What is a Human Subject Research Determination request?

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(TCPS 2): 21 CFR 50.3(c) and (g); 21 CFR 56.102(c) and (e); 45 CFR 46.102(d) and (f); TCPS 2 Article 2.1.