1. Single, Central & commercial
Consolidation of IRB review
Kyle Conner, MA, CIP

2. The RIFT
Over the past 20 years, the model of regulatory review for multicenter clinical trials conducted at academic sites has gradually shifted from exclusively decentralized, local IRB review to increasing centralized review.
Commercial IRBs came into existence ~40 years ago to meet the need for reviewing clinical trials for pharma.
Sites approved under commercial IRBs at this time were largely community hospitals, private practices, and independent research sites.
Academic sites had a very territorial and protectionist attitude and did not want to cede control of regulatory review and oversight to commercial IRBs.

3. The RIFT
There was suspicion that commercial IRBs were inherently conflicted as for-profit companies and thus gave biased, subpar reviews. Academic IRBs claimed the moral highground.
Pharma pushed back in some instances by requiring acceptance of commercial IRB oversight for academic sites wanting to join studies.
Meanwhile, NCI began piloting its central IRB (CIRB) initiative, and mandated that all sites involved in trials reviewed by NCI CIRB must agree to its oversight. Jefferson joined the pilot initiative c

4. The rift
The mood of protectionism was heightened by the aggressive enforcement attitude of the regulatory office of DHHS, then called Office for Protection from Research Risks (OPRR)
In , OPRR made several high profile investigations of well-known academic research institutions. Its temporary suspensions of the human research programs at Duke, Virginia Commonwealth University, and University of Pennsylvania made national headlines.
Interestingly, Duke, as part of its corrective action plan, contracted with WIRB to review some of its research portfolio.

5. The rift
Academy could “afford” to take this position of moral highground. Until early 2000s, NIH funding was more plentiful, and pharma comprised smaller piece of the funding pie.
But then…

6. Summary of Trends in NIH Funding FY1995-FY2016

7. The shift
Supposition: Scarcity of NIH funding contributed to the Academy’s greater willingness to move toward use of commercial IRBs in order to bring in more pharma clinical trials. “Do more with less.”
A general thaw of attitudes was occurring. In the 2000s, commercial IRBs were becoming more visible and intertwined with PRIM&R, whose founding was academically based. Representatives from commercial IRBs were included in panel discussions and academics were crossing over into commercial IRBs, and vice versa.
AAHRPP was founded in Accreditation of commercial IRBs elevated them to the same standard being used by academic IRBs. There was less basis for viewing commercial IRBs as the “other.”

8. The new plateau
Jefferson entered first master service agreement with Western IRB (WIRB) in July 2014.
MSAs with Quorum IRB and Schulman IRB followed.
Numerous per study agreements have been executed with other commercial IRBs over past several years.

9. The new plateau
Further supporting this trend, NIH has issued mandate that all NIH-funded research for multicenter studies must use a single IRB.
This mandate takes effect for all competing grant applications for due dates on or after January 25, 2018.
The Revised Common Rule includes new regulation that certain multicenter research should use a single IRB. This regulation includes exceptions and requires further interpretation for application.

10. The new plateau
The attitude within the IRB world has changed from one of protectionism and enforcement to one of facilitation, education and collegiality.
Commercial IRBs are viewed as partners in a larger research enterprise.
The job of IRBs is twofold: to promote ethical compliance of the highest standard while facilitating efficient and transparent review processes that encompass various models of regulatory oversight.

11. THANKS