IRB Non-Compliance Policy

Purpose

The purpose of this document is to establish procedures for handling reports of non-compliance with IRB policies and procedures. The policy applies to all FIT researchers involved with human subject research.

Policy

All FIT researchers are required to conduct research projects in accordance with IRB policies and procedures as published on the IRB website. Failure to do so constitutes noncompliance in the research endeavor, irrespective of the magnitude or intent of the deviation from the approved protocol.

Who Should Report?

Principal Investigators are responsible for reporting incidents of serious or continuing noncompliance to the IRB chair 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. Research subjects/families, research staff, whistle blowers, regulatory agencies or any other personnel, who are aware of an instance of noncompliance, are also required to report non-compliance incidents to the IRB chair.

Reports of noncompliance involving the conduct of any of the IRB member or their staff should be reported to the institutional official (IO).

Definitions

1. Noncompliance: Failure of researchers to comply with applicable federal regulations, FIT IRB policies and procedures, or the determinations made by FIT IRB.
2. Serious non-compliance: An action or omission taken by a researcher involved with human subject research 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:
   2. Failure to obtain IRB approval prior to initiation of research procedures
   3. Failure to notify the IRB of changes in approved procedures
   4. Failure to obtain informed consent as appropriate
   5. Failure to document informed consent as appropriate
   6. Failure to maintain complete record of informed consent as appropriate
   7. IRB approval expires due to failure to renew
   8. Failure to notify the IRB of changes in the scope/intent of the study
   9. Failure to obtain renewal of an approved study in the required time frame
   10. Failure to adhere to institutional polices where subject’s well-being or rights have been affected.
3. 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, FIT IRB policies and procedures, or the determinations made by FIT IRB.

Procedures

1. Receiving allegations of non-compliance
   Verbal or written reports of non-compliance may be provided to the IRB chair, IRB members or Institutional Official from anyone listed in section 3 above or anyone who has reason to believe that noncompliance with human subject research regulations and/or IRB policies and procedures has occurred.
2. Assessment of allegations
1. IRB chair will first determine whether the facts justify the allegations i.e. there are supporting documents or statements.
2. If the allegations are unsubstantiated, the IRB Chair may decide no additional action is needed, further inquiry is necessary, or the issue should be presented to a full board IRB.
3. If the allegations are substantiated, the IRB chair will report the matter to full IRB. During the meeting, a determination will be made whether the allegation constitutes as non-compliance that is not serious and not continuing, or non-compliance is serious or continuing.
4. If a determination is made that the non-compliance is not serious and not continuing, the IRB chair will discuss the issue with the alleged researcher and the complainant and an action plan will be drafted regarding the documentation of the event.
5. If a determination is made that the non-compliance is serious or continuing, the IRB chair will notify the alleged researcher and provide an opportunity to clarify or explain the issue. IRB may impose restrictions to the research study until satisfactory answers are received from the researcher.
3. Actions that may be taken during or after the investigation of non-compliance include, but are not limited to, the following.
   • No action.
   • Suspension: Suspend enrollment and/or all research procedures for the specific research study in question.
   • Termination of the research.
   • 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.
   • 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.

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

Upon determination by the IRB of a serious or continuing noncompliance incident, IRB chair is required to report the incident to OHRP using their online incident reporting form, and to the complainant, if identity is known.

Where applicable, the IRB will also notify the researcher, the researcher’s department chair, Office of Institutional Research and Effectiveness, funding agency involved, and the IRB chair of any other institutions participating in the research.

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 researcher at the start of the investigation. Throughout the investigation, the researcher will be provided the opportunity to respond. In instances of noncompliance, an investigative report and any appropriate corrective action taken with the researcher (such as retraining or modification to research procedure) will be documented by IRB. The investigator will be provided written notification of the outcome of the investigation.

Allegations that are determined to not constitute non-compliance will nonetheless be documented in an IRB compliance file and an explanation of this determination will be provided to the complainant.  

Timeline

While there are no strict timelines for the assessment, evaluation, notification, and reporting, it is recommended that all matters be handled as promptly as possible. Incidents needed to be reported to OHRP are encouraged to follow timelines within a couple of weeks to a month.