Are the rules for research with subjects with dementia changing?: views from the field.
Deliberative bodies have recommended additional protections for persons with dementia included in clinical trials. This survey of experienced dementia researchers revealed that 45 to 64% considered that specific ones of these recommendations would increase subject protection, and 40 to 86% considered they would make research less feasible. The real tradeoff between protection and difficulty in conducting research on devastating illnesses needs to be confronted when new regulations in this area are debated.
Stocking
Carol B
CB
Section of Geriatrics, MacLean Center for Clinical Medical Ethics, Department of Medicine, University of Chicago, IL 60637, USA. cstockin@medicine.bsd.uchicago.edu
Hougham
Gavin W
GW
Baron
Aliza R
AR
Sachs
Greg A
GA
D000544:Alzheimer Disease / Q000150:complications / Q000503:physiopathology; D003625:Data Collection / Q000706:statistics & numerical data; D003657:Decision Making; D003704:Dementia / Q000150:complications / Q000503:physiopathology*; D028744:Ethics Committees, Research / Q000941:ethics; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D016743:Mental Competency; D009483:Neuropsychological Tests; D012108:Research Personnel / Q000706:statistics & numerical data; D035842:Research Subjects / Q000331:legislation & jurisprudence; D012306:Risk