Attachment 6 - Model Consent Form

Transgender HIV Behavioral Survey

Attachment 6

Model Informed Consent Form

Transgender HIV Behavioral Survey: Model Consent Form

English Version (February 2008); Grade Reading Level by Flesch-Kincaid Method: 7.3

The [Agency Name(s)] and the Centers for Disease Control and Prevention (CDC) invite you to be part of a research study about HIV-related behaviors and prevention experiences. The information I will give you can help you make a good choice about joining the study.

A. Purpose

The purpose of this study is to learn about risks for HIV. We will use this information to plan better HIV prevention and treatment programs for people in your community. This study will also be used to improve future surveys. Being in this study is voluntary.

B. Procedures

If you agree to be in this study, you will do a survey using a computer. The computer will read the questions to you. You will enter your response into the computer. The survey has questions about your health, drug use, sex practices, and HIV prevention services. It will take about 45 minutes. After the survey, I will ask a few questions about what you thought about the survey.

This is an anonymous survey. We will not write your name or other identifying information on the interview form. The survey has questions that are personal. They may be hard to talk about. You may refuse to answer any questions at any time for any reason. If you refuse to answer a question or want to end the interview you will not be punished in any way.

At the end of the survey, I will tell you about a chance to recruit other people for this study.

C. Discomforts and Risks

There are minimal risks from being in this study. Some of the questions in the survey are about sex and drugs and may make you feel uncomfortable. All answers you give will be kept confidential.

D. Benefits

Benefits you may get from being in this study include:

1. You will receive some condoms and information on HIV/AIDS and STDs.

2. You may also receive referrals to other local programs, medical programs, support groups, and health projects, as needed.

Also, information gained from this study will help the [Agency Name(s)] to know more about HIV and how it is spread. This information will be used to improve health programs and to develop new ways of helping others prevent disease and promote good health.

E. Alternatives

You will get no medical treatment in this study.

F. Compensation

You will be paid $25 to thank you for your participation and to cover any expenses you might have incurred for taking part in the study.

You may also get $10 each for as many as three people who you send to us for the study.

G. Persons to Contact

This study is run by: [name of principal investigator and phone number]. You may call [him/her] with any questions about being in the study.

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 are less than 18 years of age and have questions about providing your consent, you may contact [name of child advocate and phone number].

If you want one, you will get a copy of this form to keep.

H. Confidentiality Statement

What you tell us is confidential. Your responses will be labeled with a study number only. No one except the study staff at [Agency Name(s)] and CDC will have access to the survey, except as otherwise required by law. Your responses will be grouped with survey answers from other persons.

Although your responses are anonymous, there is a slight chance that your information might become known by someone who is not authorized to have it. Several steps will be taken to help prevent this:

1. You do not have to give your name to any member of the [insert local study name] team.

2. The only way of linking your interview and results will be by a special code number.

3. The computer is kept in a locked file cabinet at the study office when not in use.

4. A coded password is needed to access the computer used to collect your information.

I. Costs

You will not be charged for HIV prevention materials, referrals to appropriate agencies, or any other services provided by this study.

J. Right to Refuse or Withdraw

This study is completely VOLUNTARY. You are not giving up any legal claims or rights for being a part of this study. If you agree to participate, you are free to quit at any time. You can choose to only do the survey and not recruit others.

K. Agreement

Do you have any questions?

Interviewer: Answer the participant’s questions about the study before proceeding to the next question.

Consent will be documented by the interviewer in the computer after conducting the eligibility screener. The consent will be documented as follows:

Did the participant provide consent to participate in the survey?

¨ No

¨ Yes