Recruitment - 2a Consent

Document Approved On: 02/08/12 Project Approval Expires On: 02/07/13

Model Consent: On Line Focus Group

Emory University, Rollins School of Public Health

Consent to be a Research Subject

Title: Development of Recruitment Strategies for the Web-Based HIV Behavioral Survey among Men who have Sex with Men: Online Focus Group

Principal Investigator: Patrick Sullivan, PhD DVM

Funding Sources: Emory University, Centers for Disease Control and Prevention (CDC), Manila Consulting Group, Inc.

Introduction

You are being invited to be in a research study being conducted by Emory University’s Rollins School of Public Health. You are being invited because you have told us that you are a man who has sex with men and is over 18 years of age. We expect to have 10 men taking part in the group discussion today. If you decide to take part, the things we learn from you today will help improve an online men’s health study.

Purpose

This study will find out more about what men think about being in an online HIV research study. This study aims to find out about the use of technology and your knowledge of different ways you can keep from getting HIV. The study will also ask about general health and sex health among men who have sex with men (MSM). We want to know how we can make online ads to bring people into the study and how we can make the online study easy for men to participate.

We expect to have 10 men participate in the online focus group today. The focus group will last around 1.5 hours and will be recorded. We will ask you about different online ad ideas and get your thoughts on how men who have sex with men use the internet for different reasons. We are not asking you to be in the online study at this time. We want you to share your ideas that will help us best advertise the online study to others.

Procedures

If you decide that you would like to join, you will first be asked to fill in a short survey. This survey will ask about your age, race and if you’ve ever taken part in an online study. Your answers, along with your answers to questions about what media you use, will help determine whether you are eligible for the study. This survey should take no longer than a minute to complete. If we pick you to be in the group discussion, we will then ask for an email address so that we can send you the web link to the focus group. We will also give you a toll-free number for any concerns that you may have with the research staff. You will be invited into a secure online site on which the focus groups will be performed.

Before the focus group starts, the leader will discuss the consent. You will then have the chance to ask any questions and make sure everyone is comfortable with the discussion.

The focus group will take about 1.5 hours and may be taped and copied. The tapes and copies will be destroyed after any transcription of the focus group. The research team will ask how you would feel about being asked to take part in an online HIV study and how you would feel about taking part in such a study. You will also be shown advertisements that would be placed on websites to recruit men into an online study. You will be asked what you like and do not like about these advertisements. You will also be asked about the types of images that you would like to see in online ads for a research study.

Risks and Discomforts

We do not expect there to be any risks or discomforts in this study. However, this is a group discussion, and we cannot be certain that others in the group will not discuss what was said. The discussions will be around participating in an online HIV study. You may feel uncomfortable talking about these issues. You can choose not to answer any of the questions asked. We know that these issues may be very sensitive so we will try to protect your confidentiality. We will not collect any information that could identify you, except for the recording of your voice. If you decide to join, you will be given a study number. You will use that number when you complete the survey. No names will be used in the group discussion. You are free to decide not to answer any of the questions asked in the group discussion.

Benefits

Taking part in this study may not benefit you personally, but researchers will learn new things that will help them better design the online HIV study and improve the health of MSM.

Token of Appreciation

If you decide to join in the research you will be given a token of our appreciation. We will give you $25 for participating in the online focus group through an Amazon.com gift card or iTunes gift card.

Confidentiality

We will not collect any information that will identify you personally. We will ask how we can best get in touch with you for the focus group. Once the focus group begins, your contact information will be destroyed. No names will be used in the group discussions. We will tape record the group discussions. This allows the researches to listen to them later and to identify the main issues from the discussion. You have the right to listen to your audio-recorded interview. We will transcribe the tapes within 10 days and then we will destroy the original tapes. If a name or any other personal information enters the discussion by accident, we will not include this information in the transcription. The tapes will be stored in a locked cabinet where only the investigators to this study will have access to them. Agencies and Emory departments and committees that make rules and policy about how research is done have the right to review these records. So do companies and agencies that pay for the study which includes Manila Consulting Group, Inc. and the Centers for Disease Control and Prevention (CDC). We will keep all records that we produce private to the extent we are required to do so by law.

Voluntary Participation and Withdrawal:

Being in this study is voluntary and you have the right to refuse to be in this study. You can stop at any time after giving your consent. The researcher may stop you from taking part in this study at any time if he decides it is in your best interest, if you do not follow study instructions, or if their behavior becomes destructive to the group discussion.

Contact Persons

If you have any questions about this study or feel you have been harmed in this study please contact a member of the research team:

Patrick Sullivan, DVM PhD

Emory University

Rollins School of Public Health

1518 Clifton Rd.

Room 3023

Atlanta, GA 30322

If you have any questions about your rights as a participant in this research study or feel you have been harmed by participation in this study you can contact the institutional review board at Emory University.

For Emory University contact:

Emory IRB

1599 Clifton Road

5th Floor East

Atlanta, GA 30322 USA

Tel: 404 712 0720

Toll free: 877 503 9797

Email:[email protected]

You may keep a copy of this consent information sheet for your records if you like.

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Version: 2/10/2011

IRB SHB Consent Template 8/27/2009