Model Consent Form

Att 10_Model Consent Form.pdf

National HIV Behavioral Surveillance System

Model Consent Form

OMB: 0920-0770

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Appendix F

Model Consent Form

English Version; Grade Reading Level by Flesch-Kincaid Method: 7.9
National HIV Behavioral Surveillance System
Model Consent Form
The [Agency Name] and the Centers for Disease Control and Prevention (CDC) invite you to be part of a
project about HIV in your community. The information I will give you can help you make a good choice
about joining the project.
A.

Why we are doing this project

The purpose of this project is to learn about risk for HIV. We will use this information to plan better HIV
prevention and treatment programs for people in your community. This project is private, which means no
one outside of the project will be able to connect your responses to you. Being in this project is voluntary.
B.

What will happen

If you agree to be in this project, this is what will happen.
1.

You will do an interview with a trained staff member. The questions will ask about your health,
drug use, sex practices, and HIV prevention services. It will take about 40 minutes. [For RDS
only] At the end of the interview, you may be offered a chance to recruit up to 5 other people for
this project.

2.

If you agree to the interview, we will offer you a free HIV test. If you already know that you have
HIV, we would still like to offer you an HIV test so that we can link the HIV test result with your
interview responses.

3.

[For project areas doing hepatitis testing] We will also offer you free hepatitis B and C testing.

4.

[For project areas doing blood-based HIV or hepatitis testing] If you agree to an HIV test [if
applicable: or hepatitis] test, you will also be asked to have your blood sample stored.

5.

[For project areas doing STI testing] We may also offer you free gonorrhea and chlamydia
testing. If you agree to the STD testing, you will also be asked to have your leftover STD samples
stored.

If you agree to the HIV test [insert names of additional tests offered, if applicable], you will have about a
10-minute prevention counseling session with a trained staff member. The session will cover the meaning
of results from the HIV test [insert names of additional tests offered, if applicable]. You will also learn
about how to reduce your chances of being infected with HIV and other infectious diseases. You will get
referrals for additional testing and services, if needed. You will NOT get medical treatment in this project.
The HIV test will be done by a rapid test.

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[For project areas doing the Rapid Test Algorithm]
Rapid Test Algorithm
We will [draw less than 1 tablespoon of blood/stick the tip of one of your fingers to obtain a few drops of
blood]. You can get the result of your HIV test within [1 hour/maximum time for the specific test used]. If
the first rapid test is reactive, we will do a second rapid test to confirm your results. For the additional
rapid test, we will [use the blood we drew for the first test/stick the tip of one of your fingers to obtain a
few drops of blood]. If you already know you have HIV, we may only do one rapid test. [For project
areas required/choosing to do laboratory confirmation in addition to the algorithm] Finally, we will use
the blood to confirm your rapid test result in a laboratory. The result of the test will be ready within one
week. We will set up a day and time for you to get your results. [For project areas that allow HIV test
phone results: If you prefer, you can arrange to receive your counseling and confirmatory test results by
telephone.]
[For project areas doing only one Rapid Test with local Laboratory Testing]
Rapid Test
We will [stick the tip of one of your fingers to obtain a few drops of blood/draw less than 1 tablespoon of
blood]. You can get the result of your HIV test within [1 hour/maximum time for the specific test used]. If
the rapid test result is reactive, or if you already know you have HIV, we will [draw less than 1
tablespoon of your blood by needle/stick the tip of one of your fingers to obtain a few drops of blood/use
the blood we drew for the rapid test] for a second test to confirm your rapid test result. The result of the
confirmatory test will be ready within one week. We will set up a day and time for you to get your results.
[For project areas that allow HIV test phone results: If you prefer, you can arrange to receive your
counseling and confirmatory test results by telephone.]
[For project areas doing hepatitis B and C tests]
Hepatitis B and C tests
We will offer you free screening for hepatitis B and C infection. We will perform a rapid hepatitis C
antibody test at the same time as performing the finger prick for your rapid HIV test. Additionally, we
will collect a blood sample (about 2 teaspoons) with a needle from your veins. You can get the result of
your rapid hepatitis C test within [20-30 minutes/maximum time for the specific test used]. If the rapid test
is positive, that only tells us that you have ever been exposed to hepatitis C. Additional tests are needed to
tell us whether you have hepatitis C right now and whether you have hepatitis B. The result of the
additional hepatitis tests will be ready within [two weeks/maximum time for local lab to return results].
We will set up a day and time for you to get your results. [For project areas that allow hepatitis test
phone results: If you prefer, you can arrange to receive your counseling and test results by telephone.]
[For project areas doing STI tests for MSM]
Gonorrhea and chlamydia tests
We may offer you free screening for gonorrhea and chlamydia. This STD testing includes swabbing the
back of your throat and gently inserting a swab in your rectum (butt) to self-collect the samples. The
results of the gonorrhea and chlamydia tests will be ready within two weeks. We will set up a day and
time for you to get your results. [For project areas that allow gonorrhea and chlamydia test phone
results: If you prefer, you can arrange to receive your results by telephone.]
[For project areas doing STI Tests for HET (women)]
Gonorrhea and chlamydia tests
We may offer you free screening for gonorrhea and chlamydia. We will ask you to swab the back of your
throat and gently swab your vagina to collect samples. The results of the gonorrhea and chlamydia tests

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will be ready within two weeks. We will set up a day and time for you to get your results. [For project
areas that allow gonorrhea and chlamydia test phone results: If you prefer, you can arrange to receive
your results by telephone.]
[Include any additional test to be offered].
Linkage
We will link your test results with your interview responses so we can learn about sexual and drug-use
risk behaviors known to be connected with HIV infection. We will link your test results using the same
ID assigned to the interview. Your name will not be on the test results or the interview. No one besides
you will be told your test results, and neither your interview responses nor the test will be placed in any
medical record.
[For project areas doing Storage for Additional Tests]
Storage for Additional Tests
As part of today’s testing, we would like to store your test sample(s), that is blood [for project areas
offering STI testing: and other body fluids], for testing we will do in the future. We will store your
sample(s) with some data about you, such as your age, race, and sex. We will not put your name on the
sample(s) and there will be no way to know it is yours: thus, we will not be able to report back any results
to you. We will not use your sample(s) for cloning. You can decline to let us store your sample(s) and
still be in this project. If you do not wish to have us store your sample(s), your sample(s) will be
destroyed after the specific testing you agree to is completed. If you agree to have us store your sample(s),
we will destroy your sample(s) within 10 years.
C.

Things to consider

There are minimal risks from being in this project:
1.

Some of the questions in the interview are about sex and drugs and may make you feel
uncomfortable.

2.

[For project areas conducting blood-based HIV or hepatitis testing] [The fingerstick/drawing
blood] may cause temporary discomfort from the needle stick, bruising, bleeding, lightheadedness, and local infection.

3.

[For project areas offering STI testing] Collecting pharyngeal (throat) samples may cause
gagging and temporary discomfort. Collecting [For MSM: rectal] [For HET (women): vaginal]
samples may cause temporary irritation, discomfort, and mild bleeding.

4.

You may feel uncomfortable finding out you might have been infected with HIV [or diseases
tested for].

5.

If your HIV test result [for project areas offering STI testing: or STD test results] [for project
areas offering hepatitis testing: or hepatitis test results] is/are negative, there is a slight chance
that the results are wrong and that you could still be infected.

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D.

Benefits

Benefits you may get from being in this project include:
1. You will receive condoms and information on HIV/AIDS and STDs.
2. You will receive free referrals to other local programs, as needed.
3. If your HIV [or additional tests offered] results are positive, you will receive counseling about
ways to prevent the spread of infection and you will be able to talk about your concerns, if you
wish. You will also be referred for medical care.
4. If your test results are negative, you will receive counseling on how to prevent future infections.
E.

Alternatives

If you choose not to take part in the project but would like to take an HIV test [or additional tests
offered], we will inform you of agencies or organizations that provide testing.
F.

Compensation

For completion of the interview, you will get [interview incentive]. If you take part in the HIV test, you
will get an additional [HIV test incentive]. [For additional tests only] If you take part in other tests
offered, you will get [incentives for additional tests offered]. [For RDS only] You may also get
[recruitment incentive] each for up to 5 people whom you send to us for the project.
G.

Persons to Contact

This project is run by: [name of principal investigator and phone number]. You may call [him/her] with
any questions about being in this project.
If you have questions about your rights as a participant or if you feel that you have been harmed, contact
[IRB committee or contact name and phone number].
If you want one, you will get a copy of this form to keep.
H.

Confidentiality Statement

This project is private. Your responses and test results will be labeled with a project number only. The
project staff at [Agency name] and CDC will have access to the interview and testing data. Other
collaborators will have access to the interview and testing data but will not be allowed to see any
information that could identify you. Your responses will be grouped with interview answers from other
persons.
If you know your interviewer, you may ask for another staff member so that your answers will be fully
private.

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[For project areas collecting contact information] If you prefer, you can give us your phone number
and/or email address so that we can contact you when your test results are ready. Contact information will
be kept separate from the interview and testing data and only limited staff will have access to that
information. Once the results are returned to you, we will destroy your contact information. If you prefer
to not provide your contact information, you can call this number [provide project number] or come to
this office to check if your results are available.
I.

Costs

You will not be charged for counseling, the HIV test [any additional tests offered], safer sex and HIV
prevention materials, referrals to appropriate agencies, or any other services provided by this project. [
J.

Right to Refuse or Withdraw

Participation in this project is completely VOLUNTARY. You are not giving up any legal claims or
rights for being a part of this project. If you agree to participate, you are free to quit at any time. You may
refuse to answer any question. You can choose to only do the interview and not to have an HIV test [or
any additional tests offered]. [For RDS only] You can also choose not to recruit others.
K.

Agreement

Do you have any questions?
Interviewer: Answer the participant’s questions before proceeding to the next question.
You have read or had read to you the explanation of this project, you have been given a copy of this form,
the opportunity to discuss any questions that you might have and the right to refuse participation. I am
going to ask for your consent to participate in this project.
(Consent will be documented by the interviewer as follows:)
Do you agree to take part in the interview?

Yes

No
If yes:
Do you agree to HIV counseling and testing?

Yes

No
[if offered] Do you agree to hepatitis testing?

Yes

No
[if offered] Do you agree to STD testing?

Yes

No

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[if applicable] Do you agree to let us store some of your test sample(s) for future testing?

Yes

No
If declined:
We’re interested in knowing why people do not want to do this project. Would you mind telling me
which of the following best describes the reason you do not want to do this project?






You don’t have time
You don’t want to talk about these topics
Some other reason
You’d rather not say why

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