Regulation & Ethics Core

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PROJECT SUMMARY Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) place a significant social and economic burden on patients, families, and health care systems (HCS). Persons with dementia (PWD) experience distressing symptoms such as agitation, pain, and difficulty eating, and their caregivers suffer physical, emotional, and financial strain. At present, there is a limited evidence-base to support interventions and services that could address these problems. Embedded pragmatic clinical trials (ePCTs) in HCS offer an opportunity to remedy this. To be successful, however, this type of research must address the regulatory and ethical challenges of research that involves this vulnerable population and also address perceived barriers to conducting ePCTs in PWD in HCS that may be less familiar with research. Thus, the overarching objective of the Regulation and Ethics Core within the National Institute of Aging (NIA) AD/ADRD HCS Collaboratory is to clarify the appropriate balance among the competing priorities of promoting ePCTs in AD/ADRD, protecting the interests of PWD and their caregivers, and providing HCS with assurance that regulatory issues are satisfactorily addressed. The Regulation and Ethics Core will be led by Jason Karlawish M.D., a geriatrician and authority on ethical and policy issues in research and care involving PWD, and will engage a multi-disciplinary team of experts in AD/ADRD, geriatric medicine, ePCTs, health law, policy, and research regulation and ethics. The Aims are: (1) to serve as a national resource for the research community (i.e., investigators, institutional review boards, the NIA, the Office for Human Research Protections) by developing and disseminating guidelines and best practices to address the particular ethical issues and regulatory structures encountered in conducting ePCTs with PWD in their caregivers; (2) to identify and address the ethical and regulatory concerns and barriers (e.g., lack of familiarity with research, stigma and changing nomenclature) to conducting ePCTs in PWD and their caregivers from the perspectives of diverse HCS stakeholders; and (3) to provide guidance and training to AD/ADRD Collaboratory-funded pilot project leaders, career development awardees, and NIA-funded investigators, regarding ethical and regulatory issues. To achieve these aims, the Regulation and Ethics Core will collaborate closely with the other AD/ADRD Collaboratory Working Group Cores and Teams. IMPACT: There is an urgent need to improve the care provided by HCS for PWD and their caregivers; ePCTs are a novel approach to transform the delivery, quality, and outcomes of care, but PWD are a vulnerable population that present particular ethical and regulatory challenges for research. This Core will set the ethical and regulatory foundation for the conduct of ePCTs in PWD and their caregivers. We are well positioned to achieve this given our existing collaborative relationships, experience running center cores and multi-disciplinary expertise in ethical and regulatory issues encountered in research and care that involves PWD and their caregivers.