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Currents in Contemporary Ethics

Published online by Cambridge University Press:  01 January 2021

T. Howard Stone
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Extract

In what is clearly an important development related to research integrity and the protection of human research subjects, the U.S. government has instituted two new training requirements as a condition of receiving federal financial support. First, the National Institutes of Health (NIH) is requiring, as a condition of funding, that key research personnel involved in human subject research complete education “in the protection of human subjects.” Evidence that key personnel have completed this training must be provided in NIH grant applications or contract proposals.

The NIH education policy will eventually be superseded by a more broadly applicable instructional policy for the “responsible conduct of research,” which will be promulgated by the Department of Health and Human Service's Office of Research Integrity and the Public Health Service (PHS). The instructional policy will apply to all persons engaged in any research or research training with PHS support. Presently, the only version of the policy is in draft form.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 29 , Issue 1 , Spring 2001 , pp. 94 - 99
Copyright
Copyright © American Society of Law, Medicine and Ethics 2001

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Footnotes

Mark A. Rothstein serves as the section editor for “Currents in Contemporary Ethics.” Professor Rothstein is the Herbert F. Boehl Chair of Law and Medicine at the University of Louisville School of Medicine in Kentucky.

References

National Institutes of Health, U.S. Dep't of Health and Human Services, Required Education in the Protection of Human Research Participants, NIH Guide OD-00-039 (Washington, D.C.: U.S. Gov't Printing Office, June 5, 2000): At “Implementation” [hereinafter cited as NIH, Required Education].Google Scholar
Public Health Service, U.S. Dep't of Health and Human Services, PHS Draft Policy on Instruction in the Responsible Conduct of Research, NIH Guide OD-00-045 (Washington, D.C.: U.S. Gov't Printing Office, July 17, 2000) [hereinafter cited as PHS, Draft Policy]. For purposes of this article, the terms “responsible conduct of research” and “responsible research” will include human subject protection, which is consistent with the PHS draft policy. See id. at sec. II, VII(6).Google Scholar
Office of Research Integrity, U.S. Dep't of Health and Human Services, Notice of Suspension of PHS Policy, NIH Guide OD-01-020 (February 22, 2001).Google Scholar
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Id. at n.1. Because the PHS instructional policy will eventually supersede the current NIH education policy, most analysis here is reserved for the PHS policy; any relevant differences will be mentioned.Google Scholar
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