Ethical and legal considerations for Canadian registries.

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 research6 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 Guide5 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.