PubMed · 1773282
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H A Dudley. 1991. Informed consent--issues for the 1990s.. https://doi.org/10.1111/j.1464-410x.1991.tb15414.x
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On November 10, 1997, the Food and Drug Administration (FDA), in consultation with the Office for Protection from Research Risks (OPRR) at the National Institutes of Health, requested written comments relating to the proposed republication of the list that identifies certain research activities involving human subjects that may be reviewed by the Institutional Review Board (IRB) through the expedited review procedure authorized in 21 CFR 56.110. The comment period closed on March 10, 1998. FDA and OPRR received a combined total of 108 comments. After a review of the comments, FDA and OPRR are now simultaneously publishing identical revised lists of categories of research activities that may be reviewed by the IRB through the expedited review procedure.
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This final rule amends the Department of Veterans Affairs (VA) medical regulations to provide (or to pay for the provision of) necessary medical treatment to certain human subjects injured as a result of participation in VA research. Under the final rule all participants in research approved by a VA Research and Development Committee (regardless of source of funding), and conducted under the supervision of one or more VA employees, are eligible for treatment unless injuries are due to noncompliance by a research subject with study procedures. VA will provide medical care in those circumstances where VA has some responsibility for the need for medical care.