Administrative Hold, Expiration, Suspension, or Termination of IRB Approval

Administrative Hold

Unless otherwise indicated, it is the policy of the Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS) Institutional Review Board (IRB) to approve research for a period not to exceed one year upon initial review. (Continuing review beyond one year may not be deemed necessary, especially in light of the new 2018 Common Rule with its option to eliminate continuing review.) The Board further recognizes that all currently approved research is subject to change or modification in approval status and, as a result, may ask the PI to put the research on administrative hold until additional information has been obtained. Administrative holds constitute an action to temporarily or permanently stop, at minimum, some research activities in modification to approved research. They are not considered suspensions or terminations, and do not meet reporting requirements to OHRP and other federal agencies. The IRB may also suspend or terminate research if there is evidence that the research is not being conducted in accordance with the IRB’s requirements or the Federal regulations or if the research has been associated with unexpected serious harm to participants.

Examples leading to suspension might include:

• Inappropriately involving human participants in research.
• Inhibiting the rights or welfare of participants.
• Serious or continuing noncompliance with Federal regulations or IRB policies.
• New information indicating increased risk to human participants, etc.

The IRB may ask the PI to put some or all research activities on hold until additional information can be obtained in order to determine if a change in the risk-potential benefit has occurred, if a change in the welfare or rights of the participants has occurred, or if potential areas of noncompliance exist in a currently approved research protocol. Evidence to support this request may occur through a variety sources including:

• A complaint received by the TDMHSAS IRB.
• An allegation of noncompliance to the IRB.
• A discovery by the PI of potential additional risks.
• IRB deliberations.

Often noncompliance will take the form of protocol deviations. These deviations are unplanned diversions from the protocol that was not intended to be nor implemented as systematic change. The three (3) types of protocol deviations are: those that occur because a researcher/investigator intentionally decides to deviate from the approved protocol; those identified before they occur but cannot be prevented; and those that are discovered after they happen. Any such deviation should be reviewed and approved by the IRB and/or other necessary entities in advance of implementation. Intervention drift as evident in protocol deviations is indicative of noncompliance.

The IRB will notify the PI in writing of its request for “Administrative Hold”, the time frame for responding, and the specific requested activities to be put on hold.  If the PI does not respond within the IRB’s requested time frame, the study may be suspended and/or appropriate sources, including the Commissioner and the study’s sponsor will be notified.

The TDMHSAS-IRB Chairperson and/or the IRB can choose instead to recommend additional education and/or compliance interventions for the PI and his or her key study personnel through the TDMHSAS-IRB Chairperson. In some cases the PI/researcher will recommend a course of action that is approved by the Chairperson, his/her designee, and/or the IRB. This recommendation may be accepted in full, be expanded and accepted, or totally replaced with a new recommendation from the Chairperson, his/her designee, and/or the IRB. 

If the additional information indicates that no change to the risk-potential benefit has occurred, the welfare or rights of participants has not been compromised, and/or the issue of noncompliance has been ruled out, the IRB through the IRB Administrator (IA) will notify the PI that the study may return to active status. Otherwise, the matter will be referred to the convened IRB.

The research remains subject to continuing review and requirements for reporting non- compliance and unanticipated problems/adverse events involving risks to participants or others when a study has been placed on administrative hold.

Study Expiration

When a PI fails to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the specified expiration date, the study expires. This means that enrollment of new participants cannot occur and all research activities must stop.

PIs should be notified regarding IRB actions around an expired study. The Board can institute a “grace period” and/or request that enrollment of new participants cease and/or all research activities stop. The PI must immediately submit to the IRB a list of research participants for whom stopping the research would cause harm. Once the list is received, the IRB will review and determine for which individual participants continuing to participate in the research is in their best interest.

Research studies not reviewed and approved within ninety (90) days of the date of expiration must be administratively closed by the IRB. Reinstatement of the research will require submission of a new research proposal for initial review.

Suspensions

Suspensions can be initiated by a sponsor or the IRB.  Sponsor-initiated suspensions are likely related to risk involving the potential for unanticipated problems with increased risk to participants.  The IRB’s suspension typically involves placing a temporary interruption or stop of some or all currently approved research activities for concern regarding the rights, safety, or welfare of service recipients/participants, investigators, or others pending one or more corrective actions or events.  Any suspensions should be communicated to the PI in writing, with explanations of the IRB's action.

The PI should submit proposed procedures for withdrawing currently enrolled service recipients/participants, for IRB review. Procedures should incorporate a script/letter notifying the service recipients/participants of the suspension. The IRB can decide how follow-up will be handled and whether oversight/transfer of responsibility for implementing the procedures to another Investigator would be more appropriate.

Terminations

A PI or researcher may request termination of a study at any time, including when it has not been possible to begin research activities. For example, a researcher may not be able to secure participant involvement in the research and request termination.

The IRB may decide to terminate a study for safety reasons. For example, the risks may start to outweigh any benefits. The IRB, in consultation with appropriate institutional officials, must determine whether follow-up should continue or cease in a terminated study.  Decisions will be communicated to the PI in writing. PI contact (written and/or face-to-face) with current service recipients/participants must have IRB approval.

Any unanticipated serious adverse events or unanticipated problems involving risks to service recipients/participants or others must be reported to the appropriate sources, such as the IRB, sponsor, OHRP.

IRB Procedures