Bioethics Blogs

PRIM&R Releases White Paper on the Boundaries Between Research and Practice

by Hugh Tilson, MD, MPH, DrPH, PRIM&R Board Member and Co-Chair of the PRIM&R Project on the Boundary Between Research and Practice

Please join the PRIM&R Project on the Boundary Between Research and Practice in celebrating the release of a white paper titled Health-Related Activities Along the Boundary Between Research and Practice: When to Take Alternate Approaches to Providing Ethical Oversight. The paper, which is now available on PRIM&R’s website, summarizes a three-year effort to develop guidance for persons making decisions regarding the need for ethical review or oversight of health-related activities conducted along the boundary between research and practice.

Whether you work with an IRB or in any one of the four domains of health practice identified in the report that share a sometimes porous boundary with research—namely, (1) innovative medical and surgical clinical interventions, (2) public health practices, (3) community-engaged health activities, or (4) quality assurance/quality improvement activities—you know that determining whether a project requires formal review can be especially challenging. To help you address those challenges, we have developed a set of recommendations regarding ethics review aimed at assisting research professionals who regularly encounter activities that contain elements that resemble experimentation with human beings, but that fall short of the regulatory definition of research involving human subjects.

Drawing on the expertise of stakeholders from a wide range of disciplines and institutional settings, we examined the four domains of health practice mentioned above. In all of these disciplines, situations frequently arise in which practitioners are employing new approaches and strategies, and often—though not always—evaluating how those approaches and strategies work.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.