The Learning Health Care System

Traditional informed consent requirements were developed for research to explore the safety and efficacy of new treatments. The requirements reflect a view that clinical research may compromise important patient interests in ways that clinical care does not. In reflection of these distinctions, regulations governing clinical research require that investigators provide potential patient-participants with extensive, written informed consent materials in advance of participation, and (usually) obtain patient signatures to document consent.

However, recent changes in the research landscape have called into question the continued appropriateness of traditional informed consent for all types of clinical research. In particular, there is debate over whether traditional informed consent should be required for comparative effectiveness research, which seeks not to determine if a new treatment is safe or effective, but instead aims to compare commonly used treatments to one another. Reports exist of these studies being delayed by IRB review, or of not being conducted at all due to concerns about the length of time required for extensive informed consent processes. Researchers also note these delays result in fewer studies being conducted, which undermines the evidence needed to deliver high-quality, high-value care.

This project explores patient and public attitudes regarding streamlined models of informed consent for comparative effectiveness research.

Supported by: Patient-Centered Outcomes Research Institute

Principal Investigators

Nancy Kass, Sc.D., Principal Investigator, Johns Hopkins University Berman Institute of Bioethics

Ruth Faden, Ph.D., M.P.H., Principal Investigator, Johns Hopkins University Berman Institute of Bioethics

Baylor Project Personnel

Stephanie Morain, Ph.D., M.P.H.

Project Personnel

Alistair Erskine, M.D., Geisinger Health System

Rebecca Stametz, D.Ed., M.P.H., Geisinger Health System

Abraham E, Blanco C, Castillo Lee C, Christian JB, Kass N, Larson EB, Mazumdar M, Morain S, Newton KM, Ommaya A, Patrick-Lake B, Platt R, Steiner J, Zirkle M, Hamilton Lopez M. Generating Knowledge from Best Care: Advancing the Continuously Learning Health System. National Academy of Medicine. Sept. 6, 2016.

Morain S. Conversations in Bioethics: Consequences of Integrating Research and Clinical Care. Health Science Scholars Distinguished Speakers Series, Austin, TX. February 2016.