Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants?

Abstract

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.” A working group convened by the National Institutes of Health has recommended that brain imaging research studies should establish protocols for handling incidental findings. However, there is little ethical guidance available to steer such efforts, and practices appear to vary widely. Although several articles have catalogued the ethical dilemmas surrounding incidental findings, 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, systematic ethical analysis of the incidental findings problem is lacking.