Attachment 5a Community Survey Consent Script

Attachment 5a Clinic Survey Consent Script

Community Survey

Statement of Informed Consent

The following information must be read to all potential participants:

Participation in this project is voluntary. You can choose to participate or not to participate. You do not have to be in the project if you do not want to be. You may stop answering questions at any time. If you decide you do not want to participate further, this will not result in any penalty or loss of benefits to which you are entitled.

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. Being in this project is voluntary.

What will happen

If you agree to be in this project, this is what will happen. You will do a survey with a trained interviewer. The survey has questions about your health, drug use, sex practices, and HIV prevention services. It will take about 25 minutes.

We will not ask for your name or other identifying information. 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.

Things to consider

There are minimal risks from being in this project. 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 private.

could still be infected or test positive at some time in the future.

Benefits

Benefits you may get from being in this project include knowing that the information gained from this project will help local and national public health official learn 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.

Compensation

For completion of the survey, you will get $25.

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 the 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 local IRB approval is required; name of principal investigator and phone number, if local IRB approval is not required].

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

Confidentiality Statement

What you tell us is confidential. Your responses will be labeled with a project number only. No one except project staff 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. Survey forms and handheld computers will be locked in a file cabinet at the project office. Computers with project data will be physically secured and protected by coded passwords. Only specific project staff will have access to the locked file cabinet or the computers. If you know me, you may ask for another staff member so that your answers will be fully private.

Right to Refuse or Withdraw

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.

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 in the handheld computer as follows:)

Do you agree to take part in the survey?

 Yes

 No