Post-Approval Consultation (PAC)

Upon request, after IRB approval but prior to subject enrollment, OHSP-QI is available to work with the PI and study team to identify and comply with the Reviewing IRB’s determinations and policies. More specifically, PAC consultations can help:

• Assess your preparedness to achieve compliance with IRB approved protocol/modification(s), IRB requirements, OHSP and UR Policy, applicable federal regulations, and the University’s Federalwide Assurance
• Identify processes for ensuring protocol adherence
• Discussed planned consenting methods
• Evaluate planned study documentation (e.g., study site file, data collection forms, source documents)
• Evaluate risk areas for the Investigator, the subjects, and the University
• Detail the PI oversight plan
• Identify tools and resources to support training, mentoring and research staff development
• Establish a forum for frequent communication between OHSP-QI staff and Research Staff
• Focus on outcomes to support clinical management, essential documentation, subject safety, quality of care, and research oversight

PACs are designed to be informal and flexible. This is the PI/study team’s opportunity to ask any questions and clarify responsibilities. If the PI and/or study team would like to spend more or less time on any particular topic, the PAC can be adjusted accordingly.

After the consultation, OHSP-QI provides a written summary, educational materials/references, support, and study tools.

OHSP-QI has demonstrated that providing study-specific training to study teams via a PAC, increases compliance in human subject research. Study teams who utilized this service had fewer high-risk findings and improved ratings upon internal review compared to those who did not. Reference Q&A commentary from study staff who have utilized the service.

PACs are held after IRB approval and before subject enrollment. The timing of PACs is specific to this period of time because:

• Performing the PAC within the context of an IRB-approved protocol is of greater benefit to the PI/study team. The IRB-approval provides a concrete protocol to work from over one that is still undergoing IRB review and therefore subject to change.
• The aim of the PAC is to set study teams up for success prior to initiating the research; it ensures teams have ‘all of their ducks in a row’ prior to initiating the research and provides an opportunity to clarify/correct any potential pitfalls priors to enrolling subjects.

PIs who have already initiated their research but feel they would benefit from consultation with OHSP-QI can contact ohspqi@urmc.rochester.edu to discuss alternative options.

Yes–in fact, it’s encouraged! Even though the University may defer IRB review to an external IRB, the local PI remains responsible for the conduct of the study and human subject safety.