PRIM&R Project on the Boundary Between Research and Practice

When activities contain elements that resemble experimentation with human beings, the persons carrying them out have to decide whether they should—or may be told they must—submit them to an institutional review board (IRB) for formal ethics review. Yet the need for review may or may not correlate with whether the activities meet the regulatory definition of “research,” which would make IRB approval mandatory. Thus, practitioners, as well as ethicists and other interested parties, lack—and need—clear decision rules to guide them in making such decisions.

In 2011, PRIM&R gathered stakeholders from a wide range of disciplines and institutional settings to address this issue and 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. Since that time, PRIM&R has continued to gather input from members of the research community. The result of these efforts is reflected in PRIM&R’s white paper titled Health-Related Activities Along the Boundary Between Research and Practice: When to Take Alternate Approaches to Providing Ethical Oversight.  

The project organizers selected four domains of health practice in which such boundary questions arise: (1) innovative medical and surgical clinical interventions; (2) public health practices; (3) community-engaged health activities; and (4) quality assurance/quality improvement activities. PRIM&R assembled working groups, which included ethicists and subject-matter experts, on each of the domain. These groups were charged with describing the features of the practices in question that resemble research and the circumstances under which those practices might merit formal ethical review. They also worked to identify mechanisms other than IRBs that could provide the needed ethical review.

The findings and conclusions of the four working groups were then assembled to ascertain commonalities across the four domains. From these, the project organizers produced a proposed set of considerations to help decision-makers determine what ethics review, if any, might be required for activities conducted along the boundary between research and practice and a working list of alternative strategies for ethics review.

We invite you to read the full white paper below as well as the appendices, which provide insight into the methodology, case examples, and reports on each of the four domains. 

Please note that the case studies in Appendix B were provided by project participants and PRIM&R members. In their current form, the cases demonstrate issues encountered along the boundary between research and practice. Over the course of the next year, PRIM&R will work to further organize, format, and refine these cases as we develop a framework for analyzing them in relation to the recommendations laid out in the white paper.