Attachment 6 Consent Documents

Form Approved

OMB No. 0920-XXX

Expiration Date XX/XX/20XX

ATTACHMENT 6:

CONSENT FORMS

Statement of burden for consent forms

Public reporting burden of this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX)

Consent Form – Exploratory

One-on-One Interviews

Formative Research, Evaluation Planning, and Evaluating HIV Prevention Social Marketing Campaigns

Reading level 7.1 (assessed by Flesch-Kincaid)

Introduction and Purpose:

You have been asked to take part in a one-on-one interview as part of a research study. The purpose of the interview is to hear your opinions about HIV testing. RTI International, a non-profit company in North Carolina is conducting the interview. The interview is sponsored by the Centers for Disease Control and Prevention (CDC).

Procedures:

During the interview, we will ask you to talk a little bit about yourself and what you think and feel about HIV testing. The interview will take about an hour.

We will be doing interviews with people in 12 cities. About 108 people will take part in the interviews.

The person doing the interview will take notes. CDC staff working on this project may observe the interview through a one-way mirror.

Risk/Discomforts:

You might feel embarrassed or upset by the things that are talked about during the interview. If that happens, we will refer you to someone who can talk with you about your concerns. You can decline to talk about any topic for any reason. You can stop being in the interview at any time.

Before or after the interview, you may be asked to fill out a paper and pencil survey. Your name will not go on this survey. The survey will contain some personal questions about your sexual behavior and HIV. It is your right to refuse to answer any questions or stop taking the survey at any time.

Benefits:

There is no direct benefit to you for being in this interview. However, you may learn more about your own risk behaviors and HIV testing. What we learn from the interview will help us to develop materials about HIV testing.

Confidentiality:

We will be audio-taping the interview. Tapes will be kept in a locked cabinet. They will be destroyed at the end of the project. Notes will be made of the tapes. We will only refer to first names in the notes. Your comments will be kept private to the extent allowable by law. The notes will be kept on a password-protected computer. Only authorized project staff will be able to see them. Any forms related to the project that have your name or information that could identify you will be kept in a locked file cabinet. These forms will be destroyed at the end of the project. However, there is still a small risk that your privacy could be broken.

Also, any information that this local facility already has about you -- because you have been in other projects -- will still be kept there. You may be contacted by them to be in other projects in the future. If you have not been contacted by this facility before this project, they will not keep any of your contact information.

Payment:

We will give you $50 to help repay you for your time, effort and travel expenses.

Right to Refuse or Withdraw:

It is your choice to do this interview. You can choose not to talk about any topic. You can stop being in the interview at any time.

Persons to Contact:

If you have questions about the interview, you can call Jennifer Uhrig at 1-800-334-8571 extension 3311. She can be reached between 9 AM and 5 PM Eastern Standard Time Monday - Friday. If you have questions about your rights as a participant, you can call Wendy Visscher of RTI’s Office of Research Protection toll-free at 1-866-214-2043.

Your Consent:

I have read this consent form. I had a chance to ask questions and my questions were answered. I was given a copy of this consent form. I agree to be in the interview.

Signature – First Name Only

Date

Facilitator Signature

Consent Form - Exploratory

Focus Groups

Formative Research, Evaluation Planning, and Evaluating HIV Prevention Social Marketing Campaigns

Reading level 6.5 (assessed by Flesch-Kincaid)

Introduction and Purpose:

You have been asked to be in a focus group as part of a research study. The purpose of the group is to hear what you think and feel about HIV testing. RTI International, a non-profit company in North Carolina is conducting the groups. The project is sponsored by the Centers for Disease Control and Prevention (CDC).

Procedures:

A focus group is where 8-10 people get together for about 2 hours to talk about a topic and share their opinions. During the group, we will ask you to talk a little bit about yourself and to share your thoughts about HIV testing.

We will do groups in 12 cities. About 108 people will be in the groups across all 12 cities.

A facilitator and an assistant will be there to guide the discussion and to take notes. CDC staff working on this project may observe the group through a one-way mirror.

Risk/Discomforts:

You might feel embarrassed or upset by the things that are talked about during the group. If that happens, we will refer you to someone who can talk with you about your concerns. You can refuse to talk about any topic for any reason. You can stop being in the group at any time. Someone you know could be in the group. We will ask everyone in the group to not talk about who is in the group or what is said in the group, but we cannot be sure that this information will be kept private. Please do not tell anyone about who is in the group or what you talk about today. We ask that all participants respect the comments and views of others in the group. Any participant who is disruptive will be immediately asked to leave the group.

Before or after the group, you may be asked to fill out a paper and pencil survey. Your name will not go on this survey. The survey will contain some personal questions about your sexual behavior and HIV. It is your right to refuse to answer any questions or stop taking the survey at any time.

Benefits:

There is no direct benefit to you for being in this group. However, you may learn more about your own risk behaviors and HIV testing. What we learn from the groups will help us to develop materials about HIV testing.

Confidentiality:

We will be audio-taping the group. Tapes will be kept in a locked cabinet. They will be destroyed at the end of the project. Notes will be made of the tapes. We will only refer to first names in the notes. Your comments will be kept private to the extent allowable by law. The notes will be kept on a password-protected computer. Only authorized project staff will be able to see them. Any forms related to the project and/or that have your name or information that could identify you will be kept in a locked file cabinet. These forms will be destroyed once the project ends. However, there is still a small risk that your privacy could be broken.

Also, any information that this local facility already has about you -- because you have been in other projects -- will still be kept there. You may be contacted by them to be in other projects in the future. If you have not been contacted by this facility before this project, they will not keep any of your contact information.

Payment:

We will give you $100 to help repay you for your time, effort and travel expenses.

Right to Refuse or Withdraw:

It is your choice to be in this group. You can choose not to talk about any topic. You can stop being in the group at any time.

Persons to Contact:

If you have questions about the group, you can call Jennifer Uhrig at 1-800-334-8571 extension 3311. She can be reached between 9 AM and 5 PM Eastern Standard Time Monday - Friday. If you have questions about your rights as a participant, you can call Wendy Visscher of RTI’s Office of Research Protection toll-free at 1-866-214-2043.

Your Consent:

I have read this consent form. I had a chance to ask questions and my questions were answered. I was given a copy of this consent form. I agree to be in the group.

Signature – First Name Only

Date

Facilitator Signature

Consent Form –Message/Concept/Materials Testing

One-on-One Interviews

Formative Research, Evaluation Planning, and Evaluating HIV Prevention Social Marketing Campaigns

Reading level 7.1 (assessed by Flesch-Kincaid)

Introduction and Purpose:

You have been asked to take part in a one-on-one interview as part of a research study. The purpose of the interview is to hear your thoughts on materials that are being developed about HIV testing. RTI International, a non-profit company in North Carolina is doing the interview. The interview is sponsored by the Centers for Disease Control and Prevention (CDC).

Procedures:

During the interview, we will ask you to review some draft materials and tell us your thoughts. The interview will take about an hour.

We will be doing interviews with people in 12 cities. About 108 people will take part in the interviews.

The person doing the interview will take notes. CDC staff working on this project may observe the interview through a one-way mirror.

Risk/Discomforts:

You might feel embarrassed or upset by the things that are talked about during the interview. If that happens, we will refer you to someone who can talk with you about your concerns. You can decline to talk about any topic for any reason. You can stop being in the interview at any time.

Before or after the interview, you may be asked to fill out a paper and pencil survey. Your name will not go on this survey. The survey will contain some personal questions about your sexual behavior and HIV. It is your right to refuse to answer any questions or stop taking the survey at any time.

Benefits:

There is no direct benefit to you for being in this interview. However, you may learn more about your own risk behaviors and HIV testing. What we learn from the interview will help us to develop materials about HIV testing.

Confidentiality:

We will be audio-taping the interview. Tapes will be kept in a locked cabinet. They will be destroyed at the end of the project. Notes will be made of the tapes. We will only refer to first names in the notes. Your comments will be kept private to the extent allowable by law. The notes will be kept on a password-protected computer. Only authorized project staff will be able to see them. Any forms related to the project that have your name or information that could identify you will be kept in a locked file cabinet. These forms will be destroyed once the project ends. However, there is still a small risk that your privacy could be broken.

Also, any information that this local facility already has about you -- because you have been in other projects -- will still be kept there. You may be contacted by them to be in other projects in the future. If you have not been contacted by this facility before this project, they will not keep any of your contact information.

Payment:

We will give you $50 to help repay you for your time, effort and travel expenses.

Right to Refuse or Withdraw:

It is your choice to do this interview. You can choose not to talk about any topic. You can stop being in the interview at any time.

Persons to Contact:

If you have questions about the interview, you can call Jennifer Uhrig at 1-800-334-8571 extension 3311. She can be reached between 9 AM and 5 PM Eastern Standard Time Monday - Friday. If you have questions about your rights as a participant, you can call Wendy Visscher of RTI’s Office of Research Protection toll-free at 1-866-214-2043.

Your Consent:

I have read this consent form. I had a chance to ask questions and my questions were answered. I was given a copy of this consent form. I agree to be in the interview.

Signature – First Name Only

Date

Facilitator Signature

Consent Form - Message/Concept/Materials Testing

Focus Groups

Formative Research, Evaluation Planning, and Evaluating HIV Prevention Social Marketing Campaigns

Reading level 6.5 (assessed by Flesch-Kincaid)

Introduction and Purpose:

You have been asked to be in a focus group as part of a research study. The purpose of the group is to hear your thoughts on materials that are being developed about HIV testing. RTI International, a non-profit company in North Carolina is doing the groups. The project is sponsored by the Centers for Disease Control and Prevention (CDC).

Procedures:

A focus group is where 8-10 people get together for about 2 hours to talk about a topic and share their thoughts. During the group, we will ask you to review draft materials and tell us your thoughts.

We will do groups in 12 cities. About 108 people will be in the groups across all 12 cities.

A facilitator and an assistant will be there to guide the discussion and to take notes. CDC staff working on this project may observe the group through a one-way mirror.

Risk/Discomforts:

You might feel embarrassed or upset by the things that are talked about during the group. If that happens, we will refer you to someone who can talk with you about your concerns. You can refuse to talk about any topic for any reason. You can stop being in the group at any time. Someone you know could be in the group. We will ask everyone in the group to not talk about who is in the group or what is said in the group, but we cannot be sure that this information will be kept private. Please do not tell anyone about who is in the group or what you talk about today. We ask that all participants respect the comments and views of others in the group. Any participant who is disruptive will be immediately asked to leave the group.

Before or after the group, you may be asked to fill out a paper and pencil survey. Your name will not go on this survey. The survey will contain some personal questions about your sexual behavior and HIV. It is your right to refuse to answer any questions or stop taking the survey at any time.

Benefits:

There is no direct benefit to you for being in this group. However, you may learn more about your own risk behaviors and HIV testing. What we learn from the groups will help us to develop materials about HIV testing.

Confidentiality:

We will be audio-taping the group. Tapes will be kept in a locked cabinet. They will be destroyed at the end of the project. Notes will be made of the tapes. We will only refer to first names in the notes. Your comments will be kept private to the extent allowable by law. The notes will be kept on a password-protected computer. Only authorized project staff will be able to see them. Any forms related to the project and/or that have your name or information that could identify you will be kept in a locked file cabinet. These forms will be destroyed once the project ends. However, there is still a small risk that your privacy could be broken.

Also, any information that this local facility already has about you -- because you have been in other projects -- will still be kept there. You may be contacted by them to be in other projects in the future. If you have not been contacted by this facility before this project, they will not keep any of your contact information.

Payment:

We will give you $100 to help repay you for your time, effort and travel expenses.

Right to Refuse or Withdraw:

It is your choice to be in this group. You can choose not to talk about any topic. You can stop being in the group at any time.

Persons to Contact:

If you have questions about the group, you can call Jennifer Uhrig at 1-800-334-8571 extension 3311. She can be reached between 9 AM and 5 PM Eastern Standard Time Monday - Friday. If you have questions about your rights as a participant, you can call Wendy Visscher of RTI’s Office of Research Protection toll-free at 1-866-214-2043.

Your Consent:

I have read this consent form. I had a chance to ask questions and my questions were answered. I was given a copy of this consent form. I agree to be in the group.

Signature – First Name Only

Date

Facilitator Signature

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