Informed Consent

Principal Investigator: Dr. Ilana Halperin 
Sunnybrook Health Sciences Centre
2075 Bayview Ave., Room H121
Toronto, ON, Canada, M4N 3M5
Email: ilana.halperin@sunnybrook.ca
Sponsor: This study is not funded.
INFORMED CONSENT
You are being asked to consider participating in a research study.  A research study is a way of gathering information on a treatment, procedure or medical device or to answer a question about something that is not well understood.

This form explains the purpose of this research study, provides information about the study, the tests and procedures involved, possible risks and benefits, and the rights of participants. 

You may take as much time as you wish to decide whether or not to participate. Feel free to discuss it with your friends and family, or your family doctor. Please ask the study staff or one of the investigators to clarify anything you do not understand or would like to know more about.  Make sure all your questions are answered to your satisfaction before deciding whether to participate in this research study. 

Participating in this study is your choice (voluntary). You have the right to choose not to participate, or to stop participating in this study at any time.

INTRODUCTION
You are being asked to consider participating in this study because you are or have previously used an open-source automatic insulin delivery (AID) system during pregnancy.

WHY IS THIS STUDY BEING DONE?
The purpose of this study is to understand the patient’s experience with using open-source automatic insulin delivery (AID) systems during pregnancy, and provider experiences caring for patients who have used AID systems during pregnancy.

WHAT WILL HAPPEN DURING THIS STUDY?
During this study you will be asked to complete a 20-minute questionnaire on SurveyMonkey

HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
We anticipate that about 100 patients will participate in the SurveyMonkey questionnaire. The length of the SurveyMonkey questionnaire for participants is approximately 20 minutes. The entire study is expected to take about one year to complete and the results should be known by June 2023.

WHAT ARE THE RESPONSIBILITIES OF STUDY PARTICIPANTS?
If you decide to participate in this study you will be asked to acknowledge the informed consent and complete the 20-minute questionnaire.

WHAT ARE THE RISKS OR HARMS OF PARTICIPATING IN THIS STUDY? There are no medical risks to you from participating in this study, but taking part in this study may make you feel uncomfortable. You may refuse to answer questions or stop the survey at any time if you experience any discomfort. While no identifying information will be collected through the survey, as SurveyMonkey collects the IP address of responses, there is a risk that data may become identifiable in SurveyMonkey’s possession. Your physician will not know the results of your questionnaire and therefore this will not affect your overall medical care.

WHAT ARE THE BENEFITS OF PARTICIPATING IN THIS STUDY?
You will not benefit directly from participating in this study. The main benefit this study hopes to provide is knowledge. We hope to gather enough information in this study to better understand the patient experience in using open-source AID systems during pregnancy.

WHAT OTHER CHOICES ARE THERE?
Participation in this study is completely voluntary.

WHAT ARE THE COSTS OF PARTICIPATING IN THIS STUDY?
There are no costs to you for participating in this study.

ARE STUDY PARTICIPANTS PAID TO PARTICIPATE IN THIS STUDY?
You will not be paid to participate in this study.
HOW WILL MY INFORMATION BE KEPT CONFIDENTIAL?
You have the right to have any information about you and your health that is collected, used or disclosed for this study to be handled in a confidential manner. The investigator(s), study staff and the other people listed above will keep the information they see or receive about you confidential, to the extent permitted by applicable laws. Even though the risk of identifying you from the study data is very small, it can never be completely eliminated. Any information sent outside of Canadian borders may increase the risk of disclosure of information because the laws in those countries dealing with protection may not be as strict as in Canada. However, any information will be transferred in compliance with all relevant Canadian privacy laws.

When the results of this study are published, your identity will not be disclosed.

Collecting data using technology over the internet or using apps/tools/devices can increase potential risks to privacy and confidentiality.  This study will be using SurveyMonkey to collect data for this study. The data will reside on an external server and no assurance can be made about its confidentiality or that it will only be used for this research purpose. Please read the terms and agreement of the service provider for further information regarding data security and confidentiality of the technology being used. This study will be using U.S. based internet service providers which means that the electronic data will be stored and accessed in the U.S. and is therefore subject to U.S. laws including the U.S Freedom Act. The Freedom Act allows authorities access to the records of internet service providers. It is therefore possible that this information could be disclosed to U.S. federal officials.

ARE THERE ANY CONFLICTS OF INTEREST/RELATIONSHIPS?
None of the investigators in this study have conflicts of interest.

WHAT ARE THE RIGHTS OF PARTICIPANTS IN A RESEARCH STUDY?
You have the right to ask questions and to receive answers throughout this study.

If you have any questions about this study you may contact the person in charge of this study (Principal Investigator) Dr. Ilana Halperin, Sunnybrook Health Sciences Centre, 2075 Bayview Ave., Room H121, Toronto, ON, Canada, M4N 3M5, Email: ilana.halperin@sunnybrook.ca

The Sunnybrook Research Ethics Board has reviewed this study.  If you have questions about your rights as a research participant or any ethical issues related to this study that you wish to discuss with someone not directly involved with the study, you may call the Chair of the Sunnybrook Research Ethics Board at (416) 480-6100 ext. 88144.  

Question Title

* 1. By acknowledging accept to participation on the SurveyMonkey questionnaire I confirm that:
· This research study has been fully explained to me and all of my questions answered to my satisfaction
· I understand the requirements of participating in this research study
· I have been informed of the risks and benefits, if any, of participating in this research study
· I do not give up any of my legal rights
· I have been informed of any alternatives to participating in this research study
· I have been informed of the rights of research participants
· I have read each page of this form
· I have agreed, or agree to allow the person I am responsible for, to participate in this research study

By completing this survey via SurveyMonkey, you are providing consent for your answers to be used for this study only.

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