Abstract
Background/Aims Institutional Review Boards (IRBs) are charged with protecting human subjects, balancing experimental risks against potential benefits. IRB members sometimes raise concerns that project findings may create risks for an organization. Even if the concerns are legitimate, IRBs have neither the responsibility nor the appropriate expertise to address them. These concerns arise not from research processes potentially addressable by changing the study methods, but from potential findings. Ex ante reviews are speculative; ensuring low probability scenarios never occur means avoiding most delivery system research. Ex post review and approval allows projects to begin, but are generally unacceptable to researchers, funders, and journals. A two-phase process incorporating ex post reviews, but not approvals, offers a solution.
Methods At the request of its Research Institute (RI), the Palo Alto Medical Foundation (PAMF) established an Advisory Committee Concerning Organizational Risk and Dissemination (ACCORD). Members include PAMF’s Chief Risk, Compliance, and Operations Officers, the Vice President for Strategic Planning and Business Development, Regional General Counsel, Director of Communications and Public Affairs, and the medical group’s Chief Medical Quality and Medical Officers. Input from the 8-person ACCORD occurs at two major junctures of the project’s life—-before submission to a funding agency (or if no external funds are requested, before submission to the IRB) and if requested, before manuscript submission.
Results An Organizational Risk Assessment (ORA) form elicits from investigators potential risks in specific areas and how they can be mitigated or managed. Questions focus on organizational image, business strategy, legal/regulatory issues, compliance, quality, operations, and the medical group. ACCORD members raise concerns they have, offer suggestions, and score the project from “serious concerns—let’s discuss” to “risks identified and managed” to “potential value to us.” The first triggers before project commencement a discussion between those raising the concerns and the investigator. The RI director can suggest risk mitigation and management strategies. The ACCORD may ask to comment on project manuscripts before submission, or just be notified before publication. The process is being implemented; early results will be discussed.
Discussion Delivery system research entails various organizational risks. A proactive two-phase advisory process may efficiently balance organizational concerns and researcher autonomy.
