The NIH Collaboratory Regulatory/Ethics Core

Co-Chairs:

Jeremy Sugarman, MD, MPH, MA, Harvey M. Meyerhoff Professor of Bioethics and Medicine, Berman Institute of Bioethics, Johns Hopkins University
Kevin Weinfurt, PhD, Professor of Psychiatry and Behavioral Sciences, Duke University School of Medicine

About the Project:

2012–

The Regulatory/Ethics Core identifies areas of regulatory and ethical uncertainty arising from pragmatic clinical trials and other research involving collecting data from routine care. The team works with the Demonstration Projects to navigate regulatory and ethical complexities associated with pragmatic clinical trials conducted within health care systems.

Read more on the NIH Collaboratory Website.

Publications

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.

See all LHS publications.