Compliance and Monitoring

Compliance and Monitoring

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

  • Notify the IRB when a protocol is changed to eliminate an apparent immediate hazard to one or more human subjects—as soon as possible and not later than 5 working days after the change.
  • Notify the IRB of any information related to non-compliance with federal regulations, state laws, institutional policies, or IRB requirements and determinations—as soon as possible and not later than 10 working days from the date of learning the information.
  • Respond in a timely manner to all IRB requests regarding compliance.

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.)

Monitoring IRB Protocols

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:

  • Original IRB Protocol approval
  • Amendments
  • Consent Forms
  • IRB Continuing Review materials (this would include Final Report)
  • Final Report
  • Adverse Events or Unanticipated Problems
  • Sponsor Correspondence
  • Investigator Brochure
  • FDA Form 1572, if applicable
  • Participant Screening and Enrollment Logs
  • Monitoring Report

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.

Classifying, Correcting, and Reporting Non-compliance

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.

Definitions Related to Non-compliance

Allegation of non-compliance:
An unproven assertion of non-compliance.
Compliance Review Subcommittee:
A standing subcommittee established to provide a thorough factual basis and recommendations in response to allegations or reports of non-compliance before the matter is presented to the convened IRB. The subcommittee will consist of at least three IRB members nominated by the IRB Chair and confirmed by the IRB and the Regulatory Compliance Manager of the OIRB. Appointments are for 2-year renewable terms.
Continuing Non-compliance:
A pattern of repeated non-compliance actions or omissions that, if unaddressed, may compromise the integrity of the UAB human research protection program. The pattern may reflect a lack of knowledge on the part of the investigator or a lack of commitment by the investigator and/or research team to human subject’s protection. Non-compliance may be both serious and continuing.
Finding of non-compliance:
Non-compliance that is proven by substantial evidence.
Non-compliance:
Failure of an investigator or member of the research team to adhere to the terms of IRB approval or other requirements or determinations by the IRB; or failure to abide by applicable laws or regulations or UAB policies, including failure to submit research for IRB review and approval before initiating research.
Non-serious, non-continuing (NSNC) non-compliance:
Non-compliance which is neither serious nor continuing. NSNC non-compliance if repeated may result in continuing and possibly serious non-compliance.
Serious Non-compliance:
Failure to comply with laws or regulations, UAB policies, or the requirements or determinations of the reviewing IRB when that failure increases the risk to subjects or adversely affects the rights and welfare of the subjects. A single instance of non-compliance may be serious. Examples of serious non-compliance may include the following:
  • Falsifying IRB documents
  • Conducting human subjects research without IRB approval
  • Deviating from the IRB-approved protocol or consent process
  • Modifying the protocol or consent process without prior IRB approval
  • Failing to maintain regulatory documents
  • Inadequately overseeing research

Page updated: May 8, 2013