The pdf of the information and consent form can be found below.
INFORMATION AND CONSENT FORM
REGISTRY OF INDIVIDUALS LIVING WITH TYPE 1 DIABETES IN CANADA : THE BETTER REGISTRY
Principal investigator: Dr Rémi Rabasa-Lhoret, Institut de recherches cliniques de Montréal
Dr Anne-Sophie Brazeau, McGill University
Dr André Carpentier, Centre Hospitalier Universitaire de Sherbrooke
Dr Kaberi Dasgupta, McGill University Health Centre
Dr Claudia Gagnon, Centre Hospitalier de l'Université Laval
Dr Melanie Henderson, Centre Hospitalier Universitaire Sainte-Justine
Dr Laurent Legault, McGill University Health Centre
Dr Meranda Nakhla, McGill University Health Centre
Dr Bruce Perkins, University of Toronto
Dr Peter Senior, Alberta Diabetes Institute
Dr Nadine Taleb, Centre Hospitalier de l'Université de Montréal
Dr Cynthia Turcotte, Centre de Psychologie de la Rive-sud
Funding agencies : Canadian Institutes of Health Research and Juvenile Diabetes Research Foundation
Registry coordinator : Virginie Messier, Institut de recherches cliniques de Montréal
Multicenter Identifier: MP-02-2019-7992
No of the project at the CHUM: 18.232
We request your participation in a data registry because you have type 1 diabetes. However, before agreeing to participate in this registry, please take the time to read, understand and consider carefully the information that follow.
This form may contain words that you do not understand. We invite you to ask any questions you may find useful to the researcher in charge of the registry or co-researchers and to ask them to explain the elements that are not clear (email@example.com
; 514-987-5696 or 1-833-897-3172).
NATURE AND OBJECTIVES OF THE STUDY
Type 1 diabetes requires individuals to inject themselves with insulin to control their blood sugar levels because their pancreas no longer produces insulin. A consequence of this treatment is a risk of low blood sugar episodes called hypoglycemia. In some cases, hypoglycemic episodes can be severe (very low blood sugar) meaning that the individual needs the help of another person to raise his sugar level. Hypoglycemia, especially severe, is a very uncomfortable experience, which can make people confused, cause accidents (for example, driving) or injury (for example, a fall). If hypoglycemia is not treated and gets worse, it can lead to coma and sometimes death. Many people living with type 1 diabetes have expressed the need to identify better strategies to reduce these episodes of hypoglycemia.
We are creating a registry of individuals with type 1 diabetes. Any individual with type 1 diabetes living in Canada will be eligible to participate in the registry. The objective of the registry is to measure the frequency and the severity of episodes of hypoglycemia. Participants will be invited to answer questionnaires about the frequency of their hypoglycemic episodes, their fear about hypoglycemia, their symptoms of hypoglycemia, the factors in cause (insulin therapy, nutrition, exercise, etc.), etc. The data collected through the registry questionnaires will enable research projects to be carried out.
Participation in the registry will be divided in 3 phases. The first phase is mandatory for all participants. Phases 2 and 3 are optional. This information and consent form is for phase 1 only. At the end of each questionnaire, you will be asked if you want to participate in the next phase of the registry. You can answer all questionnaires one after each other or start a questionnaire, save your answers and come back later to answer the remaining questions.
NUMBER OF STUDY PARTICIPANTS AND LENGTH OF THE PARTICIPATION
We hope to recruit 6,000 participants for phase 1 of the registry, 3,000 participants for phase 2 and 1,500 participants for phase 3.
The duration of the study is 6 years. The duration of your participation will depend on your degree of participation:
• Estimated time for Phase 1: 15 minutes
• Estimated time for Phase 2: 45 minutes
• Estimated time for phase 3: 25 minutes
NATURE OF THE REQUESTED PARTICIPATION
If you agree to participate in phase 1 of the registry, you will have to answer an online questionnaire whose objective is to draw an overall picture of the population with type 1 diabetes in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. It will take you about 15 minutes to answer the questionnaire. When you answer the questionnaire, you can save your answers and come back later to answer the remaining questions. If you are using a continuous glucose monitor, you will be invited to send us the report of the last 14 days of your continuous glucose monitor.
Participation in phases 2 and 3 also consists of answering an online questionnaire. The objective of phase 2 and 3 is to obtain more details about the causes and consequences of hypoglycemia. At phase 2, if you accept, you will be invited to provide to the research team your latest list of medications as well as your latest blood and urine tests. Finally, at phase 3, if you accept, you will be invited to can also answer a food questionnaire, wear a step counter and measure your waist circumference.
Phase 1 will be done on an annual basis meaning that in one year from today, you will be invited to answer the same questionnaire once again, and if you accept, send us the report of the last 14 days of your continuous glucose monitor (if you are using one). In addition, you will be invited to answer additional questions coming from phase 2 and 3, and if you accept, to measure your waist circumference, wear a step counter, answer the food questionnaire and send us your latest blood and/or urine tests as well as your list of medications.
STORAGE OF DATA
All data will be stored in a secure database located on a server at the Institut de recherches cliniques de Montréal (Montreal, Quebec, Canada), under the responsibility of Dr. Rémi Rabasa-Lhoret, director of the BETTER registry. Security backup copies of the data are generated daily.
The data included in the registry will only be accessible by the director of the BETTER registry and its immediate collaborators in accordance with the BETTER Registry Management Framework.
There is no known physical risk to participate in this registry. However, the time required to answer the questionnaire can be a disadvantage for some participants and cause questions or stress. You may stop responding to the questionnaire at any time or continue at another time if you wish.
Risk associated with a breach of confidentiality: There is a risk of a possible breach of confidentiality regarding your personal information that could result in a breach of your privacy. This risk however is minimal. Every effort will be made to protect your privacy and confidentiality as described in the "Confidentiality" section.
You will not derive any personal benefit from participating in this registry or in the research projects in which your data will be used. However, the research done with your data included in the registry may enable the researchers to learn more about the occurrence of hypoglycemia and improve patient care in the future.
The principal investigator will protect your file so that your name, address and telephone number will remain confidential.
Your data entered into the database will be identified only by your identification number. It will be possible to identify you and link your data only by the identification number kept by the principal investigator and the coordinator responsible of the entry of your data in the registry.
Any researcher who is not part of the BETTER research team and who wants to have access to the registry data will have to submit his project to the Registry Management Committee, which will evaluate the research projects for which access to the registry data will be granted, in accordance with the registry management framework. In addition, a research ethics board will have approved any research based on your data included in the registry.
The reports concerning any research done using data included in the registry will not be sent to you because the research will be done based on data of a very large number of participants and will not be of any diagnostic or therapeutic consequence to you. Research data may be published or be the subject of scientific discussion, but it will not be possible to identify you.
You will receive no financial compensation for your participation in this registry. However, you have the chance to win a cash gift worth $500 (1 cash gift will be drawn for every 500 participation coupons). Your chances of winning will increase according to your degree of participation in the registry:
• Phase 1: one chance to win (1 coupon)
• Phase 2: two additional chances to win (3 coupons)
• Phase 3: two additional chances to win (5 coupons)
• Annual questionnaire: one additional chance to win (1 coupon per year)
• Annual questionnaire - Part 2: one additional chance to win (1 coupon per year)
• Annual questionnaire - Part 3: one additional chance to win (1 coupon per year)
• Report of the last 14 days of the continuous glucose monitor: one additional chance to win (1 coupon per year)
• Food questionnaire: one additional chance to win (1 coupon per year)
• Waist circumference measurement: one additional chance to win (1 coupon per year)
• Wear step counter for 14 consecutive days: one additional chance to win (1 coupon per year)
• Send latest blood and/or urine tests results: one additional chance to win (1 coupon per year)
• Send list of medications: one additional chance to win (1 coupon per year)
SHOULD YOU SUFFER ANY HARM
Should you suffer harm of any kind related to your participation in this registry, you are not waiving any of your legal rights nor discharging the principal investigator, the funding agencies or the institution, of their civil and professional responsibilities.
POSSIBILITY OF MARKETING
Your participation in this registry could lead to the creation of commercial products that could potentially be protected by patent or other intellectual property rights. However, in such a case, you will not be able to obtain any financial benefit.
FUNDING OF THE REGISTRY
This registry is funded by the funding agencies.
VOLUNTARY PARTICIPATION AND THE RIGHT TO WITHDRAW
Your participation in this registry is voluntary. You can decide not to participate or withdraw your consent at any time. If you choose not to participate or to withdraw from this registry, it will have no impact on the quality of care and services you receive or on your relationship with your doctor and the healthcare team.
If you decide to stop participating in the registry and no longer want your data to be used for research purposes, you must inform the research team. Your data will then be destroyed.
Any new information acquired during the course of the project likely to influence your decision to continue to participate in the registry will be communicated to you without delay verbally and in writing.
IDENTIFICATION OF CONTACT PEOPLE
Should you have any question regarding this registry, you may contact the principal investigator and director of the registry, Dr. Rémi Rabasa-Lhoret, at the following number: 514-987-5696 (between 8:00 and 16:00, Monday to Friday).
Shoud you have any questions about your rights as a participant in a registry or have any complaints or comments, you can contact:
• The associate commissioner for complaints and service quality of the CHUM at (514) 880-8484.
• The patient ombudsman of the Royal Victoria Hospital (MUHC) at (514) 934-1934, extension 35655.
• The CIUSSS de l'Estrie-CHUS' Office of Complaints and Quality of Services at firstname.lastname@example.org or at the following number: 1-866-917-7903.
• The commissioner for complaints and service quality of the CHU de Québec-Université Laval at (418) 654-2211.
• The commissioner for complaints and service quality of the CHU Sainte-Justine at (514) 345-4749 or by email at email@example.com.
• The commissioner for complaints and service quality of the CIUSSS du Saguenay-Lac-Saint-Jean at (418) 541-7026 or at 1-877 662-3963.
• The commissioner for complaints and service quality of the CISSS de Chaudière-Appalaches at 1-877 986-3587.
• Service Quality and Complaints Commissionner of the CIUSSS du Nord-de-l'Île-de-Montréal at (514) 384-2000, extension 3316 or by email at firstname.lastname@example.org.
• The commissioner for complaints and service quality of the CISSS des Laurentides at (450) 432-8708 or at 1-866 822-0549, or by email at email@example.com.
• The Office of the Service Quality and Complaints Commissioner of the CISSS de Laval at (450) 668-1010, extension 23628 or by email at firstname.lastname@example.org
• The commissioner for complaints and service quality of the CIUSSS de la Mauricie-et-du-Centre-du-Québec at 1-888 693-3606 or by email at email@example.com.
• The Local Commissioner of Complaints and Quality of Service of the CIUSSS Centre-Ouest-de-l'Île-de-Montréal or the ombudsman of the institution at (514) 340-8222, extention 24222 or at the Jewish General Hospital Endocrinology clinic at (514) 340-8090.
• The Service Quality and Complaints Commissioner for the CIUSSS of the Est-de-l'Île-de-Montréal region at (514) 252-3400, extension 3510.
• The commissioner for complaints and service quality of the CISSS du Bas-Saint-Laurent at 1-844 255-7568 or by email at firstname.lastname@example.org.
• The commissioner for complaints and service quality of the CISSS de Lanaudière at (450) 759-5333, extension 2133 or by email at email@example.com.
• The Commissioner for Complaints and Quality Services of the CISSS de la Montérégie-Centre at (450) 466?5434.
• The commissioner for complaints and service quality of the CISSS de l'Outaouais at (819) 771-4179 (free call : 1 844 771-4179) or by email at firstname.lastname@example.org.
• The commissioner for complaints and service quality of the CIUSSS Centre-Sud-de-l'Île-de-Montréal at 514-593-3600.
APPROVAL OF THE RESEARCH ETHICS BOARD
The CHUM's Research Ethics Board has approved the project to establish a registry and is responsible for monitoring it at all participating institutions in the health and social services network in Quebec.
COMMITMENT OF THE PRINCIPAL INVESTIGATOR
I undertake, together with the research team, to respect what was agreed upon in the information and consent form.
CONSENT TO PARTICIPATE IN PHASE 1 OF THE BETTER REGISTRY
I declare that I have read this consent form (or that it has been read to me), specifically as regards the nature of my participation in the registry and the extent of the associated risks. I acknowledge that all of my questions have been answered and that I have been given the necessary time to make a decision. I freely and voluntarily agree to participate in this registry.
By clicking on YES, I voluntarily agree to participate in phase 1 of the registry and will be redirected to the questionnaire.
By accepting to participate in phase 1 of the registry, I am not waiving any of my legal rights or and I do not release the researchers, funding agencies or the institution from their civil and professional responsibilities.