IRB Policy Holds, Suspensions and Terminations I. Purpose: The Principal Investigator may place subject enrollment or all study activities on administrative hold. Also, the IRB may suspend or terminate a study if there are serious concerns about the protection of the rights and welfare of the participants. This policy describes the responsibilities of the PI and the procedures that the IRB will follow when administrative holds, suspensions, and terminations are applied. II. Definitions: a. Administrative Hold – A voluntary action by an investigator to temporarily or permanently stop some or all approved research activities. Protocols remain open and require continuing review. b. Suspension of IRB Approval – A directive of the fully convened IRB, or IRB designee either to stop temporarily some or all previously approved research activities, or to stop permanently some previously approved research activities. Suspended protocols remove open and require continuing review. c. Termination of IRB Approval – A directive of the fully convened IRB, or IRB designee either to stop permanently all previously approved research activities in previously approved research protocol. Terminated protocols are considered closed and no longer require continuing review. III. Administrative Hold An administrative hold is a voluntary interruption of research enrollments and ongoing research activities by an appropriate VA or GRU facility official, researcher or sponsor (including ORD when ORD is the sponsor). The term “administrative hold” does not apply to interruptions of research related to concerns regarding the safety, rights, or welfare of human research participants, research investigators, research staff, or others. An administrative hold must not be used to avoid reporting deficiencies or circumstances that otherwise require reporting by federal agencies. If the PI places a hold on the study, the PI must submit a reportable event to the GRU IRB to include the following information: 
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The reason for the hold Description of the research activities that will be stopped The actions to be taken to protect current participants The actions that will be taken prior to IRB approval of proposed changes in order to eliminate apparent immediate harm to research subjects. Version Date: 9.30.15 Page 1 of 4 IRB Policy Holds, Suspensions and Terminations The IRB Chair or designee will determine whether any additional procedures are needed to protect the safety, rights and welfare of current research participants and how and when currently enrolled subjects will be notified. IV. Suspensions, and Terminations of IRB Approval Suspension refers to a temporary interruption in the enrollment of new participants, activities involving previously enrolled participants, or other research activities. Termination refers to a permanent halt in the enrollment of new participants, activities involving previously enrolled participants, or other research activities. The terms “suspension” and “termination” apply to interruptions related to concerns regarding the safety, rights, or welfare of human participants, researchers, research staff, or others. Suspensions and terminations do not include: 
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Interruptions in research resulting solely from the expiration of a protocol approval period. Administrative holds or other actions initiated voluntarily by a VA facility official, researcher, or sponsor for reasons other than those described in preceding items. Research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects may be suspended or terminated by the fully convened IRB or IRB designee. The Institutional Official (IO), IRB Chair or designee may suspend or terminate research if immediate action is required to protect research subjects or others. If the IO suspends or terminates a study, the action is reported to the IRB Chair immediately who reports it to the convened IRB. If the IRB Chair or designee suspends or terminates a study, the action will be reported to the convened IRB at the next IRB meeting for their review. For VA studies, the VA Associate Chief of Staff for Research or other VA facility official may suspend or terminate the study if related to concerns about the safety, rights, or welfare of human researcher participants, research staff, 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 to the applicable department or agency head. IRB actions will occur in compliance with 45 CFR 46.103(b)(5)(ii) and 46.113, and 21 CFR 56.108(b)(3) and 56.113. Suspension of IRB approval is an action that can be taken by the fully convened IRB or IRB designee. When a protocol is suspended, the PI must 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. Version Date: 9.30.15 Page 2 of 4 IRB Policy Holds, Suspensions and Terminations Termination of IRB approval is an action that can be taken by the fully convened IRB or IRB designee. When the protocol is terminated, the PI must permanently stop all previously approved research activities. Protocols are closed with the IRB and do not require continuing review. The reasons for suspending or terminating a protocol could include, but are not limited to, the following: 
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VI. The PI fails or appears to fail to comply with federal regulations or GRU policy regarding the protection of human subjects New information becomes available that could alter the original determination by the IRB to approve the study The PI fails to respond to stipulations from the IRB at continuing review within the time frame designated by the IRB to meet those stipulations The PI fails to provide additional information requested by the IRB at a time during the current approval period that the IRB feels is necessary for the IRB to conduct continuous oversight of the study Considerations for Currently Enrolled Participants When a protocol is suspended or terminated, the fully convened IRB or IRB designee considers whether any actions are needed to protect the safety, rights and welfare of current participants and orders any actions that need to be taken prior to review by the convened IRB in order to eliminate an apparent immediate hazard. These actions might include: 
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VII. Assigning a new PI to the study Making arrangements for clinical care outside of the research Allowing continuation of some research activities under the supervision of an independent monitor Notification of current/former participants Requiring or permitting follow‐up of participants for safety reasons Requiring adverse events or outcomes to be reported to the IRB and the sponsor (if applicable) Communication of a Suspension or Termination of IRB Approval Suspensions and terminations are communicated with the PI in a formal letter. Documentation of the IRB’s suspension or termination of IRB approval will be sent no later than 30 days to the following:  IRB Director  IRB Regulatory Manager Version Date: 9.30.15 Page 3 of 4 IRB Policy Holds, Suspensions and Terminations 
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IRB Chair, Institutional Official Senior Vice President for Research FDA if study is FDA regulated DHHS OHRP if study is DHHS regulated Regulatory agencies DoD human research protections officer (if DoD regulated) For VA studies:  The Office of Research and Development, if VA funded  Regional Office of Research Oversight  VA Privacy Office (if the report involves unauthorized use, loss, or disclosure of PHI)  VHA Information Security Officer (if the report involve violations of VA information security requirements)  Other individuals as appropriate If the research is conducted at the Charlie Norwood VA Medical Center, the report will also be sent within 5 business days to the following individuals who will carry out the required reporting in accordance with VA regulations:  VA Medical Center director  Associate Chief of Staff for Research  The Research and Development Committee The VA is responsible for meeting reporting requirements per the VHA Handbook. {Refer to IRB Policy: Research Non‐Compliance} Version Date: 9.30.15 Page 4 of 4