The Research-Clinical Practice Distinction, Learning Health Systems, and Relationships

Howard Brody, Franklin G. Miller

Research output: Contribution to journalArticlepeer-review

29 Scopus citations


A special report of The Hastings Center and the Association of American Medical Colleges addressed the ethical oversight of learning health systems, which seek to combine high-quality patient care with routine data collection aimed at improving patient outcomes. The report contained two position papers, authored by a number of distinguished bioethicists, and several commentaries. The position papers urged two changes. First, they urged a rethinking of our approach to the regulation of human subjects research, so as to make it easier in the future for learning health systems to function well. Second, they argued that the rethinking required dispensing with a strict distinction between research and therapy, which has been a major tenet of bioethics since the Belmont Report, which explicated basic ethical principles governing human subjects research. We fully support the objectives of the authors, and we agree that the learning health system is an important advance that serves patients well. Unnecessary regulatory burden ought not impede this progress. We disagree, however, that the best way to bring about these needed changes in the regulatory environment is to reject the basic distinction between research and treatment. Unfortunately, we find the arguments in favor of that strategy to be, in places, reminiscent of what we take to be basic conceptual errors that hampered the ethical understanding of human subjects research prior to adoption of the Belmont Report. To see why one need not reject the research-treatment distinction in order to promote learning health systems, we first investigate in some detail the arguments offered for eliminating the distinction. We next turn to an issue not addressed by those authors, namely, the relationship between the physician or investigator and the patient or subject, to illustrate why the distinction is important and what is lost if it is jettisoned.

Original languageEnglish (US)
Pages (from-to)41-47
Number of pages7
JournalHastings Center Report
Issue number5
StatePublished - Sep 2013
Externally publishedYes

ASJC Scopus subject areas

  • Health(social science)
  • Issues, ethics and legal aspects
  • Philosophy
  • Health Policy


Dive into the research topics of 'The Research-Clinical Practice Distinction, Learning Health Systems, and Relationships'. Together they form a unique fingerprint.

Cite this