By Leah Pierson, Sophia Gibert, and Joseph Millum
Clinical researchers frequently collect samples of blood, skin, and other bodily tissues from their patient-participants and have samples left over when their research is complete. These biospecimens are often in high demand from other scientists who want them for their own research. How should such collections of biospecimens be distributed?
A researcher brought this question to our Bioethics Consultation Service at the U.S. National Institutes of Health. She had recently completed a project investigating rare, neurodegenerative diseases and had leftover tissues from her research participants. A number of scientists were interested in using her remaining samples, but because they were limited, she couldn’t give them to everyone. While trying to answer this researcher’s questions, we discovered that the subject was complex, understudied, and important. Very little has been written on the ethics of allocating biospecimens, and there are few guidelines for allocators. Moreover, we found evidence that access to biospecimens has limited scientific progress and that the lack of guidance has had a chilling effect on researchers wishing to allocate their unused samples.
In approaching the question of how biospecimens ought to be allocated, we wanted to ensure that whatever framework we developed for allocating biospecimens would not reinforce existing research disparities. Poorer, marginalized, and otherwise disadvantaged populations have historically been overlooked by the research enterprise, leading to large research funding disparities. We concluded that biospecimens, just like research dollars, should be used in the most socially valuable ways. All else equal, research projects are more socially valuable when they benefit more disadvantaged groups. Research projects are also more socially valuable when they produce greater overall benefits. For example, all else equal, a research project that generates a cure for a disease affecting a million people is more socially valuable than a research project that cures a disease affecting a thousand people. The social value of research is therefore a function of how badly off the expected beneficiaries are and the magnitude of the expected benefits.
Our general proposal—that scientists planning to distribute biospecimens should assess the social value of competing applications—is easier said than done. There are many factors to consider, including the quantity of samples a project requires, whether it could make use of other available samples, and how likely it is to meet its scientific aims. Many scientific projects are never completed or published, and many of the promising findings generated by research fail to ever be utilized in clinical settings. Moreover, it may be daunting to assess the expected outcomes of a proposed project, especially when it involves basic science research, and to determine how medically and socially disadvantaged the project’s likely beneficiaries are. Our modest aim was to develop a framework that is both accurate, insofar as it tends to identify the most socially valuable projects, and accessible, insofar as it is straightforward for allocators to use. To some extent, there is a tradeoff between these two goals; we are curious to hear whether you think we strike the right balance.
A key takeaway is that more needs to be done to ensure that biospecimens don’t sit unused in lab freezers, but instead are distributed to the researchers who will put them to the best use. Accomplishing this will require exploring a number of related ethical issues. For instance, when are researchers ethically required to share their samples, and what duties do they have to inform the research community about their collections? How much burden should researchers take on in order to distribute their samples fairly and in the most socially valuable ways? How should consent for specimen donation be designed so as to balance facilitating sample sharing and providing participants with adequate control over their samples? We hope our paper will draw needed attention to these questions, and we look forward to hearing your thoughts.
Authors: Leah Pierson1 (co)*, Sophia Gibert2 (co)*, Benjamin Berkman3,4, Marion Danis3, Joseph Millum3,5
*These authors contributed equally to the work.
1 MD-PhD Program, Harvard Medical School. Boston, MA (USA)
2 PhD Program, Department of Philosophy, Massachusetts Institute of Technology. Cambridge, MA (USA)
3 Department of Bioethics, Clinical Center, National Institutes of Health. Bethesda, MD (USA)
4 Bioethics Core, National Human Genome Research Institute, National Institutes of Health. Bethesda, MD (USA)
5 Fogarty International Center, National Institutes of Health. Bethesda, MD (USA)
Competing interests: None declared.
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