The historical foundations of the research-practice distinction in bioethics

Abstract

The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities and interventions. This model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons.

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Notes

  1. 1.

    In 1991 fifteen federal agencies adopted 45 CFR 46, Subpart A, which then became informally known as the Common Rule (formally “Federal Policy for the Protection of Human Research Subjects”). In 2005 technical amendments were made.

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Acknowledgments

This article was supported by Award Number RC1RR028876 from the National Center for Research Resources. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health. We thank our colleagues on a larger, connected project: Ruth R. Faden, Steven Goodman, Nancy Kass, Peter Pronovost, and Sean Tunis.

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Correspondence to Tom L. Beauchamp.

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Beauchamp, T.L., Saghai, Y. The historical foundations of the research-practice distinction in bioethics. Theor Med Bioeth 33, 45–56 (2012). https://doi.org/10.1007/s11017-011-9207-8

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Keywords

  • Belmont report
  • Research
  • Practice
  • Innovative treatment
  • IRBs
  • History of medical ethics
  • Nonvalidated treatment
  • Politics of bioethics
  • Regulation
  • Research ethics