Informed Consent- Label Comp Study

Attachment C

Low literate

INFORMED CONSENT

Condom Package Information

The US Public Health Service is working on new package information for condoms. The US Public Health Service wants to make sure the information about condoms is as clear as possible. Today we will give you condom package information to read. In order to test the understanding of condom package information, you will be asked to answer questions in a survey, after you finish reading. The survey will also include a few questions about yourself, such as your years of education and ethnic background. Also, you will read some lists of words out loud.

• You are agreeing to participate in a survey.

• It is expected that the time to complete the survey will be 20 minutes.

• Your name will not be on the survey questionnaire. Your responses will remain anonymous and completely confidential.

• The information collected from you is for research only. Your name will not be used in any reports.

• Your participation in the study is voluntary. You may choose not to participate.

• You do not have to answer a question if you do not want to. You may also choose to withdraw from the study at any time.

• You will be paid $20 for participating in the survey. The payment will be given at the end of the survey.

Risk:

• You may feel embarrassed by the sensitive nature of some of the questions.

Benefit:

• The information you provide will help the US Public Health Service make condom package information that is clear to understand.

If you have any questions about your participation in this study, or any concern about this research later, you can contact the study investigator: Paula Silberberg, at 240-276-3234. If you have questions about your rights as a participant, you can contact Cunlin Wang, MD, PhD, at 240-276-2368.

The data collection company is:

M Davis & Company/Pegus Research

1520 Locust Street, 3^rd Floor

Philadelphia, PA 19102

Phone: 215-790-8900

Consent:

I have read this consent form, and had it read to me. I understand the information about this study. Questions that I wanted to ask about the study have been answered. My signature says that I agree to participate in this study. I understand that I will get a copy of this informed consent document to keep.

Participant’s Signature ___________________________

Print Name ____________________________________

Date _________________________

I state that the individual did review, understand and signed consent to participate in this study.

Study Staff’s Signature ___________________________

Date_________________________

OMB Control #

Attachment C

Mall recruits

INFORMED CONSENT

Condom Package Information

The US Public Health Service is working on new package information for condoms. The US Public Health Service wants to make sure the information about condoms is as clear as possible. Today we will give you condom package information to read. In order to test the understanding of condom package information, you will be asked to answer questions in a survey, after you finish reading. The survey will also include a few questions about yourself, such as your years of education and ethnic background. Also, you will read some lists of words out loud.

• You are agreeing to participate in a survey.

• It is expected that the time to complete the survey will be 20 minutes.

• Your name will not be on the survey questionnaire. Your responses will remain anonymous and completely confidential.

• The information collected from you is for research only. Your name will not be used in any reports.

• Your participation in the study is voluntary. You may choose not to participate.

• You do not have to answer a question if you do not want to. You may also choose to withdraw from the study at any time.

• You will be paid $10 for participating in the survey. The payment will be given at the end of the survey.

Risk:

• You may feel embarrassed by the sensitive nature of some of the questions.

Benefit:

• The information you provide will help the US Public Health Service make condom package information that is clear to understand.

If you have any questions about your participation in this study, or any concern about this research later, you can contact the study investigator: Paula Silberberg, at 240-276-3234. If you have questions about your rights as a participant, you can contact Cunlin Wang, MD, PhD, at 240-276-2368.

The data collection company is:

M Davis & Company/Pegus Research

1520 Locust Street, 3^rd Floor

Philadelphia, PA 19102

Phone: 215-790-8900

Consent:

I have read this consent form, and had it read to me. I understand the information about this study. Questions that I wanted to ask about the study have been answered. My signature says that I agree to participate in this study. I understand that I will get a copy of this informed consent document to keep.

Participant’s Signature ___________________________

Print Name ____________________________________

Date _________________________

I state that the individual did review, understand and signed consent to participate in this study.

Study Staff’s Signature ___________________________

Date_________________________

OMB Control #