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:
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

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;
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

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
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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.
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