21 - The Safety and Welfare Analysis Group, an Efficient and Cost-effective Approach to Reviewing IRB Compliance

Background: The Office of Human Research Ethics (OHRE) provides IRB oversight to five health schools (Medicine, Public Health, Pharmacy, Dentistry and Nursing), Arts & Sciences, a statewide health system, and 46 research centers/institutes. An essential part is to ensure prompt review of Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) and non-compliance with laws/policies governing human subjects protections.

Program

Description: The Safety and Welfare Analysis Group (SWAG) was created to efficiently manage the volume of Promptly Reportable Information (PRI), including UPRISOs and non-compliance. It is not a convened IRB. SWAG consists of a Compliance Manager and Analyst, and two clinical researchers: a physician in the Division of Gynecologic Oncology and a physician assistant at the Department of Neurology. When a researcher submits PRI, it is reviewed by the compliance team to assess immediate risk or whether it can be resolved without going to SWAG or the full IRB committee. The remaining PRI are then assigned to a SWAG member and reviewed by the group weekly. The goals are to apply a multidisciplinary approach, obtain information for a concise understanding of the event, and to properly apply human subjects research regulations and policies to recommended determinations. SWAG can resolve an event as non-compliance or assign for review by a convened IRB.

Program

Assessment: In 2022, OHRE received an estimated 824 PRI reports, with the majority requiring an administrative review (e.g., minor noncompliance or investigator's brochure update). SWAG reviewed 257 of these, as well as 142 investigator responses to stipulations requesting additional information. SWAG referred 92 events to the convened IRB. The clarifications generated by SWAG facilitated timely reviews by the convened IRB, enabling the committee to consider a full agenda of initial reviews, renewals, and modifications. The preparatory work to get a submission on a board's agenda was reduced as expertise was routinely available, and this also contributed to efficient reviews by the convened IRB, with only 11 out of the 92 full board reviews requiring a deferral (several of which were suspensions).
A key driver of success in managing the volume of PRI is the diversity of expertise within SWAG from both the regulatory and the research perspectives, which generates precise and succinct descriptions of events in relation to potential increase in risk to human subjects. In addition, each SWAG member brings their experience in reviewing PRI back to their home department, creating shared understanding of the regulatory requirements for human subjects research and how OHRE can adapt to assist researchers in overcoming regulatory challenges to their work.

Limitations: It has been important to educate boards that SWAG referrals are only recommendations, and the convened IRB has the independence to make the final determinations. Furthermore, SWAG referrals to full board are not always unanimous. An event will be referred to board if there is disagreement within SWAG. Also, as SWAG members are researchers and their roles evolve, a system to verify potential conflict of interest and group member recusal from reviews was developed.

Discussion: For the University, SWAG offers an in-depth learning opportunity to improve research compliance. For study teams with compliance issues, attending SWAG, much like students attending board meetings for education, may offer insights into how to best ensure human subject protections.
For other institutions, the SWAG model is a solution to managing compliance reviews. IRBs have limited personnel and clinical expertise. SWAG raises the analytical capabilities to review complex research and brings a researcher perspective to the process. It reduces costs by only bringing to board PRI that require a convened IRB, and ensuring boards have the appropriate information to make determinations without an unnecessary deferral.