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March 19, 1997

Institutional Review Board Approval and Publication of Human Research Results

Author Affiliations

From the Dartmouth-Hitchcock Medical Center, Lebanon, NH.

JAMA. 1997;277(11):909-914. doi:10.1001/jama.1997.03540350059034

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that about half of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus do not publish guidelines indicating that IRB approval of studies involving human research subjects is a requirement for publication.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.