RESEARCH AND TREATMENT IN COMPARATIVE EFFECTIVENESS, QI AND IND RESEARCH PROJECT

2010-2015


There is growing recognition that high value health care will be achievable only if the outcomes of medical interventions and practices are continuously under study. The challenge with this shifting environment is to adapt traditional paradigms for the ethics of research to this new paradigm for a research and treatment interface, where research and treatment are increasingly, yet to varying degrees, integrated in what some have called the total learning environment or the learning healthcare system, relying heavily on opportunities offered by electronic medical records and big data.

The US regulatory system is built upon a sharp distinction between research activities that warrant an ethics oversight through IRBs, and clinical practice that is not governed by such oversight system. This project was intended to begin to fill the knowledge and policy gap in research ethics created by the increasing integration of research with treatment, which questioned this sharp distinction and its related regulatory oversight apparatus. The project explored three areas in which research and practice are often integrated:

  1. Traditional clinical trials of unapproved drugs/devices (Investigational New Drugs)

  2. Comparative effectiveness research

  3. Quality improvement research

This project explicated the reasons for rejecting a sharp distinction between research and practice, and put forward an alternative ethics framework for an integrated learning healthcare system and a different oversight system of all learning activities:

Source: the project's  website

Source: the project's website

Deliverables:

  • 9 academic journal articles, including two that I co-authored:
    • A 2012 history and philosophy of science paper, “The Historical Foundations of the Research-Practice Distinction in Bioethics," co-written with Tom Beauchamp (Department of Philosophy and Kennedy Institute of Ethics, Georgetown University). This paper relied on in-depth historical research I conducted in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research's archives (Bioethics Research Library, Georgetown University). Our investigation uncovered surprising evidence about the political, pragmatic, and conceptual rationale behind the objectionable research-practice distinction enshrined in US regulations.
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Team:

  • Ruth Faden, PhD, MPH, Co-Principal Investigator, Johns Hopkins Berman Institute of Bioethics
  • Nancy Kass, ScD, Co-Principal Investigator, Johns Hopkins Berman Institute of Bioethics
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Cor Team Members: Tom Beauchamp, Sean Tunis, Peter Pronovost, Steven Goodman

Staff: Daniel O’Connor, Yashar Saghai, Danielle Whicher