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Washington State University

HRPP policies & procedures manual

406: Non-compliance with IRB policies and procedures

1. Purpose

The purpose of this policy is to establish procedures for processing reports of non-compliance with IRB policies and procedures.  This policy also applies to routine and for-cause audits conducted by the ORA.

The policy applies to all University investigators and research personnel who conduct research involving human subjects as well as University designees responsible for the oversight of human research.

2. Policy

All members of a research team are required to conduct research projects in accordance with the protocol as approved by the IRB, and in accordance with federal regulations, state law, and University policy. Failure to do so constitutes noncompliance in the research endeavor, irrespective of the magnitude or intent of the deviation from the approved protocol. Principal Investigators are responsible for reporting incidents of serious or continuing noncompliance to the IRB along with any proposed corrective action plan to ensure the safety of research subjects and others and future compliance with the approved protocol and to prevent reoccurrence.

Other entities responsible for the oversight of human research and University personnel, who believe in good faith that they are aware of an instance of noncompliance, also are required to report such incidents to the IRB office.

Reports of noncompliance which are reported to the IRB will be promptly reviewed and resolved in a fair process and in accordance with all applicable regulatory requirements and WSU policies.

Reports and allegations of serious noncompliance must be reported to the Office of Human Subjects Protection (OHRP) or FDA within 5 working days. Studies conducted by researchers from WSU should be reported to the director of the Office of Research Assurances (ORA). Reports of noncompliance involving the conduct of any of the IRBs or their staff should be reported to the institutional official (IO).

2.1. Definitions

Noncompliance

Failure to comply with applicable federal regulations, WSU IRB policies and procedures, WSU policy, or the determinations of the WSU IRB.   

Serious non-compliance

An action or omission taken by an investigator, study personnel or individual in the ORA that any other reasonable individual would have foreseen as compromising the rights and/or welfare of the subject.

Examples of serious non-compliance:

  1. Failure to adhere to the federal regulations governing the use of humans in research:
    • Failure to obtain IRB approval prior to initiation of research procedures
    • Failure to notify the IRB of changes in approved procedures
    • Failure to obtain informed consent
    • Failure to document informed consent
    • Failure to maintain complete record of informed consent
    • IRB approval expires due to failure to renew
    • Failure to notify the IRB of changes in the scope/intent of the study
    • Failure to obtain renewal of an approved study in the required time frame
  2. Failure to adhere to institutional polices where subject’s well-being or rights have been affected.
Continuing non-compliance

A pattern of repeated actions or omissions taken by an investigator or individual that indicates a lack of ability or willingness to comply with federal regulations, WSU IRB policies and procedures, or the determinations of the WSU IRB.

3. Specific policies

3.1 Receiving reports of non-compliance

Reports of non-compliance may be provided to the IRB chair, IRB members and ORA staff from anyone inside or outside of the University community who has reason to believe that noncompliance with human subject research regulations and/or IRB policies and procedures has occurred. These complaints will be accepted verbally or in writing.

Receipt of verbal reports

Allegations that are presented via telephone or in person to the ORA office will be directed to the ORA director.

The recipient of the call should take care to record all relevant information in a thorough manner and request that the caller provide a contact number for follow-up calls, unless the caller desires to remain anonymous.

Anonymous callers

The person making the allegation may choose to remain anonymous. The recipient of an anonymous call should inform the caller that the matter will be investigated to the extent possible, given the information provided. The recipient of the call should ask the caller for any available evidence that the caller is willing to give that will facilitate an investigation into the matter, but should not encourage the caller to provide a name or contact information if the caller has expressed a desire to remain anonymous. ORA staff may advise the caller to provide additional information at a later date if new information becomes available or if the caller remembers details that were not presented originally.

3.2 Investigation

Report to IRB of pending investigation

If investigation of the allegation has not been completed prior to the next scheduled meeting of the appropriate IRB, the IRB will be notified that an allegation of non-compliance has been received and that an investigation has been initiated. This information will be presented in a manner that does not identify the investigator, study or facility. However, if the allegation will impact other IRB business at that or another meeting, the IRB will be informed as needed to ensure effective decision-making by the IRB relative to that investigator, protocol or facility.

Report of allegation/investigation complete

If the allegation was received and the investigation completed prior to the next scheduled meeting of the appropriate IRB, the IRB will be presented with the allegation and findings.

Investigation

The ORA director and/or IRB chair and, if necessary, the IO will investigate the allegation upon notification of the alleged non-compliance. The matter will be reported to the full IRB at its next scheduled meeting.

Determinations

After the investigation, the ORA director and/or IRB chair will determine whether:

  1. The non-compliance is not serious and not continuing, or
  2. The non-compliance is serious or continuing.
Not serious and not continuing

If it is determined by the ORA director and/or IRB chair that the allegation is not serious and not continuing, the investigator/study personnel will be notified by the IRB coordinator.  In addition, the IRB coordinator will discuss the issue with the investigator/study personnel and an action plan will be drafted. The final action plan will be forwarded to the investigator/study personnel via letter or e-mail and will be included in the IRB agenda as an information item.

Non-compliance that is serious or continuing

The investigator/study personnel will be notified by the ORA director and/or chair of the findings and/or requests for information by phone call, letter or e-mail.

The investigator will be asked to respond in writing to the allegation and/or finding and/or request for information.  The individual will have 14 business days to respond.  If the individual needs more time, an extension may be granted by the ORA director or chair.

During the investigation, the ORA director, chair and/or IO may impose restrictions to the research study until satisfactory answers are received from the PI.

Actions that may be taken during or after the investigation of non-compliance
  • No action.
  • Suspension: Suspend enrollment and/or all research procedures for the specific research study in question; (in accordance with policies and procedures on suspension and termination of IRB approval).
  • Termination of the research (in accordance with policies and procedures on suspension and termination of IRB approval).
  • Require a response from the investigator with a plan for corrective action.
  • Initiate audits of all or some part of the investigator’s active protocols.
  • Modify the research protocol.
  • Modify the information disclosed during the consent process.
  • Provide additional information to past subjects. Modify the continuing review schedule.
  • Obtain more information pending final decision.
  • Conference with other IRBs involved with the research.
  • Require that current subjects re-consent to participation.
  • Provide information to current subjects whenever such information might relate to the subjects’ willingness to continue to take part in the research.
  • Monitor the research.
  • Monitor the consent process.
  • Refer to other organizational entities.

3.3 Notification of relevant parties of reports and findings of serious or continuing non-compliance

Upon determination by the ORA director, IRB chair and IO that an incident of noncompliance is either serious or one of continuing non-compliance, the incident will be reported according to reporting requirements for unanticipated events, serious and continuing non-compliance, and/or suspensions or termination of IRB approval.

If the identity of the person who reported the allegation, complaint, or concern is known, a summary of the findings of the investigation will be forwarded to this person as well.

3.4 Record keeping and further reporting requirements

Whenever an allegation or complaint of noncompliance warrants inquiry and further action involving an investigation, notice of the allegation(s) will be provided to the investigator at the start of the investigation. Throughout the investigation, the investigator will be provided the opportunity to respond. In instances of noncompliance, an investigative report and any appropriate corrective action taken with the investigator (such as retraining or modification to research procedure) will be documented in the study file. The investigator will be provided written notification of the outcome of the investigation.

Allegations that are determined to not actually constitute noncompliance will nonetheless be documented in an IRB compliance file and an explanation of this determination may be provided to the complainant when the reviewer deems it appropriate.

For all incidents determined to be serious or continuing noncompliance the IRB will notify the following individuals within 7 days:

  • principal investigator
  • his or her department chair

Where applicable, the IRB will also notify the following:

  • Office of Grant and Research Development
  • OHRP
  • FDA
  • funding agency
  • for other institutions participating in the research, the IRB chair(s) of those institutions

When the IO makes a decision to suspend or terminate approval of any research for any reason, the following individuals will be notified within 5 working days:

  • principal investigator
  • his or her department chair
  • Office of Grant and Research Development
  • OHRP
  • FDA
  • funding agency
  • other institutions participating in the research and the IRB directors of those institutions

3.5 Additional FDA reporting requirements

Under 21 CFR 56.113, an IRB shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB`s action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration.

21 CFR 56.108(b) requires that the IRB follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of:

  1. Any unanticipated problems involving risks to human subjects or others
  2. Any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or any suspension or termination of IRB approval

When reporting suspensions or terminations of IRB approval, please include the Investigational New Drug (IND) or Device Exemption (IDE) number, the full name of the research protocol, the name(s) of the clinical investigators, and the reason(s) for the suspension or termination. These reports may be submitted via e-mai: irb@wsu.edu

4. Applicable regulations and guidelines

21 CFR 56.108(b)(2), 56.113

45 CFR 46.113

5. Forms

None

6. Procedures employed to implement this policy & assignment of responsibility

WhoTask
ORA director, IRB coordinator Receive notification of (alleged) non-compliance and initiate the process.

Notify the investigator of the IRB’s determination and corrective action.

Notify all appropriate parties of the allegation and outcome.
IO, ORA director, IRB chair Conduct investigation into (alleged) non-compliance.

Determine if the allegation has a basis in fact.

Keep IRB notified as appropriate.

Present the facts and findings to the IRB upon completion of the investigation.