Manson Neil C
Lancaster University, Lancaster, United Kingdom.
J Med Philos. 2017 Nov 15;42(6):720-739. doi: 10.1093/jmp/jhx024.
Informed consent requirements for medical research have expanded over the past half-century. The Declaration of Helsinki now includes an explicit positive obligation to inform subjects about funding sources. This is problematic in a number of ways and seems to oblige researchers to disclose information irrelevant to most consent decisions. It is argued here that such a problematic obligation involves an "informational fallacy." The aim in the second part of the paper is to provide a better approach to making sense of how a failure to inform about funding sources wrongs subjects: by making appeals to obligations to refrain from misleading by omission. This alternative approach-grounded in a general obligation to refrain from misleading, an obligation that is independent of informed consent-provides a basis for a norm that protects subjects' interests, without the informational fallacy. The approach developed here avoids the problems identified with the currently specified general obligation to inform about funding sources.
在过去的半个世纪里，医学研究中的知情同意要求有所扩展。《赫尔辛基宣言》现在包括一项明确的积极义务，即告知受试者资金来源。这在许多方面都存在问题，似乎迫使研究人员披露与大多数同意决定无关的信息。本文认为，这种有问题的义务涉及一种“信息谬误”。本文第二部分的目的是提供一种更好的方法，以理解不告知资金来源如何侵害受试者权益：通过诉诸避免因不作为而产生误导的义务。这种基于避免误导的一般义务（一种独立于知情同意的义务）的替代方法，为保护受试者利益的规范提供了基础，而不存在信息谬误。这里提出的方法避免了目前规定的告知资金来源的一般义务所存在的问题。
