Version
1.2
Date Updated
Tuesday, April 17, 2012
Descripton

Approved by:   Human Protections Administrator; Executive Chair, UIC IRB
AAHRPP REF#:  175
AAHRPP Elements:  I.1.C., I.5.D., II.2.G, III.2.D..


POLICY


  1. Relevant Federal Regulations.
    1. An IRB shall have 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 46.113, 38 CFR 16.113] or Food and Drug Administration [21 CFR 56.113]. (University Department Heads may be included in reporting, as applicable).
  2. Definitions.
    1. SUSPENSION: A suspension means a determination from the IRB to temporarily withdraw approval of all or some specific research activities or permanently withdraw approval of some specific research activities, indicating that the specified activities must stop immediately. The appropriate party may impose additional criteria for suspension, if needed, to protect the participants from potential harm per the UIC HSPP policy Administrative Hold, Suspension, or Termination of IRB Approval. Suspended research projects still have IRB approval and require continuing review. For example, the IRB may stop the enrollment of new subjects, although may allow the continuation of currently enrolled subjects, if appropriate. The convened IRB would review the investigator’s response, if any.
    2. ADMINISTRATIVE HOLD: An administrative hold is a voluntary action by an investigator or sponsor (or VA facility official for VA research) to temporarily or permanently stop some or all research activities as a modification to approved research. Administrative holds must not be used to avoid reporting deficiencies or circumstances that otherwise require reporting by federal agencies. Administrative holds are not considered suspensions or terminations, and do not meet reporting requirements to OHRP, FDA and other federal agencies. Although the investigator may discuss this action beforehand with the IRB, IRB chair, OPRS Director, OPRS Associate Director or Assistant Director, the hold must be initiated voluntarily by the investigator and must not be used to avoid IRB mandated suspension or termination or reporting requirements. During administrative hold, the research remains subject to continuing review and requirements for reporting non-compliance and unanticipated problems involving risks to subjects or others.
      Administrative Hold, Suspension or Termination of IRB Approval, Version 1.0
    3. TERMINATION: A termination represents a directive from the IRB to permanently stop all previously approved research activities.
  3. UIC policy provides:
    1. The IRBs have the authority to suspend or terminate their approval of research that is not being conducted in accordance with IRB requirements or federal regulations, when the research is associated with unexpected serious harm to research participants or others or when there are immediate serious issues involving participant and/or others safety.
    2. The IRB chairs, IRB members designated by the chair, and IO with the authority to suspend previously approved research when required for the urgent protection of the rights and welfare of participants and insufficient time exists for the convened IRB to review the event. Any suspension of research by the above individuals is placed on the agenda and reviewed and upheld, overturned or supplemented by the convened IRB at their next meeting.
    3. That previously approved research may only be terminated by the convened IRB, including protocols originally approved under expedited procedures.