Reporting of ethical review of clinical research submitted to the Journal of the American Academy of Dermatology.
BACKGROUND: In recent years there has been an increasing focus on human subject protection and on documentation of ethical review in published clinical research. The JAAD clearly states in its instructions to authors, which adhere to the guidelines set forth by the International Committee of Medical Journal Editors, "studies involving live human subjects must have been approved by the author's Institutional Review Board or its equivalent." OBJECTIVE: To determine what proportion of prospective studies on human subjects submitted to the clinical trials and therapeutics section lacked mention of review by an ethics board and to determine the outcome of these manuscripts. METHODS: We reviewed 150 prospective studies submitted from July 1, 2004 to January 16, 2006 to a single associate editor, who receives the majority of reports requiring ethics board review. RESULTS: Of 150 prospective studies, 36% (n = 54) had no mention of ethics review or consent, whereas 15% (n = 22) mentioned consent but not ethics review. Forty-two papers were returned asking for ethics information, and of these, 48% were resubmitted with confirmation of ethics review, 22% were withdrawn, 12% were never resubmitted, 12% responded that ethical review was not obtained, and 7% were clarified as exempt from review. Of the 150 papers, 45% were from US authors and 55% were from international authors. Sixty-seven percent of US papers and 35% of international papers included ethics board information (P <or= .001). Of the remaining authors who did not initially provide information on ethics review, 25% of US and 53% of international authors were able to provide documentation of ethics board review when asked. Of international authors asked for ethics information, 67% of European authors provided confirmation of ethical review, as compared with 48% of non-European authors. LIMITATIONS: It is not possible to know with certainty whether each study not citing ethics review actually did not undergo review by an ethics board. Additionally, other editors may have handled some studies requiring ethics review. CONCLUSIONS: One half of authors submitting papers on prospective clinical studies to the JAAD did not provide evidence of ethical review on initial submission. The reason for omission was likely oversight in half of the cases, but in others ethics review and approval were likely not obtained. International authors were more likely to omit mention of ethics review, but, although sample size was too small for statistical analysis, international authors were more often able to provide it when asked, suggesting oversight or misunderstanding as a reason for omission. Furthermore, ethics review may be more standard in the European Union, as European authors were more likely to be able to provide the information when asked, although small sample size precluded statistical analysis.