Projects

Ethics of Integrating Research and Treatment

Research and Treatment in Comparative Effectiveness, Quality Improvement and Investigational New Drug Research

About the project

As continuous learning is more regularly adopted into medical care, learning and care delivery increasingly will be integrated, rather than being designed to be separate, independent activities. This poses challenges for the regulatory system that has relied historically on a distinction between research and care activities to determine where oversight is needed. This project conducted historical and policy research, empirical work with health system leaders, and ultimately created a framework for ethics and learning health systems that advocates for more integration of learning and practice while outlining a set of ethics obligations to undergird both.

Principal investigators

Ruth R. Faden, PhD, MPH

Berman Institute Founder; Philip Franklin Wagley Professor of Biomedical Ethics

Tom Beauchamp, PhD

Professor Emeritus, Georgetown University

Peter Pronovost, MD, PhD

Chief Clinical Transformation Officer, University Hospitals

Nancy E. Kass, ScD

Deputy Director for Public Health; Phoebe R. Berman Professor of Bioethics and Public Health

Sean Tunis, MD, MSc

Founder and Senior Strategic Advisor, Center for Medical Technology Policy

Steven Goodman, MD, PhD

Associate Dean for Clinical and Translational Research, Professor of Medicine and of Health Research & Policy, Stanford University

Staff

Daniel O’Connor
Yashar Saghai
Danielle Whicher

Publications

Danielle Whicher, Nancy Kass, Yashar Saghai, Ruth Faden, Sean Tunis and Peter Provonost. The Views of Quality Improvement Professionals and Comparative Effectiveness Researchers on Ethics, IRBs and Oversight. Journal of Empirical Research on Human Research Ethics 10:2, 2015.

Danielle Whicher, Nancy Kass and Ruth Faden. Stakeholders’ Views of Alternatives to Prospective Informed Consent for Minimal-Risk Pragmatic Comparative Effectiveness Trials. Journal of Law, Medicine & Ethics 43:2, 2015.

Ruth Faden, Nancy Kass, Danielle Whicher, Walter Stewartand Sean Tunis. Ethics and Informed Consent for Comparative Effectiveness Research with Prospective Electronic Clinical Data. Medical Care 51, 2013.

Richard Platt, Nancy Kass, Deven McGraw. Ethics, Regulation, and Comparative Effectiveness Research: Time for a Change. The Journal of the American Medical Association 311:15, 2014.

Ruth Faden, Tom Beauchamp and Nancy Kass.Informed Consent, Comparative Effectiveness and Learning Health Care. New England Journal of Medicine 370:8, 2014.

Nancy Kass, Ruth Faden, Sean Tunis. Addressing Low Risk Comparative Effectiveness Research in Proposed Changes to US Federal Regulations Governing Research. The Journal of the American Medical Association 307:15, 2012.

Nancy Kass, Ruth Faden, Steven Goodman, Peter Pronovost, Sean Tunis and Tom Beauchamp. The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight. Hastings Center Report 43:1, 2013.

Ruth Faden. Nancy Kass, Steven Goodman, Peter Provonost, Sean Tunis and Tom Beauchamp. An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics. Hastings Center Report 43:1, 2013.

Tom Beauchamp and Yashar Saghai. The historical foundations of the research-practice distinction in bioethics. Theoretical Medicine and Bioethics 33(1): 45-46. 2012.