Dickert Neal, Kass Nancy, Paasche-Orlow Michael, Taylor Holly
Department of Health Policy and Management, Phoebe R. Berman Bioethics Institute, John Hopkins University Bloomberg School of Public Health, Hampton House 348, 624 N. Broadway, Baltimore, MD 21205, USA.
Account Res. 2005 Jan-Mar;12(1):33-45. doi: 10.1080/08989620590918916.
Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor's name on the consent form may allow the form to serve as a surrogate for subjects' HIV status. There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.
尽管知情同意程序对于保护人类研究对象至关重要，但在某些情况下，同意书中的特定信息可能会给这些对象带来风险。在本文中，我们研究了一个案例，即在同意书上列出赞助商的名字可能会使该同意书成为对象艾滋病毒感染状况的替代物。目前尚无文献探讨从同意书中排除特定信息的伦理可接受性，关于这个问题也几乎没有监管指导。我们认为，当在同意程序中已口头披露某信息，但该信息出现在同意书上会给同意程序旨在保护的对象带来风险时，实际上从同意书中排除该信息是必要的。此外，我们认为法规应进行修订以体现这一必要性。
