Breimer Lars H, Nilsson Torbjorn K
Consultant Physician, Department of Laboratory Medicine, Clinical Chemistry, Orebro University Hospital, SE-701 85 Orebro, SWEDEN,.
Professor of Clinical Chemistry, Consultant Physician, Department of Medical Biosciences/Clinical Chemistry, Umea University, SE-90185 Umea, SWEDEN,.
Indian J Med Ethics. 2017 Oct-Dec;2(4):260-265. doi: 10.20529/IJME.2017.056.
The year 2016 witnessed the anniversaries of several key events related to the prevention of neural tube defects (NTD) with folate supplementation. However, the road leading up to this achievement was full of stumbling blocks, both in terms of research ethics and researcher ethics. First, the decisions of ethics review boards differed with respect to allowing placebo groups in folate trials, thus reducing the level of evidence obtained from the earliest studies. Second, statisticians insisted on analysing the outcome of a trial by intention-to-treat - which turned out to be non-significant - rather than by treatment received, which was statistically significant. Third, the recognition of positive results was stymied by the reluctance of some researchers to recognise and quote others' contributions. All this needlessly delayed the recognition of the NTD-preventive effects of folate by a decade. The story of the prevention of NTD thus offers insights into research inadequacies that have the potential to impede the advance of medical science, with the ethical aspects having the most immediate impact. Efficient ethics review boards play a major role worldwide and if they play safe, they may risk disallowing high-quality studies of great public health import.
2016年见证了与通过补充叶酸预防神经管缺陷（NTD）相关的几个关键事件的周年纪念。然而，通往这一成就的道路在研究伦理和研究者伦理方面都充满了绊脚石。首先，伦理审查委员会在叶酸试验中是否允许设立安慰剂组的问题上存在不同意见，从而降低了从最早的研究中获得的证据水平。其次，统计学家坚持按意向性分析试验结果——结果证明无统计学意义——而不是按实际接受的治疗进行分析，后者具有统计学意义。第三，一些研究人员不愿承认和引用他人的贡献，阻碍了对阳性结果的认可。所有这些都不必要地将叶酸预防NTD的作用的确认推迟了十年。因此，预防NTD的故事揭示了可能阻碍医学进步的研究不足之处，其中伦理方面的影响最为直接。高效的伦理审查委员会在全球发挥着重要作用，如果他们过于保守，可能会冒着不允许开展具有重大公共卫生意义的高质量研究的风险。
