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The Office of Behavioral and Social Clinical Trials

BSR supports a range of behavioral and social interventions and pragmatic trials, conducted in a variety of community, healthcare, and institutional settings, and spanning both scientific branches of the division. BSR’s interventions target mechanisms of individual and institutional behavior change to promote health and wellbeing at older ages, including interventions to reduce social isolation and loneliness, improve cognitive function and prevent dementia, enhance emotion regulation and wellbeing, help individuals cope with chronic illness and disability, support informed end of life decision making, and many other aging-related topics. Specifically related to Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD), BSR supports non-pharmacological prevention interventions, as well as interventions to minimize and manage the stress and burdens of AD/ADRD caregiving and improve dementia care. BSR intervention research is aligned with principles of the Science of Behavior Change Program and the NIH Stage Model for Behavioral Intervention Development.

The Office of Behavioral and Social Clinical Trials oversees pre-award policy compliance, risk management, training, outreach, and administrative support for BSR-supported clinical trials. Prior to a clinical trial grant award being issued, the office conducts risk assessments to evaluate risk to human subjects, data, and NIH/NIA with the goal of ensuring appropriate oversight and monitoring. The office also reviews all Data and Safety Monitoring Plans and works with investigators and institutions to ensure compliance with NIH and NIA policy. Post-award, the office facilitates appointment of and coordination with NIA-approved Safety Officers and Data and Safety Monitoring Boards, who are advisory to NIA regarding human subjects protections, adverse events, and recruitment and retention. The office also supports large clinical trials infrastructure projects, including the NIA IMPACT Collaboratory and the Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging.

Program Contacts:

Director: Petra Jacobs, MD, MHS

Clinical Trials Coordinator: Dennis Ongubo, MD, MPHTM

Clinical Trials Specialists: Ama Donkor, MPH and Liza Zeinert, MA

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An official website of the National Institutes of Health