Participant Consent Form |
Participant Consent Form
You are invited to participate in a research study entitled:
Exploring musculoskeletal health after gender affirming surgery
Principal Investigator/Supervisor:
Dr. Angelica Lang, Ph.D. Canadian Centre for Rural and Agricultural Health, University of Saskatchewan, Phone: 306-966-5544, Email: angelica.lang@usask.ca
Co-investigators:
Dr. Brenna Bath, School of Rehabilitation Science, Canadian Centre for Rural and Agricultural Health, University of Saskatchewan
Dr. Tracey Carr, Department of Community Health and Epidemiology, University of Saskatchewan
Dr Soo Kim, School of Rehabilitation Science, University of Saskatchewan
Dr. Rachel Loewen Walker, Women's and Gender Studies/Department of Political Studies, University of Saskatchewan
Liz McKnight, Community Partner
Meaghan Ray Peters, Community Partner
Student Researcher(s):
Rosmary Martinez Rueda, PhD candidate, Department of Community Health and Epidemiology, University of Saskatchewan, Email: rom694@usask.ca
Purpose and Objective of the Research:
The purpose of this survey is to explore the musculoskeletal health-related experiences after gender-affirming chest surgery. A secondary purpose of this project is to bring together a team of collaborative, multi-disciplinary researchers to begin research in the area of post-gender affirming surgery experiences.
Musculoskeletal (MSK) health refers to the abilities and symptoms (pain, injury, etc.) related to the muscles, bones, joints, and connective tissues. For this survey, we are interested in the MSK health symptoms beyond the typically expected surgical and/or healing symptoms, such as incisional pain, bruising, or itchiness, in the period immediately after your surgery. We would like you to answer this survey about the MSK symptoms that you experienced after you felt your incisions were fully healed.
We recognize that many people have experiences outside of what is being asked in this survey, such as mental health considerations, infections, difficulty with the medical or insurance systems, and varying levels of support, among others. We are planning to incorporate these other aspects of the post-surgery experience in future research.
Finally, we acknowledge the important positive outcomes from gender-affirming surgery, notably relief from gender dysphoria, and fully support all those who want or need this procedure.
Inclusion Criteria:
· Transgender diverse population from any province or territory in Canada and at any stage or time point post-gender affirming chest surgery both, feminizing and masculinizing.
· Participants must be fluent in English as the survey will be only available in English.
· Adults over the age of 18 years old.
Procedures:
· You will be asked to complete an online questionnaire about your demographics, and experiences with chest gender affirmation surgery and musculoskeletal symptoms.
· Questions are a mixture of multiple choice and open-ended.
· It is estimated that the questionnaire will take 20 minutes to complete.
Funded by:
· This project is funded by the Saskatchewan Health Research Foundation Align grant.
Potential Risks:
· There is a potential risk of emotional or cognitive distress when completing the survey, as it may require you to recall distressing experiences.
· Any distress you experience answering the questions will likely be similar to what you experience at a medical appointment when you are describing your symptoms in order to receive care.
· If you are ever uncomfortable, you will be able to save, exit, and return to the survey at any time.
· We will provide links to resources and support, or you can contact the researchers if you have any concerns.
If you need more information and support, consider the available resources:
All Canadians:
• Mental Health Support Canada.ca (opens in a new tab): 1-866-585-0445
or text WELLNESS to 686868 for youth and 7417 41 for adults
• TransLifeOrg: 1-877-330-6366
In Saskatchewan:
• Health Line (opens in a new tab): Dial 811
A 24 hour, 7 day a week confidential, health, mental health, and addictions advice,
education, and support telephone line available to the people of Saskatchewan.
• Saskatoon Crisis Intervention Service (opens in a new tab): 1-306-933-6200
Potential Benefits:
· There are likely no direct benefits to you for participating in this research. However, the knowledge gained from this research may assist in future research and interventions for individuals who seek or underwent chest gender affirmation surgery in Saskatchewan.
Compensation:
· There is no compensation for participating in this research.
Confidentiality:
· Participation in this study is completely anonymous, and your identity will not be disclosed when the results are disseminated.
· Any contact information will be collected separately from the survey responses so that your responses will remain anonymous.
· To assure a participant of anonymity means that the research participant's identity will not be known to anyone, including the researcher.
· Data from this study will be disseminated in an aggregate and summarized form in conference presentations and scientific publications.
· Researchers will prevent the linking of responses to identifiable information about the participant, and therefore maintain anonymity of the responses.
· If the need to monitor this research study arises, a member of University of Saskatchewan Research Ethics Board and/or this institution may also consult your research data. By agreeing to participate in this study, you authorize such access.
· This survey is hosted by RedCap, a secure service used by the University of Saskatchewan to manage online surveys for research studies. For more information please visit: https://projectredcap.org/software/mobile-app/privacypolicy/.
Storage of Data:
· Electronic data collected by RedCap will be stored in secure servers in Canada.
· Data collected for analysis by the researchers will be stored on a password-protected computer and accessible only by the researchers. After analysis is complete, the data will be moved to DataStore.
· Any identifying information, such as contact information for future studies, will be collected in a different link and kept separately from study data on the Principal Investigator's password-protected computer.
· Contact information will be collected and stored separately from your responses to ensure anonymity, in a password-protected worksheet on a password protected computer accessible only by the researchers.
· Five years after publication data will be permanently deleted.
Right to Withdraw:
· Participation in this survey is voluntary.
· You can decide not to participate at any time by closing your browser, or choose not to answer any questions you do not feel comfortable with. Survey responses will remain anonymous. Since the survey is anonymous, once it is submitted it cannot be removed.
· Whether you choose to participate or not will have no effect on your position (e.g., employment, academic status, access to services) or how you will be treated.
Follow up:
· To obtain a summary of the results from the study, please contact the researchers using the information at the top of page 1.
· It is expected that the results summary will be available by December 2024.
Questions or Concerns:
· Contact the researcher(s) using the information at the top of page 1.
· This research project has been approved on ethical grounds by the University of Saskatchewan Behavioural Research Ethics Board. Any questions regarding your rights as a participant may be addressed to that committee through the Research Ethics Office: ethics.office@usask.ca; 306-966-2975; out of town participants may call toll free 1-888-966-2975.