儿科肿瘤学研究中的自愿知情同意
Voluntary Informed Consent in Paediatric Oncology Research.
作者信息
Dekking Sara A S, Van Der Graaf Rieke, Van Delden Johannes J M
出版信息
Bioethics. 2016 Jul;30(6):440-50. doi: 10.1111/bioe.12237. Epub 2015 Dec 21.
In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context.
在儿科肿瘤学中,研究与治疗常常紧密结合,这可能会损害父母的自愿知情同意权。我们确定了两种关键情形,在这两种情形下,由于研究与治疗的交织,儿科肿瘤学研究的自愿知情同意权可能会受到损害。第一种情形是由负责治疗的儿科肿瘤学家纳入研究,第二种情形涉及仅限于研究背景下的治疗。在本文中,我们探讨了在这两种情形下父母对研究的自愿知情同意权是否受到损害,如果受到损害,这在道德上是否也存在问题。为此,我们采用了纳尔逊及其同事关于自愿同意的观点,他们认为自愿同意需要在很大程度上不受控制因素的影响。我们认为,在没有劝说或操纵的情况下,由负责治疗的医生纳入研究不会损害自愿性。然而,这可能会成为控制因素影响的一个风险因素,因为它缩小了父母做出决策的范围。此外,医生诉诸互惠并不具有控制性,因为这属于劝说。另外,构建信息是一种信息操纵形式,构成一种控制影响。在第二种情形中,如果通过操纵选项来限制可用选择,那么仅限于研究背景下的治疗就属于控制性的。尽管这些影响本身在道德上都没有问题,但多种影响的组合可能会造成非自愿知情同意的道德问题情形。因此,应该实施保障措施,以便在研究与治疗相结合的背景下为父母提供自愿知情同意创造一个最佳环境。