Reporting to Institutional and External Authorities
This policy describes how the UW-Madison assures compliance with the federal regulations requiring prompt reporting of unanticipated problems, noncompliance and suspensions and terminations of approved research.
- In all non-exempt human research that is federally funded or regulated by the U.S. Food and Drug Administration (FDA), UW-Madison assures prompt reporting to the appropriate IRB, institutional officials, and federal department or agency heads (including those funding the research if applicable) of any relevant determinations under the Noncompliance, Suspension and Termination of Approved Research, or Unanticipated Problems Policies.
- When research is neither federally funded nor FDA-regulated, the IRB or the UW-Madison Institutional Official (IO) may determine that reporting to federal authorities is desirable and the best method to provide equal or greater protection to participants.
- The IO will report to appropriate institutional and/or external authorities when the IRB, or an ad hoc committee appointed by the IO to investigate institutional or IRB noncompliance, makes a relevant determination under the Noncompliance, Suspension and Termination of Approved Research, or Unanticipated Problems Policies.
- The report will be drafted by the IRB or the ad hoc committee based on the discussions and determinations made by the IRB or the ad hoc committee regarding the incident for review by the IO.
- The report should include:
- A description of the nature of the event.
- The findings of the IRB or ad hoc committee.
- Actions taken by the IRB or the ad hoc committee.
- Reasons for the IRB’s or ad hoc committee's actions.
- Plans for continued investigation or action, if applicable.
- Corrective actions taken by the study team, IRB or institution, if applicable.
- The original report will be maintained by the IO or their designee and copies of the report will be distributed to individuals or entities as deemed appropriate by the IO.
- Examples of individuals or entities that may receive reports include, but are not limited to the following:
- funding agency or sponsor
- federal oversight agencies
- principal investigator
- Personnel in the principal investigator's departmental, college, or unit
- Reviewing IRB’s chair and director
- In the case of federally funded and FDA-regulated research, a preliminary report may be filed by the IO or other appropriately designated University official with federal agencies or department heads. The report should identify the study in which the incident occurred and indicate that an investigation is in progress and whether the study has been suspended or terminated.
- In the case of federally funded and FDA-regulated research, when required by Sections I and II of this policy, the IO or other appropriately designated University official will make a report of the noncompliance, suspension, termination, or unanticipated problems to federal agencies or department heads within fourteen (14) business days of the date that the IO receives the report of the incident.
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: April 10, 2008
Revised: December 4, 2008
Revised: March 1, 2012
Revised By: Cross-Campus HRPP Committee
Effective Dates of Revision: August 28, 2015
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