Consent

Attachment 5_Informed Consent.docx

CDC/ATSDR Formative Research and Tool Development

Consent

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Georgia State University - Department of Sociology

Informed Consent


Title: Understanding Strategies to Improve Sexual Health Messaging to Prevent Multidrug-resistant Shigella Infections among Men who have Sex with Men


Principal Investigator: Eric R. Wright, Ph.D.


I. Purpose:


You are invited to voluntarily participate in a focus group. The purpose of the study is to better understand the sexual health messaging needs, preferences, and strategies of men who have sex with men (MSM), including gay and bisexual men. The intent is to develop messages to inform about shigellosis in MSM, how you can prevent infection. You are invited to participate because you are an adult man who has sex with men. The target number of participants for this focus group is approximately 50. Participation will take roughly one hour of your time.


II. Procedures:


If you decide to participate, you will be asked about your life. You will be asked about your background, your knowledge of shigellosis, and preferences in terms of prevention messages. We are asking your permission to audio record the interview. Audio recording will allow the interviewer to focus on what you (all) have to say rather than taking notes. The interview will be transcribed by a persona affiliated with Georgia State University, and the only other person who will have access to the recordings is the study’s principal investigator, Dr. Eric Wright. The interview will be conducted in a comfortable as well as safe space. The focus group is planned for one sitting lasting around one hour. If for any reason you wish to stop your participation in the focus group, you are free to do so at any time.


III. Risks:


In this study, you will not have any more risks than you would in a normal day of life. You may find some questions uncomfortable to answer. If so, you are free to skip any and all questions you do not wish to answer.


IV. Benefits:


Participation in this focus group may not benefit you personally. Overall, we hope to gain information about how to inform MSM about shigellosis, appropriate messages to help MSM prevent infection during sexual encounters, and understand the behaviors that may result in disease.



V. Compensation:


You will receive $40 for participating in this focus group. You will receive the gift card at the end of the interview.


VI. Voluntary Participation and Withdrawal:


Participation in research is voluntary. You do not have to be in this study. If you decide to be in the study and change your mind, you have the right to drop out at any time. You may skip questions or stop the interview at any time. Whatever you decide, you will not lose any benefits to which you are otherwise entitled.


VII. Confidentiality:


We will keep your records private to the extent allowed by law. Eric Wright and Ebony Townsend will have access to the information you provide. All parties involved in a focus group will be asked to maintain each other’s confidentiality; however, confidentiality cannot be guaranteed given the other parties involved in the focus group will be present during the interview. Information may also be shared with those who make sure the study is done correctly (GSU Institutional Review Board, the Office for Human Research Protection (OHRP)).


We will use a pseudonym (nickname) rather than your name during audio recording; however, this Informed Consent requires your signed, legal name. The information you provide will be audio recorded. The audio recording files will be stored on a password and firewall protected computer, and all paperwork with identifying information will be kept in a locked box. All study materials, including original audio recordings and Informed Consent forms will be maintained until successful completion of the study, at which time these materials will be destroyed. Your name and other facts that might point to you will not appear when we present this study or publish its results. You will not be identified personally, rather by the selected nickname.


VIII. Contact Persons:


Contact Eric Wright at 404-413-6527 if you have questions, concerns, or complaints about this study. You can also call if you think you have been harmed by the study. Call Susan Vogtner at Georgia State University Office of Research Integrity at 404-413-3513 or [email protected] if you want to talk to someone who is not part of the study team. You can talk about questions, concerns, offer input, obtain information, or suggestions about the study. You can also call Susan Vogtner if you have questions or concerns about your rights in this study.


IX. Copy of Consent Form to Subject:


We will give you a copy of this consent form to keep.


If you are willing to volunteer for this research and to be audio recorded, please sign your name below.



_________________________________________ _______________

Participant Date



_________________________________________ _______________

Student Principal Investigator Date 




File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorEbony Townsend
File Modified0000-00-00
File Created2021-01-22

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