Is there an upper limit to the risks that humanitarian research may legitimately visit upon research participants?

AUTHOR AFFILIATION: Nir Eyal, Harvard T. H. Chan School of Public Health, USA, neyal@hsph.harvard.eduIs there an upper limit to the risks that medical studies may legitimately visit upon their participants? This question can arise in humanitarian crises. For example, a vaccine challenge study for a pandemic strain can save time and many lives, but would transgress the present status quo in research ethics, simply because it would visit extremely high risk on study participants--who are deliberately exposed to that pandemic strain. Bioethicists Frank Miller and Steve Joffe, Annette Rid and Dave Wendler, Alex London, and David Resnik, as well as many research ethics documents and regulations endorse or defend such upper limits and would oppose very risky humanitarian research, regardless of its benefits. My presentation will argue against upper limits to the risks that humanitarian research (and medical research in general) may legitimately visit upon its participants, on multiple grounds. Such limits seem committed to an implausible ethical absolutism. Invitations to participate in extremely risky studies could target populations who are at high risk anyhow. A high medical and direct risk for study participants does not mean that their participation is necessarily unfree, uninformed, incompetent, or irrational. And finally, such limits are incompatible with a certain plausible view on the legitimate level of risk to research nonparticipants. I also expose the weakness of a few defenses of limits to the risks that medical studies may legitimately visit on their participants