From Evidence-Based Medicine to Evidence-Based Practice

Abstract

In the pursuit of truly evidence-based medicine (EBM) and the "learning health care system" that the Institute of Medicine has called for, both bioethicists and federal regulators are, happily, rethinking the way that we govern both biomedical research and medical practice, as well as the sharp boundary that the field has assumed can and should exist between them.

Meanwhile, a parallel conversation is taking place among legal scholars, political scientists, lawmakers and others, who increasingly argue that all decisions affecting human welfare — and not just medical decisions — should, wherever possible, be based on sound evidence about the comparative effects of available alternatives. Participants in this second conversation, explicitly invoking EMB and the gold standard for producing the evidence base underlying it, the randomized controlled trial (RCT), argue for widespread experimentation in law and policy to effect evidence-based practice (EBP) across several "practice" domains, including legal services, education, criminal justice, housing, voting practices, welfare reform, tax law, and environmental regulation.

This Politics and Policy column, forthcoming in the Hastings Center Report, argues that these conversations should not be separate. The problem with the EBP conversation proceeding on its own is that most of its participants are unaware (perhaps blissfully so) of the elaborate regulatory apparatus that govern all manner of knowledge production; they assume that informed consent is the only potential ethical-legal obstacle to EBP. And the problem with the EBM conversation proceeding on its own is that doing so threatens a repeat of the late 1970s, when regulations and ethical norms that came to govern knowledge production involving all disciplines and methodologies were developed by a relatively insular group within biomedicine.

The column ends by sketching some of the questions that diverse decision-makers will have to confront as they move towards a world in which research is integrated into various practice areas.

Keywords: evidence-based medicine, evidence-based practice, policy experiments, RCT, research ethics, Common Rule, OHRP, experimentation, data privacy, HIPAA