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Managing the Research University$
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Dean O. Smith

Print publication date: 2011

Print ISBN-13: 9780199793259

Published to Oxford Scholarship Online: September 2011

DOI: 10.1093/acprof:oso/9780199793259.001.0001

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Human Subjects

Human Subjects

(p.197) Chapter 12 Human Subjects
Managing the Research University

Dean O. Smith

Oxford University Press

In most developed countries, current standards for the responsible conduct of research with human subjects derive from the Nuremberg Code. It has been amplified in the Belmont Report, which is the basis of federal guidelines (known as the common rule) for research using human subjects. Each institution that conducts research on human subjects must submit an assurance that guarantees compliance with federal policy. No research project involving human subjects may proceed without an approved assurance on file. Federal policy also requires the establishment of an institutional review board (IRB) to review all proposed and ongoing research projects involving human subjects. The IRB has the authority to approve human subject research protocols. Federal policy dictates IRB membership criteria. Some universities use independent, for-profit IRBs to review protocols. Guidelines for expedited and exempt protocol reviews are described. The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accredits institutional human research protection programs, including IRB activities. The chapter concludes with an analysis of current federal regulations on research using human embryonic stem cells.

Keywords:   nuremberg code, belmont Report, common rule, assurance, institutional review board, IRB, AAAHRP, AAAHRP, human research protection program, stem cells

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