Demonstrating Respect and Acceptable Consent Strategies: What Matters to Patients in PCOR?

(project underway—no publications to date)

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.

Realizing the Goals of Continuous Learning: Insights on Ethics & Implementation from Institutional Leaders in Learning Health Care

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.
Morain SR, Kass NE, Grossmann C. What Allows a Health Care System to become a Learning Health Care System: Results from Interviews with Health System Leaders. Learning Health Care (forthcoming).
Abraham E, Blanco C, Lee CC, Christian JB, Kass N, Larson EB, Mazumdar M, Morain S, Newton KM, Ommaya A, Patrick-Lake B, Platt R, Steiner J, Zirkle M, Lopez MH. Generating Knowledge from Best Care: Advancing the Continuously Learning Health System. National Academy of Medicine Discussion Paper. September 6, 2016.

Research and Treatment in Comparative Effectiveness, QI and IND Research

2Danielle Whicher, Nancy Kass, Yashar Saghai, Ruth Faden, Sean Tunis and Peter Pronovost. 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 Pronovost, 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.

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.

The NIH Collaboratory Regulatory/Ethics Core

Jeremy Sugarman. Ethics of research in usual care settings: Data on point. AJOB Empirical Bioethics, 7(2): 71–75, 2016.
Rachel Topazian, Juli Bollinger, Kevin P. Weinfurt, Rachel Dvoskin, Debra Mathews, Kathleen Brelsford, Matthew DeCamp, Jeremy Sugarman. Physicians’ perspectives regarding pragmatic clinical trials. Journal of Comparative Effectiveness Research, 5(5): 499–506, 2016.
Kenneth P. Weinfurt, Juli M. Bollinger, Kathleen M. Brelsford, Travis J. Crayton, Rachel J. Topazian, Nancy E. Kass, Laura M. Beskow, Jeremy Sugarman. Patients’ views concerning research on medical practices: Implications for consent. AJOB Empirical Bioethics 7(2):76–91, 2016.
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.

Other Publications

Jeremy Sugarman. Ethics and regulatory challenges and opportunities in patient-centered comparative effectiveness research. Academic Medicine 91: 455–457, 2016.
 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 Families in 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 Association 311:23, 2014.
Danielle Whicher. Rethinking Informed Consent Requirements for Pragmatic Comparative Effectiveness Trials. Doctoral dissertation, Johns Hopkins University, 2014.