8.6 Study Hold, Suspension, and Termination

1.0 Purpose

The purpose of this policy and procedure is to describe the IRB’s authority to: a) accept a study hold; b) impose a study hold; c) suspend IRB approval of research; d) terminate IRB approval of research, and e) implement an Organizational directed termination of IRB approval of research.

2.0 Policy

2.1. It is the policy of the Organization that the IRB has the authority to:
- 2.1.1. Accept a study hold imposed by the PI, sponsor, DSMB, FDA or other funding agency.
- 2.1.2. Suspend or terminate IRB approval of research.
- 2.1.3. Implement institutional directed suspension or termination of IRB approval of research.

3.0 Definitions

3.1. Study Hold: A unplanned temporary halt to subject accrual and/or research activities, that is imposed by the PI, sponsor, DSMB, or FDA or other funding agency. A study hold may be full (affecting accrual and all study activities), or partial (affecting only accrual, or only some study activities).

Note: A study hold as described above in Section 3.1 which is not imposed by the IRB does not constitute a suspension or termination of IRB-approval of research under 45 CFR 46.113; 21 CFR 56.113.
3.2. Suspension of IRB Approval: A directive of the IRB at a convened meeting, or a directive of the IRB Executive Chair (in consultation with the IO as appropriate), that all, or some, research activities in one or more protocols must be temporarily suspended. Study suspension usually (but not exclusively) results from concerns regarding the safety, rights, or welfare of human research subjects, investigators, research staff, or others, or due to noncompliance concerns.

Note: interruptions in human research resulting solely from the expiration of the IRB approval period does not constitute suspension of IRB-approval of research under 45 CFR 46.113; 21 CFR 56.113.
3.3. Termination of IRB Approval: A directive by the IRB at a convened meeting that all research activities must permanently cease in one or more protocols. Study termination usually (but not exclusively) results from concerns regarding the safety, rights, or welfare of human research subjects, investigators, research staff, or others, which cannot be otherwise resolved, or due to serious or continuing noncompliance with the applicable federal regulations and HRPP policies.
3.4. Organization Directed Termination of IRB Approval: A directive by the Institutional Official (IO) that an IRB approved study be terminated.

4.0 Procedures for Study Holds by PI, Sponsor, DSMB, FDA or Other Funding Agency

5.0 Suspension of IRB Approval

5.1. The full IRB, or the IRB Executive Chair, may suspend IRB approval of research if such action is warranted due to concerns regarding the safety, rights, or welfare of human research subjects, investigators, research staff, or others, or due to noncompliance concerns, or other similar circumstances.
- 5.1.1. The IRB Executive chair may exercise his/her authority to suspend research when, in his/her judgement, such action is necessary the protect the safety, rights, or welfare of human research subjects, investigators, research staff, or others before the next convened IRB meeting.
5.2. The IRB will take appropriate action(s) to protect the rights and welfare of currently enrolled subjects.
5.3. The PI will be responsible for notifying all study personnel that the study has been suspended and that all, or some, research activities are suspended.
5.4. The PI must report to the IRB any adverse events or outcomes associated with the suspension.
5.5. The PI must notify research subjects currently on study of suspension of IRB approval of research activities. Subjects should be advised of any follow-up necessary for safety reasons.
5.6. The IRB, or the Executive Chair, has the authority to permit subjects currently on study to continue if it is in their best medical interest to do so.
5.7. If the study was suspended by the Executive Chair, the IRB will be notified at the next convened meeting of the suspension.
5.8. The PI may file a written appeal of the suspension to the IRB. The IRB is granted the final authority to act on any appeals and the decision of the Board cannot be overturned.
5.9. The full IRB has the sole authority to release a study suspension.

6.0 Termination of IRB Approval

6.1. The full IRB may terminate IRB approval of research if such action is warranted due to concerns regarding the safety, rights, or welfare of human research subjects, investigators, research staff, or others, which cannot be otherwise resolved, or due to serious or continuing noncompliance with the applicable federal regulations and HRPP policies, or due to other similar circumstances.
6.2. The IRB will provide the PI with written justification for termination of IRB approval of the research.
6.3. The IRB will promptly notify the IO and other appropriate Organization officials of the termination of IRB approval of research.
6.4. The IRB will take appropriate action(s) to protect the rights and welfare of currently enrolled subjects.
6.5. The PI will be responsible for notifying all study personnel that the study has been terminated and that all research activities must cease.
6.6. The PI must report to the IRB any adverse events or outcomes associated with the termination.
6.7. The PI must notify research subjects currently on study of termination of the study. Subjects should be advised of any follow-up necessary for safety reasons.
6.8. The PI may file a written appeal of the suspension to the IRB within 30 days of the termination. The IRB shall give the PI an opportunity to appear before the Board. The PI will be afforded due process and may bring legal counsel who will be restricted to observation only. The IRB is granted the final authority to act on any appeals and the decision of the Board cannot be overturned.

7.0 Organization Directed Termination of IRB Approval

7.1. In consultation with appropriate Organization officials the IO may direct that one or more of an investigator’s IRB approved studies be terminated.
7.2. The IO will provide the PI with written justification for termination of the research.
7.3. The IO will notify appropriate the IRB Executive Chair, and Organization officials of the termination of the research.
7.4. The IRB will take appropriate action(s) to protect the rights and welfare of currently enrolled subjects.
7.5. The PI will be responsible for notifying all study personnel that the study has been terminated and that all research activities must cease.
7.6. The PI must report to the IRB any adverse events or outcomes associated with the termination.
7.7. The PI must notify research subjects currently on study of termination of the study. Subjects should be advised of any follow-up necessary for safety reasons.
7.8. The PI may file a written appeal of the suspension to the IO within 30 days of the termination. The IO has full authority to act on the appeal and may at his/her discretion convene an Appeals Panel to make a recommendation regarding appropriate action. The PI will be afforded due process and may be offered the opportunity to meet with the IO and/or the Appeals Panel. The investigator may bring legal counsel who will be restricted to observation only. The decision of the IO with regard to any appeal is final.

8.0 Reporting Suspensions and Terminations to OHRP, Department and Agency Heads, and FDA

Suspensions and terminations are reported in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).

DOCUMENT

~~ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL~~

~~POLICY AMENDED:~~HISTORY:

 ~~REVISED~~Written: ~~FEBRUARY~~4/4/2016 2,(Approved ~~2018~~4/4/2016) - original author not recorded

 ~~INITIAL~~Revised: ~~APRIL~~2/2/2018 4,- ~~2016~~revision not documented