Institutional review board approval and publication of human research results

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study suggest that about half the 102 English-language biomedical research journals listed in the 1995 Index Medicus do not publish guidelines indicating that IRB approval studies involving human research subjects is a requirement for publication.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