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Ethical Oversight of Learning Health Care Systems

learning_health_care_systems_coverThe 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.

Guest editors: Mildred Z. Solomon, president of The Hastings Center, and Ann C. Bonham, chief science officer of the American Association of Medical Colleges

  

Introduction

Ethical Oversight of Research on Patient Care (FREE)

Mildred Z. Solomon and Ann C. Bonham

So far, there has been no foundational analysis of the fit between the existing human subjects protection framework in the United States and the new kinds of data collection activities being undertaken by learning health care systems. 

  

Articles

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

Conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice. 

  

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

Toward a new ethics framework for learning health care systems. 

  

Commentaries

A Prescription for Ethical Learning

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

Ruth Faden and colleagues advance the scholarly debate, but at least three issues they raise require additional attention. 

  

The Unbelievable Rightness of Being in Clinical Trials

Jerry Menikoff

Although much of what Ruth Faden and colleagues say meshes with the ideas of the U.S. DHHS for reforming the research subjects protection system, a more robust informed consent requirement should be retained. 

  

Making the Transition to a Learning Health Care System

Christine Grady and David Wendler

In what way, is the proposed framework novel and transformative? The answer appears to lie largely in the obligation to conduct learning activities. 

  

Ethical Oversight: Serving the Best Interests of Patients

Joe V. Selby and Harlan M. Krumholz

Should ethical oversight simply be eliminated research activities that cannot be distinguished from clinical care? 

  

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

Richard Platt, Claudia Grossmann and Harry P. Selker

Rigorous, systematic evaluation should be considered part of normal, expected operations, rather than exceptional behavior that requires extraordinary regulatory control. 

  

Reform within the Common Rule?

Tom Puglisi

Meaningful systemic modernization of the Common Rule is not likely to occur any time soon, yet is desperately needed. In the short term, the agencies that implement it must update their practical guidance for implementing the current regulatory requirements. 

  

Advances in the Research Enterprise

Joel Kupersmith

The VA has been a leader in learning health systems, using electronic health records and other inputs to form large databases and a data-driven health care system. 

  

Authors

  

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