Institutional review board approval and publication of human research results

R. J. Amdur and C. Biddle
Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756, USA. robert.amdur@hitchcock.org

OBJECTIVE: To determine if journals' instructions for authors require that manuscripts being considered for publication indicate that studies involving human subjects had appropriate institutional review board (IRB) approval. DESIGN: A descriptive study of the ethical guidelines published in the Instructions for Authors sections of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus. INTERVENTION: Literature review. MAIN OUTCOME MEASURE: Policy regarding IRB approval of studies that involve human subjects. RESULTS: Of the 102 journals surveyed, 48 (47%) require IRB approval of studies involving human subjects as a prerequisite for publication, and 25 (24%) do not present or refer the author to any information related to human research ethics. Of the remaining journals, 15 (15%) referred authors to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 3 (3%) to the Declaration of Helsinki, and 10 (10%) simply indicated that informed consent should be obtained. There was only 1 medical specialty (anesthesiology) in which all the representative journals presented the same ethical requirement. In the 48 journals that clearly required IRB approval of studies, 37 (77%) documented IRB approval with a statement in the manuscript, 7 (15%) required a separate signed statement from the author, and 4 (8%) did not mention a method of documentation. CONCLUSIONS: The results of this study suggest that about half of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus do not publish guidelines indicating that IRB approval of studies involving human research subjects is a requirement for publication. The manner in which publication requirements related to ethical standards are presented in biomedical research journals is extremely variable.

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