The concept of vulnerability and the protection of human subjects of research.
This article provides an overview of the concept of vulnerability through the lens of the U.S. federal regulations for the protection of human subjects of research. General issues that emerge for nurse researchers working with regulated vulnerable populations are identified. Points of current controversy in the application of the regulations and current discourse about vulnerable groups are highlighted. Suggestions for negotiating the tension between federally regulated human subject requirements and the realities of research with vulnerable subjects are given. The limitations of the designation of vulnerable as a protection for human subjects will also be discussed.
Beattie
Elizabeth R A
ER
University of Michigan, School of Nursing, Ann Arbor 48109-0482, USA. ebeattie@umich.edu
VandenBosch
Terry M
TM
D002648:Child; D005260:Female; D033161:Government Regulation; D006801:Humans; D007231:Infant, Newborn; D016743:Mental Competency; D033242:Minors; D011247:Pregnancy; D011329:Prisoners; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D014481:United States; D035862:Vulnerable Populations