HRPP Manual Section 4-8

Reporting Policy

 “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), 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 for reporting responsibilities for investigators.

Michigan State University (MSU) is required to promptly report to appropriate officials and entities determinations 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 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 Research” 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.

Each report, at a minimum, should include:

  • FWA00004556 (Michigan State University)

  • Identification of the type of reportable event

  • MSU IRB#

  • Title of research study

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

  • Name of MSU principal investigator

  • 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

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

An IRB administrator, in consultation with others (e.g. IRB chair, HRPP Manager), will draft the report, typically using a template letter, and will provide the draft report to the HRPP Director for review. The HRPP Director will provide the draft report to the Assistant Vice President for Regulatory Affairs (AVP ORA) to finalize. The AVP ORA will consult with the Institutional Official as appropriate. The AVP ORA, the Institutional Official, or designee will finalize the report and will provide the report to the HRPP Director to send.

The report will be sent to:

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

  2. The MSU Institutional Official

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

  4. The U.S. Office for Human Research Protection (when research is covered by U.S. Department of Health and Human Services (DHHS) regulations)

  5. The U.S. Food and Drug Administration (FDA) (for all regulated FDA research)

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

  7. Other IRBs which have approved the study or rely on an MSU IRB (if applicable)

  8. Administrators at other sites where the research is being performed (if applicable)

  9. The Funding agency or sponsor (if applicable)

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

  11. Other federal agencies when the research is overseen by those agencies, and they require reporting separate from to OHRP (if applicable) (e.g., Department of Defense)

  12. The Appropriate MSU IRB chair

  13. Other affected individuals as appropriate

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.

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