Department of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA.
AIDS. 2011 Jan 2;25(1):107-14. doi: 10.1097/QAD.0b013e328340fec7.
Some commentators argue that informed consent for clinical research should be an on-going process, which begins, rather than ends, with participants' initial consent. Lacking, however, are empirical data on whether there is a need for 'on-going consent'.
Two self-administered surveys - a baseline survey at initial consent and a follow-up survey 2-3 years later - to assess whether participants remain informed over time.
Respondents were adults with HIV disease from Argentina, Brazil and Thailand enrolled in a long-term clinical trial.
Respondents overall were well informed at baseline. At follow-up, many reported being not informed about aspects of the study central to their on-going participation. With respect to the possibility of withdrawal, 38.5% of respondents at follow-up reported being 'not at all' informed. At follow-up, 71.1% wanted more information. Yet, 62.8% had not asked any questions during the entire study. Reasons for not asking questions included not having an opportunity (16.4%) and not knowing whom to ask (15.5%).
The standard consent process resulted in participants being well informed at enrollment. Yet, this process was not sufficient to keep them informed about aspects of the study central to their on-going participation. In addition, participants who wanted more information often did not ask for it. These findings provide empirical support for recommendations that clinical trials should consider including a process of 'on-going consent'.
一些评论员认为，临床研究的知情同意应该是一个持续的过程，这个过程应该从参与者最初的同意开始，而不是结束。然而，关于是否需要“持续同意”，缺乏实证数据。
两次自我管理的调查——在最初同意时进行基线调查，在 2-3 年后进行随访调查——以评估参与者是否随着时间的推移保持知情。
受访者是来自阿根廷、巴西和泰国的感染艾滋病毒的成年人，他们参加了一项长期临床试验。
受访者总体上在基线时信息充分。在随访时，许多人报告说，他们对研究中与其持续参与相关的方面并不了解。关于退出的可能性，38.5%的受访者在随访时表示“完全不了解”。在随访时，71.1%的人希望获得更多信息。然而，62.8%的人在整个研究期间没有提出任何问题。不提问的原因包括没有机会（16.4%）和不知道向谁提问（15.5%）。
标准的同意过程使参与者在入组时得到了充分的信息。然而，这个过程不足以让他们了解研究中与其持续参与相关的方面。此外，那些希望获得更多信息的参与者往往没有要求。这些发现为临床试验应考虑包括“持续同意”过程的建议提供了实证支持。
