Ethics and Regulation Core (C)

Brown University, Providence RI

Investigators

Linked publications & trials

Abstract

Embedded pragmatic clinical trials (ePCTs) have the potential to improve care outcomes for people living with dementia (PLWD) and their care partners (CPs), but their unique designs raise specific ethical and regulatory concerns, especially when conducted in this population. The Ethics and Regulatory Core (ERC) of National Institute on Aging IMbedded Pragmatic Alzheimer's disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory addresses these concerns. Their work aims to assure ePCTs meet the ethical challenges and regulatory requirements for human subjects research with attention to the unique considerations of PLWD and their CPs. In the first IMPACT funding cycle, the ERC addressed foundational issues. To support the conduct of dementia-focused ePCTs, the ERC provided consultations to close to 50 applicants for IMPACT project grants, revealing two major challenges: 1. Investigators had a paucity of knowledge about the appropriate application of consent waivers and modifications, and 2. The entire ePCT design, from unit of randomization to implementation strategies, was deeply intertwined with the approach to consent. The ERC developed training materials on waivers and modifications of informed consent, the assessment of decisional capacity, and the assessment of research risks. The ERC participated in all IMPACT- wide training activities, and moved the field forward through knowledge generation, including 14 peer-reviewed papers. In the renewal period, the ERC will build on this foundational work to address ongoing and emerging gaps in the field. The ERC plans to develop guidance to help investigators distinguish between procedures that need research versus clinical consent. It will tackle the ethical implications of emerging methods to identify persons with undiagnosed or ‘preclinical’ AD/ADRD using real world data (e.g., eRADAR) and biomarkers to enroll them in ePCTs. The ERC will also examine obligations of HCS partnering in ePCTs, such as sharing data, managing potential harms to PLWD, and HCS/clinician relationships. Finally, recognizing that the very nature of ePCTs risks reinforcing existing differences in access, quality, and outcomes that currently characterize dementia care, the ERC will ensure that these variations are considered and addressed throughout their work. Related to the ethical and regulatory issues pertinent to ePCTs in dementia care, the Specific Aims are: Aim 1: Support the design and conduct of ePCTs among PLWD and their CPs by providing guidance and consultation to investigators; Aim 2: Enhance investigator capacity to design and conduct ePCTs by participating in all IMPACT training activities; Aim 3: Develop and disseminate knowledge to advance best practices and methodologies. IMPACT: Through consultation and guidance to investigators, training, and generating knowledge related to the ethical and regulatory issues pertaining to the design and conduct of ePCTs, the ERC is critical to IMPACT’s mission. Good science must be ethical science, and the ERC intends to promote both while building an evidence-base to improve dementia care for all Americans.