Perceptions of Reproductive Care during Preconception and Pregnancy Among Individuals with Inflammatory Bowel Diseases; A Comparison between Immigrant and Non-Immigrant Populations

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Title Perceptions of Reproductive Care during Preconception and Pregnancy Among Individuals with Inflammatory Bowel Diseases; A Comparison between Immigrant and Non-Immigrant Populations

Investigator Dr. Vivian Huang, MD FRCPC
Gastroenterologist
441-600 University Avenue
Toronto, ON M5G 1X5
416-586-4800 ext 2475

Co-Investigators Dr. Parul Tandon, DO PhD FRCPC
Gastroenterologist

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
You have been asked to take part in this research study you have Inflammatory Bowel Disease (IBD) and are considering pregnancy, are pregnant or are post partum. The information collected through this study will be used to help healthcare professionals to advocate to health policy makers to increase resources to provide equitable and culturally appropriate care to all women with IBD.

Study Visits and Procedures
Your participation in this study requires the completion of an online survey, which will be completed through SimpleSurvey , a secure online survey platform. The online survey should take about 15-20 minutes to complete. You will be asked to complete a questionnaire which will contain questions regarding demographics, IBD history and IBD activity and your healthcare experiences.

Risks Related to Being in the Study
There are no medical risks if you take part in this study but being in this study may make you feel uncomfortable. You may refuse to answer questions or end the survey at any time if there is any discomfort

Benefits to Being in the Study
You may not receive any direct benefit from being in this study. Information learned from this study may help other people with IBD in the future.

Voluntary Participation
Your participation in this study is voluntary. You may decide not to be in this study, or to be in the study now and then change your mind later. We will give you new information that is learned during the study that might affect your decision to stay in the study.

Confidentiality

Personal Health Information
If you agree to join this study, the study doctor and his/her study team will look at your personal health information and collect only the information they need for the study. Personal health information is any information that could be used to identify you and includes your:

name,
address,
date of birth,
new or existing medical records, that includes types, dates and results of medical tests or procedures.

The information that is collected for the study will be kept in a locked and secure area by the study doctor for 15 years. Only the study team or the people or groups listed below will be allowed to look at your records. Your participation in this study also may be recorded in your medical record at this hospital.
The following people may come to the hospital to look at the study records and at your personal health information 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.

In Case You Are Harmed in the Study
If you become ill, injured or harmed as a result of taking part in this study, you will receive care. The reasonable costs of such care will be covered for any injury, illness or harm that is directly a result of being in this study. In no way does signing this consent form waive your legal rights nor does it relieve the investigators, sponsors or involved institutions from their legal and professional responsibilities. You do not give up any of your legal rights by signing this consent form.

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 ext 2475. 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.

22-Nov-24

*Consent

This study has been explained to me and any questions I had have been answered. I know that I may leave the study at any time. I agree to take part in this study and to the use of my personal health information as described above.