All protocols reviewed by the IRB are subject to regulatory monitoring by the IRB and OIRB personnel. Studies are selected at random as well as according to criteria listed in the UAB Policy and Procedure for Compliance Issues with Human Subjects Regulations or IRB Requirements or Determinations.
As detailed in the UAB Policy on the Protection of Human Subjects in Research, investigators and other study personnel involved in human subjects research are required to comply with all laws and regulations governing their research activities, as well as with requirements and determinations of the IRB. Study personnel includes the principal investigator and any staff members directly involved with participants or the informed consent process.
Specifically, study personnel are required to
In cases where serious or continuing non-compliance has occurred, the IRB may exercise its authority to monitor, suspend, or terminate the research. (See Definitions, below.)
After a protocol has been selected for monitoring and usually 2 to 4 days before the planned visit, the OIRB Regulatory Manager or designee contacts the investigator, and study coordinator if applicable, to schedule the monitoring appointment. A written follow-up message from the OIRB confirms the appointment and lists materials that should be available for the reviewer, as well as any issues that need to be specifically addressed.
The monitor inspects the general maintenance of study records, including the following specific documents as applicable:
Within 2 weeks of completing the monitoring visit, the OIRB Regulatory Compliance Manager completes the monitoring report and provides a copy to the IRB Chair and to the principal investigator. The OIRB puts a copy of the report in the protocol file and schedules the report for review by the convened IRB.
The convened IRB reviews all monitoring reports in accordance with its scheduled deadlines and meetings. After the review is completed, the OIRB sends the principal investigator a copy of the IRB's determinations and puts a copy in the protocol file.
The UAB IRB is responsible for determining whether alleged activities constitute non-compliance and, if so, whether the non-compliance is serious and/or continuing.
When the IRB determines non-compliance in the conduct of a protocol, it may request one or more corrective actions before considering the protocol for approval such as increasing its oversight through more frequent continuing reviews or completing additional human subjects training.
An allegation of non-compliance that is potentially serious or continuing will be referred to the Compliance Review Subcommittee of the IRB for further evaluation and fact finding. The subcommittee recommendation is forwarded to the IRB. Before making any determination of serious or continuing non-compliance, the IRB will review the subcommittee recommendation at a convened board meeting to which the investigator will have the opportunity to attend. When the IRB finds non-compliance that is determined to be serious or continuing, the IRB reports its findings to UAB's Institutional Official (IO). The IO then reports the finding to other appropriate institutional officials and external agencies including the sponsor (e.g., UAB personnel, OHRP, FDA) in accordance with UAB policy.
All such IRB determinations and requested corrective actions are communicated in writing to the principal investigator.