IRB: Reporting Requirements Policy number: 409 References: 45 CFR 46.103(b) (4,5) 21 CFR 56.108(b) Board of Regents Policy on Research Involving Human Subjects: AAHRPP I.5.D AAHRPP II.2.F. AAHRPP II.2.G. Guidance on Reporting Incidents to OHRP June 20, 2011 Date: 03/22/2014 Policy Owner: Executive Director, HRPP Cross references: 101A Role of Institutional Official 408 Non-compliance 408A Investigations 410 Suspension and Termination 411 Unanticipated Problems Involving Risk to Subjects or Others 900 Accreditation of the HRPP Definitions: None 1.0 Reason for Policy This policy describes the regulatory requirements for reporting incidents. Incident reports include: reports of unanticipated problems involving risks to subjects or others; serious or continuing noncompliance with applicable regulations, or the requirements or determinations of the institutional review board (IRB); suspension or termination of IRB approval. 2.0 Scope of Policy This policy applies to the HRPP staff, IRB and the Institutional Official. 3.0 Policy Statement The IRB will notify appropriate University and external officials (within 30 days) of the following determinations: Page 1 of 4 Any unanticipated problems involving risks to subjects or others Any serious and/or continuing noncompliance with federal policy or the requirements or determinations of the IRB Any suspension or termination of IRB approval. Whether an incident requires reporting will be determined by the IRB, in consultation with the Institutional Official and the Office of the General Counsel as needed. Unanticipated problems involving risk are handled under IRB Policy 411 Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO). Determinations of serious or continuing non-compliance are made by the IRB following a review or investigation into allegations of non-compliance under IRB policies 408 and/or 408a (NonCompliance with IRB Policies and Procedures and Investigation Process). Suspensions or terminations of IRB approval may be based on considerations of subjects’ safety/welfare or researcher noncompliance and are addressed under IRB Policy 410 Suspension and Termination. In all instances where reporting is required, the IRB will notify: The researcher The Institutional Official Appropriate academic or departmental leadership. The Director of the University’s Research Education and Oversight Program (REO) will be copied on all reports. The Institutional Official will report, as required by federal regulations and Regents Policy, to: The Office for Human Research Protection (if the research is federally funded or subject to the Federalwide Assurance) Food and Drug Administration (if the research is regulated by FDA) The appropriate designee of the funding department/agency, and/or the sponsoring company/organization, as applicable Healthcare component institutions, as applicable Association for the Accreditation of Human Research Protection Programs—AAHRPP (if the incident meets AAHRPP’s reporting requirements) The report will include: Name of the institution conducting the research; Title of the research project and/or grant proposal that was the subject of the incident; Name of the principal investigator on the protocol; Page 2 of 4 Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement); A complete description of the problem or reason for the report; AND: For unanticipated problems involving risks to subjects or others: Actions the institution is taking or plans to take to address the problem (e.g., revise the protocol, suspend subject enrollment, terminate the research, revise the informed consent document, inform enrolled subjects, increase monitoring of subjects, etc.). For serious or continuing noncompliance: Actions the institution is taking or plans to take to address the noncompliance (e.g., educate the investigator, educate all research staff, educate the IRB or institutional official, develop or revise IRB written procedures, suspend the protocol, suspend all studies involving the investigator, conduct random audits of the investigator or all investigators, etc.). For suspension or termination: The actions the institution is taking or plans to take to address the suspension or termination (e.g., investigate alleged noncompliance, educate the investigator, educate all research staff, require monitoring of the investigator or the research project, etc.) Additional information and guidance can be found at http://www.hhs.gov/ohrp/compliance/reports/index.html 4.0 Required approvals for this document Title Executive Director, HRPP Counsel to IRB Page 3 of 4 5.0 Revision History Revision Reason for change Date of release 03/22/2014 07/05/2011 06/01/11 04/14/11 11/03/09 07/27/09 04/27/09 05/16/07 03/15/07 09/30/06 Administration review and changes OHRP guidance Process review revision Process review revisions Revision and update AAHRPP references Revision New format Revision Revision Policy development 09/02/14 07/05/11 06/01/11 04/14/11 11/09/09 To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654. Page 4 of 4