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8.7 Reporting Incidents to Institutional Officials and Federal Agencies

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements to ensure prompt reporting to Institutional Officials and Federal Agencies (including OHRP and FDA) unanticipated problems involving risk to the subject or others, serious or continuing noncompliance, suspensions of IRB approval, and terminations of IRB approval.

2.0 Policy

  • 2.1. It is the policy of the Organization that unanticipated problems involving risk to the subject or others (UPs), serious or continuing noncompliance, suspensions of IRB approval, and terminations of IRB approval will be promptly reported to the Institutional Official (IO).
  • 2.2. It is the policy of the Organization that unanticipated problems involving risk to the subject or others (UPs), serious or continuing noncompliance, suspensions of IRB approval, and terminations of IRB approval be reported to OHRP, FDA, and other Common Rule Department or Agencies, in accordance with federal requirements and the terms of the Organization’s Federalwide assurance.

3.0 Definitions

  • 3.1. Unanticipated Problems Involving Risk to the Subject or Others: as per HRPP policy 8.3 (IRB Review of Unanticipated Problems Involving Risk to the Subject or Others).
  • 3.2. Serious Noncompliance: as per HRPP policies 8.4 (Noncompliance Involving the PI and Study Personnel) and 8.5 (Noncompliance by the IRB or Other Components of the HRPP).
  • 3.3. Continuing Noncompliance: as per HRPP policies 8.4 (Noncompliance Involving the PI and Study Personnel) and 8.5 (Noncompliance by the IRB or Other Components of the HRPP).
  • 3.4. Suspension of IRB Approval of Research: as per HRPP policy 8.6 (Study Hold, Suspension, and Termination).
  • 3.5. Termination of IRB approval of Research: as per HRPP policy 8.6 (Study Hold, Suspension, and Termination).

4.0 Procedures

  • 4.1. The IRB Executive Chair/designee will submit all required written reports to the IO promptly (as appropriate in consideration of the nature of the event but no longer than 30 days following determination that the event is a reportable incident). Follow-up reports will be provided as necessary in conjunction with ongoing investigations
  • 4.2. For Federally funded research subject to the Common Rule, the IO will submit all required written reports to OHRP and Department or Agency heads as appropriate promptly (as appropriate in consideration of the nature of the event but no longer than 30 days following determination that the event is a reportable incident). Follow-up reports will be provided as necessary in conjunction with ongoing investigations.
  • 4.3. For research subject to FDA regulations, the IO will submit written reports to FDA promptly (as appropriate in consideration of the nature of the event but no longer than 30 days following determination that the event is a reportable incident). Follow-up reports will be provided as necessary in conjunction with ongoing investigations.
  • 4.4. For non-Federally funded or FDA regulated research, reports of unanticipated problems involving risks to participants or others will not be reported to OHRP and/or FDA. However, the IO retains the right to submit written reports to OHRP and Department or Agency heads as appropriate if, in consultation with the IRB Executive Chair and Organizational officials, the IO determines that the seriousness of the incident justifies such reporting.
  • 4.5. Copies of the report and any necessary supporting documents will be provided to the PI.
  • 4.6. For Federally funded research, it is the responsibility of the PI to notify the federal department or agency sponsoring the research. Any expenditure of federal funds during research which is not in compliance with federal regulations is prohibited. Verification of this notification must be provided to the IRB.
  • 4.7. For commercially sponsored research, it is the responsibility of the PI to notify the sponsor and the Contract Research Organization (as applicable) and provide verification of this notification to the IRB.
  • 4.8. Reporting events which occur at institutions not under the jurisdiction of the UNMC IRB are the responsibility of the external institution

5.0 Contents of Reports

  • 5.1. Reports to the IO, OHRP, FDA and Common Rule Department or Agencies must include the information described in OHRP document “Guidance on Reporting Incidents to OHRP (2011)”, or any succeeding guidance.

  • 5.2. Reports to FDA must also include IND or IDE number, if applicable.

    Note: Reports to the OHRP should be sent to the Division Director for Compliance Oversight, Office for Human Research Protections. The current mailing address may be found on the OHRP website.

    Note: Reports to the FDA should be sent to the appropriate division (i.e., drug products, biologic products, or medical devices.) Mailing addresses may be found on the FDA website.

DOCUMENT

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:HISTORY:

REVISEDWritten: FEBRUARY1/20/2016 2,(Approved: 20181/20/2016) - original author not recorded

INITIALRevised: JANUARY2/2/2018 20,- 2016revision not documented

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