Center for Bioethics Papers

Document Type

Journal Article

Date of this Version

September 1998

Comments

Copyright © 1998 by The Johns Hopkins University Press. All rights reserved. Postprint version. Published in Kennedy Institute of Ethics Journal, Volume 8, Issue 3, September 1998, pages 329-337.
Publisher URL: http://muse.jhu.edu/journals/kennedy_institute_of_ethics_journal/

Abstract

The spring and summer of 1998 were seasons in the sun for institutional review board (IRB) aficionados. Rarely have the arcana of the local human subjects review panels been treated to so much attention in both the executive and the legislative branches of government, not only at the federal but also at the state level. And it looks as if the attention will continue for some time. The spate of interest is due to a series of coincidences: a powerful House of Representatives subcommittee held hearings after its chairman learned about the IRB system during a previous session on research in underdeveloped communities; the Department of Health and Human Services's Inspector General (DHHS-IG) released a report on IRBs; the National Institutes of Health (NIH) Office of Extramural Research completed a report on clinical trial monitoring; the National Bioethics Advisory Commission (NBAC) readied a report on research involving persons with mental disorders; the states of Maryland and New York completed studies of research with subjects who lack decision-making capacity; and advocacy groups protested a psychiatric research project involving inner city children.

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Date Posted: 08 June 2007

This document has been peer reviewed.