In this series of Ampersand posts, PRIM&R touches base with those who presented programmatic and research-based findings at past PRIM&R conferences.

Spotlight on an abstract from the 2009 AER Conference

Title: Implementation of the University of California System’s IRB Memorandum of Understanding

Authors: Rebecca D. Armstrong, DVM, PhD and Lisa Voss, MPH

Affiliation: University of California, Berkeley

Abstract summary: This program sought to evaluate the success of the University of California (UC) System’s IRB Memorandum of Understanding (MOU). The MOU was endorsed in 2006 with the goal of decreasing the number of UC IRBs that need to review collaborative research taking place at multiple UC sites, thereby reducing the burden on principal investigators and increasing the speed of study implementation.

The authors’ findings indicate the MOU saves principal investigators hours in IRB preparation and review. In addition, an unanticipated benefit is an increased understanding of each others’ policies, procedures and institutional climate—along with more cooperation among IRB offices.

PRIM&R Staff (PS): In the months since you presented this abstract at PRIM&R’s 2009 AER Conference, how has your program changed or evolved?

Rebecca D. Armstrong, DVM, PhD (RA): Due to increased institutional concerns about liability and post-approval monitoring within our system, the UC IRB directors placed a temporary “hold” on relying on each other’s full committee reviews system-wide.

The “pilot” group of institutions (UC Berkeley, UC San Francisco, UC Davis, and Lawrence Berkeley National Lab) that began this level of reliance are continuing to rely on each other for full committee reviews. Another change pertains to the UC Office of the President (UCOP) that had been maintaining a central database and website about this MOU. The IRB directors decided that the original purpose of such a database and public website was not being met, and that the effort to keep the website updated was not worth the time involved. Therefore, the website has been taken down, although UCOP will continue to be notified of MOU projects and a standardized protocol identification system has evolved to facilitate tracking.

PS: What challenges have you faced in implementing this program?

RA: The biggest challenge has been the administrative management of this reliance process given the system-wide furloughs, layoffs, and budget cuts. This has resulted in some schools wanting to streamline our documentation even more in order to reduce the staff workload.

For questions or comments about this program, please contact Dr. Armstrong.

Interested in submitting an abstract to present at PRIM&R’s next animal or human research ethics conference? Please e-mail us for more information.