Our virtual library of published works organized by project

PCORnet Ethics and Regulatory Task Force

Joseph 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

Morain SR, Kass NE 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.

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.

Ethics of Integrating Research and Treatment

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

Stakeholder Views on Streamlined Informed Consent

Kass NE, Faden RR, Fabi RE, Morain SR, Hallez K, Whicher D, Tunis S, Moloney R, Messner D, Pitcavage J Alternative consent models for comparative effectiveness studies: Views of patients from two institutions

Morain SR, Whicher DM, Kass NE, Faden RR  Deliberative Engagement Methods for Patient-Centered Outcomes Research.

Morain SR, Tambor E, Moloney R, Kass NE,  Tunis S, Hallez K, Faden RR  Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research

NIH Health Care System Research Collaboratory Regulatory/Ethics Core

Weinfurt KP, Bollinger JM, Brelsford KM, Bresciani M, Lampron Z, Lin L, Topazian RJ, Sugarman J. Comparison of approaches for notification and authorization in pragmatic clinical research evaluating commonly used medical practices.Med Care2017; 55: 970-978.. doi: 10.1097/MLR.0000000000000762. PMID: 28650924. 

Weinfurt KP, Hernandez AF, Coronado GD, DeBar LL, Dember LM, Green BB, Heagerty PJ, Huang SS, James KT, Jarvik JG, Larson EB, Mor V, Platt R, Rosenthal GE, Septimus EJ, Simon GE, Staman KL, SugarmanJ, Vazquez M, Zatzick D, Curtis LH. Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory. BMC Med Res Methodol2017; 17: 144. doi: 10.1186/s12874-017-0420-7. PMID: 28923013.

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.

Robert Califf and Jeremy Sugarman. Exploring the Ethical and Regulatory Issues in Pragmatic Clinical Trials. Clinical Trials 12:5, 2015.

Monique Anderson, Robert Califf and Jeremy Sugarman. Ethics and Regulatory Issues of Pragmatic Cluster Randomized Trials in Contemporary Health Systems. Clinical Trials 12:3, 2015.

Jeremy Sugarman. Is Shared Decision Making an Appropriate Analytic Frame for Research on Medical Practices? The American Journal of Bioethics 15:9, 2015.