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. Health-Related Activities Along the Boundary Between Research and Practice provides guidance for determining whether such activities require formal ethics review, as well as approaches to ethics review other than appeal to an often over-worked and ill-suited-for-the-context IRB.

In conjunction with the release of this white paper, we are also pleased to be able to make available a series of case studies, which were submitted by project participants and PRIM&R members. In their current form, the cases provide examples of issues encountered along the boundary between research and practice. Over the course of the next year, we will work to further organize, format, and refine these cases and develop a framework for analyzing them in relation to the recommendations laid out in our report. We appreciate those who have already submitted cases to this collection, and as we continue to grow this component of our project, we plan to solicit additional cases as well.

There are also a number of sessions planned for the 2014 Advancing Ethical Research Conference that will address “boundary” issues. These sessions have been labeled with special language, and can be identified by performing a keyword search of the interactive conference schedule for the phrase “boundary between research and practice.”

To further share the strategies and suggestions put forward in Health-Related Activities Along the Boundary Between Research and Practice, members of the PRIM&R Project on the Boundary Between Research and Practice will work with the facilitators of those sessions to ensure that they are aware of this resource, so that they, and you, can benefit from the recommendations offered in the report, and be part of our efforts toward continuous quality improvement. As you make use of the white paper and put our recommendations into practice, we encourage you to share your thoughts and suggestions and, of course, send us any case studies that you might have.

Finally, a word about this milestone itself. The PRIM&R Board of Directors is committed to being active in public policy matters, a goal that we achieve, in part, by commenting on regulatory and legislative proposals and issues where we believe that our unique perspective might be helpful. As part of our continued commitment to public policy, we promise to be proactive—to look for areas where the field seems to be in need of guidance or direction and to do our best to help fill that void. As a first step, with input from many of you, we chose to examine the boundaries between research and practice, and we are pleased to make available to you the result of that effort. We hope it does justice to the many remarkable contributions from so many of you, for, after all, your engagement is what makes PRIM&R such a priceless learning community. Thanks for all you do to make it so.