Ethical and Legal Considerations for Canadian Registries

Abstract

This section summarizes the ethical and legal considerations that will impact the creation and operation of neurological disease registries in Canada. This document is not meant to provide legal or ethical advice. In order to ensure that applicable laws and organizational policies are adhered to in an appropriate manner, it is recommended that legal advisors and relevant organizational representatives be consulted. For registries to succeed, it is critical to proactively consider legal and ethical issues such as consent and privacy. Additional ethical and legal considerations include: the involvement of Aboriginal people and their communities, languages and communication; setting up of biobanks; data management; data ownership; and conducting transparent registry operations. The Belmont Report-Ethical Principles and Guidelines for the protection of human subjects of research 6 and the Government of Canada Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) 7 should be referred to for the ethical principles that need to be considered during the creation of disease registries. In addition, Registries for Evaluating Patient Outcomes: A User's Guide 5 produced by The Agency for Healthcare Research and Quality provides useful information. However, this document presents perspectives and reviews legislation particularly relevant to the United States which differ in some respects from Canadian law and research policies and practice. In preparation of this guideline, we examined relevant Canadian and international literature as well as Canadian policy and legislation. We also consulted with Canadian privacy officers and specialists in research ethics. Finally, topic themes and issues were discussed with patients and families in project focus groups. BACKGROUND In Canada, Research Ethics Boards (REBs) are the equivalent of what is more commonly known as Institutional Review Boards (IRBs) in other jurisdictions. The TCPS-2 describes the authority, mandate and accountability of REBs. In some cases, provincial and federal legislation also applies. While Suppl. 2-S5

“If it helps someone, then I want to do it”: Perspectives of persons living with dementia on research registry participation

“…Specifically, they were worried that employers, insurance companies, or unauthorized individuals may gain access to their health information. These worries further emphasized the importance of the de-identification of medical records stored in the registry as an added layer of confidentiality protection for research participants (Hogan, Warner, Patten, & Godlovitch, 2013). In addition to the strict privacy rules detailed in The Government of Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2), each Canadian province has legislations, policies, and research ethics boards put in place to protect participant information (Hogan et al., 2013).…”

“…These worries further emphasized the importance of the de-identification of medical records stored in the registry as an added layer of confidentiality protection for research participants (Hogan, Warner, Patten, & Godlovitch, 2013). In addition to the strict privacy rules detailed in The Government of Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2), each Canadian province has legislations, policies, and research ethics boards put in place to protect participant information (Hogan et al., 2013). A Canadian study surveyed 590 cardiology patients on their perspectives of access and use of administrative databases and registry records for the facilitation of clinical trials and 97.4% of the respondents would allow research access to their confidential records (Avram et al., 2018).…”

Clinical quality registries have the potential to drive improvements in the appropriateness of care

“…39 Barriers to effective reporting Barriers to registry development are well documented. [41][42][43][44][45] Adequate funding is a problem that registries share with many other health care initiatives. Funding aside, the principal barriers to the development of clinical quality registries in Australia are:…”

NARCOMS and Other Registries in Multiple Sclerosis

“…Detailed discussions of legal and ethical issues can be found elsewhere. 10,11 NARCOMS Registry participants agree to the use of their information for research purposes. Each survey receives institutional review board approval.…”