Attachment 5b Clinic Survey consent Script

Attachment 5b Community Survey Consent Script

Clinic Survey

Statement of Informed Consent

The following information must be read to all potential participants:

You have been selected participate in this project because you have HIV. 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

HIV is the virus that causes AIDS. Your health department, together with the Centers for

Disease Control and Prevention (CDC), is doing this project to learn more about people who are infected with HIV and the types of services they use and need. This information will help us improve programs to prevent other people from getting HIV and improve services for those who already have HIV.

What we will need from you

If you choose to be in this project, we will ask you questions.

The questions

Answering the questions will take about 40 minutes. You do not have to answer any question you do not want to answer.

The questions will ask about your

• medical past

• use of medical and social services

• sex practices

• use of drugs and alcohol

• reproductive history (if you are a woman)

We will not share any information that could identify you or be traced back to you. Your answers will be kept confidential, identified only by a code number, and kept in a locked file that only project staff can open.

What you can expect from us

Privacy

We protect your privacy. All information you give us will be kept private and confidential. Your records will be kept confidential as much as the law allows. Your answers will be grouped together with answers from other participants so that no one will know which answers came from you. We will send information from this project to CDC, but we will not send any information that could identify you. Federal law protects the confidentiality of information kept at CDC.

Payment

If you answer the questions, you will receive $___ as payment for your participation. If you later choose to leave the project, you may keep the money.

Things to consider

• There is no cost to you (other than your time and effort) for participating in this project.

• If you would like, we can give you information about how to avoid giving HIV to someone else.

• If you would like, we can give you information about where to get medical and social services in your area.

• Although you will gain no direct benefits from taking part in this project, you will help us learn more so we can improve services available to other people with HIV and AIDS.

• Some of the questions may make you feel uncomfortable or may be too personal.

• Remember: You do not have to answer any questions you do not wish to answer.

Questions?

About this project, please

• ask the person who asks you the interview questions

• call (local principal investigator) at (phone number).

About your rights, please contact

• The institutional review board (IRB) at (State/Local Health Department) at (phone number). (IF LOCAL IRB IS REQUIRED)

• (Local IRB contact) at (phone number)

• CDC at 1-800-584-8814. This is a toll free call. Please leave a brief message including your name and phone number. Say that you are calling in reference to CDC protocol # 04155. Someone will return your call as soon as possible.

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