Strech Daniel, Metz Courtney, Knüppel Hannes
Hannover Medical School, CELLS - Centre for Ethics and Law in the Life Sciences, Institute for History, Ethics and Philosophy of Medicine, Hannover, Germany.
Hannover Medical School, CELLS - Centre for Ethics and Law in the Life Sciences, Institute for History, Ethics and Philosophy of Medicine, Hannover, Germany; Leibniz University of Hannover, CELLS - Centre for Ethics and Law in the Life Sciences, Department of Philosophy, Hannover, Germany.
PLoS One. 2014 Jun 5;9(6):e97492. doi: 10.1371/journal.pone.0097492. eCollection 2014.
According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal's instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent.
The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author's instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard.
Only every second psychiatry journal adheres to the ICMJE's recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE's recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research.
根据《赫尔辛基宣言》及其他指南，临床研究应经研究伦理委员会批准，并征得参与者有效的知情同意。国际医学期刊编辑委员会（ICMJE）和出版伦理委员会（COPE）鼓励医学期刊编辑在期刊的作者指南中纳入这些原则的要求。本研究评估了精神病学期刊关于伦理审查和知情同意的编辑政策。
在123种符合条件的精神病学期刊的作者指南和在线投稿程序中，评估了有关伦理审查和知情同意的信息以及对ICMJE和COPE建议的提及情况。虽然54%和58%的编辑政策要求进行伦理审查和知情同意，但只有14%和19%要求在稿件中报告这些问题。排名前十的精神病学期刊（按影响因子排名）在这方面表现类似。
只有大约一半的精神病学期刊遵循ICMJE的建议，告知作者关于知情同意和伦理审查的要求。此外，我们认为，即使是ICMJE在这方面的建议也不够充分，至少对于具有伦理挑战性的临床试验而言。同时，出于伦理原因，有时甚至需要在理想的科学设计上做出妥协。我们建议，临床研究中那些使其在道德上具有争议性但不一定不道德的特征，类似于方法学上的局限性，因此应明确报告。编辑政策以及诸如CONSORT等报告指南应予以扩展，以支持对伦理研究进行有意义的报告。
