TY - JOUR

T1 - Misleading by omission

T2 - rethinking the obligation to inform research subjects about funding sources

AU - Manson, Neil Campbell

N1 - This is a pre-copy-editing, author-produced PDF of an article accepted for publication in The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine following peer review. The definitive publisher-authenticated version Manson, Neil C Misleading by Omission: Rethinking the Obligation to Inform Research Subjects about Funding Sources The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 2017 42: 720–739 is available online at: https://academic.oup.com/jmp/article/42/6/720/4629371

PY - 2017/11/15

Y1 - 2017/11/15

N2 - Informed consent requirements for medical research have expanded over the past half-century. The focus here is upon one aspect of this expansion: the introduction of explicit obligations to inform subjects about funding sources, in the Declaration of Helsinki. Whilst it is agreed from the outset that a failure to inform about funding sources can wrong a research subject, a general obligation is problematic in a number of ways: including, determining the scope of the norm; plus problems with subjects’ comprehension of complex funding information, and, most importantly, that such a norm seems to oblige researchers to disclose too much, including information irrelevant to most consent decisions. We ask whether the general obligation in Helsinki might be justified by appeal to respect for autonomy and informed consent, but find that it cannot be. The general obligation seems to rest upon an “informational fallacy”. We then note that this orthodox justification of research ethics—by appeal to respect for autonomy and informed consent—has been subject to various critiques. 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: making appeal to obligations to refrain from misleading by omission. This alternative approach—grounded in obligations to refrain from misleading—provides a basis for a norm that protects subjects interests without being hostage to the orthodox justification, that avoids the informational fallacy, and that—by and large—avoids the problems noted above about the scope of the obligation, and its implications for subjects’ comprehension.

AB - Informed consent requirements for medical research have expanded over the past half-century. The focus here is upon one aspect of this expansion: the introduction of explicit obligations to inform subjects about funding sources, in the Declaration of Helsinki. Whilst it is agreed from the outset that a failure to inform about funding sources can wrong a research subject, a general obligation is problematic in a number of ways: including, determining the scope of the norm; plus problems with subjects’ comprehension of complex funding information, and, most importantly, that such a norm seems to oblige researchers to disclose too much, including information irrelevant to most consent decisions. We ask whether the general obligation in Helsinki might be justified by appeal to respect for autonomy and informed consent, but find that it cannot be. The general obligation seems to rest upon an “informational fallacy”. We then note that this orthodox justification of research ethics—by appeal to respect for autonomy and informed consent—has been subject to various critiques. 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: making appeal to obligations to refrain from misleading by omission. This alternative approach—grounded in obligations to refrain from misleading—provides a basis for a norm that protects subjects interests without being hostage to the orthodox justification, that avoids the informational fallacy, and that—by and large—avoids the problems noted above about the scope of the obligation, and its implications for subjects’ comprehension.

M3 - Journal article

VL - 42

SP - 720

EP - 739

JO - Journal of Medicine and Philosophy

JF - Journal of Medicine and Philosophy

SN - 0360-5310

IS - 6

ER -