TGNC Survey Consent Form

April 1, 2021 by kem6e@virginia.edu

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Informed Consent Agreement

This Great New Community Survey (TGNC): Investigating the health and wellness of the transgender and gender non-conforming population residing or receiving care in Virginia

Please read this consent agreement carefully before you decide to participate in the study.

COVID-19: Due to the COVID-19 virus pandemic, we will not be conducting any surveys in-person until restrictions have been lifted.

Purpose of the research study: The purpose of the study is learn about the health status and social determinants of health for transgender and gender non-conforming persons in Virginia; evaluate access to quality health care; and to assess psychological and behavioral factors associated with increased HIV risk.

What you will do in the study: If you agree to participate, you will complete a survey with a member of the study team. A study team member will read the survey questions out loud to you and record your responses. These questions will ask about your experience with healthcare providers and services, items related to your experience as a transgender person living in Virginia, personal health, health-related behaviors, substance use, social support, adverse experiences, and mental health. You may skip any questions that you do not wish to answer. At the end of the survey, you may be provided with recruitment flyers if you are interested in letting others know about the survey.

Time required: The survey will require about 60-90 minutes of your time although it may go shorter or slightly longer depending on your responses to the questions.

Risks: There is minimal risk that harm could occur. You will be asked a series of questions, some of which are related to your personal health information. This data will be collected through secure survey software. Despite steps taken to ensure your data is secure, there is a chance that a data breach could occur. Some of the questions asked in the survey ask about sensitive matters and may trigger psychological distress. Should this occur, study team members are able to refer you to appropriate resources to receive help.

Benefits: There are no direct benefits to you for participating in this research study.  The study may help us identify any gaps between provided healthcare and healthcare needs. It may inform future health initiatives, program, and activities that will support the transgender and gender non-conforming population of the state.

Confidentiality: The information that you give in the study will be handled confidentially.  Your information will be assigned a code number. The list connecting your name to this code will be kept on a secure UVA server.  When the study is completed and the data have been analyzed, this list will be destroyed.  Your name will not be used in any report.

Certificate of Confidentiality: The study team has received a Certificate of Confidentiality from the National Institutes of Health. This means that study team members cannot share information or documents that may identify you in any subpoena or court order unless you say it is okay. They also cannot provide information or documents as evidence unless you have agreed.  This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings.

Voluntary participation: Your participation in the study is completely voluntary.

Right to withdraw from the study: You have the right to withdraw from the study at any time.

How to withdraw from the study: If you want to withdraw from the study, please inform the researcher of your decision right away. There is no penalty for withdrawing.  If you would like to withdraw after your materials have been submitted, please contact the study coordinator, Kirsten MacDonnell, kem6e@hscmail.mcc.virginia.edu, 434-962-1255

Payment: You will a $50 gift card for completing the survey.

If you have questions about the study, contact:
Karen Ingersoll

PO Box 801075

University of Virginia, Charlottesville, VA

434-982-5960

Kes7a@hscmail.mcc.virginia.edu

To obtain more information about the study, ask questions about the research procedures, express concerns about your participation, or report illness, injury or other problems, please contact:
Tonya R. Moon, Ph.D.
Chair, Institutional Review Board for the Social and Behavioral Sciences
One Morton Dr Suite 500
University of Virginia, P.O. Box 800392
Charlottesville, VA 22908-0392
Telephone:  (434) 924-5999
Email: irbsbshelp@virginia.edu
Website: www.virginia.edu/vpr/irb/sbs

Agreement:
I agree to participate in the research study described above.

IRB-SBS# 3915

Revision date: 1/7/21

 

More questions?

Email us at TGNCstudy@virginia.edu, or you can call 1-855-488-2248 during business hours.

 

Click here to participate!

 

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IRB SBS #3915

Principal Investigator:  Dr. Karen Ingersoll, Faculty member, Psychiatry and Neurobehavioral Sciences at the University of Virginia

                     UVA SOM          VA Dept of Health