An Introduction to the HREA

The Health Research Ethics Authority (HREA) of Newfoundland & Labrador was established by the Health Research Ethics Authority Act 2011. On July 1, 2025 the former HREA Act was repealed and replaced by the Health Research Ethics Act (The Act). https://www.assembly.nl.ca/Legislation/sr/statutes/h01-03.htm

The Act, section 2(h) defines “health research involving human subjects” as activities whose primary goal is to generate knowledge in relation to human health, health care and health care systems, and involving human beings as research subjects, health care information respecting human beings or human biological material. This also includes all research related to health education.

Health research does not include tests on non-healthcare equipment or tools to be used by humans, even where the research methods may put humans at risk (e.g. automobile or helicopter safety studies, research to study early childhood learning patterns, human kinetic research to establish parameters of safety for sports equipment).

All health research conducted in this province requires the approval of the Health Research Ethics Board (HREB) or a research ethics body that has been approved by the HREA.

Health research being conducted where the researcher is not affiliated with MUN, and participants or data are not about Newfoundland and Labrador (NL) or its population, does not require local ethics review. In addition, national health surveys being conducted where the researcher is not affiliated with MUN that include Newfoundlanders and Labradoreans as participants, but do not identify NL as an aggregate and do not report findings specific to NL or to aggregates within NL, does not require local ethics review.

The HREA:

• ensures that all health research involving human subjects within the province is conducted in an ethical manner;
• enhances public awareness of the ethical dimension of health research involving human subjects;
• appoints the members of the provincial HREB;
• may approve other research ethics bodies in the province; and
• maintains an inventory of all human health research conducted in the province.

The HREB:

• is responsible for the ethical review and approval of applications for health research projects involving human subjects;
• reviews all genetics research (other health research may be reviewed by other approved research ethics bodies); and
• monitors the research activities of persons engaged in health research involving human subjects in the province.

In carrying out their duties the HREA, the HREB and other approved ethics review research ethics bodies will apply the Tri-Council Policy Statement (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2022) and the Guidelines for Good Clinical Practice of the International Committee on Harmonization.