Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, UK.
Environ Health. 2011 Dec 21;10:107. doi: 10.1186/1476-069X-10-107.
In recent years there has been a major change on the part of funders, particularly in North America, so that data sharing is now considered to be the norm rather than the exception. We believe that data sharing is a good idea. However, we also believe that it is inappropriate to prescribe exactly when or how researchers should preserve and share data, since these issues are highly specific to each study, the nature of the data collected, who is requesting it, and what they intend to do with it. The level of ethical concern will vary according to the nature of the information, and the way in which it is collected - analyses of anonymised hospital admission records may carry a quite different ethical burden than analyses of potentially identifiable health information collected directly from the study participants. It is striking that most discussions about data sharing focus almost exclusively on issues of ownership (by the researchers or the funders) and efficiency (on the part of the funders). There is usually little discussion of the ethical issues involved in data sharing, and its implications for the study participants. Obtaining prior informed consent from the participants does not solve this problem, unless the informed consent process makes it completely clear what is being proposed, in which case most study participants would not agree. Thus, the undoubted benefits of data sharing does not remove the obligations and responsibilities that the original investigators hold for the people they invited to participate in the study.
近年来，资助者（尤其是北美的资助者）发生了重大转变，他们现在认为数据共享是一种常态，而不是例外。我们认为数据共享是一个好主意。然而，我们也认为，规定研究人员应该何时以及如何保存和共享数据是不恰当的，因为这些问题高度取决于每项研究的具体情况、所收集数据的性质、请求数据的人员以及他们打算如何使用这些数据。伦理关注的程度将根据信息的性质以及收集信息的方式而有所不同——对匿名住院记录的分析可能与直接从研究参与者那里收集的潜在可识别健康信息的分析承担着截然不同的伦理负担。引人注目的是，大多数关于数据共享的讨论几乎完全集中在所有权（由研究人员或资助者拥有）和效率（由资助者）问题上。通常很少讨论数据共享所涉及的伦理问题及其对研究参与者的影响。除非知情同意过程明确提出了所提议的内容，否则从参与者那里获得事先知情同意并不能解决这个问题，而在这种情况下，大多数研究参与者都不会同意。因此，数据共享的明显好处并不能免除原始调查员对其邀请参与研究的人员的义务和责任。
