Do Researchers Have a Legal Duty to Disclose Individual Research Findings to Research Subjects? Why They Might, and Why it Matters

Abstract

Exploration of the frontiers of biomedical research requires the willing participation of millions of human subjects. This participation primarily facilitates breakthroughs in generalized knowledge, but it also reveals personal information about the human subjects, some of which is potentially significant. Researchers who possess such personal information about the subjects of their studies arguably have – or should have – a legal duty to inform the subjects, at least when the information is medically significant. While there is no such explicit duty in positive law and none has been previously announced by a common law court, some courts have softened the requirements for finding that a physicians and life insurers have such a duty in analogous situations. The law has thus developed such that a finding that researchers have a similar duty would appear to be a logical next step. In fact, the argument for a duty to disclose for researchers is arguably even stronger. Courts faced with litigation alleging a researcher duty to disclose should not, however, merely import the reasoning from the analogous cases because doing so would further cloud the already fuzzy state of the interaction between researchers and subjects. And a federal regulatory answer appears to be preferable than the imposition of a duty via the common law.