Opinion: Risk to study nonparticipants: A procedural approach

Current ethical guidance for research on human subjects is primarily concerned with protecting study participants.* They are, after all, the “human subjects” whose interests are the focus of oversight. But research—whether on human subjects or not—may also strongly affect individuals who are not study participants. US law defines study participants as living people about whom data are obtained through intervention or interaction or about whom identifiable private information is collected (1). Many individuals about whom no data are obtained through intervention, interaction, or other means can be affected by a study. Research on human subjects can affect people other than the subjects. What protections are owed to study nonparticipants? Image courtesy of Dave Cutler (artist). A complex ethical question therefore arises. What protections are owed to study nonparticipants? Except in the case of fetuses (a relatively complex case in light of their debatable moral status), US law governing all federally funded research does not address risk to nonparticipants (1). Although guidance exists on specific risks—for example, risks from xenotransplantation trials to surrounding individuals and communities and risks from genetic studies to the privacy of relatives—a comprehensive approach or ethical theory is missing. Certainly there is no philosophical foundation that covers highly discrepant risks to third parties from infection, radiation, data exposure, stigmatization, a fully warranted bad name, and so forth. And reasoning in this area pays little attention to relevant normative work on risks to bystanders and collateral damage in tort law, just war theory, and other parallel discussions. Nor, finally, do we even know the scope and intensity of likely nonparticipant effects in typical research practice. It would be helpful to develop a comprehensive and consistent account of whether and when risks to nonparticipants make research activities illegitimate and which regulatory responses are appropriate. But how to develop … [↵][1]1To whom correspondence should be addressed. Email: neyal{at}hsph.harvard.edu. [1]: #xref-corresp-1-1