Consent Forms -- UNCG

HIV/AIDS Risk Reduction Interventions for African-American Heterosexual Men

0920-10CM

Attachment 4c

Consent Forms - UNCG

Informed Consent

University of North Carolina at Greensboro

Project Title: Brothers Leading Healthy Lives Brotherhood Retreat

Project Director: Robert Aronson, Dr.PH, MPH

We invite you to participate in an intervention designed to reduce HIV risk. We asked you to volunteer because you are an African American male between the ages of 18 and 24. If you participate, we will ask you to attend a one day/ ten hour retreat. At the retreat, we will ask you to complete a survey and five education workshops. Three months after the retreat will ask you to complete another survey.

PURPOSE OF THIS STUDY:

The purpose of this research study is to learn about college males’ views about sexuality. This retreat is part of a larger study that will develop and test a sexual health program among African-American males age 18-24. This study is funded by the Centers for Disease Control and Prevention (CDC). We expect about 80 people from this area to join.

PRIVACY:

• Your name will not appear with the answers you give.

• Also, it will be stressed in the retreat that personal information about people in the retreat or third parties (e.g., sex partners of other people in the retreat) should not be discussed outside of the retreat.

• To guard your privacy, we will give you a unique study ID number.

• Data will be kept in computer files that are protected by passwords. Hard copies of the data or lists of names and ID codes for participants will be kept in a separate locked file cabinet in the project office.

• Data will be transferred to CDC but will not include any information that will identify you directly.

• When results of this study are published, your name will not be used.

EXCEPTIONS TO PRIVACY:

According to the law, our staff must report some things to the authorities. We must report if:

• You aim to harm yourself or others;

• Someone under age 18 is being physically or sexually abused;

• An elder or dependent adult is being physically or sexually abused.

RISKS AND DISCOMFORTS:

The risks for being in this study are small. You may feel stress about sharing private views and information during this retreat. All information will stay private to the extent allowed by law. Any reports that depict the results will not include real names or anything that will identify you. Your name will not appear in any of the data from the retreat.

POTENTIAL BENEFITS:

There will be no direct benefits to you for being in this study. Information will be used to create a sexual health program for African American men.

COSTS:

There will be no costs to you for being in this study other than your time.

REIMBURSEMENT:

You will be given a gift card worth $160.00 for completing this retreat which includes a pre-test survey. You must complete the entire retreat in order to receive the reimbursement.

CONSENT:

By signing this consent form, you agree that you understand the risks and benefits involved in this study. At any time you can refuse to be a part of the study. There is no penalty if you decide to stop at any time. Your involvement in all parts of this study is fully voluntary. Your privacy will be safe because you will not be identified by name as a member in this project.

QUESTIONS:

The study has been approved by the Institutional Review Board of UNCG. The IRB is the board that reviews research with human subjects. The Board makes sure that research involving people meets federal regulations. The Board has approved the research and this consent form. If you have questions about your rights in this study, they can be answered by calling Mr. Eric Allen (Research Compliance Officer) at (336) 256-1482. . If you feel you have been harmed by this study you can contact Dr. Jen Day Shaw (Dean of Students) at (336) 334-5514. Questions regarding the study itself will be answered by Dr. Robert Aronson (principle investigator) by calling (336) 256-0119, or by email at rearonso@uncg.edu. Dr. Aronson can also be contacted if you would like to receive the overall study findings.

By signing this form, you understand that:

• there is no penalty if you decide to stop the study at any time. Your involvement in this study is fully voluntary.

• your name will not be linked to your answers on your survey.

• you are agreeing to participate in the study described to you.

____________________________________ ______________

Participant's Signature* Date

____________________________________ ______________

Staff Witnessing Signature Date