Policy statement

UAB grants the IRB 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 serious harm to subjects or others related to the research. For the purposes of this policy “IRB approval” refers to IRB approved human subjects research, as well as exempt research that is subject to the limited IRB review requirements.

Suspension or termination of IRB approval will be determined by convened board procedures. Proceedings to suspend or terminate approved research may be based upon an IRB determination of unanticipated problems involving risks to subjects or others, determination of serious or continuing non-compliance, or findings arising from continuing review or monitoring of research activities. The IRB will notify the investigator of the date, time, and location of any meeting which will consider the suspension or termination of the investigator’s approved research and offer the investigator an opportunity to respond in writing or in person at the meeting. Following any determination of suspension or termination of IRB approval, the IRB will notify the investigator and Institutional Official immediately in accordance with the UAB Policy for Reporting to Institutional Officials and Regulatory Agencies. (See also PRO140 Procedure for Suspension or Termination of IRB-Approved Research and Administrative Hold.)

Notwithstanding the above the IRB Chair (or Vice-Chair acting for the Chair) is authorized to impose an administrative hold (i.e., temporary halt) of IRB-approved research activity in whole or in part whenever the Chair receives credible information which, if true, would justify suspension or termination of research by the IRB. After imposing an administrative hold the IRB Chair will expedite convened board review of the affected protocol and notify the Institutional Official. An administrative hold will only be effective until the convened IRB has time to consider whether suspension or termination is warranted.

Following a determination of suspension or termination of IRB approval, the convened IRB will take action to establish orderly cessation of research activity, including some or all of the following steps:

Ensure that current subjects are notified of the termination or suspension of the study through communications which receive IRB approval;
Ensure that procedures for withdrawal of enrolled subjects consider the rights and welfare of the subjects and receive IRB approval;
Ensure that subjects are informed of any follow-up procedures permitted or required by the IRB;
Ensure that any reportable adverse events/unanticipated problems involving risks to subjects or others are reported to the IRB and the sponsor when follow-up of subjects is permitted or required by the IRB.

DEFINITIONS

Administrative Hold–An investigator-initiated action, either self-generated or in response to a determination of the IRB Chair, which halts temporarily research activities and allows assessment of the conduct of the research.

Administratively Terminated–Category for OIRB termination of either an expired protocol or a protocol voluntarily withdrawn by the investigator and where no human research protection issues are outstanding.

Sponsor-Imposed Hold–A determination from the sponsor of the study to place specific research activities on hold. This determination may be made for interim data analysis; inadequate drug availability; response to a DSMB report/recommendation; or a pre-planned stopping point, as well as for changes in the potential risk-benefit ratio to subjects.

Suspension of IRB Approval–An action by the IRB used to halt temporarily approval for some or all research procedures for any reason.

Termination of IRB Approval–An action by the IRB used to permanently withdraw approval for some or all research procedures for any reason.