Including Vulnerable Subjects with Cognitive Impairment in Research

SOCRA's 2019 Annual Conference

Laura Holtz, MS, CCRP, Senior Research Manager, IU Center for Aging Research, Regenstrief Institute

This talk will review the new common rule definition of vulnerable subjects including “individuals with impaired decision making ability.” It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer’s research. Finally, it will review the ethical guidelines and discuss practical strategies for obtaining informed consent for subjects who may lack decision making capacity.