A broad consensus affirms the concept that all human beings have equal moral worth
(Beauchamp and Childress 1994; Rawls 1971). Translating this ethical norm into practice …

Ethics and regulation of research with humans have coexisted in a somewhat uneasy
relationship in the United States for the past 60 years. Wartime atrocities committed by Nazi …

Federal regulations establish basic protections for human subjects that cannot be
diminished by state law. That is, a researcher or institution subject to a federal requirement …

In recent months, updates have been proposed to two important documents in human
subjects research oversight: the Federal Policy for the Protection of Human Subjects or …

Research involving human subjects is much more stringently regulated than many other
nonresearch activities that appear to be at least as risky. A number of prominent figures now …

A common assumption in the selection of nonhuman animal subjects for research and the
approval of research is that, if the risks of a procedure are too great for humans, and if there …

All proposals undergoing initial full review need to be reviewed by IRBs with the information,
range and depth of expertise, and capacity to adequately appreciate and assess the …

The understanding of appropriate ethical protections for participants of biomedical research
has not been static. It has evolved over time, with the evolution of biomedical research as …

Writing in 2001, the National Bioethics Advisory Commission (" NBAC") complained that
Institutional Review Boards (" IRBs") were overwhelmed not only by high workloads and …

Lancet, the Journal of the American Medical Association, CMAJ and the New England
Journal of Medicine), that in September 2001 they set new rules. These journals34 and …