Research ethics oversight of biomedical clinical trials

This National Standard of Canada applies to Research Ethics Boards (REBs) that evaluate applications for ethical acceptability. If an REB grants ethics approval to conduct biomedical clinical trials, it will provide research ethics oversight of biomedical clinical trials that are subject to the Food and Drugs Act and applicable Regulations (see 2.1).

This Standard does not preclude or override any applicable regulatory or legal requirement.

Intended users —This Standard is intended for use primarily by:

— REB chairs, members and administrative staff,

— qualified investigators and study teams conducting biomedical clinical trials,

— sponsors and funders of biomedical clinical trials,

— those with responsibility for establishing and ensuring effective REB operations,

— those with responsibility for research ethics oversight of biomedical clinical trials in organizations where they are conducted, and

— regulatory authorities that evaluate REBs with research ethics oversight of biomedical clinical trials.

An organization with an REB intending to use this Standard will take responsible measures to ensure that the roles and responsibilities of the REB are defined, resources are made available, and processes are in place for research ethics oversight of biomedical clinical trials conducted under its auspices, to ensure that the REB meets the requirements of this Standard and applicable statutory and regulatory requirements.