Termination of Approval

POLICY

The IRB has the authority to suspend or terminate IRB approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to subjects.

Key Terms:

Suspension of IRB approval: An action initiated by the IRB to temporarily stop the research study pending future action by the IRB or by the Principal Investigator or his/her study personnel.

Termination of IRB approval: An action initiated by the IRB to permanently stop the research study.

Sponsor-Imposed Termination / Suspension:  A determination from the sponsor of the study to terminate a research study or place a specific research study on hold.  This determination may be made as a result of interim data analysis, inadequate drug availability, response to a DSMB report/recommendation or any other reasons.

Principal Investigator-Imposed Termination / Suspension:  A determination from the Principal Investigator of the study to terminate a research study or place a specific research study on hold.  This determination may be made as a result of interim data analysis, inadequate drug availability, response to DSMB recommendation or any other reasons.

PROCEDURE

Suspension or Termination of IRB Approval - The IRB may decide at a convened meeting to suspend or terminate approval for a study that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to the research subjects, including, but not limited to:

1. Inappropriate involvement of human subjects in research,
2. Inhibition of the rights or welfare of participants,
3. Serious or continuing noncompliance,
4. New information regarding increased risk to human participants.

IRB staff will gather information about the problem and place the study on the agenda for the next meeting. All IRB members have access to all protocol related information in iRIS. IRB staff will assign the research to the same IRB panel and if possible the same sub-committee that conducted the initial review or previous continuing review.

When a decision has been made to suspend or terminate approval, the IRB may suspend or terminate approval of the entire research study or just certain research activities and allow the research to go forward without those activities.

The IRB staff will prepare a letter in iRIS with a statement of the reasons for the IRB decision to hold, suspend or terminate approval. In this letter, the IRB may request information on the status of existing subjects, how the existing subjects will be notified of the suspension, and what impact the hold, suspension or termination will have on the care or participation of the existing subjects.  The IRB may require the PI to submit:

1. A corrective and preventative action plan.
2. Proposed procedures for withdrawing currently enrolled subjects that takes into consideration their rights and welfare. The IRB will review the proposed procedures and may mandate oversight or transfer responsibility to another Investigator to ensure implementation of these procedures.
3. A proposed script or letter notifying currently enrolled participants that are affected by the hold, suspension or termination.
4. Any adverse events or outcomes.

If IRB staff determines that the problem is serious and urgent, the Institutional Official or IRB chair will be notified. The IO or IRB chair may decide to suspend approval for a research study on an urgent basis, to eliminate immediate harm to subjects or request for it to be placed on the agenda for the next Full Board meeting. When approval for research study is suspended or terminated by the IRB chair or IO, the IRB staff will place it for review at the next convened IRB meeting.

Investigator Initiated or Sponsor-Imposed Suspension or Termination: The Principal Investigator submits notification to IRB via iRIS if the research study is suspended or terminated.  IRB staff makes a determination of whether the suspension or termination is related to risk. When the suspension or termination is unrelated to risk, IRB staff review this administratively or assign for expedited review.

When the suspension or termination is related to risk, IRB staff will assign the submission for review by the subcommittee, if possible the same subcommittee that initially reviewed the proposal or conducted previous continuing review. The subcommittee will determine whether full committee review is warranted at the next convened meeting or may postpone further review until such time as the sponsor and Principal Investigator provides further information. The IRB may require the Principal Investigator to submit a plan to manage the subjects who were enrolled. The IRB may also require Principal Investigator to submit a letter for communicating the additional safety information to subjects who have completed the study.

Reinstatement – To reinstate IRB approval for a suspended research study, the investigator must submit a written request to the IRB. For holds and suspensions unrelated to risk, IRB staff will review administratively or assign the reinstatement request for expedited review.

For suspensions related to risk, the IRB staff will include the reinstatement request on the agenda for the next convened meeting. The possible actions that the IRB may take include, but are not limited to:

1. Reinstate approval,
2. Reinstate approval with stipulations or additional restrictions, or
3. Continue suspension.

Reporting – The IRB staff will notify appropriate department heads, sponsors, institutional officials, and applicable regulatory authorities of the termination as per policy and procedure Reporting.

APPLICABLE REGULATIONS

1. 45 CFR 46 Protection of Human Subjects
2. 21 CFR 56 Institutional Review Board

REFERENCES TO OTHER POLICY AND PROCEDURES

1.  Reporting

ATTACHMENTS

1. None

If you find errors in this document, contact cphs@uth.tmc.edu 

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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