Att 2_Deep South Informed Consent

Att 2_Deep South Informed Consent Forms.docx

Using Qualitative Methods to Understand Issues in HIV Prevention, Care and Treatment in the United States CHANGE REQUEST to Mitigate COVID-19 Risks: Using Qualitative Methods [...]

Att 2_Deep South Informed Consent

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HIV Prevention and Treatment Services among Young Men of Color who Have Sex with Men (YMSM of Color) and Young Transgender Persons of Color (YTG of Color) in the Deep South



Attachment 2: Informed Consent Forms for Deep Program Staff, and for Deep South Clients















Consent to be a Research Subject



Title: Factors that Influence Use of HIV Prevention and Treatment Services among Young Men of Color who Have Sex with Men (YMSM of Color) and Young Transgender Persons of Color (YTG of Color), Living in the Deep South


Principal Investigator: James W. Carey, PhD, MPH


Project Director: Alisú Schoua-Glusberg, PhD


Funding Source: Centers for Disease Control and Prevention (CDC)


Introduction

We are asking you to be in a research study. This form tells you things you need to think about before deciding if you want to be in the study. It is entirely your choice. If you decide to take part, you can change your mind later on and leave the research study. You can skip any questions that you do not wish to answer.


Before making your decision:

  • Please carefully read this form or have it read to you

  • Please ask questions about anything that is not clear


You can take a copy of this consent form to keep. Feel free to take your time thinking about whether you want to be in the study. By signing this form, you will not give up any legal rights.

Study Overview

The purpose of this study is to understand how young men of color who have sex with men (YMSM) and young transgender persons of color (YTG) use HIV prevention or treatment services. These are services provided by community-based organizations (CBOs). The study will take place in four CBOs in Georgia, Louisiana, Florida, and South Carolina. We will conduct interviews with YMSM and YTG who previously received HIV prevention or treatment services at these CBOs. We also will interview program staff who work at these CBOs. Our interview questions will ask about the HIV services that your CBO clients use. We also will ask questions about how easy or hard it is for clients to get services at your CBO.

Procedures

If you decide to be in the study, we will ask you to take part in an interview that will last about 1 hour. You can skip any questions that you do not want to answer. Being in this study will not affect your work. We will not share information you tell us with your CBO supervisors or any other people. If you decide that you do not want to be in the study anymore, please tell the person who is interviewing you and they will stop.


Audio Recording

With your permission, your interview will be audio-recorded. The person who does the interview will also take notes. When the interview is over, we will use the recording to make a written copy of our interview. We will not include your name or the names of other people that you might talk about in this interview write-up. We will destroy the audio recording after the interview has been copied into the written document.

Risks and Discomforts

Some of the interview questions might make you feel uncomfortable. You do not have to answer any questions that make you feel uneasy. If you want to know more about a problem in your life that you need help with – like depression – we can give you the names of places that can help you.


The greatest risk to you is an unplanned release of your private information. To prevent this from happening, we will not use your name on any study records, except on a hand written contact form. We will destroy this contact form after your interview is finished. We will give your interview an identification number. We will use this number in the written copy of your interview instead of your name. After we destroy your contact form, we will not be able to link your identification number or your interview write-up back to your name.

Benefits

This study will not benefit you directly. The study results will help CDC support CBOs and find better ways to provide HIV prevention or treatment services to other people in the future.

Privacy

We will do everything we can to protect your privacy to the extent allowed by law. We will not share your name or contact information with other study participants or with other people. CDC will never learn your name or contact information.


If you decide to participate, we will give you a code number. We will use this number instead of your name in the interview write up and other data sets. We will keep the interview notes and audio recordings in a locked file cabinet in a secure place. Only study staff can access this information. Your interview write up will be kept in secure computers and in password-protected files. Your name and other facts that might point to you will not appear when we present this study or publish its results.


Voluntary Participation and Withdrawal from the Study

You have the right to leave a study at any time without penalty. Your participation in this study is voluntary. That means it is completely up to you to be in this study. You can stop being in the study even after you agree to be in the interview. You may refuse to do anything makes you uncomfortable. You can refuse to answer any questions that you do not want to answer. Your decision will not affect the care, treatment, or services that you are getting right now or in the future. We may ask you to stop being in the study at any time if we think that participation is not in your best interest, we think that you are not following study instructions, or we see you are having trouble with the interview.


Contact Information

If you have any questions about this study or if you feel you have been harmed, please call Dr. Alisú Schoua-Glusberg at 1-847-971-9068. If you have any questions about your rights as a participant in this study, please contact CDC/ATSDR’s Deputy Associate Director for Science at 1-800-584-8814. Leave a message with your name, phone number, and refer to CDC protocol # ____, and someone will call you back.




Consent

Please, print your name and sign below if you agree to be in this study. By signing this consent form, you will not give up any of your legal rights. We will give you a copy of the signed consent, to keep.



Name of Subject



Signature of Subject Date Time



Signature of Person Conducting Informed Consent Discussion Date Time






Consent to be a Research Subject



Title: Factors that Influence Use of HIV Prevention and Treatment Services among Young Men of Color who Have Sex with Men (YMSM of Color) and Young Transgender Persons of Color (YTG of Color), Living in the Deep South


Principal Investigator: James W. Carey, PhD, MPH


Project Director: Alisú Schoua-Glusberg, PhD


Funding Source: Centers for Disease Control and Prevention (CDC)


Introduction

We are asking you to be in a research study. This form tells you things you need to think about before deciding if you want to be in the study. It is entirely your choice. If you decide to take part, you can change your mind later on and leave the research study. You can skip any questions that you do not wish to answer.


Before making your decision:

  • Please carefully read this form or have it read to you

  • Please ask questions about anything that is not clear


You can take a copy of this consent form to keep. Feel free to take your time thinking about whether you want to be in the study. By signing this form, you will not give up any legal rights.

Study Overview

The purpose of this study is to understand how young men of color who have sex with men (YMSM) and young transgender persons of color (YTG) use HIV prevention or treatment services. These are services provided by community-based organizations (CBOs). The study will take place in four CBOs in Georgia, Louisiana, Florida, and South Carolina. We will conduct interviews with YMSM and YTG who have received HIV prevention or treatment services at these CBOs. We also will interview program staff who work at these CBOs. Our interview questions will ask about the HIV services you have used. We also will ask questions about how easy or hard it is to get services at your CBO.

Procedures

If you decide to be in the study, we will ask you to take part in an interview that will last about 1 hour. You can skip any questions that you do not want to answer. Being in this study will not affect your services; nor will refusal to be in the study affect your access to services. If you decide that you do not want to be in the study anymore, please tell the person who is interviewing you and they will stop.



Audio Recording

With your permission, your interview will be audio-recorded. The person who does the interview also will take notes. When the interview is over, we will use the recording to make a written copy of our interview. We will not include your name or the names of other people that you might talk about in this interview write-up. We will destroy the audio recording after the interview has been copied into the written document.

Risks and Discomforts

Some of the interview questions might make you feel uncomfortable. You do not have to answer any questions that make you feel uneasy. If you want to know more about a problem in your life that you need help with – like depression – we can give you the names of places that can help you.


The greatest risk to you is an unplanned release of your private information. To prevent this from happening, we will not use your name on any study records, except on a hand written contact form. We will destroy this contact form after your interview is finished. We will give your interview an identification number. We will use this number in the written copy of your interview instead of your name. After we destroy your contact form, we will not be able to link your identification number or your interview write-up back to your name.

Benefits

This study will not benefit you directly. The study results will help CDC support CBOs and find better ways to provide HIV prevention or treatment services to other people in the future.


Study Consideration

You will receive $40 as a token of appreciation for being in this study.

Privacy

We will do everything we can to protect your privacy to the extent allowed by law. We will not share your name or contact information with other study participants or with other people. CDC will never learn your name or contact information.


If you decide to participate, we will give you a code number. We will use this number instead of your name in the interview write up and other data sets. We will keep the interview notes and audio recordings in a locked file cabinet in a secure place. Only study staff can access this information. Your interview write up will be kept in secure computers and in password-protected files. Your name and other facts that might point to you will not appear when we present this study or publish its results.


Voluntary Participation and Withdrawal from the Study

You have the right to leave a study at any time without penalty. Your participation in this study is voluntary. That means it is completely up to you to be in this study. You can stop being in the study even after you agree to be in the interview. You may refuse to do anything that makes you uncomfortable. You can refuse to answer any question that you do not want to answer. Your decision will not affect the care, treatment, or services that you are getting right now or in the future. We may ask you to stop being in the study at any time if we think that participation is not in your best interest, we think that you are not following study instructions, or we see you are having trouble with the interview.


Contact Information

If you have any questions about this study or if you feel you have been harmed, please call Dr. Alisú Schoua-Glusberg at 1-847-971-9068. If you have any questions about your rights as a participant in this study, please contact CDC/ATSDR’s Deputy Associate Director for Science at 1-800-584-8814. Leave a message with your name, phone number, and refer to CDC protocol # ____, and someone will call you back.



Consent

Please, print your name and sign below if you agree to be in this study. By signing this consent form, you will not give up any of your legal rights. We will give you a copy of the signed consent, to keep.



Name of Subject



Signature of Subject Date Time



Signature of Person Conducting Informed Consent Discussion Date Time




Page 1 of 3 Version Date: 7/24/2018

IRB Form xxxx


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File Created2021-01-13

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