Bioethics Forum Essay
Is There a Duty to Participate in Biospecimen Research?
In an essay in the May-June 2017 Hastings Center Report, Holly Fernandez Lynch and Michelle N. Meyer assess the impact of the revised Common Rule on biospecimen research. They believe that the proposed “broad consent” approach – which involves participants agreeing to the storage of blood and other biological samples for subsequent use in a broad range of research projects –will rarely be used because of practical challenges in implementing it. In addition, they argue that ethical justifications are not robust enough to encourage researchers to use broad consent. To justify this claim, they write, “Many have argued that there is a duty based in justice and reciprocity to allow one’s biospecimens to be used in this way.” My concern is with the ethical calculus they describe and its use of the idea that people have a duty to participate in medical research.
Bioethicists debate whether there is a duty to participate and how it impacts ethical decision-making. Arguments for the duty to participate have been grounded in both beneficence and justice, but justice is the primary justification being offered here. The justice argument is that since everyone can benefit from medical research then everyone has an obligation to participate. This obligation is most often framed as a prima facie obligation—if no other duty or obligation conflicts, then one should participate in research. In many ways, biospecimen research is the perfect case for a duty to participate. It is a low-risk, potentially high-reward type of research, especially in the case of specimens remaining after a medical test or treatment. Why not let researchers use it? I believe there are three reasons to be skeptical of a duty to participate in biospecimen research.
First, we should consider more carefully the history of justice in bioethics, since the duty to participate is framed as an outcome of justice. Justice is a universally desired good. People seek it in courts, in politics, and in their everyday lives. People try to live justly. While the obligation of research participants to seek justice is controversial, it is incontrovertible that researchers have an obligation to seek justice in their work. Researchers—not the general public or participants—are obligated to consider how the benefits and burdens of research fall on individuals and groups. Researchers are required to make sure that they do not unduly burden those who are poor, experience racial or other discrimination, lack access to health care, or are vulnerable in other ways. The context in which justice is applied to medical research suggests that participants and the public were not meant to carry that obligation.
What happens if we do impose this duty on participants? Who will be most exposed to the demand to participate? Those who are ill and have frequent contact with health care systems will be those most likely to be asked. Those with the fewest resources at their disposal will feel the demand most keenly, and they will be the ones least able to say no because they might fear reprisals, like a reduction in care, if they refuse the request from researchers and institutions. Even when research leads to therapies, the poorest people are often the last to benefit. And for one category of therapies—so-called lifestyle drugs for conditions like erectile dysfunction or baldness—it is unlikely that poorer research participants will ever be able to benefit from the research conducted on them.
Second, history shows us the danger of assuming that individuals ought to participate in research. We have already seen how this story played out in the tale of Henrietta Lacks. Researchers in the first two-thirds of the twentieth century argued that indigent patients had an obligation to participate in research in order to “pay their way” and cover the costs of their medical care. Doctors at Johns Hopkins took a biopsy of Lacks’s cancer and turned it into the first immortal cell line. When the family discovered this fact years later, they were shocked and horrified. The outcome was an ethical crisis for research. The fact that Henrietta Lacks was a poor African-American woman further supports my contention that this duty would fall disproportionately on vulnerable patients.
Third, advocates for the duty to participate often argue that there is a lack of participants in research. Recognizing a duty to participate, they argue, would help resolve this issue. Yet, my own experience with biobanks and biospecimen research shows that participation is not an issue. People understand the potential value of biospecimen research, especially with residual clinical samples. Research has shown that people participate in clinical research for altruistic reasons, as well as because they hope to benefit from the eventual products of research. Given the minimal risks and discomfort in biospecimen research, we should expect altruism to lead to even greater rates of participation. The main concern for participants is whether they trust the institution maintaining the biobank or repository. If there is a lack of trust, people are less likely to agree to participate. Imposing a duty to participate overlooks the fact that with a little work by a biorepository to maintain positive relationships with the surrounding community, most individuals would happily participate in the institution’s research.
For these reasons, we should resist arguments that patients, participants, and the public have a duty to participate in biospecimen research. There is no need to impose such a duty when individuals are likely to participate. And the general public will participate when researchers develop positive relationships with their local communities and establish that those communities can trust the researchers and their home institution to use biospecimens for responsibly conducted research. While there might still be practical challenges to implementing broad consent, the ethical calculus is clearly in favor of it.
John Lynch, PhD, is an associate professor in the Department of Communication at the University of Cincinnati.