Implied Consent Form
Study Title: Canadian Patient Perspectives on Data Sharing : A Survey Study
OHSN-REB Number: 20260006-01H
Principal Investigator: Dr. Kelly Cobey, PhD, kcobey@ottawaheart.ca
Co-Investigator: Dr. David Moher, PhD, dmoher@ohri.ca
INTRODUCTION
You are being invited to participate because you have interacted with the Canadian health system, either as a patient, a caregiver, or someone who has taken part in a clinical trial. This study aims to understand the perspectives of people in Canada on sharing personal health and research data.
We will specifically examine perspectives on sharing individual-level data collected during a) clinical care; and b) participation in research studies. We will examine for potential differences in patient perspectives regarding the sharing of different types of data in each of these contexts (e.g., behavioural data vs clinical lab results vs imaging data). We will examine perceptions of risks and benefits, patients’ willingness to share data, and which types of data, and in what circumstance, people are most willing to share. Having specific data from Canada on patient preferences for how data is shared, what data is shared, and to whom, is critical to implementing data sharing policies and practices in a way that best serves the Canadian community
ARE THERE ANY CONFLICTS OF INTEREST?
Some team members hold paid or volunteer roles with organizations involved in patient and public engagement and patient advocacy, including positions that receive funding from pharmaceutical companies, government, research institutes, and other sources. One team member also receives an annual honorarium for service on an open science steering committee.
The University of Ottawa Heart Institute is receiving external funding from the Canada First Research Excellence Fund for the Brain-Heart Interconnectome (CFREF-2022-00007) to cover the cost of conducting this study.
WHAT WILL HAPPEN DURING THIS STUDY?
Your participation in this study will require the completion of a survey. The survey asks questions about clinical data sharing. This should take approximately 15 minutes of your time.
The information you provide is for research purposes only. Some of the questions are personal. You can choose not to answer questions if you wish.
VOLUNTARY PARTICIPATION AND WITHDRAWAL:
You do not have to be in this study if you do not want to be. You can choose to end your participation in this research (called withdrawal) at any time without having to provide a reason.
The survey is anonymous. This means that you can withdraw from participating at any time while completing the survey simply by closing your browser; however, once the completed survey has been returned to the study team, it will not be possible to withdraw your information. Any information recorded before you withdraw will be used by the researchers for the purposes of the study, but no information will be collected after you withdraw your permission.
RISKS AND/OR BENEFITS:
This study poses minimal risk to you. Some of the questions may however make you feel uncomfortable.
You are free to skip any questions or leave the survey at any time.
There are no direct benefits to you for participating. However, your input may contribute to a better understanding of reproducibility in the Canadian research environment, which may lead to improved policies and practices in the future.
PRIVACY/CONFIDENTIATLITY:
Your email can be collected for contact purposes for payment of the gift card if you wish to enter; however, the main survey is anonymous which means that your answers will not be linked to you in any way.
Authorized representatives of the following organizations may look at your original research records at the site where these records are held, to check that the information collected for the study is correct and follows proper laws and guidelines.
- The Ottawa Health Science Network Research Ethics Board who oversees the ethical conduct of this study.
- Ottawa Heart Institute Research Corporation, the Sponsor of this study, to oversee the conduct of research at this location.
Information that is collected about you for the study (called study data) may also be sent to the organizations listed above. Your name, email, or other information that may directly identify you will not be used. The records received by these organizations may contain your age group, sex/gender, and race/ethnicity.
This research study is collecting information on race and ethnicity as well as other characteristics of individuals because these characteristics may influence how people respond. Providing information on your race or ethnic origin is voluntary.
If the results of this study are published, shared, or presented at scientific meetings, your identity will remain confidential. Any publications, presentations, or reports based on this study will report anonymous data only, meaning no participant will be directly identifiable. It is expected that the information collected during this study will be used in analyses and will be published/ presented to the scientific community at meetings and in journals.
Communication via e-mail is not secure. We do not recommend that you communicate sensitive personal information via e-mail.
Even though the risk of identifying you from the study data is very small, it can never be completely eliminated.
Open Science & Future Research:
Anonymous study data will also be shared on open access websites, such as the Open Science Framework, and/or be used in future research projects. Anonymous participant data will be shared on open access platforms such as the Open Science Framework (OSF) and may be used in future research. This will include anonymous survey response data and basic demographic information (e.g., sex/gender and other non-identifying characteristics). No identifying information will be shared.
“Open Access” means making study data publicly available, for anyone around the world to freely access and use. Making study data more easily accessible and readily available can facilitate research that may improve science.
Open Access Website policies may require that users only use data for research purposes; however, it is not possible to guarantee that everyone will respect these policies, or to monitor how data is used.
It is not currently possible to define all the types of research that may be done in the future using your data. The research may be about similar diseases or conditions to this study but also about unrelated diseases and conditions, or other types of research. Some of the methods or analyses used may not even have been invented yet.
Any information made publicly available outside of Canadian borders on Open Access websites may increase the risk of disclosure of information because the laws in those countries dealing with protection of information may not be as strict as in Canada. However, all study data will be anonymous. The information will be made publicly available in compliance with all relevant Canadian privacy laws. By returning your completed survey, you are consenting to the disclosure of your anonymous information to organizations located outside of Canada.
COST AND/OR PAYMENT:
There will not be any cost to you. By participating, you may enter a raffle where you can win one of three $100 President’s Choice gift cards.
RIGHTS OF PARTICIPANTS
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected.
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 the research team.
QUESTIONS
If you have questions about taking part in this study, you may contact Dr. Kelly Cobey at kcobey@ottawaheart.ca, or Dr. David Moher , dmoher@OHRI.ca
If you have questions about your rights as a participant or about ethical issues related to this study, you can talk to someone who is not involved in the study at all. Please contact The Ottawa Health Science Network Research Ethics Board, Chairperson at 613-798-5555 extension 16719, or at rebadministration@toh.ca.
CONSENT
By completing this survey your consent to participate is implied.
