Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia
June 26, 2020
Authors: Emily A. Largent, JD, PhD, RN, Spencer Phillips Hey, PhD, Kristin Harkins, MPH, Allison K. Hoffman, JD, Steven Joffe, MD, MPH, Julie C. Lima, PhD, MPH, Alex John London, PhD, and Jason Karlawish, MD
Core/Team: Ethics and Regulation Core
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 Ethics and Regulation Core of the National Institute on Aging Imbedded Pragmatic Alzheimer’s disease (AD) and ADrelated 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. J Am Geriatr Soc 68:S37-S42, 2020.
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Keywords: dementia; ethics; informed consent; human subjects research
About this Special Issue: The Journal of the American Geriatrics Society (JAGS) has published a special issue (Volume 68, S2) focused solely on the National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory and the activities and progress it has made since the September 2019 announcement.
The special issue, published online June 26, includes an introductory article describing the mission and vision of the IMPACT Collaboratory and articles from each of the 10 IMPACT cores and teams describing how they are working to achieve that mission. The introductory article authors are the two IMPACT principal investigators, Susan Mitchell, MD, MPH and Vincent Mor, PhD, as well as the two executive directors, Ellen McCarthy, PhD, MPH, and Jill Harrison, PhD.