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ARTICLE |

Inconsistency and Institutional Review Boards FREE

Jerry Goldman, PhD; Martin D. Katz
[+] Author Affiliations

Reprint requests to Department of Political Science, Northwestern University, Scott Hall, 1890 Sheridan Rd, Evanston, IL 60201 (Dr Goldman).


JAMA. 1982;248(2):197-202. doi:10.1001/jama.1982.03330020041027
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To assess the adequacy of peer review for research on human subjects, identical research protocols in oncology and anesthesiology were submitted to 32 institutional review boards (IRBs) at major universities with medical colleges. Each of the protocols posed serious ethical issues, contained flaws in scientific design, and provided an incomplete consent form. Twenty-two IRBs participated in the investigation, which revealed (1) consistency in the nonapproval of the three protocols, (2) substantial inconsistency among IRBs in the reasons offered in support of similar decisions, and (3) substantial inconsistency in the application of ethical, methodological, and informed-consent standards for individual review boards. This evidence suggests that revision of the protocols to satisfy particular objections would result in approval of flawed investigations.

(JAMA 1982;248:197-202)

REFERENCES

Leake CD (ed): Percival's Medical Ethics . Baltimore, Williams & Wilkins Co, 1927;, p 76.
 Final regulations amending basic HHS policy for protection of human research subjects . Federal Register 1981;;46( (Jan 26) ):8366-8392.
Barber B, Lally J, Makarushka J, et al: Research on Human Subjects . New York, Russell Sage, 1973;.
Gray B: Human Subjects in Medical Experimentation . New York, John Wiley & Sons Inc, 1975;.
Cooke R, Tannenbaum A: A Survey of Institutional Review Boards and Research Involving Human Subjects: Appendix to Report and Recommendations: Institutional Review Boards . Washington, DC, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, US Dept of Health, Education, and Welfare, 1977;.
DuVal BS:  The human subjects protection committee: An experiment in decentralized federal regulation . Am Bar Found Res J , 1979;, pp 571-688.
Bart AJ, Wheeler AS:  Comparison of epidural saline and epidural blood placement in the treatment of post-lumbar-puncture headache . Anesthesiology 1978;;48:221-223.
45 CFR §102 (1980).
 Protection of human subjects: Informed consent: Definition amended to include advice on compensation . Federal Register 1978;;43( (Nov 3) ):51559.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

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Leake CD (ed): Percival's Medical Ethics . Baltimore, Williams & Wilkins Co, 1927;, p 76.
 Final regulations amending basic HHS policy for protection of human research subjects . Federal Register 1981;;46( (Jan 26) ):8366-8392.
Barber B, Lally J, Makarushka J, et al: Research on Human Subjects . New York, Russell Sage, 1973;.
Gray B: Human Subjects in Medical Experimentation . New York, John Wiley & Sons Inc, 1975;.
Cooke R, Tannenbaum A: A Survey of Institutional Review Boards and Research Involving Human Subjects: Appendix to Report and Recommendations: Institutional Review Boards . Washington, DC, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, US Dept of Health, Education, and Welfare, 1977;.
DuVal BS:  The human subjects protection committee: An experiment in decentralized federal regulation . Am Bar Found Res J , 1979;, pp 571-688.
Bart AJ, Wheeler AS:  Comparison of epidural saline and epidural blood placement in the treatment of post-lumbar-puncture headache . Anesthesiology 1978;;48:221-223.
45 CFR §102 (1980).
 Protection of human subjects: Informed consent: Definition amended to include advice on compensation . Federal Register 1978;;43( (Nov 3) ):51559.
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