Are the rules for research with subjects with dementia changing?: views from the field

Neurology. 2003 Dec 23;61(12):1649-51. doi: 10.1212/01.wnl.0000098888.97357.06.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alzheimer Disease / complications
  • Alzheimer Disease / physiopathology
  • Data Collection / statistics & numerical data
  • Decision Making*
  • Dementia / complications
  • Dementia / physiopathology*
  • Ethics Committees, Research / ethics
  • Human Experimentation / ethics*
  • Human Experimentation / legislation & jurisprudence
  • Humans
  • Informed Consent / ethics*
  • Informed Consent / legislation & jurisprudence
  • Informed Consent / standards
  • Mental Competency*
  • Neuropsychological Tests
  • Research Personnel / statistics & numerical data
  • Research Subjects* / legislation & jurisprudence
  • Risk