Dessislava Fessenko reveals that ethical concerns surrounding the participation of healthy volunteers in Phase 1 clinical trials have deep roots in broader social conditions, which require social policy responses.
Payments to healthy participants in Phase 1 clinical trials have long raised ethical concerns. Some of them have to do with whether offering a payment in and of itself unduly induces health volunteers to assume disproportionate risks of testing experimental therapies. Other concerns relate to the amount of study compensations, in particular whether high amounts may improperly lure healthy participants and inhibit their ability to freely consent to participation, and that low amounts might be exploitative. These types of concerns are considered to squarely fall within the prerogatives of research ethics boards or institutional review boards.
Research by scholars at University of North Carolina at Chapel Hill, however, sheds light on the broader social contours of healthy volunteers’ participation in Phase 1 clinical trials in the United States. The research reveals that for 39% of the healthy participants interviewed, study compensations represent a critical financial lifeline. More vulnerable populations featured in that category primarily, such as Hispanic participants, individuals with a high-school degree or less educational attainment, and unemployed participants. 34% of the interviewees valued their participation in Phase 1 clinical trials for the health screening that they received.
This background alludes to fundamental structural issues that underpin some healthy volunteers’ motivation to participate in clinical trials: no or limited access to employment or healthcare, low educational attainment, job insecurity and indebtedness. Those issues have profound bioethical dimensions along two lines: structural injustice and the resulting social inequalities. As the American philosopher Iris Marion Young observed, structural injustice arises whenever the existing social conditions and processes by their very operation deprive certain groups of people from the opportunity to develop and exercise their individual capabilities, to flourish personally and professionally, to participate in and contribute to public life. As a result, those people are exploited, marginalized or otherwise socially suppressed.
Structural injustice and the ensuing social inequalities appear to be byproducts of two major shortcomings of public policy- and law-making. The first one is their failure to set up institutions and processes that preempt the emergence or overcome the existence of power asymmetries and social disparities in fundamental social settings (for example, education, the labour market). Policies and regulations are often crafted from the position of the majority’s predispositions and needs. Cases in point are the United States Supreme Court’s judgement in Dobbs v. Jackson, which is expected to have disproportionate effects on African-American women. The other major shortcoming is the failure of policies, regulations and their enforcement to render vulnerable social groups better off. Policies and regulations often advance solely the agendas of the powerful and the privileged. Examples are certain financial regulations and antitrust policies, as research by the jurist Katharina Pistor and the economist Thomas Philippon show.
Social and business practices may contribute equally starkly to the perpetuation of social inequalities. Segregation bars members of marginalized groups from adequate healthcare, education, employment, housing, and financing. Business models may have features or operate in ways that inadvertently disadvantage certain social groups to the benefit of others. A case in point is credit card reward schemes, which appear to disproportionately benefit the more affluent and burden the poor. Charging excessive consumer prices and paying low wages transgress into exploitation and propagate poverty.
Remedying such structural issues does not fall within the remit of research ethics. Strictly speaking, such a venture does not fall within the purview of bioethics at large either. Structural issues demand social policy responses aiming at better access to education, jobs, housing, food security, social support and adequate healthcare for those in need. Such policies and implementation regulations are the responsibility of national and local governments, politicians and law enforcers. Thus, were the root causes for ethical concerns in healthy volunteer Phase 1 research to be truly resolved, political action and social change are needed.
Bioethics alone cannot effectuate such transformation. Yet, it has still a role to play. Bioethics can learn from non-ideal social realities and advance its normative framework beyond distributive principles to promote structural justice. Bioethics can initiate the public debate about the need for social change and political action. Bioethics can also inform and further advance our moral beliefs as to what is just and how it can be implemented fairly. In this way, we can spearhead social change through our socio-cultural practices and through our participation in institutional and political processes that set the policy and legislative agendas.
Dessislava Fessenko is a Master of Bioethics candidate in the Center for Bioethics at Harvard Medical School. She is also an antitrust and technology lawyer and a policy researcher working on AI policy and governance. @DessiFessenko