Introduction/Purpose
You are being asked to participate in a voluntary research study looking to measure sexual function and satisfaction after the gender-affirming genital surgery called vaginoplasty (or bottom surgery) in transgender women and gender diverse individuals. We are asking individuals to participate if they have undergone this surgery. The purpose of this study is to test if a newly-designed questionnaire works to accurately assess sexual function and satisfaction. If the questionnaire is found to be effective, health care providers can use this tool in gender-affirming care and supporting people's sexual needs. The research project is being conducted by Rachel Pope, MD, MPH. The study will include up to 200 people.
This research is funded by a grant from the Patty Brisben Foundation for Women's Sexual Health. Visit www.pattybrisbenfoundation.org/research-education/#focus for more information.
ParticipationYou may or may not qualify to be in this study. Your participation in this study is voluntary. You may refuse to take part in the research or exit the study at any time without penalty.
QUESTIONNAIRE: In this study you will be asked to fill out one questionnaire online. This will take about 30 minutes to complete. If you want to stop the questionnaire at any time and return to complete it later, you can follow the on-screen directions and use a return code. The survey will close one week after you begin your responses.
The questionnaire will collect some brief information about your demographics, gender identification, and gender-affirming surgery. The rest of the questionnaire consists of questions about sexual function and satisfaction. It will ask multiple-choice questions about your sexual experiences, desire, confidence, self-image of genitals, and related topics. Your responses will help the researchers to analyze if the questionnaire is a valid measurement. There are 86 questions in total. If you do not wish to answer a question, you may skip it or use the "prefer not to answer" option.
If you change your mind and do not want to complete the questionnaire after starting it, that is OK. You may withdraw from participation in this research by simply clicking the WITHDRAW option and clicking SUBMIT at the end of the survey. If you withdraw, we will not use any of your partial answers and you will not receive compensation. This research is completely voluntary.
OPTIONAL INTERVIEW: There is also an optional one-on-one interview for up to 30 participants who complete the questionnaire. This will take about 30 minutes to complete and can be done by Zoom or in person. The interview will be a discussion about the same topics covered in the questionnaire. You can say "yes" or "no" to the interview and still participate in the study by completing the questionnaire. If you decide to do the interview, there is a separate consent form for you to read and sign at that time. We will invite participants with a sufficiently-completed questionnaire to take part in the interview until we have completed 30 interviews. A "sufficiently-completed questionnaire" means a survey with minimal skipped questions.
Benefits
There will be no direct benefit to you by your participation in this research study. Your participation in this study might help us better understand the needs of trans and gender diverse people and improve gender affirming care. We hope that the knowledge gained will help us benefit others like you in the future.
Risks
There is no physical risk to being in this study. There is always the risk that your information may be seen by someone who shouldn't have access. We will work to prevent this by keeping all of the data in password protected documents/databases on secure computers/systems.
You may feel somewhat or very uncomfortable answering many highly personal and sensitive questions about your sexuality and sexual function. There is the risk that some questions may be distressing to you as you think about your experiences. If you want support, we encourage you to reach out to the mental health resources we will provide at the end of the questionnaire.
Alternatives to Study Participation
The alternative to participation in this study is to NOT participate. This will not affect your care in any way.
Financial Information
There is no cost to you for participating in the study.
A $50 payment will be issued to you through a gift card or check if you participate in the questionnaire and submit it.
Another $50 payment will be issued by gift card or check if you also complete the optional interview.
To receive compensation for participation you must provide your SSN or TIN to University Hospitals by completing a W-9 or applicable tax form. You may choose to waive compensation for any reason without affecting your participation. Waiving compensation does not affect payments or reimbursements related to travel so you will still be eligible for these if they are applicable to your study.
If you receive USD $600 or more in a calendar year (January to December) from University Hospitals, the IRS will require a Form 1099 to be issued to you. Money paid back to you for study-related travel and other out-of-pocket expenses such as parking and meals are not included on the IRS form since reimbursements are not considered compensation per IRS regulations.
Disclosure
If your doctor is also the person responsible for this research study, please note that he/she/they is interested in both your clinical care and the conduct of this research study. This disclosure is made so that you can decide if you want a second opinion regarding your participation in the study.
Confidentiality
To maintain confidentiality, your data will be coded with a unique study ID number and not stored
by your name or other information that could directly identify you. Only members of the study team will have access to the link between your study ID number and your name. Your study documents and data will be stored in secure locations with access limited to the study team. The people collaborating on this project may include researchers from Case Western Reserve University as well as University Hospitals. Efforts will be made to keep the personal information in your research record confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals Cleveland Medical Center Institutional Review Board may review your study records. If your records are reviewed your identity could become known.
Your de-identified information may be used or shared with other researchers without your additional informed consent.
If you participate in other research studies, there may be future research done that involves combining the data from different studies for a new research purpose. At the end of this form, there will be a section asking if we can link your data if you happen to participate in more than one study.
Students or Employees
If you are a student or employee at University Hospitals (UH) or Case Western Reserve University (CWRU), choosing not to participate or withdrawing from this study will not affect your employment or class standing. The study data/results will not be shared with your supervisors or professors (unless your supervisor/professor is also a member of the study team).
Privacy of Protected Health Information (HIPAA)The Health Insurance Portability & Accountability Act (HIPAA) is a Federal law that helps to protect the privacy of your health information and to whom this information may be shared within and outside of University Hospitals. This Authorization form is specifically for a research study entitled "Sexual Satisfaction and Function of Transgender Women and Gender Diverse Individuals Post Vaginoplasty (Satisfunction Survey Validation Study)" and will tell you what health information (called Protected Health Information or PHI) will be collected for this research study, who will see your PHI and in what ways they can use the information. In order for the Principal Investigator, Dr. Rachel Pope, and the research study staff to collect and use your PHI, you must sign this authorization form. You will receive a copy of this signed Authorization for your records. If you do not sign this form, you may not join this study. Your decision to allow the use and disclosure of your PHI is voluntary and will have no impact on your treatment at University Hospitals. By signing this form, you are allowing the researchers for this study to use and disclose your PHI in the manner described below. Generally the Principal Investigator and study staff at University Hospitals and Case Western Reserve University who are working on this research project will know that you are in a research study and will see and use your PHI. The researchers working on this study will collect the following PHI about you: your name, date of birth, and surgery date/s. This PHI will be used to test the validity of a new survey to measure sexual satisfaction and function after vagionoplasty. Your access to your PHI may be limited during the study to protect the study results. Your PHI may also be shared with the following groups/persons associated with this research study or involved in the review of research: • The Food and Drug Administration • The Department of Health and Human Services • Other Institutional Review Boards • Data Safety and Monitoring Boards • Other staff from the Principal Investigator's medical practice group that are involved in the research • University Hospitals, including the Clinical Research Center and the Law Department; any UH or CWRU employee required to process information for research, finance, compliance, or hospital operation, and Government representatives or Federal agencies, when required by law.
It is possible, that in the future, additional research sites may be added. In this event, your PHI that was collected during this research project may be shared with research personnel at these additional sites. Your permission to use and disclose your PHI does not expire. However, you have the right to change your mind at any time and revoke your authorization. If you revoke your authorization, the researchers will continue to use the information that they previously collected, but they will not collect any additional information. Also, if you revoke your authorization you may no longer be able to participate in the research study. To revoke your permission, you must do so in writing by sending a letter to: RACHEL POPE MD, MPH UROLOGY INSTITUTE, LAKESIDE Suite 4554 11100 EUCLID AVENUE, CLEVELAND, OH 44106 If you have a complaint or concerns about the privacy of your health information, you may also write to the UH Privacy Officer, Management Service Center, 3605 Warrensville Center, MSC 9105, Shaker Heights, OH 44122 or to the Federal Department of Health and Human Services (DHHS) at DHHS Regional Manager, Office of Civil Rights, US Department of Health and Human Services Government Center, JF Kennedy Federal Building, Room 1875, Boston, MA 02203. Complaints should be sent within 180 days of finding out about the problem. The researchers and staff agree to protect your health information by using and disclosing it only as permitted by you in this Authorization and as directed by state and Federal law. University Hospitals is committed to protecting your confidentiality. Please understand that once your PHI has been disclosed to anyone outside of University Hospitals, there is a risk that your PHI may no longer be protected; however other Federal and State laws may provide continued protection of your information.
Summary of your rights as a participant in a research study
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. If information generated from this study is published or presented, your identity will not be revealed.
Disclosure of your study records
Efforts will be made to keep the personal information in your research record private and confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals Cleveland Medical Center Institutional Review Board may review your study records. If this study is regulated by the Food and Drug Administration (FDA), there is a possibility that the FDA might inspect your records. In addition, for treatment studies, the study sponsor and possibly foreign regulatory agencies may also review your records. If your records are reviewed your identity could become known.
Contact Information
If you have questions at any time about the study or the procedures, you may contact Dr. Rachel Pope, Principal Investigator, via phone at (216) 286-6873 or via email at PopeResearch@UHhospitals.org . If you have any questions, concerns or complaints about the study in the future, you may also contact her later.
If the researchers cannot be reached, or if you would like to talk to someone other than the researcher(s) about; concerns regarding the study; research participant's rights; research- related injury; or other human subject issues, please call the University Hospitals Cleveland Medical Center's Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061.
Discontinued 1/25/2024
Please review the 5 questions below to confirm that you are eligible for the study. 1. Are you 18 years of age or older? 2. Do you identify as a transgender woman or gender diverse individual? 3. Are you able to read and understand English in order to read and complete the survey independently? 4. Did you undergo vaginoplasty at least 3 months ago?
If you answered YES to all of the above questions, please proceed to question 5.
If you answered NO to any of the above questions, you are not eligible for this study. Please do not proceed .
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5. Did you already participate in a survey study at UH about sexual function and satisfaction after vaginoplasty surgery?
If YES, you are not eligible for this study. Please do not proceed .
If NO, you are eligible for this study and may proceed.
If you are NOT SURE and want to check with the Study Team, please call us at 216-286-8005.
Please review the questions below to confirm that you are eligible for the study. 1. Are you 18 years of age or older? 2. Do you identify as a transgender woman or gender diverse individual? 3. Are you able to read and understand English in order to read and complete the survey independently? 4. Did you undergo vaginoplasty at least 3 months ago?
If you answered YES to all of the above questions, please proceed.
If you answered NO to any of the above questions, you are not eligible for this study. Please do not proceed .
You have read and understand the description of the study
* must provide value
Yes
No
You voluntarily agree to participate in this study
* must provide value
Yes
No
Do you have questions for Study Team and would like someone to call you to discuss this study further?
Yes
No
If yes, please provide your contact information below.
Optional Interview
Please check "yes" or "no" below to indicate if you are willing to participate in the optional 30-minute interview if you are invited. If you check "yes," you will be prompted below to provide your contact information for scheduling the interview. We will send you a copy of the consent form for the interview by email to read at your convenience before scheduling. After 30 individuals have completed interviews, we will stop inviting participants, even if you say "yes" here.
* must provide value
Yes
No
If yes, please provide your contact information for interview scheduling.
Best time to call to schedule the interview:
Preferred Interview Time Options (check all that apply):
Linking your Data for other Research
It is possible that some of the data collected during this research project may be helpful for other project(s) as well. We would like to ask your permission to link your data from this study to other research projects. In order to link your data, we would be confirming your name and date of birth in each study to ensure a match. If you agree to this, your identifiable protected health information will be kept by the study team in a secure database and used for additional research without your further consent. Please check the option that correctly indicates your choice.
My data may be linked and used for future research:
* must provide value
Yes
No
Consent to Contact for Future Research
Our study team may have additional research studies in the future. We would like your permission to contact you in the future if we think you could be a potential participant in one of our studies. Please check "yes" or "no" below to indicate your choice about contact for future research.
Would you like to be contacted about future research opportunities?
* must provide value
Yes
No
If yes, fill in which way(s) we can contact you (phone, email, or both):
SIGNATURESigning below indicates that you have read and understand the description of the study and you voluntarily agree to participate in this study. By signing this form, you do not waive any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may have. A copy of this form will be provided to you.
Signature of Participant"Add signature"
* must provide value
Printed Name of Participant
* must provide value
Date - click the TODAY button
* must provide value
Today M-D-Y Click the TODAY button
Time - click the NOW button
* must provide value
Now H:M Click the NOW button
Signature of person obtaining informed consent
Printed name of person obtaining informed consent
Today M-D-Y Click the NOW button
Now H:M Click the NOW button
START QUESTIONNAIRE: to start the questionnaire which may take about 30 minutes to complete.
STOP & RETURN TO QUESTIONNAIRE: If you want to start the questionnaire and then stop at any point and complete it at a later time, follow the onscreen instructions and write down your return code. There will be an option to have the system send you an email with the link to return to the survey. The survey will close one week after you begin your responses-after that it will be inaccessible and you will not be able to complete the study and receive compensation.
WITHDRAW: If you change your mind and do not want to complete the questionnaire after starting it, you may withdraw from participation in this research by simply leaving the questionnaire page and not clicking SUBMIT. Alternately, you can click the WITHDRAW option at the end and click SUBMIT. If you withdraw, we will not use any of your partial answers and you will not receive compensation.
PAYMENT: After you complete the questionnaire, you must click the "submit" button in order for compensation to be received. After you click SUBMIT, you will arrive at the Study Payment Page. Here, you will enter your date of birth and see all the instructions for completing the W-9 form which is needed to issue your payment by gift card or check. You will be able to complete the W-9 form electronically or complete a paper copy by mail.
If you have any questions, please contact us at 216-286-8005 or PopeResearch@UHhospitals.org .
Thank you!
CONTINUE TO QUESTIONNAIRE
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