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Academy News: January 2003 Determining Authorship:
When Does Participation Justify Credit? Dr. Z has a very active clinical trials unit, and he recently hired Dr. A to help with the multiple studies with which he was involved. Dr. A was given responsibility for one of the more exciting studies, examining the efficacy of Hirsuitus, a new anti-balding agent. The pharmaceutical company that makes Hirsuitus designed the protocol for this study, and the investigators only responsibility was to enroll a certain number of patients. Because Dr. A’s site enrolled more patients than any other site, the pharmaceutical company offered him first author status on the upcoming manuscript. When Dr. Z heard about this, he demanded authorship status as well, since Dr. A had been working in his employ when the study was performed. Although they did not see the paper until the accepted manuscript was in proof form, both Dr. A and Dr. Z were listed as co-authors. This vignette illustrates potential problems associated with determination of authorship—especially in multi-center clinical trials. Specifically, should Dr. Z have been listed as an author? How about Dr. A? What are appropriate benchmarks for determining if an individual’s participation merits authorship? The International Committee of Medical Journal Editors (ICMJE) first met in 1978 (then known as the Vancouver Group) to develop a uniform set of guidelines for biomedical manuscripts. Since then there have been several updates in their guidelines, the most recently available being in October 2001.1,2 In this document the editors explicitly list three requirements for authorship: Authorship credit should be based only on 1) substantial contributions to conception and design or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Conditions 1, 2 and 3 must all be met. Acquisition of funding, the collection of data, or general supervision of the research group, by themselves, do not justify authorship.1,2 These criteria were, in part, developed by the ICMJE because of the explosion in pharmaceutical company sponsored trials. In particular, they were concerned about studies in which the investigators had “little or no input into trial design, no access to the raw data, and limited participation in data interpretation.” The requirements for authorship demand that the authors have made “substantial contributions” and should not simply have collected data. Furthermore, the ICMJE asks that authors “provide a description of what each contributed,” and the editors publish this information. If we return to the situation of Drs. A and Z, it is clear that several inappropriate events have occurred in the publication of the Hirsuitus study results. First, Dr. Z by simply hiring Dr. A failed to provide any substantial contribution to the design, acquisition, analysis or interpretation of the data; therefore, he fails to meet any of the criteria that would qualify for authorship. The issue of Dr. A’s author status is more difficult to assess. Clearly Dr. A was involved in acquiring data, but he did not have any significant role in the drafting of the manuscript—indeed he did not even see the article until it was in the proof stage (a point at which only minor editorial corrections can be made). Therefore, he failed to meet all three of the requirements, and should not have been listed as an author. The situation would have been much different if either of the investigators had been involved in the development of the research protocol, and wrote and/or revised the manuscript prior to submission. The ICMJE also stipulates, “all persons designated as authors should qualify for authorship, and all those who qualify should be listed.” Therefore, if the acquisition of data in a clinical trial were enough participation to merit authorship, then all of the investigators would have to be listed as such. In general this is not the case, as a few investigators normally are responsible for the design of the study and the development of the manuscript. The other investigators should be mentioned in the Acknowledgements section. Finally, the ICMJE states that “authors [and those mentioned in the Acknowledgement section] should provide a description of what each contributed,” and the editors should publish this information. In this way it will be possible to determine exactly what each individual’s role was in a study. If these rules were followed in the vignette, it is clear that Dr. A would receive an acknowledgement and Dr. Z would be left off the manuscript completely. References:1International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts submitted to Biomedical Journals. NEJM. 1997;336:309-316. 2Most recent version available at: www.icmje.org. Accessed March 24, 2003. The Ethics Committee provides these discussions as a way to open a dialogue on the various ethical issues that confront our specialty on a daily basis. These issues are often quite complex and do not have simple right or wrong solutions. The articles are meant to highlight the various issues that are involved in these ethical dilemmas, and should not be viewed as the Ethics Committee or the Academy’s particular stance on an issue. Disclosure: Dr. Grayson is on the speaker’s bureau for Merck & Co. |
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