Patient Perceptions and Attitudes Regarding Aspirin Prescribing for the Prevention of Preeclampsia in Women with Inflammatory Bowel Disease
CONSENT TO PARTICIPATE IN A RESEARCH STUDY - PATIENT CONSENT FORM

Title            Physician and Patient Perceptions and Attitudes Regarding Aspirin for the Prevention of Preeclampsia in Women with Inflammatory Bowel Disease

 

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

Co-Investigators              Dr. Cynthia Maxwell, MD, FRCSC
                                           Obstetrician

Sponsor                           N/A

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 are being asked to take part in a research study because you have inflammatory bowel disease (IBD) and are considering pregnancy or are currently pregnant or recently gave birth. We are looking to assess the thoughts of women with IBD in relation to Aspirin for the prevention of preeclampsia (a disorder in pregnancy that is characterized by high blood pressure and protein in the urine).
 
Study Visits and Procedures

Your participation in this study requires the completion of an online survey, which will be completed through Novi Survey, a secure online survey platform. The online survey should take about 10 minutes to complete. You will be asked to complete a questionnaire consisting of the following:

a) Maternal baseline information/Demographics: You will be asked to provide demographic information including demographics, IBD history, reproductive history, medications and co-morbidities

b) Aspirin Questionnaire: You will be asked to complete this questionnaire to assess
your thoughts on Aspirin for the prevention of preeclampsia (i.e. side effects,
potential benefits)

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. You may leave the study at any time without affecting your care. You may refuse to answer any question you do not want to answer.

We will give you new information that is learned during the study that might affect your decision to stay in the study.

Alternatives to Being in the Study

You do not have to join this study to continue receiving care and treatment for your condition. This study will not directly impact your treatment in any way.

Confidentiality

The information that is collected for the study will be kept in a locked and secure area by the study doctor for 7-10 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.

All information collected during this study, including your personal health information, 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.

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.

Expenses Associated with Participating in the Study

You will not have to pay for anything involved with this study. You will not be reimbursed for transportation, meals, time, inconvenience, etc.

Conflict of Interest

All of these people have an interest in completing this study. Their interests should not influence your decision to participate in this study. You should not feel pressured to join this study.

Questions About the Study

If you have any questions, concerns or would like to speak to the study team for any reason, please call: Principal Investigator, 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.
 
Version Date: 30/Jun/21
 
1.
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:

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