Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia

Journal of the American Geriatric Society, vol. 68, p. S37-S42, 2020

25 Pages Posted: 3 Sep 2020

See all articles by Emily Largent

Emily Largent

University of Pennsylvania - Perelman School of Medicine

Spencer Phillips Hey

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Kristin Harkins

affiliation not provided to SSRN

Allison K. Hoffman

University of Pennsylvania Carey Law School

Steven Joffe

University of Pennsylvania - Perelman School of Medicine

Julie Lima

Brown University - School of Public Health

Alex John London

Carnegie Mellon University - Philosophy Department

Jason Karlawish

University of Pennsylvania - Perelman School of Medicine, Department of Medical Ethics and Health Policy

Date Written: 2020

Abstract

Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identify who is a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration of informed consent is justifiable. If informed consent is needed, the question arises of how it should be obtained because researchers must acknowledge the vulnerability of PLWD due in part to diminished capacity and also to increased dependence on others. Further, researchers should recognize that many sites where ePCTs are conducted will be unfamiliar with human subjects research regulations and ethics. In this report, the Regulation and Ethics Core of the National Institute on Aging Imbedded Pragmatic Alzheimer’s disease (AD) and AD-related dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science.

Keywords: Medical research design, bioethics, Alzheimer’s disease, dementia, informed consent, human subjects

Suggested Citation

Largent, Emily and Hey, Spencer Phillips and Harkins, Kristin and Hoffman, Allison K. and Joffe, Steven and Lima, Julie and London, Alex John and Karlawish, Jason, Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia (2020). Journal of the American Geriatric Society, vol. 68, p. S37-S42, 2020, Available at SSRN: https://ssrn.com/abstract=3684748

Emily Largent

University of Pennsylvania - Perelman School of Medicine ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Spencer Phillips Hey

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

23 Everett Street
Cambridge, MA 02155
United States

Kristin Harkins

affiliation not provided to SSRN

Allison K. Hoffman (Contact Author)

University of Pennsylvania Carey Law School ( email )

3501 Sansom Street
Philadelphia, PA 19104
United States

HOME PAGE: https://www.law.upenn.edu/cf/faculty/ahoffma1/

Steven Joffe

University of Pennsylvania - Perelman School of Medicine ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Julie Lima

Brown University - School of Public Health ( email )

Providence, RI
United States

Alex John London

Carnegie Mellon University - Philosophy Department ( email )

5000 Forbes Avenue
Pittsburgh, PA 15213
United States

Jason Karlawish

University of Pennsylvania - Perelman School of Medicine, Department of Medical Ethics and Health Policy ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

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