Ethical Oversight of Learning Health Care Systems

Editors: Mildred Z. Solomon and Ann C. Bonham

The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” in which care of patients is integrated with medical research so that the health care practices offered in the system are continuously studied and improved.  Traditionally, research and care have been seen as distinct, conceptually and in practice, and have had distinct oversight regimes. In this special report, two feature-length articles raise questions about the traditional distinction and propose a new moral framework that can provide guidance for both care and research. Half a dozen commentaries following the articles offer a range of critical perspectives.

Table of Contents

Introduction: Ethical Oversight of Research on Patient Care 

Mildred Z. Solomon and Ann C. Bonham


The Research-Treatment Distinction:A Problematic Approach for Determining Which Activities Should Have Ethical Oversight 

Nancy E. Kass, Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis and Tom L. Beauchamp

An Ethics Framework for a Learning Health Care System:A Departure from Traditional Research Ethics and Clinical Ethics 

Ruth R. Faden, Nancy E. Kass, Steven N. Goodman, Peter Pronovost, Sean Tunis and Tom L. Beauchamp


A Prescription for Ethical Learning 

Emily A. Largent, Franklin G. Miller and Steven Joffe

The Unbelievable Rightness of Being in Clinical Trials 

Jerry Menikoff

Making the Transition to a Learning Health Care System 

Christine Grady and David Wendler

Ethical Oversight:Serving the Best Interests of Patients 

Joe V. Selby and Harlan M. Krumholz

Evaluation as Part of Operations:Reconciling the Common Rule and Continuous Improvement 

Richard Platt, Claudia Grossmann and Harry P. Selker

Reform within the Common Rule? 

Tom Puglisi

Advances in the Research Enterprise 

Joel Kupersmith