Human Research Protection Program: Policy

Reporting to Federal Authorities

(Unanticipated Problems, Noncompliance and Suspensions and Terminations of Research)

 

Adopted By: All Campus IRB

Adoption Date:  November 10, 2005

Revised: April 10, 2008

Revised: December 4, 2008

Purpose:  This document 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.

Policy

I.      In all nonexempt human research that is federally funded or regulated by the U.S. Food and Drug Administration (FDA), UW-Madison assures prompt reporting to the IRB, appropriate institutional officials, and appropriate federal department or agency heads of any of the following incidents occurring in human subjects research: [45 CFR 46.103(a) and (b)(5)] [21 CFR 56.108(b)]

A.  an unanticipated problem involving risks to participants or others

B.  serious or continuing noncompliance

C.  a suspension or termination of previously approved research.

 

For more information, see, UW-Madison’s Unanticipated Problem Policy, Noncompliance Policy, and Suspension and Termination of Research Policy.

II.     These reporting requirements do not apply to research that is neither federally funded nor FDA-regulated unless the IRB or the UW-Madison Institutional Official (IO) determines that such reporting is desirable and is the best method to provide equal or greater protection to participants in non-federally funded research as those protections experienced by participants in federally funded or FDA-regulated research.

Procedure

III.    Reporting Procedures

A.  The reporting will occur when an IRB makes a determination under Sections I.A, I. B, or I.C or Section II of this policy.

B.  The IO will report the incidents when required by Sections I and II of this policy to appropriate institutional officials and appropriate federal department or agency heads.

C.  Reporting will be done as follows:

 

1.  Drafting and finalizing a report:

 

a.       The report will be drafted by the IRB based on the discussions and determinations made by the IRB regarding the incident.

 

b.       The report will be sent to the manager of the Human Research Protection Program (HRPP) for coordination of review and signature by the IO.

 

2.  The report should include the following information:

 

a.       A description of the nature of the event.

 

b.       The findings of the organization.

 

c.       Actions taken by the organization or IRB.

 

d.       Reasons for the organization’s or IRB’s actions.

 

e.       Plans for continued investigation or action.

 

f.         Corrective actions taken by the investigator, if applicable.

 

g.       Mitigating circumstances, if applicable.

 

3.  The original report will be maintained by the IO and copies of the report will be distributed to:

 

a.       The principal investigator

 

b.       The chair and director of the office of the reviewing IRB

 

c.       The HRPP Advisory Committee

 

d.       The research sponsor

 

e.       Those federal departments or agencies that have regulatory oversight due to funding, conduct, or an assurance of compliance:

(i)     OHRP

(ii)    FDA

(iii)   Other “Common Rule signatories” or other federal agencies or departments that may require reporting separate from OHRP

(iv)   For Department of Veterans Affairs (VA) research, the Middleton VA Research and Development Office.  UW-Madison relies on VA policies for further reporting to other VA office and departments.

 

f.         Dean of the investigator’s College or School

 

g.       Investigator’s Department Chair

 

4.  When appropriate, a copy of the report may also be sent to:

 

a.       Appropriate official of any other institution, if the reportable incident occurred at a non-UW-Madison institution

 

b.       UW-Madison Office of Research and Sponsored Programs, when report is sent to funding agency

 

c.       Other institution’s IRB, when investigator who is the subject of a report is subject to another institution’s federalwide assurance.

 

5.  UW-Madison need not report to those federal department or agency heads and applicable regulatory authorities already made aware of the event through other mechanisms, such as reporting by the investigator, sponsor, or another organization.

 

6.  Timing of Report

 

a.  In the case of federally funded and FDA regulated research, the IO will make a preliminary report of the following incidents to federal agencies or department heads within fourteen (14) business days of the date that the IO receives the report of the incident:

 

i.         Any suspension or termination of previously approved research pending review by an IRB of the issues of noncompliance or unanticipated problem underlying the suspension (See, Suspension and Termination of Research Policy)

 

ii.       Any determination by an IRB that an incident constitutes serious or continuing noncompliance or an unanticipated problem involving risks to participants or others but which involves an ongoing investigation and more information may need to be reported to federal authorities after the investigation concludes. (See, Noncompliance Policy and Unanticipated Problem Reporting Policy)

 

Any preliminary report filed by the IO with federal agencies or department heads should identify the protocol in which the incident occurred and indicate that an investigation is in progress and whether the protocol has been suspended or terminated.

 

b.  When required by Sections I and II of this policy, the following incidents will be reported by the IO to appropriate federal department or agency heads within fourteen (14) business days of the date that the IO signs the letter to the principal investigator informing him or her of the IRB’s final determination of the incident:

 

i.         Any final determination of suspension or termination of previously approved research (See, Suspension and Termination of Research Policy)

 

ii.       Any final determination by the IRB that an incident constitutes serious or continuing noncompliance or an unanticipated problem involving risks to participants or others (See, Noncompliance Policy and Unanticipated Problem Reporting Policy)

 

If there is no appeal by the investigator, the fourteen (14) business day period begins to run after expiration of the 10 day period to appeal described in the Noncompliance Policy, the Unanticipated Problem Policy and the Suspension and Termination of Research Policy.

 

In the event of an appeal by the investigator, pursuant to the Advisory Committee Charter, Section I.B, the IRB’s “final determination,” for purposes of the fourteen (14) business day reporting period, is the IRB determination made following the completion of the appeal process as described in the Noncompliance Policy, the Unanticipated Problem Policy, and the Suspension and Termination of Research Policy.