Misleading by Omission: Rethinking the Obligation to Inform Research Subjects about Funding Sources

• Published in: The Journal of medicine and philosophy Vol. 42; no. 6; pp. 720 - 739
• Main Author: Manson, Neil C
• Format: Journal Article
• Language: English
• Published: United States 15.11.2017
• Subjects: Disclosure - ethics; Ethics, Research; Humans; Informed Consent - ethics; Personal Autonomy; Research Subjects; Research Support as Topic - ethics; Declaration of Helsinki; disclosure; obligation to inform; informed consent; research ethics
• ISSN: 0360-5310; 1744-5019; 1744-5019
• 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.