UAB Policy on Suspension or Termination of IRB-Approved Research and Administrative Hold
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.
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 UABPolicy for Reporting to Institutional Officials and Regulatory Agencies. (See also PRO140 Procedure for Suspension or Termination of IRB-Approved Research and Administrative Hold.)
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:
Prior to administratively terminating a protocol, the individual entering the action will ensure all requirements for cessation above are met.
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Administratively Terminated–Category for OIRB termination of either an expired protocol or a protocol voluntarily withdrawn by the investigator and where no human research protection issues are outstanding.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.
Approved on March 1, 2010, by:
Ferdinand Urthaler, MD
Sheila Deters Moore, CIP