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CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Title Exploring Clinician Perceptions of IBD and Fertility: An Anonymous Survey Study
Investigator Dr. Vivian Huang MSc, MD, FRCPC
Mount Sinai Hospital
441 – 600 University Avenue
Toronto, ON M5G 1X5
416-586-4800 ext. 2475
Vivian.Huang@sinaihealth.ca
Co-Investigators: Dr. Parul Tandon, DO, PhD, FRCPC
Driscoll Family Digestive Health Centre
Toronto Western Hospital, UHN
399 Bathurst St, 13MP 302
Toronto, ON M5T 2S8
416-603-5949
Parul.Tandon@uhn.ca
Dr. Kimberly Liu, MD, FRCSC, MSL
Mount Sinai Fertility
700 – 250 Dundas Street West
Toronto, ON M5T 2Z5
416-586-5367
Kimberly.Liu@sinaihealth.ca
Introduction
You are being asked to take part in a research study. Please read this explanation about the study and its risks and benefits before you decide if you would like to take part. You should take as much time as you need to make your decision. You should ask the study doctor or study staff to explain anything that you do not understand and make sure that all of your questions have been answered before signing this consent form. Before you make your decision, feel free to talk about this study with anyone you wish. Participation in this study is voluntary.
Background and Purpose
IBD is a growing concern in Canada. Since many women are diagnosed before the age of thirty-five, it can impact their childbearing years. While pregnancy with IBD carries increased risks, proper care can improve outcomes. For example, existing research shows preconception counselling benefits patients by improving medication adherence, reducing disease flare-ups, and addressing fertility concerns. However, there's a lack of information on how well Canadian specialists perceive and understand the impact of IBD on fertility and how to manage it in patients considering pregnancy. This study aims to address this gap and assess the knowledge and practices of specialists caring for women with IBD.
Study Design
Should you choose to participate in this study, we will give you a questionnaire. The questionnaire will take approximately 7-10 minutes to complete, and you will be asked to choose from multiple choices and provide free response answers. Please answer the questions to the best of your ability. You have the right to decline to answer any question you do not feel comfortable answering.
Risks Related to Being in the Study
Your participation in the study simply involves the completion of the questionnaire. Please note that the survey includes questions that you may find uncomfortable.
Benefits of Being in the Study
You will not receive any direct benefit from being in this study. Information learned from this study will allow improve the treatment program in place at the Preconception and Pregnancy in IBD Clinic.
Voluntary Participation
Your participation in this study is voluntary. You may decide not to be in this study. You may refuse to answer any question you do not want to answer. Please note that once submitted, however, there is no way of retracting the survey since it is not linked to the participant.
Confidentiality
If you agree to join this study, your survey data will be collected using SimpleSurvey, an online survey platform. The data collected will be anonymous, which means that no information that identifies you will be linked to your survey responses. The information that is collected for the study will be transferred from SimpleSurvey to secure internal servers at Sinai Health where it will be kept for 10 years. Only the study team or the people or groups listed below will be allowed to look at your survey responses.
The following people may come to the hospital to look at the study records to check that the information collected for the study is correct and to make sure the study followed proper laws and guidelines: Representatives of the Mount Sinai Hospital Research Ethics Board.
All information collected during this study will be kept confidential and will not be shared with anyone outside the study unless required by law. You will not be named in any reports, publications, or presentations that may come from this study. If you decide to leave the study, the information about you that was collected before you left the study will still be used. No new information will be collected without your permission.
Email is not a secure form of communication and should not be used for conveying sensitive information, or in the event of an emergency.
Research Results
You have the right to be informed of the results of this study once the entire study is complete. If you would like to be informed of the results of this study, please contact Dr. Vivian Huang.
Questions About the Study
If you have any questions, concerns or would like to speak to the study team for any reason, please call: Dr. Vivian Huang at 416-586-4800 x2475 or Mr. Varun Srikanth at 416-586-4800 x5957.
If you have any questions about your rights as a research participant or have concerns about this study, call the Chair of the Mount Sinai Hospital Research Ethics Board (REB) or the Research Ethics Office number at 416-586-4875. The REB is a group of people who oversee the ethical conduct of research studies. These people are not part of the study team. Everything that you discuss will be kept confidential.
Consent
Clicking on the link below will imply that you have consented to participate in this study, and for the study investigators to use any data collected for analytic purposes. The research survey will not be collecting any information that will make it possible to positively identify you. There will be no way to link the survey responses to your email address.