ELEMENT I.5.D.

ELEMENT I.5.D.: The organization has and follows written policies and procedures for addressing allegations and findings of non-compliance with Human Research Protection Program requirements. The organization works with the Institutional Review Board or Ethics Committee, when appropriate, to ensure that participants are protected when non-compliance occurs. Such policies and procedures include reporting these actions, when appropriate.

Non-compliance refers to not following laws or regulations that govern research involving human participants, the organization’s policies and procedures, or the requirements or determinations of the IRB or EC. Non-compliance can be relatively minor or serious. Non-compliance can also be a one-time event or a continuing problem. Policies and procedures should consider a range of corrective actions that are applicable to the spectrum of non-compliance. Corrective actions should be appropriate to the nature and degree of the non-compliance. Some laws or regulations specify reporting requirements to regulatory agencies, sponsors, or other entities that should be incorporated into the organization’s policies and procedures. Additionally, written materials describe requirements for reporting to AAHRPP, per AAHRPP Accreditation Procedures.

Regulatory and guidance references

DHHS: 45 CFR 46.103(b)(5)(i), 45 CFR 46.116(b)(5), OHRP Guidance on Reporting Incidents to OHRPDoD: Instruction 3216 .02 6 para.4.b.(4)., SECNAVINST 3900.39D, para. 8d(2) and 6k
DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
FDA: 21 CFR 50.25(b)(5), 21 CFR 56.108(b)(2)
ICH-GCP: 5.20
VA: VHA Directive 1200.05(3), VHA Directive 1058.01

Required written materials

Essential requirements:
1. Policies and procedures define:
  1. Non-compliance.
  2. Serious non-compliance.
  3. Continuing non-compliance.
2. Policies and procedures include non-compliance of researchers, staff, other employees, and of the IRB or EC.
3. Policies and procedures describe the various mechanisms for informing the organization or IRB or EC of non-compliance:
  1. Reporting requirements for researchers, staff, and employees.
  2. Consideration of complaints and protocol deviations.
  3. Results of audits.
4. Policies and procedures describe:
  1. The organization’s process to decide whether each allegation of non-compliance has a basis in fact.
  2. The organization’s process to decide whether each incident of non-compliance is serious or continuing.
5. Policies and procedures describe the organization’s process to manage non-compliance that is neither serious nor continuing.
6. Policies and procedures describe the process for management of serious or continuing non-compliance by the convened IRB or EC, including:
  1. If a primary reviewer system is used, documents distributed to primary reviewers.
  2. Documents distributed to all IRB or EC members.
  3. Policies and procedures indicate the IRB or EC is required to consider the following range of possible actions:
    1. Suspension of IRB approval the research.
    2. Termination of IRB approval the research.
    3. Notification of current participants when such information might relate to participants’ willingness to continue to take part in the research.
  4. Policies and procedures indicate that, in addition to the required actions, the IRB or EC optionally may consider the following possible actions:
    1. Modification of the protocol.
    2. Modification of the information disclosed during the consent process.
    3. Providing additional information to past participants.
    4. Requiring current participants to re-consent to participation.
    5. Modification of the continuing review schedule.
    6. Monitoring of the research.
    7. Monitoring of the consent process.
    8. Referral to other organizational entities.
7. Policies and procedures describe the reporting of serious or continuing non-compliance, including:
  1. A requirement for the report to be distributed to:
    1. Specific organizational officials.
    2. Other agencies when the research is overseen by those agencies.
  2. The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements.
8. Policies and procedures describe the reporting to AAHRPP as soon as possible but generally within 48 hours after the organization or any researcher (if the researcher is notified rather than the organization) becomes aware of:
When following DHHS regulations:
1. Policies and procedures describe the reporting of serious or continuing non-compliance to OHRP.
When following DoD requirements:
1. Policies and procedures must describe who is responsible and the process used to promptly (AAHRPP defines “promptly” as within 30 days) report to the Component Office of Human Research Protections (COHRP):
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 any known or potential incidents of noncompliance.
When following FDA requirements:
1. Policies and procedures describe the reporting of serious or continuing non-compliance to FDA.
When following VA requirements:
1. Policies and procedures include the following definitions, procedures, and timeframes:
  1. Serious non-compliance is a failure to follow requirements for conducting human research that may reasonably be regarded as:
    1. Presenting a genuine risk of substantive harm to the safety, rights, or welfare of human research participants or others, including their rights to privacy and confidentiality of identifiable private information.
    2. Presenting a genuine risk of substantive harm to the safety, rights, or welfare of research personnel who conduct research.
    3. Presenting a genuine risk of substantive reputational harm to VA.
    4. Substantively compromising a VA facility’s HRPP.
  2. Continuing non-compliance means repeated instances of noncompliance with applicable laws, regulations, policies, agreements, or determinations of a research review committee or the prolonged persistence of noncompliance occurring after its identification, awareness, or implementation of a corrective action intended to effectively resolve the noncompliance.
    1. The determination that non-compliance is “serious” or “continuing” rests with the IRB.
2. Apparent serious or continuing non-compliance:
  1. VA personnel must ensure that the appropriate IRB of Record is notified, in writing, within five (5) business days after becoming aware of any apparent serious and/or continuing noncompliance with applicable laws, regulations, policies, and agreements pertaining to non-exempt human participants research. This includes, but is not limited to, serious or continuing noncompliance with the Common Rule, local VA medical facility policies and SOPs related to human participants research, if developed, IRB-approved protocols, and the requirements or determinations of the IRB.
  2. In response to the written notification, the IRB must:
    1. Review the written notification at its next convened meeting, not to exceed 30 calendar days after the date of written notification. NOTE: Incidents covered by this paragraph may call for immediate attention and require the IRB to convene an emergency session prior to its next scheduled meeting.
    2. Determine and document within 60 calendar days of the convened IRB’s initial review:
      1. Whether or not serious or continuing noncompliance actually occurred; and if so,
      2. What, if any, remedial actions are needed to resolve present noncompliance or prevent future noncompliance.
    3. If the IRB determines that serious or continuing noncompliance actually occurred, it must notify the VA medical facility Director, the RCO, and the ACOS/R&D in writing of its determinations within five (5) business days after making those determinations.
    4. The VA medical facility Director, or designee, must report the IRB’s determinations to the appropriate ORO workgroup within five (5) business days after receiving the IRB’s written notification.
3. For VA facilities:
  1. The VA facility Director is responsible for:
    1. Ensuring timely implementation of remedial actions to address research noncompliance identified by VA medical facility personnel, VA Office of Research Oversight (ORO), and other entities.
    2. Notifying, or designating an individual to notify, the appropriate ORO workgroup(s) within five business days of becoming aware of the issuance of a research-related citation or determination of noncompliance by a state or federal entity (including the VA Office of Inspector General) or an accrediting organization, pertaining to an event(s) within the scope of this directive.
    3. Ensuring timely implementation of remedial actions to address research noncompliance identified by VA medical facility personnel, ORO, and other entities.
      1. Remedial actions to correct noncompliance identified by ORO or that is otherwise required to be reported to ORO must be completed within 180 calendar days after any determination of noncompliance, except where extenuating circumstances exist (e.g., remediation requires substantial renovation or fiscal expenditure, hiring, or legal negotiations).
      2. Where remedial actions cannot be completed in 180 calendar days, the VA medical facility Director must provide the appropriate ORO workgroup(s) with written justification and a reasonable timeline for completion.

Outcomes

Researchers and research staff report allegations of non-compliance to the IRB or EC.
Non-compliance is identified and managed.
The IRB or EC or organizational official reports serious or continuing non-compliance as required.

Proceed To: STANDARD I-6

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.5.D.