Version
1.4
Date Updated
Tuesday, August 21, 2018
Descripton

Approved by:   Human Protections Administrator and Director of OPRS
AAHRPP REF#:  175
AAHRPP Elements:  I.1.C., 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] 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. 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, institutional official, or sponsor to temporarily or permanently stop some or all research activities. The administrative hold does not apply to interruptions of research related to concerns regarding the safety, rights, or welfare of human research subjects or others.  Administrative holds are not considered suspensions or terminations, and do not meet reporting requirements to OHRP, FDA and other federal agencies.  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.
    3. TERMINATION: A termination represents a directive from the IRB to permanently stop all research activities.
  3. UIC policy:
    1. The IRBs have the authority to suspend or terminate 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.
      1. All research being terminated must be reviewed by the convened IRB regardless of risk level or previous review level.
    2. The IRB Chairs, IRB members designated by the Chair, and IO have the authority to suspend 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.