HRPP Manual Section 4-8-A

Investigator Reporting

“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]:

(3) [for ensuring prompt reporting to the IRB of changes in research activity; and (4) for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.] [21 CFR 56.108(a)]

(4) Written procedures which the IRB will follow  . . . for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject. 45 CFR 46.103(b)(4)

 (5) [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), 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.”

Investigators are required to report activities, events, and/or information to the Institutional Review Board (IRB) as described in the HRPP Manual (e.g. for continuing review, for review of unanticipated events, revisions to the research, determination of exemption for emergency use of investigational drugs or devices, for closure of the research, and for any other circumstance that affects the rights and / or welfare of research subjects).

If reporting is required, the investigator notifies the IRB as detailed in the specific policy of the HRPP Manual, including but not limited to:

2-2-A    U.S. Department of Defense
2-2-B    U.S. Environmental Protection Agency
2-2-C    U.S. Department of Justice
2-2-D    U.S. Department of Education
2-2-E    U.S. Department of Energy
4-6        Responsibilities of Investigators
6-7        Data and Safety Monitoring
6-8-B    Prisoners
7-3        Emergency Use of Investigational Drugs or Devices
8-1        Exemptions
8-6        Revisions to Approved Research
8-7        Renewed Approval
8-9        Closure
9-1        Unanticipated Problems and Adverse Events
9-2        Noncompliance
9-4        Subject Complaints
9-5       Unapproved Change in Protocol
9-8       Protocol Deviations or Violations
10-1     Conflict of Interest

This policy and procedure supersedes those previously drafted.

Approved By:Vice President of Research and Graduate Studies, 12-9-2015.

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