Post-trial obligations and participant enrollment in brain pioneering research: should we expand inclusion criteria?

Abstract

Brain pioneering research investigates the clinical utility of implantable neural devices that acquire, process, and translate brain signals to enable individuals to produce actions or effects. There is a scholarly consensus that researchers, funders, and organizations have post-trial obligations to provide participants continued access to and support for implanted neural devices that benefit them. In this paper, we examine the case for post-trial obligations by critically assessing the current limitation that participation in brain-pioneering research be restricted to individuals with debilitating conditions who lack clinically acceptable or proportionate therapeutic alternatives. We consider the possibility of broadening eligibility to include anyone who meets the study's clinical and safety criteria regardless of therapeutic alternatives. Expanding inclusion criteria in this way may help address concerns about the practical feasibility of meeting post-trial obligations and obtaining valid informed consent, while affirming the equal moral respect owed to all prospective participants.