The NIH Health Care System Research Collaboratory Regulatory/Ethics Core

About the project

The Regulatory/Ethics Core identifies areas of regulatory and ethical uncertainty arising from pragmatic clinical trials. The team works with the Demonstration Projects to navigate regulatory and ethical complexities associated with pragmatic clinical trials conducted within health care systems. In addition, the Core conducts empirical research related to these regulatory issues.

Project period: 2012-

core leads

Jeremy Sugarman, MD, MPH, MA
Deputy Director for Medicine; Core Faculty; Harvey M. Meyerhoff Professor of Bioethics and Medicine
Kevin Weinfurt, PhD
Professor and Vice Chair for Research, Dept. of Population Health Sciences, Duke University School of Medicine

publications

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.