Human Subject Research Determination
An applicant may apply to Quorum Review IRB for a determination of whether a proposed activity is human subjects research in accordance with applicable U.S. federal regulations and/or the Canadian Tri-Council Policy Statement: 21 CFR 50.3(c) and (g); 21 CFR 56.102(c) and (e); 45 CFR 46.102(d) and (f); TCPS 2, Article 2.
Prior to Quorum Review IRB’s review of a Human Subjects Determination Request, the following documentation should be submitted:
- Quorum Review IRB Human Subjects Determination Request Form
- A copy of the final protocol or research proposal (and any supporting material, if applicable)
- Institutional Jurisdiction Waiver Form, if applicable
Please note that as a matter of policy, Regulatory will not make a determination that an activity is not research involving human subjects for FDA-regulated studies. If the sponsor intends to submit the research data to the FDA in support of a research or marketing permit, the FDA regulations apply and such a determination is not applicable.
Please contact Quorum Review IRB’s Initial Study Support department with any questions regarding Human Subject Determinations.