Human Research Protection Program: Policy

Suspension and Termination of Approved Research

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: January 22, 2009

Purpose:  This document describes how UW-Madison IRBs suspend or terminate previously approved research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants.

Definitions

I.      Suspension of previously approved research for cause: An action initiated by the IRB to stop temporarily some or all research procedures pending future action by the IRB or by the Investigator or his/her study personnel.

II.     Termination of previously approved research for cause: An action initiated by the IRB to stop permanently some or all research procedures except for the continuation of follow-up activities necessary to protect participant safety.

III.    A suspension or termination of previously approved research, for purpose of this policy, does not occur:

A.  when a protocol lapses due to an investigator’s failure to file an application for continuing review in a timely manner, or

B.  when an IRB instructs an investigator to stop research that was begun without prior IRB approval.

Policy

IV.   A UW-Madison IRB has the authority to suspend or terminate previously approved research for cause when the IRB determines that research:

A.  is not being conducted in accordance with the IRB’s requirements or federal regulations, state or local laws or institutional policies applicable to human subjects research

B.  has been associated with unexpected serious harm to participants. [45 CFR 46.113] [21 CFR 56.113]

V.    The chair of a UW-Madison IRB may suspend previously approved research for cause before a determination is made by the full IRB, if the IRB chair concludes that suspension must be done immediately to protect participants.

Procedure

VI.   Procedures for Suspension or Termination of Previously Approved Research for Cause

A.  Suspension or Termination of Research by an IRB

 

1.  If an IRB suspends or terminates research, the IRB will report this suspension or termination promptly to the UW-Madison Institutional Official (IO) and to the Human Research Protection Program Advisory Committee.

 

2.  The IRB will promptly notify the investigator of the suspension or termination and take steps necessary to assure that the rights and welfare of research participants are protected. 

 

3.  The IO will report the suspension or termination to other University officials and to federal departments and agencies, when appropriate, pursuant to the UW-Madison Reporting to Federal Authorities Policy.

B.  Immediate Suspension of Research by IRB Chair

 

1.  If the chair of an IRB immediately suspends previously approved research to protect research participants, the IRB chair will report the suspension promptly to the IRB and the IO. 

 

a.  The IRB chair will promptly notify the investigator of the suspension and take steps necessary to assure that the rights and welfare of research participants are protected. 

 

b.  The IO will report the suspension to other UW-Madison officials and to federal departments and agencies, when appropriate, pursuant to the UW-Madison Reporting to Federal Authorities Policy. 

C. IRB Review of Chair’s Immediate Suspension

 

1.  If an IRB chair immediately suspends research to protect participant safety, the IRB chair’s decision and the reasons for the decision will be scheduled for discussion at the next meeting of the full IRB.  The IRB will determine whether to lift or continue the suspension.  The IRB will notify the investigator and the IO promptly of its decision.  Notice will also be given to the Human Research Protection Program Advisory Committee.  IRB discussion and resolution of issues of noncompliance or unanticipated problems relating to the suspension may be scheduled for a subsequent IRB meeting.

 

a.  The IO will report any reversal of the suspension and the basis for that action to other UW-Madison officials and to federal departments and agencies, when appropriate, pursuant to the UW-Madison Reporting to Federal Authorities Policy.

VII.   Appeal to Human Research Protection Program Advisory Committee

A.  A decision of the IRB to suspend or terminate research may be appealed by the investigator to the Human Research Protection Program Advisory Committee (Advisory Committee).  See, HRPP Advisory Committee Charter, Sec. I.B.  If research is suspended pending an investigation by the IRB, the appeal cannot be filed until the IRB completes its investigation and makes a final determination on the issues underlying the suspension.

B.  The notice to the investigator of the IRB decision will inform the investigator that he or she has 10 business days from receipt of the notice to appeal the IRB’s decision to the Advisory Committee.  The notice of the right to appeal should include contact information for the Advisory Committee Chair.  The investigator may appeal the IRB’s decision by sending the Advisory Committee Chair a written notice of appeal, including the basis of the investigator’s appeal.  The investigator should send a copy of the notice of appeal to the IRB.  The basis for an appeal to the Advisory Committee is limited to one or more of the following:

 

1.  that the UW-Madison IRB has failed to follow its own procedures

 

2.  that the UW-Madison IRB has incorrectly applied federal regulatory criteria or state law, or

 

3.  that the UW-Madison IRB has incorrectly applied UW-Madison policies.

C.  Any IRB imposed suspension or termination of research will continue in effect during the entire duration of the appeal. 

D.  If an investigator appeals the IRB’s decision, the investigator’s written appeal will be considered at a regularly scheduled Advisory Committee meeting and the Advisory Committee will review the appeal following the procedures described in the Advisory Committee Charter, Section A.2.  The Advisory Committee will notify the investigator of the outcome of the appeal.

E.  If the Advisory Committee receives a notice of appeal from the investigator, the Advisory Committee will notify the IRB and the IO of the request and of the final outcome.

VIII.  Protecting Participants when Research is Suspended or Terminated for Cause

A.  When an IRB or IRB chair suspends or terminates previously approved research, the IRB or IRB chair will evaluate the potential risks to current participants and prepare an appropriate plan to protect research participants.  The plan may include:

 

1.  Notifying current participants of suspension or termination

 

2.  In clinical research, notifying participant’s primary physician of suspension or termination of research

 

3.  Providing continued treatment to current participants in therapeutic research

 

a.  If suspension or termination of research is the result of investigator noncompliance or misconduct, the IRB may require the continuation of treatment by a different investigator

 

4.  Providing monitoring and/or follow-up care to current participants in therapeutic or non-therapeutic research

B.  Principal investigators (PI) should notify the IRB Chair via the IRB Office of any adverse events that the PI believes will occur or that have occurred due to the suspension or termination of the protocol approval.