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This work focuses on research ethics in the context of studies that include participants who have Alzheimer disease and other types of dementia. It includes a series of projects sponsored by the National Institute on Aging (NIA) using qualitative and quantitative research methods. First, the Consent for Dementia Research Study (CDRS) was conducted to determine what actually occurs during informed consent sessions with individuals recruited to participate in dementia research by observing and recording the consent process. Second, quantitative data from the Maryland Assisted Living (MD-AL) study (sponsored by NIMH and NIA) were used to identify predictors of providing informed consent or assent for research participation in residents of assisted living facilities. Third, the Assent and Dissent for Dementia Research (ADDR) project was a qualitative study designed to provide recommendations on how assent and dissent should be defined and what procedures researchers should use when seeking assent and respecting dissent. One product of this research is the Assent/Dissent Checklist, which is a tool to assist researchers in documenting the assent process with individuals who lack capacity to provide informed consent.
For more information, contact Betty S. Black PhD, Principal Investigator, 410-955-2003 or firstname.lastname@example.org
Black BS, Kass NE, Fogarty LA, Rabins PV. Informed consent for dementia research: The study enrollment encounter. IRB: Ethics & Human Research, 2007, 29(4):7-14.
Black BS, Brandt J, Rabins PV, Samus QM, Steele CD, Lyketsos CG, Rosenblatt A. Predictors of providing informed consent or assent for research participation in assisted living residents. American Journal of Geriatric Psychiatry, 2008, 16(1):83-91; NIHMSID #111363.
Black BS, Rabins PV, Sugarman J, Karlawish JH. Seeking assent and respecting dissent in dementia research. American Journal of Geriatric Psychiatry, 2010; 18(1):77-85; NIHMSID #153830