Ethics of Integrating Research and Treatment

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

Investigators:

RuthFadenSq-100x100Ruth Faden, PhD, MPH, Andreas C. Dracopoulos Director, Philip Franklin Wagley Professor, Johns Hopkins Berman Institute of Bioethics
kasssq-100x100Nancy Kass, ScD, Phoebe R. Berman Professor of Bioethics and Public Health, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Deputy Director of Public Health, Johns Hopkins Berman Institute of Bioethics
Tom Beauchamp, PhD, Professor of Philosophy and Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University
Sean Tunis, MD, MSc, Founder & Chief Executive Officer,  Center for Medical Technology Policy
Peter Pronovost, MD, PhD, Senior Vice President, Patient Safety and Quality, Professor of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine
Steven Goodman, MD, MHS, PhD, Associate Dean for Clinical and Translational Research, Professor of Medicine and of Health Research & Policy, Stanford University School of Medicine

Staff:

Daniel O’Connor
Yashar Saghai
Danielle Whicher

About the Project:

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. This project is intended to begin to fill the knowledge and policy gap in research ethics created by the increasing integration of research with treatment.

Publications

2Danielle 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.
cover (1)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.
XLargeThumbRuth Faden, Nancy Kass, Danielle Whicher, Walter Stewart and Sean Tunis. Ethics and Informed Consent for Comparative Effectiveness Research with Prospective Electronic Clinical Data. Medical Care 51, 2013.
s_cover_jcv041614Richard 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.
Nejm_logo2011Ruth Faden, Tom Beauchamp and Nancy Kass. Informed Consent, Comparative Effectiveness and Learning Health Care. New England Journal of Medicine 370:8, 2014.
s_cover_jcv041812Nancy 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.
coverNancy 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.
coverRuth 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.

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