The College of St. Scholastica IRB prepares and maintains documentation of its activities as required by federal regulation and in accordance with the IRB’s record retention policy. Required documents must be submitted to the appropriate funding entity as required. This policy applies to all controlled documents used in research reviewed by the IRB.
Both the HHS regulations at 45 CFR 46.115(a)(2) and the FDA regulations at 21 CFR 56.115(a)(2) specifically require that an institution, or when appropriate, an IRB, prepare and maintain adequate documentation of IRB activities.