• Transplantation
• Genetic Engineering
• Animals
• Personal Autonomy

Kögel et al propose a multicriteria alternative to the standard early clinical selection method for xenotransplantation trials. As they note, existing recommendations for inclusion criteria indicate that only the most seriously ill—those lacking any viable alternative—should be considered for xenotransplantation. Rather than basing selection on, to put it indelicately, a Hail Mary in the face of certain death, Kögel et al recommend a selection system based on four ethical criteria: medical need, capacity to benefit, patient choice and compliance (the latter being an exclusion criterion).

Taken together, they paint a picture of an ethically ideal first-in-human xenotransplantation clinical trial participant: someone ‘in need of a heart replacement with a good capacity to benefit from a xenotransplantation who [has] a choice in terms of alternative potentially life-sustaining treatment options.’1 In other words, they argue that potential xenotransplantation organ recipients (they specify heart, but said criteria would apply to any vital organ recipient) should not be facing their imminent demise as this would inherently constrain that person’s freedom of choice, thus rendering them vulnerable. Instead, Kögel et al argue that trial participants should be selected from groups possessing genuine alternatives to xenotransplantation but opt to receive an animal organ.

Now, their concern regarding the presence of coercion in the context of what is an experimental medical intervention is fully justified, as is their claim that those facing limited viable choices at the end of their lives are an inherently vulnerable population.

Autonomy and consent are largely uncontroversial bedrocks on which most medical and research ethics theories are built. We are, all of us, familiar with the horrors from history—both distant and recent—where participant consent has taken …