CELLS-Centre for Ethics and Law in the Life Science, Institute for History, Ethics and Philosophy of Medicine, Hannover Medical School, Carl-Neuberg Straße Street 1, Hannover, Germany.
J Clin Epidemiol. 2012 Mar;65(3):276-81. doi: 10.1016/j.jclinepi.2011.07.002. Epub 2011 Oct 19.
To present a structured account of ethical problems and possible solutions related to selective publication and incomplete trial registration.
The presentation of ethical problems and possible solutions is structured using the tools of conceptual normative analysis.
Selective publication runs contrary to (1) principles of ethical research, such as social value and respect for participants, (2) sound medical decision making and clinical guideline development, (3) appropriate patient information, (4) public trust in clinical research, and (5) just allocation of public resources for clinical research. Reasons against the obligation of complete registration and publication of trials can be divided into (1) protection of private data and (2) commercial interests. Empirical findings indicate that selective publication and incomplete trial registration (1) are frequent, (2) extensively distort patient-relevant outcomes, and (3) affect a large number of patients.
Empirical data and normative arguments outweigh their counterarguments and present a clear case in favor of an even more restrictive obligation to register trials. Institutional review boards and better-educated stakeholders might play a crucial role in facilitating unbiased registration and publication of clinical research. For evaluation purposes, the field needs better standards for study protocols.
阐述与选择性发表和试验注册不完整相关的伦理问题及可能的解决方案。
使用概念规范分析工具对伦理问题及可能的解决方案进行结构化呈现。
选择性发表有悖于（1）伦理研究的原则，如社会价值和对参与者的尊重，（2）合理的医疗决策和临床指南制定，（3）适当的患者信息，（4）公众对临床研究的信任，以及（5）临床研究公共资源的公正分配。反对试验完整注册和发表义务的理由可分为（1）保护私人数据和（2）商业利益。实证研究表明，选择性发表和试验注册不完整（1）较为常见，（2）严重扭曲与患者相关的结局，（3）影响大量患者。
实证数据和规范论证超过了其反面观点，有力地支持了对试验注册实施更严格义务的观点。机构审查委员会和受教育程度更高的利益相关者可能在促进临床研究的无偏注册和发表方面发挥关键作用。出于评估目的，该领域需要更好的研究方案标准。
