being answered by the research team.
• You cannot reach the research team.
• You want to talk to someone besides the research team.
•
•
You have questions about your rights as a research subject.
You want to get information or provide input about this research.
Document Revision Date: January 25,2021
Permission to Take Part in a Human Research Study
Page 2 of 8
Why are we doing this research?
The information in the database helps doctors, researchers and other persons caring for
persons with HIV infection to know about the latest treatments, complications, conditions and
outcomes in a diverse group of patients in the United States.
How long will the research last?
We expect that you will be in this research study for years as long as the database collection
is funded and approved to continue. The study began in 1994 and has been funded every
year since then.
How many people will be studied?
We expect about 3000 people here at Temple will be in this research study out of 10,000
active people in the entire study nationally.
What happens if I say yes, I want to be in this research?
Information for the database is gathered from your medical record, and will not require any
effort by you. Your health care provider, the Cerner Corporation, and the CDC, will analyze
data about your symptoms, treatments, diagnoses, hospitalizations and medications.
You may be asked to participate in a computerized survey that will collect information about
your habits including tobacco, alcohol or drug use as well as sexual practices. This
information is anonymous and is not available to your provider. This is a Telephone Audio
Computer Assisted Clinical Interview ( T-ACASI) and is not part of your medical record or
regular database information
What are my responsibilities if I take part in this research?
You have no responsibilities if you agree to take part. All the information about you will be
collected if you continue to receive care at Temple Hospital and the ambulatory medical
practices.
If you agree to participate in the T-ACASI survey, you will be asked to complete the survey on
a phone in the medical office by a research assistant or you can complete the survey on your
own phone. You will receive only an identification number and nothing with you name or
personal health information
What happens if I say no, I do not want to be in this research?
You may decide not to take part in the research and it will not be held against you. It will in
no way affect your relationship with the study doctor.
There are no known risks involved in this study. This study will not require extra clinic visits
or extra lab tests. You will have to pay nothing to be in the study. Sometimes, extra data will
be gathered for a special study through surveys on a topic that might include questions about
sex, drug use, or medication adherence. You will not have to be in any of the extra studies
just because you are part of this study. You may refuse to participate in these special studies
and still be in the main study.
Document Revision Date: January 25,2021
Permission to Take Part in a Human Research Study
Page 3 of 8
What happens if I say yes, but I change my mind later?
You agree to take part in the research now and if you stop at any time, it will not be held
against you. Again, it will in no way affect your relationship with the study doctor.
If you stop being in the research, already collected data may not be removed from the study
database. You will be asked whether the investigator can collect data from your routine
medical care. If you agree, this data will be handled the same as research data.
Is there any way being in this study could be bad for me?
There is no way that this study could be bad for you as there is no direct treatment while
being enrolled. The study is collecting information only with your identity recorded as a study
number only.
Will being in this study help me in any way?
You gain nothing from being in this study except to aid research in HIV disease and better
understand the disease. You will not receive extra care if you agree to be in this study, and
the cost of your health care will not change.
What happens to the information we collect?
Efforts will be made to limit your personal information, including research study and medical
records, to people who have a need to review this information. We cannot promise complete
secrecy. For example, though the study team has put in safeguards to protect your
information, there is always a potential risk of loss of confidentiality.
Organizations that may inspect and copy your information include the IRB, Temple
University, Temple University Health System, Inc. and its affiliates, and other representatives
of these organizations, and the Office of Human Research Protections. In addition the Center
for Disease Control and Prevention and Cerner Corporation will be able to review the data
with no personal identifiers attached. The monitors, auditors, the IRB, and the Food and Drug
Administration will be granted direct access to the portion of your medical records which are
related to this research study for verification of the research procedures and date. You will
need to sign a separate “Authorization to use and disclose your protected health information”
to be a part of this research study.
We may publish the results of this research. However, we will keep your name and other
identifying information confidential.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required
by U.S. Law. This website will not include information that can identify you. At most, the
website will include a summary of the results. You can search this website at any time.
Federal law provides additional protections of your personal information. These are described
in an attached Authorization document referred to above.
Can I be removed from the research without my permission?
Document Revision Date: January 25,2021
Permission to Take Part in a Human Research Study
Page 4 of 8
The person in charge of the research study or the sponsor can remove you from the research
study without your approval. Possible reasons for removal include that you no longer receive
care at Temple Hospital or the ambulatory practices. The sponsor can also end the research
study early.
We will tell you about any new information that may affect your health, welfare,
or choice to stay in the research.
What else do I need to know?
If you sustain an injury as a result of your participation in this research study, the physician’s
fees and medical expenses that result will be billed to your insurance company or you in the
usual manner. Other financial compensation (such as lost wages or pain and suffering) for
such injuries is not routinely available. By signing this consent form, you are not waiving any
of the legal rights that you otherwise would have as a participant in a research study. If you
have questions about the study or a research-related injury, please contact Dr. Ellen M.
Tedaldi during regular hours and at (215) 707-1800 after hours and on weekends and
holidays.
Stipend/Reimbursement
If you agree to take part in this research study, there is no payment to you.
Participating in Future Research Studies
We may want to contact you in the future to see if you would be interested in participating in
another research study and/or to obtain additional information related to your participation in
this study. Please indicate by initialing on the line in the next paragraph below if you are
willing to be contacted. Please know that you can amend your answer below at any time
without prejudice to you or your relationship with the study, Temple University, or the Study
doctor and team.
Yes, I agree to be contacted about future research studies. ____
No, I do not want to be contacted about future research studies. ____
Yes, I agree to be contacted to obtain additional information related to my participation in this
study. ____
No, I do not want to be contacted to obtain additional information related to my participation in
this study. ____
Document Revision Date: January 25,2021
Permission to Take Part in a Human Research Study
Page 5 of 8
Document Revision Date: January 25,2021
Permission to Take Part in a Human Research Study
Page 6 of 8
Signature Block for Adult Subject Capable of Consent
Your signature documents your permission to take part in this research.
Signature of subject
Date
Printed name of subject
Signature of person obtaining consent
Date
Printed name of person obtaining consent
Document Revision Date: January 25,2021
Permission to Take Part in a Human Research Study
Page 7 of 8
Signature Block for Adult Subject Unable to Consent
Your signature documents your permission for the individual named below to take part in this
research.
Printed name of subject
Signature of legally authorized representative
Date
Printed name of legally authorized representative
Signature of person obtaining consent
Date
Assnt
Printed name of person obtaining consent
❑ Obtained
❑ Not obtained because the capability of the subject is so limited that the subject cannot reasonably be consulted.
Document Revision Date: January 25,2021
Permission to Take Part in a Human Research Study
Page 8 of 8
Document Revision Date: January 25,2021
HOPS SITE 2003
University of Illinois-Chicago (UIC)
• English language main consent
• English language consent amendment
• English language consent for T-ACASI
behavioral survey
• Spanish language main consent
• Spanish language consent amendment
• Spanish language consent for T-ACASI
behavioral survey
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
Leave box empty - For office use only
University of Illinois at Chicago
Authorization To Use And Disclose Health Information For Research
"CDC HIV Outpatient Study Database"
You are being asked to permit Dr Richard M. Novak
of the Department of Infectious Diseases in the College of Medicine and their staff to use and
disclose protected health information (PHI) that identifies you for the research purposes
described below. You are also being asked to permit your doctors and other health care
providers to disclose PHI to these Researchers for the purposes described below. The privacy
law [45 CFR Parts 160 and 164], Health Insurance Portability and Accountability Act (HIPAA)
provides additional protections for PHI. You must sign this authorization if you wish to allow
your PHI to be used or disclosed for this research.
Description of protected health information to be used and disclosed
The protected health information that may be used and disclosed includes all information
collected during the research described in the Consent for Participation in Research entitled CDC
HIV Outpatient Study Database;
The protected health information that may be used and disclosed includes all protected health
information in your medical records that is related to the research including illnesses and
hospitalizations that occur while you are participating in the research, as described in the
Consent for Participation in Research entitled CDC HIV Outpatient Study Database. This health
information includes information contained in your medical chart from all clinic visits and
hospitalizations, including demographic information such as your date of birth, age, sex, race;
blood test results, x-ray and other diagnostic test results, results of physical exams and symptoms
you describe at visits, medical and medication histories.
The protected health information that may be used and disclosed includes the information as
described above, which is collected and maintained by your physicians and other healthcare
providers which are identified below: Physicians and their staff at UIC.
Research use of your protected health information
• The Researchers can use and share your protected health information to conduct the research;
• The Researchers can disclose your protected health information to the sponsor of the
research, Cerner Corporation, as required for the research and if further information is
needed to confirm the research;
HOPS Study-Authorization
Version 7 3.11.19
Form Approved
0MB 0920-1080
Expiration Date: 08/31/2018
•
•
•
•
The Researchers can disclose your protected health information to other collaborators of the
research study: Centers for Disease Control (CDC);
The Researchers can disclose your protected health information to representatives of
government agencies (i.e., Food and Drug Administration) where required by law; and
The Researchers can disclose your protected health information to the University of Illinois
Medical Center at Chicago and University of Illinois at Chicago representatives including the
Institutional Review Board.
Once the Researchers disclose your information to anyone outside of the study, it may be redisclosed and may no longer be protected by this Authorization and the federal privacy
regulations.
Protection of your health information
The Researchers and Cerner Corporation agree to protect your health information by using and
disclosing it only as permitted by you in this Authorization or as is directed by state and federal
law. Further, no publication about the research will reveal your identity without your express
written permission. These limitations continue even if you decide to revoke (take back) this
Authorization.
Removal of your identifying information (De-Identification)
Once the information that identifies you is removed, the information that remains is no longer
subject to this Authorization or to HIPAA. The remaining information may be used and
disclosed by the Researchers as permitted by law and may be used and disclosed for other
research purposes.
Access to your protected health information collected in this research
During the time you are partidpating tn the researctt, you will not he allowed to see information
collected as part of the research study. Once the study is over, you will have the right to access
the information again.
1'ffl P'iffl-=m-nlm ffl'1i ,_.:;;;;:;;:;;.;,;.,;;.,, rn,,, :;....;. fra11nrtrr,>; , ch'r:,;.,.i..part of a
database or data repository and, therefore, this Authorization will not expire unless you revoke
(take back) your Authorization.
Your options
You do not have to sign this Authorization, but if you do not, you will not be allowed to
participate in this research study. However, if you decide not to sign this authorization it will not
affect your treatment, payment or enrollment in any health plans or affect your eligibility for
benefits.
Expiration of Authorization
ihis Authorization does not have an expiration date, but can be terminated if you decide to
withdraw your permission.
Withdrawal or removal from the study
HOPS Study - Authorization
Version6, 3.14.16
Page 2 of3
Form Approved
0MB 0920-1080
Expiration Date: 08/31/2018
You may change your mind and revoke this Authorization at any time. To revoke this
Authorization, you must write to: Dr. Richard Novak, M.D. UIC College of Medicine,
Department of Infectious Diseases (m/c 735) 808 S. Wood Street Rm 886, Chicago, IL 60612.
However, if you revoke this Authorization, you may no longer be allowed to continue
participation in the research study. Furthermore, even if you revoke this Authorization, the
Researchers may still use and disclose health information they already have obtained as
necessary to maintain the reliability of the research and to report any adverse effects (bad events)
that may have happened to you.
Contact information for questions about my rights under HIPAA
If you have questions or concerns regarding your privacy rights under HIPAA, you should
contact the University of Illinois at Chicago Privacy Officer at Ph: (312) 996-2271.
If you have not already received a copy of the Notice of Privacy Practices, you should request
one. You will be given a copy of this Authorization after it has been signed to keep for your
records.
Signature of Subject or Legally Authorized Representative
I have read (or someone has read to me) the above information. I have been given an opportunity
to ask questions and my questions have been answered to my satisfaction. I authorize the use and
disclosure of my protected health information for this research.
Signature of Subject
Date
Printed Name of Subject
Signature of Witness
Date (must be same as Subject's)
Printed name of Witness
Describe why a witness signature is required and the relationship to the Subject.
HOPS Study - Authorization
Version6, 3.14.16
Page 3 of3
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
Leave box empty - For office use only
University of Illinois at Chicago
Consent for Inclusion in the CDC HIV Outpatient Study Database
Why am I being asked?
You are being asked to allow information about your treatment for HIV at the University of
Illinois at Chicago (UIC) Medical Center to be included in a national database that already
includes data from more than seventeen medical centers and thousands of patients with HIV.
This study is conducted by Dr. Richard Novak at UIC and Cerner Corporation in Vienna,
Virginia. All patients receiving care at the UIC Medical Center clinics are being asked
permission to include their medical information in the database. We ask that you read this form
and ask any questions you may have before agreeing to be in the research.
Your decision to allow your information to be included in the database is voluntary. Your
decision will not affect the care you receive at FCID, nor will it affect future relations with the
University. If you decide to participate, you are free to withdraw at any time without affecting
that relationship.
Why is this research being done?
This database has been created to monitor trends in demographics, symptoms, diagnoses,
treatments, and disease outcomes in HIV-positive outpatients in clinics across the United States.
This database will combine your information with information from other HIV patients in
different parts of the United States to help your physician learn more about conditions associated
with HIV infections. By combining information from many different patients, it is possible to
learn more about unusual events and to compare the effects of different treatments. The database
can be used to determine how well various treatments are tolerated or taken. It can also be used
to determine what effect a treatment has on the risk of other infections or hospitalizations, etc.
Various investigators, organizations or companies interested in improving treatment of HIV may
use this information to develop new treatment strategies for HIV infection. The data may also be
used for other purposes permitted by law, including without limitation, comparative data analysis
and the development, marketing and distribution of other products and services.
HIV Observational Database
Version
6 (3.11.19)
Page 1 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
How will the data be collected?
A unique study identification number will be created for you after your visit today. After your
first clinic the study data collector will collect demographic information, including your age, sex,
ethnicity, and HIV risk behaviors from your chart. Information about your symptoms, diagnosed
conditions, medications, and laboratory results will also be collected from your chart after each
of your clinic visits. If you are hospitalized, that information will also be entered into the
database. If you are already a patient at UIC Medical Center, the data collector will enter
information for all you clinic visits since you became a patient at UIC Medical Center.
From time to time, you may be asked to complete a voluntary survey or questionnaire that asks
questions about your demographic information (such as age, race or ethnicity), sexual activities,
drug use and medication adherence. These surveys or questionnaires will be done either by paper
form or telephone at the same time as one of your scheduled clinic visits. You may refuse to
participate in these surveys or questionnaires and still be part of the main study.
What are the potential risks and discomforts?
There is a risk of loss of confidentiality, meaning that information collected about you could
become known by others outside of the research. To keep this from happening, the information
taken from your medical records and information you provide in surveys or questionnaires will
be coded with a unique study identification number.
No additional medical tests will be performed and you will not be treated any differently as a
result of you information being included in the database.
Are there benefits to taking part in the research?
While the national database may not benefit you directly, information gathered from the database
may permit a better understanding of the risks and benefits of the various treatments for HIV.
This could eventually benefit a number of persons with HIV infections, including you. Having
your clinical information in an organized database may also benefit you by allowing your doctor
to view all of your records in one place in a neatly organized manner. Currently, the database
used by UIC only includes information from the past three years.
What about privacy and confidentiality?
At no time will anyone outside of UIC be able to identify you or your information through this
database. All information will be entered into the database under your unique study number. The
only people who have access to the file that can link you to your study identification numberwill
be the UIC database staff and your physician. Cerner Corporation will never know your name,
your UIC patient number, or any other personal information about you. On occasion, a Cerner
Corporation study coordinator may ask to see your chart to verify that your medical information
in the database is correct. Or, a representative from the UIC Institutional Review
HIV Observational Database
Version 5 (10-21-15)
Page 2 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
Board may verify that you have given consent to participate. In these cases, your identity will
remain confidential and the UIC staff will maintain control of the file that links you to your clinical
information.
The only people who will know that your information is included in the database will be your
physicians, nurses and the staff entering the information into the database. No information about
you, or provided by you during clinic visits will be disclosed to others without your written
permission. When the results of the research are published or discussed in conferences, no
information will be included that would reveal your identity.
The database is password protected and the database can only be accessed on one designated
computer. Only study staff will have access to that computer, which is also password protected.
Who should I contact if I have questions?
The researcher conducting this study is Dr. Richard Novak. You may ask any questions you
have now. If you have questions later, you may contact the researchers at: 312-996-8337.
What are my rights as a research subject?
If you feel you have not been treated according to the descriptions in this form, or you have any
questions about your rights as a research subject, you may call the Office for the Protection of
Research Subjects (OPRS) at 312-996-1711 (local) or 1-866-789-6215 (toll free) or email OPRS
at uicirb@uic.edu.
Remember:
Your participation in this research is voluntary. Your decision whether or not to participate will
not affect your current or future relations with the University. If you decide to participate, you
are free to withdraw at any time without affecting that relationship.
You will be given a copy of this form for your information and to keep for your records.
Signature of Subject or Legally Authorized Representative
I have read (or someone has read to me) the above information. I have been given an opportunity
to ask questions and my questions have been answered to my satisfaction. I agree to participate
in this research. I have been given a copy of this form.
Signature
Date
Printed Name
HIV Observational Database
Version 5 (10-21-15)
Page 3 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
Signature of Researcher
Date (must be same as subject’s)
Signature of Witness (if appropriate)
Date (must be same as subject’s)
Printed name of Witness (if appropriate)
HIV Observational Database
Version 5 (10-21-15)
Page 4 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
Leave box empty - For office use only
University of Illinois at Chicago
Consent for the Telephone Behavioral Questionnaire substudy of the CDC
HIV Outpatient Study Database
Why am I being asked?
You are currently a research subject in a study called the “CDC HIV Outpatient Study
Database,” conducted by Dr. Richard Novak from the UIC College of Medicine and Cerner
Corporation in Vienna, VA. This database collects information from your medical records at this
university to monitor trends in demographics (such as age, race and ethnicity), symptoms,
diagnoses, treatments and disease outcomes in HIV positive patients. Several other sites in the
United States participate in this study as well. Additionally, you have previously signed the
addendum to this study acknowledging that on occasion voluntary surveys or questionnaires will
be offered to you to complete.
We ask that you read this form and ask any questions you may have before agreeing to this
telephone behavioral questionnaire substudy
Your decision to participate in this telephone questionnaire is voluntary. Your decision will not
affect your participation in the main database study, nor will it affect the care you receive at
FCID, nor will it affect future relations with the University. If you decide to participate, you are
free to stop the questionnaire at any time without affecting that relationship.
Why is this research being done?
This telephone questionnaire is to find out more information about some of the things you have
done in the last 6 months from the time of your completing this survey. Some of the questions
are sensitive in nature because of the personal information requested. Due to the sensitive nature
of some of the questions asked in the survey, if a loss of confidentiality were to occur, it is
possible that this loss could cause potential embarrassment or discomfort to you. This
information includes your sex and age, use of alcohol, use of drugs not prescribed by your
HIV Observational Database
Telephone Questionnaire Substudy
Version 5 (03/11/19)
Page 1 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
doctors, use of drugs for sexual dysfunction if you are male, and any kind of sex you may have
had in the last 6 months.
How will the data be collected?
You will be given a unique questionnaire number that is different from the identification number
used in the main part of the study in order to maintain confidentiality.
The questionnaire is set up so that you can skip any questions except sex and age that you do not
wish to answer. It will take you anywhere from 1 to 10 minutes to complete, depending on some
of your answers.
A handout with your unique 4 digit number and the instructions for completing the telephone
questionnaire will be given to you once you agree to participate. You will dial the 800 phone
number on the handout to get into the questionnaire. You will then punch the number that
matches your response to each question.
Once you complete the questionnaire and hang up, your responses will be transmitted to the
center that compiles all of the data for the main study. Your responses will be identified only by
your 4 digit number that is not linked to your name. Your doctor and study staff will not know
the responses you made, they will only know whether or not you completed the study.
What are the potential risks and discomforts?
There is a risk of loss of confidentiality, meaning that information collected about you could
become known by others outside of the research. To keep this from happening, this
questionnaire will be coded only with a unique study identification number; your name and any
other identifying information such as date of birth, social security number, medical record
number, address or phone number will not be associated with this number.
Are there benefits to taking part in the research?
While this questionnaire may not benefit you directly, information gathered from the questionnaire
may permit a better understanding of some of the behaviors of patients in this database study. This
could eventually benefit a number of persons with HIV infections, including you.
What about privacy and confidentiality?
At no time will anyone outside of UIC be able to identify you or your information through this
questionnaire. All information you enter on the telephone will be under your unique study number.
The only people who have access to the file that can link this questionnaire 4 digit
HIV Observational Database
Telephone Questionnaire Substudy
Version 5 (03/11/19)
Page 2 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
number to your study identification number will be the Cerner Corporation. They are the same
corportation that compiles the information from the main study. Remember, as mentioned in the
main study consent, Cerner Corporation will never know your name, your UIC patient number,
or any other personal information about you.
Your doctor and the study staff will not know what your answers are to this questionnaire. They
will only know whether or not you completed it.
Who should I contact if I have questions?
The researcher conducting this study is Dr. Richard Novak. You may ask any questions you
have now. If you have questions later, you may contact the researchers at: 312-996-8337.
What are my rights as a research subject?
If you feel you have not been treated according to the descriptions in this form, or you have any
questions about your rights as a research subject, you may call the Office for the Protection of
Research Subjects (OPRS) at 312-996-1711 (local) or 1-866-789-6215 (toll-free) or email OPRS
at uicirb@uic.edu.
Remember:
Your participation in this research is voluntary. Your decision whether or not to participate will
not affect your current or future relations with the University. If you decide to participate, you
are free to withdraw at any time without affecting that relationship.
You will be given a copy of this form for your information and to keep for your records.
Signature of Subject or Legally Authorized Representative
I have read (or someone has read to me) the above information. I have been given an opportunity
to ask questions and my questions have been answered to my satisfaction. I agree to participate
in this research. I have been given a copy of this form.
Signature
Date
Printed Name
Signature of Researcher
HIV Observational Database
Telephone Questionnaire Substudy
Date (must be same as subject’s)
Version 5 (03/11/19)
Page 3 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
Signature of Witness (if appropriate)
Date (must be same as subject’s)
Printed name of Witness (if appropriate)
HIV Observational Database
Telephone Questionnaire Substudy
Version 5 (03/11/19)
Page 4 of 4
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
Leave box empty - For office use only
Amendment to
University of Illinois at Chicago
Consent for Inclusion in the CDC HIV Outpatient Study Database
You are currently a research subject in a study called the “CDC HIV Outpatient Study
Database,” conducted by Dr. Richard Novak from the UIC College of Medicine and Cerner
Corporation in Vienna, VA. This database collects information from your medical records at this
university to monitor trends in demographics (such as age, race and ethnicity), symptoms,
diagnoses, treatments and disease outcomes in HIV positive patients. Several other sites in the
United States participate in this study as well.
You are being asked to sign this addendum consent because we would like to add the use of
voluntary surveys or questionnaires at the time of some of your clinic visits as a method of
collecting additional data. This request of use surveys or questionnaires was not included in your
original consent because at the time of your consent, we were not participating in any of the sub
studies (smaller studies of the database) that are part of the ongoing database. It is hoped that the
use of these surveys or questionnaires will allow us to use a more complete set of information in
the sub studies. Sometimes, this data will be the same data that is in your medical records that is
already collected. This addendum also includes changes to the risk and discomforts section since
there is a possibility that information you provide could result in a loss of confidentiality.
Your participation in these additional surveys or questionnaires is voluntary. You can refuse to
complete the survey or questionnaire and still be part of the main database study.
How will the data be collected?
From time to time, you may be asked to complete a voluntary survey or questionnaire that asks
questions about your demographic information (such as age, race or ethnicity), sexual activities,
drug use and medication adherence. These surveys or questionnaires will be done either by paper
form or telephone at the same time as one of your scheduled clinic visits. You may refuse to
participate in these surveys or questionnaires and still be part of the main study.
HIV Observational Database
Amendment #1
Version 4(3/11/19)
Page 1 of 2
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
What are the potential risks and discomforts?
There is a risk of loss of confidentiality, meaning that information collected about you could
become known by others outside of the research. To keep this from happening, the information
taken from your medical records and information you provide in surveys or questionnaires will
be coded with a unique study identification number.
No additional medical tests will be performed and you will not be treated any differently as a
result of you information being included in the database.
Signature of Subject or Legally Authorized Representative
I have read (or someone has read to me) the above information. I have been given an opportunity
to ask questions and my questions have been answered to my satisfaction. I agree to participate
in this research. I have been given a copy of this form.
Signature
Date
Printed Name
Signature of Researcher
Date (must be same as subject’s)
Signature of Witness (if appropriate)
Date (must be same as subject’s)
Printed name of Witness (if appropriate)
HIV Observational Database
Amendment #1
Version 3(10-21-15)
Page 2 of 2
Form Approved
OMB No. 0920-1080
Expiration Date: 09/29/2024
Leave box empty - For office use only
Universidad de Illinois en Chicago
Autorizaci6n Para Utilizar Y Revelar lnformaci6n De La Salud Para Investigaci6n
La Base de Datos del Estudio VIH Ambulatorio del CDC
(CDC HIV Outpatient Study Database)
Se le esta pidiendo que permita al doctor Richard Novak del Departamento de Enfermedades
Infecciosas del Colegio de Medicina y a su personal que utilice y revele informaci6n protejida de
la salud (protected health information, por sus siglas en ingles, PHI) que lo/la identifica para los
prop6sitos de investigaci6n descritos a continuaci6n. Tambien se le esta pidiendo que permita a
sus doctores y a otros proveedores de la salud que revelen PHI a estos investigadores con los
prop6sitos mencionados a continuaci6n. La ley de privacidad [45 CFR Partes 160 y 164], el
Acto de Responsabilidad y Aseguranza Portatil de Salud (Health Insurance Portability and
Accountability ACT, por sus siglas en ingles HIPAA) provee protecci6n adicional para PHI.
Debe de firmar esta autorizaci6n si quiere dejar que su PHI sea utilizado o revelado para esta
investigaci6n.
Dcscripci6n de informaci611 prntcjit.la tic saint.I | File Type | application/pdf |
| Subject | consent1 |
| File Modified | 2023-03-06 |
| File Created | 2023-03-06 |