The Health Research Ethics Regulations under Newfoundland and Labrador Regulation 51/25 is enacted under section 29 of the Health Research Ethics Act and are intended to modernize the ethical oversight of health research involving human participants in the province. The regulation emphasizes ethical review, committee structure, and grounds for cancellation of projects, with a particular focus on clinical trials and genetic research.

The regulation mandates that any application involving genetics or genomics research on human participants must be submitted to the designated research ethics board. This mandatory referral ensures a high level of scrutiny for sensitive genetic studies. For other types of health research involving human participants, the application may either be referred to the research ethics board or to another recognized research ethics body, providing flexibility for less complex or lower-risk research proposals.

A central element of the regulation is the structure and function of the research ethics board, which is granted the authority to appoint specialized committees to oversee various categories of health research. Three specific committees are established under the regulation. The Clinical Trials Committee will assess applications related to clinical trials, ensuring that experimental treatments or drug interventions are ethically sound and safe for participants. The Non-Clinical Trials Committee is designated to evaluate applications involving general health research that does not involve clinical trials or genetic research, covering a wide array of public health, behavioral, and observational studies. The Genetics and Genomics Committee handles proposals related specifically to genetics and genomics research, reflecting the sensitivity and complexity of such studies.

Each committee must include a minimum set of members with particular expertise and representation. At least two individuals with experience in conducting health research are required, as well as one expert in ethics, one person with knowledge of legal issues related to health research, a representative of the general public to reflect community interests, and one individual knowledgeable about privacy considerations. This composition ensures that research proposals are reviewed from multiple perspectives, combining scientific, ethical, legal, and societal viewpoints.

To address potential conflicts of interest, the regulation includes provisions for replacing committee members on a case-by-case basis. If a member is found to be in a conflict of interest with respect to a specific application, the research ethics board may appoint an alternate member from its ranks to ensure impartiality and compliance with the regulatory standards.

By establishing clearer structures, detailed review mechanisms, and stronger enforcement provisions, Regulation 51/25 attempts to improve transparency, ethical standards, and participant safety in health research involving human subjects.

Newfoundland & Labrador (51/2025) June 20, 2025
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