The notice of proposed rulemaking (NPRM), issued in the Federal Register on September 8, 2015, proposes revisions to the Common Rule—federal regulations that govern the protection of human subjects in research—including changes to the criteria for institutional review board (IRB) approval of research. This is the next installment in a blog series about those changes and their relationship to the Bioethics Commission’s work on incidental and secondary findings.
Currently, the Common Rule requires IRBs to find that certain criteria have been met in order to approve research. The NPRM proposes an addition that IRBs should evaluate the appropriateness of a plan for returning individual findings discovered during research, when that plan is submitted as part of the protocol. The proposed rulemaking also addresses the potential challenges of returning individual research findings when it is unclear if the findings are clinically valid or actionable, or when the findings might have psychological or social ramifications.
The Bioethics Commission addressed return of individual research results in its December 2013 report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The Bioethics Commission recommended that IRBs review and approve plans for the disclosure and management of incidental findings—a recommendation echoed in the proposed changes to the Common Rule. The Bioethics Commission stressed the importance of this plan, recommending both that researchers develop a plan for managing incidental and secondary findings and that, during the informed consent process, researchers clearly communicate their plan to participants.
The NPRM cites to the Bioethics Commission’s report, recognizing the importance of the issue of return of individual research results, and the challenges highlighted by Anticipate and Communicate. The challenge of incidental findings and returning individual results in a research context is a perennial one for IRBs and researchers, and due to more advanced technologies and faster and deeper data analysis, the issue is growing. Anticipate and Communicate addresses these challenges head-on, and the Bioethics Commission is pleased to see that federal research regulations are evolving to address them as well.