Conducting research in private practice groups (PPGs) facilitates diversity in the participant pool and that may result in more generalizable results. It can also increase the pool of eligible participants enhancing accrual into studies, leading to faster completion of studies.
Several federal initiatives encourage the inclusion of community partners and PPGs in clinical research. PPGs face many compliance and regulatory barriers to their participation in human subjects’ research. To promote PPG participation in multi-site research our university developed and implemented two pathways to act as the central IRB (CIRB) for PPGs that were not currently conducting human subjects’ research.
In the first pathway, PPGs obtained a federal wide assurance (FWA) and executed reliance agreements with the university to use the CIRB. Obtaining and maintaining an FWA involves establishing a HRPP to ensure compliance with the obligations of the FWA. This process presents a challenge for many PPGs. To allow use of the CIRB for those PPGs that did not have the resources to support an FWA, we extended the university's FWA using an individual investigator agreement (IIA) in accordance with Office for Human Research Protection regulations. The process required a coordinated effort between the primary clinical site, each PPG, funding agencies, the CIRB chair, CIRB administrators, and counsel. Since the first pathway requires developing a HRPP, it is only a viable option for those PPGs with the resources and experience to promptly complete the assurance and process the reliance agreement.
The second pathway involves more active collaboration between the institution and the PPGs. This pathway allows the PPGs to rely on existing HRPPs at the academic institutions decreasing the regulatory and compliance hurdles for the PPGs while increasing the CIRB’s institutional burden to ensure appropriate oversight of PPGs.
Both pathways provide a route to promote PPG and community engagement in research and will allow these sites to participate in National Institutes of Health clinical trials to provide access to diverse patient populations that will lead to more robust and generalizable results.