Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
BMC Med. 2014 Mar 24;12:52. doi: 10.1186/1741-7015-12-52.
It is thought that a dependent relationship between patients and physicians who enroll their own patients in research compromises voluntary informed consent. Therefore, several ethical guidelines for human subject research provide approaches to mitigate these compromises. Currently, these approaches have not been critically evaluated. In this article, we analyze the approaches of ethical guidelines to manage the influence of a dependent relationship between patients and physicians on voluntary informed consent and discuss the strengths and weaknesses of these approaches.
We performed a review of international ethical guidance documents on human subject research, listed in the Oxford Textbook of Clinical Research Ethics and found through cross referencing. We also searched Global Ethics Observatory (GEObs) and the World Health Organization (WHO) website. Guidelines from all years were eligible for inclusion. The date last searched was December 2013.
We identified two basic guideline approaches: 1. A process approach, which focuses on the person who obtains informed consent, that is, an independent individual, such as a research nurse or counselor; and 2. A content approach, emphasizing the voluntary nature of participation. Both approaches are valuable, either because the influence of the physician may diminish or because it empowers patients to make voluntary decisions. However, the approaches also face challenges. First, research nurses are not always independent. Second, physician-investigators will be informed about decisions of their patients. Third, involvement of a counselor is sometimes unfeasible. Fourth, the right to withdraw may be difficult to act upon in a dependent relationship.
Current guideline approaches to protect voluntary informed consent within a dependent relationship are suboptimal. To prevent compromises to voluntary informed consent, consent should not only be obtained by an independent individual, but this person should also emphasize the voluntary nature of participation. At the same time, dependency as such does not imply undue influence. Sometimes the physician may be best qualified to provide information, for example, for a very specialized study. Still, the research nurse should obtain informed consent. In addition, patients should be able to consult a counselor, who attends the informed consent discussions and is concerned with their interests. Finally, both physicians and research nurses should disclose research interests.
人们认为，患者和参与研究的医生之间的从属关系会影响到患者自愿知情同意的达成。因此，一些人类受试者研究的伦理准则提供了减轻这些影响的方法。目前，这些方法尚未经过严格评估。在本文中，我们分析了伦理准则处理患者和医生之间从属关系对自愿知情同意影响的方法，并讨论了这些方法的优缺点。
我们对牛津临床研究伦理教科书和交叉引用列出的国际人类受试者研究伦理指南进行了审查，并在全球伦理观察站（GEObs）和世界卫生组织（WHO）网站上进行了搜索。所有年份的指南都符合纳入标准。最后一次搜索日期为 2013 年 12 月。
我们确定了两种基本的准则方法：1. 一种是关注获取知情同意的人，即研究护士或顾问等独立个体的过程方法；2. 另一种是强调参与的自愿性的内容方法。这两种方法都有价值，因为医生的影响可能会减弱，或者因为它使患者能够做出自愿的决定。然而，这些方法也面临挑战。首先，研究护士并不总是独立的。其次，医师研究者将了解其患者的决定。第三，顾问的参与有时是不可行的。第四，在从属关系中，退出的权利可能难以行使。
目前保护从属关系下自愿知情同意的准则方法并不理想。为了防止对自愿知情同意的影响，同意不仅应由独立的个人获得，而且该人还应强调参与的自愿性。同时，从属关系本身并不意味着不当影响。有时，医生可能是提供信息的最佳人选，例如对于非常专业的研究。然而，研究护士仍应获得知情同意。此外，患者应该能够咨询顾问，顾问参加知情同意讨论并关注他们的利益。最后，医生和研究护士都应披露研究利益。
