HRPP Manual Section 4-8

Reporting Policy

Revised Common Rule (2018 Requirements)

“Establish and follow written procedures for . . . (iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.” 45 CFR 46.108(a)(3) (2018 Requirements)

Pre-2018 Common Rule and U.S. Food and Drug Administration (FDA) Requirements

 “Assurances applicable to federally supported or conducted research shall at a minimum include [In order to fulfill the requirements of these regulations, each IRB shall]:

 “[Follow] [w]ritten procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head [Food and Drug Administration] of (i) [1] any unanticipated problems involving risks to subjects or others [2] or any [instance of] serious or continuing noncompliance with this policy [these regulations] or the requirements or determinations of the IRB; and (ii) [or 3] any suspension or termination of IRB approval.” 45 CFR 46.103(b)(5) (Pre-2018 Requirements), 21 CFR 56.108(b) [FDA]

Compliance with the federal regulations and institutional requirements applicable to reporting concerning human subject research is required of all individuals under the jurisdiction of the Michigan State University (MSU) Human Research Protection Program (HRPP). See HRPP Manual 4-1 “Applicability.” See HRPP Manual 4-8-A “Investigator Reporting” for reporting responsibilities for investigators.

Michigan State University (MSU) is required to promptly report to appropriate officials and entities determinations on non-exempt human research of any:

  • unanticipated problem(s) involving risks to subjects or others, or

  • instance of serious or continuing noncompliance with this policy or the requirements or determinations of the Institutional Review Board (IRB), or

  • suspension or termination of IRB approval.

The policies and procedures within HRPP Manual 9-1 “Unanticipated Problems Involving Risks to Subjects or Others", 9-2 “Noncompliance,” and/or 9-3 “Termination or Suspension of IRB Approval” will be followed for review and determinations of these events.

When reporting is required, the report will provide adequate information and promptly be sent to appropriate individuals. The report must be sent within 15 working days of the determination of an unanticipated problem involving risks to subjects or others, serious or continuing noncompliance, or any suspension or termination of IRB approval, unless MSU is serving as IRB of record for another institution. When MSU is serving as IRB of record for another institution and review of the report by the other institution(s) is required, additional time may be necessary to complete the review.  The additional review will not exceed 30 working days from the date of the determination.

Each report, at a minimum, should include:

  • Federalwide Assurance (FWA) number, FWA00004556 (Michigan State University)

  • Identification of the type of reportable event

  • MSU IRB#

  • Title of research study

  • Name of MSU principal investigator (PI)

  • Title and PI of grant proposal (when funded and the title and/or PI is different than the title and/or PI of the research study)

  • Number of any applicable federal award(s) (grant, contract, or cooperative agreement) (when funded)

  • Detailed description of the unanticipated problem involving risks to subjects or others, the serious or continuing noncompliance, or the suspension or termination of IRB approval

  • Actions MSU and/or the PI is taking, plans to take, or has taken to address the reported incident, including any institution-wide actions when appropriate

  • For FDA regulated research, the Investigational New Drug or Investigational Device Exemption number (when applicable) and number of subjects enrolled

When applicable, the report will be sent in the format required by the U.S. Office for Human Research Protection (OHRP) and/or the appropriate federal department or agency.

An IRB administrator, in consultation with others (e.g. IRB chair, HRPP manager), will draft the report, typically using a template letter or form, and will provide the draft report to the HRPP director for review. When MSU is serving as IRB of record for another institution and review of the report by the other institution(s) is required, the IRB reliance coordinator will also send the report to the appropriate institutional contacts for review and will provide the revised report, if applicable, to the HRPP director when the relying institution(s)’s review is complete. If there are any questions about the relying institution(s)’s review, the IRB reliance coordinator will consult with the HRPP director and/or HRPP manager.  The HRPP director will provide the draft report to the Assistant Vice President for Regulatory Affairs (AVP ORA) and MSU legal counsel. The AVP ORA will consult with the Institutional Official as appropriate. The HRPP director will incorporate feedback from the AVP ORA, the Institutional Official, and/or MSU legal counsel and will finalize the report to send.

The report will be sent or copied to:

  1. The MSU Assistant Vice President for the Office of Regulatory Affairs

  2. The MSU Institutional Official

  3. The Principal Investigator’s Department Chair or Academic Unit Administrator

  4. The Principal Investigator

  5. The HRPP director

  6. Other appropriate MSU administrators (e.g., vice presidents, deans, chairs)

  7. The U.S. Office for Human Research Protection (only a) when research is conducted or supported by U.S. Department of Health and Human Services (DHHS), b) when research is conducted or supported by a federal department or agency that has adopted the Common Rule, or c) when an FWA assurance applies to all research regardless of funding)

  8. The U.S. Food and Drug Administration (FDA) (only for FDA regulated research)

  9. The MSU research integrity officer (in situations of possible misconduct)

  10. Other IRBs or contacts of institutions that are relying on an MSU IRB for the research study (if applicable)

  11. The funding agency or sponsor (if applicable)

  12. MSU Sponsored Programs Administration (for externally funded research)

  13. Other federal department or agencies when the research is overseen by those agencies

  14. The appropriate MSU IRB chair

  15. The appropriate MSU IRB administrator III

  16. Other affected individuals or entities as appropriate

A follow-up report may be sent if there are unresolved or pending issues that require that additional information be provided (e.g. acceptance of corrective action plan). The follow-up report will be sent promptly upon resolution of the unresolved or pending issues. The drafting and review of the follow-up report will follow the process described above and will be sent to or copied to the individual(s) listed above.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 4-5-2006. Revision 2 approved by VP Research & Graduate Studies on 3-9-2008. Revision 3 approved by VP Research & Graduate Studies on 9-3-2009. Revision 4 approved by VP Research & Graduate Studies on 7-21-2011. Revision 5 approved by VP Research & Graduate Studies on 12-9-2015. Revision 6 approved by Assistant VP Regulatory Affairs on 12-6-2021.

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