DHHS human subjects protection: the new regulations revisited

In January of 1981 DHHS released its revised regulations for the protection of human subjects. These new regulations established five categories of federally funded research--primarily in the educational, social and behavioral sciences--which, at local Institutional Review Board (IRB) US ISSN (0193-7758) 1168 option, could be made exempt from mandated peer review. A survey of the 562 member IRB system was conducted to determine, among other things, what policies individual review boards had established with regard to these optionally exempted categories. 341 (61%) of the IRBs responded to the survey. Results indicate that the IRBs have overwhelmingly opted to maintain review procedures at some level in each of the "exempted" categories and that these procedures, as well as the other DHHS standards, are being applied almost universally to all research regardless of funding source. This article presents data on IRBs and their implications for the educational, social and behavioral sciences.