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
FDA: 21 CFR 50.25(b)(5), 21 CFR 56.108(b)(2)
ICH-GCP: 5.20
VA: 38 CFR 16.103(b)(5)(i), 38 CFR 16.116(b)(5), VHA Handbook 1200.05, 14,29, VHA Handbook 1058.01; Guidance: Examples and a Brief Guide for Reporting Apparently Serious or Apparently Continuing Noncompliance in Human Research That May Be Reportable to ORO under VHA Handbook 1058.01; Guidance: Examples and a Brief Guide for Reporting Apparently Serious Research Information Security Problems That May Be Reportable to ORO under VHA Handbook 1058.0

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 FDA regulations:
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, research staff, or others, including the rights to privacy and confidentiality of identifiable private information.
    2. Substantively compromising a VA facility’s HRPP.
    3. Continuing non-compliance is a persistent failure to adhere to the laws, regulations, or policies governing human research.
    4. The determination that non-compliance is “serious” or “continuing” rests with the IRB.
2. Apparent serious or continuing non-compliance:
  1. Within five business days of becoming aware of any apparent or possible serious or continuing non-compliance, members of the VA research community are required to ensure that the apparent non-compliance has been reported in writing to the IRB.
3. Research compliance officer reports of apparent serious or continuing non-compliance.
  1. Within five business days of identifying apparent serious or continuing non-compliance based on a consent document audit, regulatory audit, or other Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the Organization’s HRPP systematic audit of VA research, the research compliance officer must provide a written report of the apparent non-compliance directly (without intermediaries) to:
    1. Facility director.
    2. Associate chief of staff for research.
    3. The Research and Development Committee.
    4. The IRB.
    5. Other relevant research review committees.
  2. Within five business days of receiving such notification, the facility director must report the apparent serious or continuing non-compliance to:
    1. The appropriate Office of Research Oversight research officer.
    2. Veterans Integrated Service Network (VISN) director.
    3. Office of Research Development.
  3. An initial report of apparent serious or continuing non-compliance based on a research compliance officer consent document audit, research compliance officer regulatory audit, or other systematic research compliance officer audit is required regardless of whether disposition of the matter has been resolved at the time of the report.
4. IRB review of apparent serious or continuing non-compliance when following VA regulations.
  1. The IRB must review a report of apparent serious or continuing non-compliance at the earliest practicable opportunity, not to exceed 30 days after notification. The IRB chair may take interim action to eliminate apparent immediate hazards to participants.
  2. The IRB must reach a determination that serious or continuing non-compliance did (or did not) occur within 30-45 days after receiving a report of apparent non-compliance.
  3. Remedial actions involving a specific study or research team must be completed within 90-120 days after the IRB’s determination.
  4. Remedial actions involving programmatic non-compliance must be completed within 120-180 days after the IRB’s determination, unless remediation requires substantial renovation, fiscal expenditure, hiring, or legal negotiations.
5. Should the IRB determine that the reported incident constitutes serious non-compliance or continuing non-compliance, within five business days after the determination the IRB chair, or designee must provide a written report of the determination directly to:
  1. Facility director.
  2. Associate chief of staff for research.
  3. Research and Development Committee.
  4. The RCO, if the apparent serious or continuing non-compliance was identified by an RCO audit, regardless of outcome.
  5. Other relevant research review committee.
6. Unless the non-compliance has already been reported, within five business days after receiving such notification, the facility director must report the determination to:
  1. The appropriate Office of Research Oversight research officer.
  2. The VISN director.
  3. Office of Research Development.
  4. An initial report of an IRB determination that serious non-compliance or continuing non-compliance occurred is required, even where the determination is preliminary or disposition of the matter has not been resolved at the time of the report.
7. Members of the VA research community must report possible serious or continuing non-compliance with VA or other federal requirements related to human research or with IRB requirements or determinations to the associate chief of staff for research and development and the IRB within five business days after becoming aware of it.
8. Policies and procedures describe the reporting of serious or continuing non-compliance to:
  1. The Office of Research and Development, if VA-funded.
  2. The Regional Office of Research Oversight.
  3. The VA Privacy Office, when the report involves unauthorized use, loss, or disclosure of individually identifiable patient information.
  4. The VHA Information Security Officer when the report involves violations of VA information security requirements.
9. A research compliance officer identifying serious or continuing noncompliance, during an informed consent or regulatory audit, must report the noncompliance to the facility director, the associate chief of staff for research and development, the Research and Development Committee, and the IRB as soon as possible but no later than five business days after becoming aware of the noncompliance.
10. IRBs of academic affiliates that are the IRB of record for VA facilities must follow the VA requirements.

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.