Center for Medical Ethics and Health Policy

Patient & Stakeholder Views on Consent & Respect in the Learning Health System

Master
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Project Description

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This research explores the attitudes of patients and other stakeholders about different ways of being informed about research projects that compare medical treatments or procedures that are widely used. In the first phase of this research, we used Deliberative Engagement Sessions with patients and stakeholders to understand their views on three different approaches to disclosure/consent for comparative effectiveness research (CER) case studies.

In the second phase of the research, we are conducting survey experiments with patients and the public to explore their views of the acceptability of streamlined disclosure/consent procedures for a low-risk randomized CER study.

Supported By: The Patient Centered Outcomes Research Institute (PCORI)

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Project Personnel

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Principal Investigators

Ruth Faden, Ph.D., M.P.H., Co-Principal Investigator
Nancy Kass, Sc.D., Co-Principal Investigator

Co-Investigators

Stephanie Morain, Ph.D., M.P.H., Co-Investigator

Project Personnel

Kristina Hallez, Research Program Coordinator
JR Johnstone, Research Program Coordinator

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Publications

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Kass NE, Faden RR, Morain SR, Hallez K. Are shorter informed consent discussions, compared with longer forms, acceptable to patients for low-risk comparative studies? Patient Centered Outcomes Research Institute/PCORI.

Morain SR, Kass NE, Faden RR. What factors predict willingness to join low-risk pragmatic clinical trials? Ethics & Human Research.

Morain SR, Majumder M, McGuire A. Learning Health Systems: Moving from Ethical Frameworks to Practical Implementation. Journal of Law, Medicine, & Ethics. 47(3): 454-458.

Morain SR, Kass NE, Faden RR. Learning is Not Enough: Earning Institutional Trustworthiness Through Knowledge Translation. Am J Bioeth 2018; 18(4): 31-34.

Morain SR, Tambor E, Maloney R, Kass NK, Tunis S, Hallez K, Faden RR. Stakeholder Perspectives Regarding Alternate Approaches to
Informed Consent for Comparative Effectiveness Research
. Learning Health Systems. Published online first: Dec. 5, 2017.

Morain SR, Whicher DM, Kass NE, Faden RR. Deliberative Engagement Methods for Patient-Centered Outcomes Research. The Patient. 2017; 10(5): 545-552.

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 SR, Largent, E. Public Attitudes toward Consent When Research Is Integrated into Care - Any “Ought” from All the “Is”? Hastings Center Report - Wiley Online Library.                   

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Presentations

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Morain S. More Learning, More Challenges? Ethics in Integrating Research & Care for Learning Health Systems. NemoursChildren's Health System, Wilmington, DE. November 2020

Morain S. Unlearning to Learn: Reenvisioning Ethical Oversight for Learning Health Systems. UT Southwestern Grand Rounds, Dallas, TX. (delivered virtually due to COVID19) September 2020

Morain S. Testing Methods to Modify the Consent Process. PRIM&R Advancing Ethical Research Conference. San Antonio, TX. November 2017

Morain S. “Streamlining Informed Consent for Patient-Centered   Outcomes Research: Empirical Findings.” PCORI Annual Meeting. National Harbor, MD. October 2016

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

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