Publications

Research and Treatment in Comparative Effectiveness, QI and IND Research
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.
Stakeholder Views of Streamlined Informed Consent Options for CER
 uabr21Nancy Kass, Ruth Faden, Rachel Fabi, Stephanie Morain, Kristina Hallez, Danielle Whicher, Sean Tunis, Rachael Moloney, Donna Messner and James Pitcavage. Alternative Consent Models for Comparative Effectiveness Studies: Views of Patients from Two Institutions” AJOB Empirical Bioethics 2016.
Demonstrating Respect and Acceptable Consent Strategies: What Matters to Patients in PCOR?
(project underway—no publications to date)
The NIH Collaboratory Regulatory/Ethics Core
5Robert Califf and Jeremy Sugarman. Exploring the Ethical and Regulatory Issues in Pragmatic Clinical Trials. Clinical Trials 12:5, 2015.
3Monique Anderson, Robert Califf and Jeremy Sugarman. Ethics and Regulatory Issues of Pragmatic Cluster Randomized Trials in Contemporary Health Systems. Clinical Trials 12:3, 2015.
uajb20Jeremy Sugarman. Is Shared Decision Making an Appropriate Analytic Frame for Research on Medical Practices? The American Journal of Bioethics 15:9, 2015.
PCORnet Ethics and Regulatory Task Force
gacr20Joseph Ali, Robert Califf and Jeremy Sugarman. Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network. Accountability in Research: Policies and Quality Assurance 23:2, 2016.
Ethics Issues Arising in the Transition to Learning Health Care Systems: Results from Interviews with Leaders from 25 Health Systems
egemsStephanie Morain and Nancy Kass. Ethics Issues Arising in the Transition to Learning Health Care Systems: Results from Interviews with Leaders from 25 Health Systems. eGEMs 4:2, 2016.
Other Publications
 2Samuel M. Brown, Hanan J. Aboumatar, Leslie Francis, John Halamka, Ronen Rozenblum, Eileen Rubin, Barbara Sarnoff Lee, Jeremy Sugarman, Kathleen Turner, Micah Vorwaller, Dominick L. Frosch. Balancing Digital Information-sharing and Patient Privacy When Engaging Familiesin the Intensive Care Unit. Journal of the American Medical Informatics Association 2016.
5Jonathan Finkelstein, Andrew Brickman, Alexander Capron, Daniel Ford, Adrijana Gombosev, Sarah Greene, Peter Iafrate, Laura Kolaczkowski, Sarah Pallin, Mark Pletcher, Karen Staman, Miguel Vazquez and Jeremy Sugarman. Oversight on the Borderline: Quality Improvement and Pragmatic Research. Clinical Trials 12:5, 2015.
JAMAJeremy Sugarman and Robert Califf. Ethics and Regulatory Complexities for Pragmatic Clinical Trials. The Journal of the American Medical Associaton 311:23, 2014.
Tom Beauchamp and Yashar Saghai. The historical foundations of the research-practice distinction in bioethics. Theoretical Medicine and Bioethics 33(1): 45-46. 2012.
Realizing the Goals of Continuous Learning: Health systems’ experiences with ethics and implementation in moving towards a Learning Health Care System