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

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.