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.