Section 22: Protocol Deviations and Noncompliance
22.1 Reporting to the IRB
When a protocol deviation or incident of noncompliance (See Section 2 – Definitions) becomes known to a researcher, they must complete and submit a Protocol Deviation or Noncompliance Report to the Office of Research Support (ORS). Upon receipt, an IRB Program Coordinator will review the report and bring it to the attention of a Designated Expedited Reviewer. Review of the report will determine the seriousness of the deviation and whether or not the deviation is an incident of noncompliance. The PI will be notified of the results of the review and if further action is necessary (e.g., a protocol amendment).
Allegations of protocol deviations and incidents of noncompliance may also be reported by someone other than the researcher through telephone calls, letters, e-mails, or any other method of communication and may be made to the ORS office, the ORS Director, ORS Assistant Director, or the IRB Chair. However, it is expected that researchers and research staff promptly self-report protocol deviations or incidents of noncompliance regardless of whether the incident is minor, sporadic, serious, or continuing. All reports and allegations of noncompliance will be thoroughly investigated by the IRB.
22.2 Response to Report
Upon receipt of a report or allegation of noncompliance, the ORS Director will be notified. An IRB Program Coordinator will prepare an e-mail or letter to the researcher responsible for the research in question informing them of the allegation and requesting a response to the allegation within 5-7 work days. Upon receipt of the researcher’s response, the allegation and response will be discussed with the ORS Director and IRB Chair or Vice Chair, if necessary. The ORS Director will then determine whether the allegation has a basis in fact or whether further information is needed. If it appears that the allegation has a basis in fact or if it cannot be determined if there is a basis in fact, an IRB investigation is initiated as described in section 22.2.2. If the allegation has no basis in fact, no further action is taken under this policy.
If the noncompliance is clearly neither serious nor continuing, and there is a corrective action plan that can be readily implemented to prevent recurrence, then the matter may be handled as a protocol deviation.
22.2.2 IRB Investigation
Reported protocol deviations or incidents of noncompliance with a basis in fact, or if it cannot be determined if there is a basis in fact, may be the subject of further inquiry. If deemed necessary by the IRB Chair, an ad hoc subcommittee of the IRB may be appointed and may include any or all of the following: IRB Chair, IRB Vice Chair, ORS Director, ORS Assistant Director, Senior Program Coordinator, other IRB members whose presence is deemed as essential and the IRB Program Coordinator responsible for the researcher’s department. It will be determined whether anyone assigned to the ad hoc subcommittee has a conflict of interest with the investigator or the research that is the subject of the inquiry and, if a conflict exists, assign other members to replace those with the conflict. The ad hoc subcommittee investigation will be accomplished as soon as possible, but should be concluded within 30 days. The IRB Chair may elect to immediately suspend the research, pending results of the investigation, in order to protect the safety, rights, or welfare of subjects.
In the event that the investigation finds evidence that federal, state, or local regulations or policies and/or any restrictions, requirements, stipulations, or determinations of the IRB have not been adhered to, the ORS Director or IRB Chair shall brief the IRB at the next scheduled convened meeting or at a specially convened meeting regarding the details of noncompliance. Applicable documents (may include the study protocol, consent form(s), initial application, description of alleged noncompliance, and results of the investigation) pertaining to the incident and the investigation will be sent to IRB members prior to the meeting. Members are expected to review all documents prior to the meeting.
At a convened meeting, the IRB will then determine if the incident of noncompliance was serious or ongoing and what restrictions, conditions, or other remedial actions are necessary to resolve the noncompliance and the procedures required to prevent future occurrences. Within 7 days of the IRB’s determination, the researcher is notified in writing of the requirements necessary to assure compliance with the restrictions and/or determinations of the IRB and the IO and other organizational officials are also notified of the IRB’s determination. Notification of regulatory agencies, as applicable, will be accomplished according to Section 24.2. All documents relating to the investigation will be retained by the IRB Office in a secure location and will be made available to authorized individuals for further reference. Records are held for at least three years.
22.2.3 Examples of Serious and Ongoing/Continuing Noncompliance
- Serious noncompliance affects or will likely affect the rights and welfare of subjects. Examples of serious noncompliance include:
- Initiation of human research related activities without IRB review and approval.
- Modifications to an IRB-approved study without prior IRB approval except to eliminate immediate hazards to the subjects.
- Continuation of research activities after the expiration date of IRB approval.
- Ongoing/Continuing noncompliance is a repeated pattern of noncompliance that is likely to continue without intervention. Examples of
- Multiple reports of an investigator failing to follow regulations and/or IRB procedures.
- The investigator frequently allows studies to lapse.
- Multiple instances of an investigator using invalid or unapproved documents.
- The investigator fails to follow a directive or corrective action established by the IRB.
22.2.4 Possible IRB Actions
- Research Suspension: Suspension is when research activities are suspended due to serious concerns regarding investigator noncompliance. For example, subjects may be at increased risk due to inappropriate investigator actions. The investigator will be notified in writing of such a determination and any other actions required. The suspension will be reported to appropriate individuals and agencies as described in Section 24.
- Research Termination: Termination of research activities occurs when the issues of noncompliance cannot be resolved. The investigator will be notified in writing of such a determination and the termination will be reported to appropriate individuals and agencies as described in Section 24.
- Other possible IRB actions include:
- Notification of current subjects when the information may relate to subjects’ willingness to continue to participate in the research.
- Modification of the protocol.
- Modification of the information disclosed during the consent process.
- Providing additional information to past subjects.
- Requiring current subjects to re-consent to participate.
- Modification of the continuing review schedule.
- Monitoring of the research or the consent process.
- Referral to other organizational entities.
Note: If an IRB suspends or terminates a protocol, the IRB must:
- Consider whether procedures for withdrawal of enrolled subjects take into account their rights and welfare.
- Consider whether current subjects should be informed of the suspension or termination.
- Require any adverse events or outcomes of withdrawal to be reported to the IRB.
22.2.5 Noncompliance that is Not Serious or Ongoing
If the IRB determines at a convened meeting that the incident of noncompliance was neither serious nor ongoing, the IRB may establish a corrective action plan that requires the researcher and/or research staff to attend specialized training. Additionally, the PI may be requested to assist in arranging specialized training for a wider departmental audience to address possible misunderstandings of policies and procedures that led to or could lead to similar incidents of noncompliance. Incidents of noncompliance that were not found to be serious or ongoing will be in the IRB minutes and reported to the Institutional Officer (IO), but will not be reported to federal regulatory agencies.
22.2.6 Reporting to IO and Others
If the incidents of noncompliance are serious or ongoing, and/or the IRB determines that a protocol must be suspended or terminated, the incidents and IRB actions must be reported to the IO and the applicable regulating agency. (See Section 24).