PERFORMANCE IMPROVEMENT/QUALITY MANAGEMENT
The primary responsibility for quality management of research protocols rests with the principal investigator and the research team. Internal assessments performed by the Institutional Review Board supplement those quality management activities performed by the Principal Investigator and his/her research team.
It is the expectations of the UMC IRB that it’s Investigators adhere to the highest standards of ethical and professional conduct in accordance with federal and state regulations and UMC institutional and IRB policies governing the conduct of research involving human subjects. If in the judgment of the IRB Chair or IRB Vice-Chairman that an investigator is not complying with the regulations and policies described in this document, receives an allegation and makes a determination as to the truthfulness of the allegation, the IRB Chairman or Vice-Chairman may request additional information or request that an audit of the research be performed.
Types of Audits:
For Cause Audits: If information is presented to the IRB raising serious concerns for patient safety and well-being or investigator non-compliance with IRB requirements, the IRB Coordinator will conduct a For Cause Audit. “For Cause” audits may be conducted without notice to the principal investigator.
Indicators for Audits
Indicators may include but are not limited to the following:
- Research participant/family member complaint
- Participant Death
- Investigator-driven studies with no DSMB
- Studies without identified oversight
- Lapses in continuing review/studies administratively closed by IRB
- Appearance of lack of staff support/resources/high staff turnover
- Ongoing concerns of quality IRB/R&D Submissions
- Ongoing document processing concerns in IRB/R&D
Scope of Site Visit
Selected subjects’ research records and medical records, where necessary, will be reviewed to assess whether the research is being conducted in accordance with he approved study protocol, whether the consent process is appropriate and adequately documented, and whether adverse events and incidents are being reported to the IRB in accordance with institutional policies and procedures.
Investigator’s Research Records
The investigator’s research records will be reviewed to assess whether required documentation is present and organized and whether appropriate reports have been submitted to the IRB.
Process for Site Visit
The investigator will be notified by the IRB Coordinator that their study has been selected for a site visit. The investigator will be required to contact the IRB Coordinator within 3 working days to schedule the site visit within the subsequent 2-4 week period. The principal investigator and research coordinator must be available to answer questions during the site visit and both must be available for an exit interview.
Once the site visit is scheduled, the investigator is asked to provide a list of subjects enrolled, and prepares the essential files for review.
The IRB Coordinator selects 2-8 subjects whose research records will be examined.
- Small (1-10 subjects): 2 records selected
- Medium (11-25 subjects): 3-4 records selected
- Large (26-40 subjects): 5-6 records selected
- Very Large (>40 subjects): 7-8 records selected
At the end of the site visit, an exit interview is conducted, by one ore more members of the site visit team, with the PI and research coordinator to review basic findings, answer questions from the researchers, provide education, and collect feedback on the IRB processes.
The IRB Coordinator, in consultation with the IRB Chair or Vice-Chair creates a written report detailing the findings of the site visit and making recommendations for improvement. Depending upon the nature of deficiencies found, the audit report may be discussed at the IRB meeting prior to being forwarded to the PI.
The report, with the addition of any IRB comments, if forwarded to the PI.
If necessary, the PI will be asked to provide a written corrective action plan to address any deficiencies noted in the report. In some cases, the PI’s assurance regarding the immediate implementation of corrective actions recommended in the audit report will suffice.
Follow-up visits may be scheduled to see whether corrective measures, where necessary, have been successfully implemented.