Incidental findings in human subjects research: what do investigators owe research participants?

A physician-investigator conducting brain imaging research to study the pathophysiology of depression detects a suspicious finding in a healthy volunteer that suggests a possible brain tumor. Must the investigator disclose this finding to the research subject? Further, is there a duty to ensure that brain scans performed to answer research questions are evaluated clinically to identify potential health problems? If so, what in the nature of the investigator-subject relationship gives rise to such an obligation? Investigators and Institutional Review Boards (IRBs) commonly struggle with the question of how to address incidental findings — that is, “a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study.”1 A working group convened by the National Institutes of Health has recommended that brain imaging research studies should establish protocols for handling incidental findings.2 However, there is little ethical guidance available to steer such efforts, and practices appear to vary widely.3 Although several articles have catalogued the ethical dilemmas surrounding incidental findings,4 with the exception of seminal work by Henry Richardson and Leah Belsky on the more general topic of researchers’ obligations to provide ancillary clinical care to research subjects,5 systematic ethical analysis of the incidental findings problem is lacking. In this article, we seek to describe an ethically defensible response to incidental findings in human subjects research, grounded in an appropriate conception of the investigator-subject relationship. To focus our analysis, we consider the simple case of the relationship between an investigator and a healthy volunteer, where there is no concurrent therapeutic physician-patient relationship that might provide an alternative source of obligations regarding incidental findings. Further, we consider what the investigator’s “default” obligations should be when no explicit promises have been made regarding disclosure of such findings, nor has the subject expressed any preferences concerning disclosure. One conceivable position on this question is that investigators have no default obligations, only duties of promise-keeping that arise when they make particular representations to subjects. This view is grounded in the notion that the researcher-subject relationship is essentially contractual in nature, as opposed to fiduciary or professional. As such, the rights and obligations that inhere in the relationship are defined by the “contracts” the parties execute — the informed consent form and surrounding interaction — and the implied warranty of good faith and fair dealing that accompanies them. This is a legalistic view, and a minimalist one in the sense that few implicit duties are presumed. Under this view, unless incidental findings fall within the terms of this contract, investigators are under no obligation to respond to them. We reject this position in favor of the view that investigators do have limited obligations to inform subjects of incidental health-related findings. There are at least three potential sources for such obligations, which we consider in turn. First, if the investigator (or another on her research team) is a physician, these obligations might derive from the nature of a physician’s professional duties. Second, they might derive from duties rooted in general beneficence, independent of any professional or other relationship between the parties. Finally, and most persuasively, they might derive from the nature of professional responsibility generally or professional responsibility in the investigator-subject relationship. Considering these possibilities, it turns out, sheds light not only on investigators’ duties regarding incidental findings, but more fundamentally on the nature of the investigator-subject relationship itself.