Element II.2.H.

Element II.2.H.: The IRB or EC has and follows written policies and procedures for suspending or terminating IRB or EC approval of research, if warranted, and for reporting these actions, when appropriate.

The IRB or EC must have the authority to suspend or terminate its approval of research that is not being conducted in accordance with the laws, regulations, codes, and guidance or the IRB’s or EC’s requirements. The IRB or EC should have policies and procedures to suspend or terminate approval of research, taking into account the rights and welfare of current participants. Written materials should indicate that authority to suspend or terminate IRB or EC approval is retained, regardless of whether research was approved by the convened IRB, or through the expedited procedure, or through limited IRB review or is exempt. The IRB or EC retains the ability to suspend or terminate research even when continuing IRB or EC review is not required. These policies and procedures should also describe the organization’s process for reporting terminations and suspensions of IRB or EC approval.

Sometimes organizations use the term “administrative hold” or “voluntary hold” to describe a temporary halt of IRB approval. An administrative hold directed by the IRB is a suspension and must be classified and reported as such. This includes a suspension of enrollment alone. An administrative hold cannot be used to extend IRB approval beyond the expiration date of a protocol without IRB approval of continuing review.

Regulatory and guidance references

DHHS: 45 CFR 46.103(b)(5)(ii), 45 CFR 46.113, OHRP Guidance on Reporting Incidents to OHRP
DoD: Instruction 3216.02 4.b.4
DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
FDA: 21 CFR 56.108(b)(3), 21 CFR 56.113, FDA Information Sheets: Continuing Review After Study Approval
ICH-GCP: 4.12.1, 4.12.2, 4.12.3
VA: VA: VHA Directive 1200.05(3), 14
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures define the process for suspending or terminating IRB or EC approval of research.
  1. Policies define:
    1. Suspension of IRB approval.
    2. Termination of IRB approval.
  2. Policies and procedures indicate that the IRB or EC can suspend or terminate approval of research that:
    1. Is not being conducted in accordance with the IRB’s or EC’s requirements.
    2. Has been associated with unexpected serious harm to participants.
  3. Policies and procedures describe who is authorized to suspend or terminate research.
  4. Policies and procedures describe who can suspend or terminate IRB approval on an urgent basis.
  5. Policies and procedures have suspensions and terminations by someone other than the convened IRB reported to and reviewed by the convened IRB.
  6. When study approval is suspended or terminated, policies and procedures have the IRB or EC or the person ordering the suspension or termination:
    1. Consider actions to protect the rights and welfare of currently enrolled participants.
    2. Consider whether procedures for withdrawal of enrolled participants take into account their rights and welfare (e.g., making arrangements for medical care outside of a research study, transfer to another researcher, and continuation in the research under independent monitoring).
    3. Consider informing current participants of the termination or suspension.
    4. Have any adverse events or outcomes reported to the IRB or EC.
  7. Policies and procedures describe the prompt reporting of suspensions and terminations of IRB or EC approval.
  8. The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements.
  9. The distribution of the report to:
    1. Specific organizational officials.
    2. Regulatory agencies when the research is overseen by to those agencies, and they require reporting.
When following DHHS regulations:
1. Policies and procedures describe the prompt reporting of suspensions and terminations of IRB or EC approval to OHRP.
When following DoD requirements:
1. The following must be promptly (AAHRPP defines “promptly” as within 30 days) reported to the COHRP:
  1. Suspensions or terminations of IRB approval.
When following DOE requirements:
1. The HSP Program Manager at DOE or NNSA must be notified within 48 hours, with a description of corrective actions taken, of:
  1. Suspensions of IRB approval.
  2. Terminations of IRB approval.
When following FDA regulations:
1. Policies and procedures describe the prompt reporting of suspensions and terminations of IRB or EC approval to FDA.
When following VA requirements:
1. The IRB of Record must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing within five business days of the suspension or early termination of a non-exempt VA human research study by the IRB or IO due to the study not being conducted in accordance with applicable regulations, policies, agreements, or IRB requirements or due to concerns about the safety, rights, or welfare of human participants or others.
2. The notification of suspension or early termination of a non-exempt VA human research study by the IRB must include a statement of the reason for the IRB's action.
3. For VA facilities:
  1. Policies and procedures include the following:
  2. 1. The R&D Committee and VA facility Director have the authority to suspend or terminate their approval of research. This authority can be delegated by the organizational official to the Chief of Staff (COS). ORD has authority to suspend or terminate any research activity it is funding.
    2. The notification of suspension or early termination of a non-exempt VA human research study by the VA IO must include a statement of the reason for the IO’s action.
    3. The facility Director, or designee, must report the termination or suspension to the VA Office of Research Oversight (ORO) within five business days after receiving such notification.

Outcomes

The IRB or EC suspends or terminates approval of research in its policies and procedures.
When the IRB or EC suspends or terminates approval of research, the rights and welfare of enrolled participants are protected.
The IRB or EC or organizational official reports suspensions and terminations of approval of research to appropriate organizational officials and applicable regulatory agencies.

Proceed To: Element II.2.I.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

Element II.2.H.