Research with Vulnerable Populations. Marisue Cody, PhD, RN IRB Chair Training Washington DC, April 9, 2004. Objectives. Criteria for permissible research Levels of risk justified Capacity assessment Surrogate decision-making and consent. Subject vulnerability.
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Marisue Cody, PhD, RN
IRB Chair Training
Washington DC, April 9, 2004
“when some or all of the subjects are likely to be vulnerable to coercion or undue influence,…additional safeguards must be included in the study to protect the rights and welfare of these subjects.”
45 CFR 46.111(b)
VHA Handbook 1200.5
If subjects with psychiatric disorders, dementia, and other mental impairments were excluded from studies, persons with these conditions would be deprived of the improved health care research can produce.
Dresser R. Mentally disabled researchsubjects: The enduring policy issues. JAMA 1996; 276: 67-72.