716. Outcomes Following Review at a Convened Meeting
IRB Determination of Minor Noncompliance
If the fully convened IRB determines that minor noncompliance has occurred, the QI Officer or qualified designee will send the PI written notification of the Board's decision and recommendations (i.e., IRB-approved action or management plan).
- The investigator must implement the action or management plan and notify the QI Officer (in writing) within 30 calendar days of successful implementation.
- The QI Officer will send the principal investigator an acknowledgement of successful implementation of the action or management plan, and confirmation that the minor noncompliance has been satisfactorily resolved.
IRB Determination that Further Investigation by Ad Hoc Panel Is Warranted
If an ad hoc panel is assembled, it will consist of a minimum of three IRB members whose areas of expertise are suited to reviewing the complaint and area of study. The IRB Chair may not be a member of the panel but the QI Officer who conducted the initial inquiry may serve in lieu of a third IRB member.
- The ad hoc panel may conduct further interviews or employ other methods to gather information.
- The ad hoc panel will provide a written report to the fully convened IRB following their inquiry, including a summary of the information gathered, conclusions and recommendations.
IRB Determination of Serious or Continuing Noncompliance
If the IRB determines that the incident constitutes serious or continuing noncompliance or both, actions may include but are not limited to the following:
- Requiring remediation or educational measures for the research team;
- Monitoring research activities by appropriate persons;
- Monitoring the informed consent process by appropriate persons;
- Notifying or providing additional information to past or current research participants;
- Requiring researchers to re-consent participants;
- Requiring modifications of the research protocol;
- Increasing investigator reporting requirements related to her or his human participant research activities for this study or all of her or his studies;
- Requiring more frequent continuing reviews;
- Requiring periodic audits by the QI Officer.
- Restricting the investigator's research practice, such as limiting her or his research privileges to minimal risk or supervised projects;
- Suspending approval for one or more of the investigator's studies; or
- Terminating approval for one or more of the investigator's studies.
If the IRB determines that an allegation constitutes serious or continuing noncompliance and may violate other University policies, the appropriate authority will be notified of the IRB's findings for possible further review and resolution by those bodies.