SOP H105: Holds, Suspensions,Terminations

The convened IRB, an IRB Chair/Vice-Chair, IRB administrator or the Institutional Official (IO) or his/her designee has the authority to suspend or terminate approved research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. 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 to the applicable department or agency head as required by 45 CFR 46.103(b)(5)(ii) and 113, and 21 CFR 56.108(b)(3) and .113.

The Principal Investigator can place any protocol on hold by emailing the IRB or terminate the study by completing the termination form. A receipt of termination will be returned by email.

An automatic hold will be placed on any study where there is an unanticipated event until the cause and any corrective action necessary are identified.

Where there is a finding of noncompliance or a serious adverse event that is related to the federally funded research, an incident notification report will be submitted to the OHRP (Office for Human Research Protections, HHS.gov) within a few weeks depending on the seriousness of the incident in alignment with the OHRP Guidance on Reporting Incidents. https://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-incident/index.html  A report will also be made to the funding agency where research is federally funded.

Unanticipated Events are defined here:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html#Q1

Administrative Hold: A voluntary action by a PI or sponsor to temporarily or permanently stop some or all approved research activities in response to a finding of concern that does not adversely affect the safety, rights and welfare of research subjects. An administrative hold is not a suspension or termination.  A hold is reversible and may be placed on a study by sending an email to the IRB.

Expiration of IRB Approval: If a PI has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the expiration date specified by the IRB, such a research study has expired. Once a protocol has expired, the investigator must reapply as a new project.  The Investigator and student adviser/faculty department chair will be notified of the expiration

Study Completion – Closure: Once any study that has active IRB approval is completed and/or stopped voluntarily by the PI the study must be closed or terminated. This includes studies that never enrolled subjects. This process is most often initiated by the PI, but can be initiated by actions of other involved parties, including study sponsors or the IRB.  There is a form for this purpose on the IRB forms list.

Suspension: An action by the convened IRB, an IRB Chair/Vice-Chair, IRB administrator or the IO or his/her designee to stop, temporarily or permanently, some or all previously approved research activities short of permanently stopping all research activities. Suspended protocols are not closed with the IRB and require continuing review by the IRB.  This will be done by the IRB Chair and approved at the next convened IRB meeting.  Suspended protocols may be terminated.

Termination: An action by the convened IRB to stop permanently all activities of a previously approved research protocol. Terminated protocols are closed protocols, and they no longer require continuing review.

Before an administrative hold, suspension or termination is put into effect, the convened IRB, or if time does not permit, an IRB Chair/Vice-Chair, considers whether any additional procedures are needed to protect the safety, rights and welfare of current subjects. Such procedures might include:

• Transferring subjects to another PI
•  Making arrangements for clinical care outside of the research for a clinical study or continuation of the research benefit if warranted
•  Allowing continuation of some research activities under the supervision of an independent monitor
• Notification of current subjects
• Notification of former subjects
• For terminated studies:
  • Requiring or permitting follow-up of subjects for safety reasons
  • Requiring adverse events or outcomes to be reported to the IRB and the sponsor.