45 CFR 46.109 (e) 45 CFR 46.115 (a) (1) Providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others as well as any serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB: 45 CFR 46.103 (b) (5) Keeping certain records as required by the HHS regulations ....