Suspension or Termination of Approved Research

I.  PURPOSE / BACKGROUND

This policy describes the authority of the Institutional Review Board (IRB) to suspend or terminate previously approved research.

II. POLICY

The University of Louisville IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements, or that has been associated with unexpected serious harm to subjects or others. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action, and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.  (45 CFR 46.11321 CFR 56.113

III.  DEFINITIONS

Convened Meeting – A meeting at which a majority of the members of the IRB is present, including at least one member whose primary concerns are in nonscientific areas.  In order for an action to be approved, it shall receive the approval of a majority of those members present at the meeting.

Key Personnel – Participants in a research team who contribute in a substantive way to the scientific development or execution of a project, including the principal investigator.

Principal Investigator - A qualified person who directs a research project or program, may write the protocol, and oversees the scientific, technical and day-to-day management of the research.  For the purpose of this policy, investigator may refer to the principal investigator, sub or co-investigator.

Suspension – The temporary closing of a human research project or discontinuing an investigator’s or key personnel’s privilege to conduct or to participate in the conduct of human research at the University of Louisville.  The suspension may be partial in that certain activities may continue while others may stop or it may be complete in that no activity related to the human research or related to the privilege to conduct or participate in the conduct of human research may proceed.  The IRB will make this determination.

Termination – The permanent closing of all activities related to a human research project or an investigator’s or key personnel’s privilege to conduct or to participate in the conduct of human research at the University of Louisville except the continuation of follow-up activities necessary to protect subject safety. 

III. PROCEDURE FOR POLICY

The chair of the IRB may act alone to suspend previously approved human research or an investigator’s or key personnel’s privilege to conduct human subject research if the purported serious or continuing noncompliance with the requirements or determinations of the IRB, or any incident that has been associated with unexpected serious harm to subjects appears to pose imminent threat to subject safety.

In the absence of the IRB chair, the Director, HSPP may act alone to suspend previously approved human research or an investigator’s or key personnel’s privilege to conduct human subject research if the purported serious or continuing noncompliance with the requirements or determinations of the IRB, or any incident that has been associated with unexpected serious harm to subjects appears to pose imminent threat to subject safety. The Director, HSPP, will contact the IRB chair as soon as possible to confirm this decision.

IRB staff will place on the agenda of the next convened IRB meeting suspensions taken by the IRB Chair, or Director, HSPP. The IRB will confirm or reverse the decision of the chair or HSPP Director to suspend or terminate previously approved human research.

Before ordering a suspension or termination of research, the convened IRB, IRB chair, or Director, HSPP, must consider the effect of the suspension or termination on the rights and welfare of current participants, and consider whether any additional actions should be taken to protect their interests, such as:

  1. Requiring follow-up by the current investigator;
  2. Transferring responsibility for the protocol to another principle investigator;
  3. Arranging for follow-up with another physician; or
  4. Arranging for the participant to stay on the study at another institution.

If a termination or suspension involves the withdrawal of current participants from the research the investigator and key personnel must:

  1. Respond immediately to any requests from the IRB for additional information regarding the suspension or termination; 
  2. Notify subjects that their enrollment in the study has been terminated and inform the subjects why their enrollment has been terminated.  The reasons given will be those reasons determined to be appropriate by the IRB.  The notice given may be oral but will also be in writing and copied to the IRB;
  3. Inform the subjects of any actions the investigator and key personnel will take to ensure the subjects rights and welfare; and
  4. When follow-up of subjects for safety reasons is permitted or required, indicate that subjects will be so informed and that any adverse events or unanticipated problems involving risks to participants or others will be reported to the IRB and others as required by the protocol and the University’s policies and procedures.

The Director, HSPP, will inform the Executive Vice President for Research, the Principal Investigator, and key personnel of the suspensions or terminations executed by the IRB chair or Director, HSPP, as they occur, and by the convened IRB immediately after the meeting in which they occur.

The Director, HSPP will notify the PI when a human research protocol on which he/she is the PI has been suspended or terminated. If the Director, HSPP cannot contact the investigator, the Director, HSPP will inform the department chair, who will be responsible for taking further action to notify the PI, key personnel and participants.

IV. REPORT OF FINDINGS

Follow the University of Louisville IRB Report of Findings policy for reporting suspensions and terminations.  This policy is located on the HSPPO website under Research Related Policies.

Approved by the Executive Vice President for Research                         

Subject: Suspension or Termination of Approved Research|  Policy and Procedure | Author: Institutional Review Board  |   Original Effective Date: 1-1-2005  | Last Revised Date: 6-8-2010