Faden et al. Question Research-Treatment Distinction

Writing in a special report of the Hastings Center Report, a team of prominent ethicists and researchers "argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice." Yet they decline to detail the implications of any regulatory change for IRB review of medical research, much less research in the social sciences and humanities.

[Kass, Nancy E., Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp. "The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight." Hastings Center Report 43, no. s1 (2013): S4–S15. doi:10.1002/hast.133. h/t Yashar Saghai]

Kass et al. note that the current distinction between research and practice dates to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s. They suggest that it was a useful distinction at the time, but that developments over the decades have made it less so:

The traditional definitions and descriptions of clinical research and clinical practice are becoming blurred as a model of health care emerges in which practice and learning are integrated, where a central goal of the health care system is to collect, aggregate, analyze, and learn from patient-level data, and where clinicians are expected to make evidence-based practice decisions guided by the general knowledge produced from structured learning. This emerging way of organizing health care did not prevail when federal regulations governing research involving human subjects were initially developed, but it increasingly does today.

What does this mean for IRB review? As other authors in the special report point out, Kass et al. "deliberately leave the role of independent oversight in a learning health care system un- specified." [Largent, Emily A., Franklin G. Miller, and Steven Joffe. "A Prescription for Ethical Learning." Hastings Center Report 43, no. s1 (2013): S28–S29. doi:10.1002/hast.135.]

But Kass et al. do make a good case that deciding what requires prior approval based on a design to contribute to generalizable knowledge or its use of a "systematic investigation" is increasingly problematic even for the purpose for which it was originally designed.