1From the *Faculty of Law, University of Macau, Macau SAR, China; and †Health Law Institute, Faculty of Law, ‡Faculty of Law, University of Alberta, and §Faculty of Law and School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
The protection of confidential research data is of key importance to clinical patient safety research. A review of selected Canadian and American case law indicates that although the relationship between researcher and participant has not been recognized as privileged, court-ordered disclosure of confidential research information seems to be a rare occurrence. In this review, we examine how confidentiality issues are presented in informed consent form templates and in relevant research ethics policies. We find an agreement among research policy documents that all information gathered should be treated as confidential, unless otherwise required by law. Confidentiality provisions in informed consent forms reflect the reality that in some cases, the law can compel disclosure of confidential data. There is, therefore, a potential tension between the law and existing research ethics policy. It has been suggested that researchers have an ethical and possibly legal duty to actively resist disclosure requests. We conclude that it is reasonable for researchers to disclose, as part of the informed consent process, how rare successful disclosure demands are and that steps will be taken to oppose such demands.