Bioethics Forum Essay
International Sharing of Biological Specimens and Health Data: A Gap in the Consent Process?
The Precision Medicine Initiative plans to collect data and biological samples from one million or more individuals in the United States and engage in internationally collaborative research. That means that genetic and other information about these people could be shared with researchers around the world. Prospective donors in the U.S., as well as in many countries, are rarely given the option to consent specifically to having their data used by researchers abroad. Should they be asked?
I recently worked on a study, Harmonizing Privacy Laws to Enable International Biobank Research, that sought to understand how privacy laws in more than 20 jurisdictions affected international sharing of biobank data and specimens. The study also made recommendations for harmonizing differences that can interfere with international research.
Though many jurisdictions have laws or policies that address international sharing of biobank data and research, the US. does not. However, only three of the jurisdictions that my colleagues and I studied discussed a process to inform donors about international sharing and ask for their consent. For instance, Finland and Denmark require consent if samples are shared with non-EU/EEA countries or countries without an EU adequacy rating. Spain requires donors to be “informed about the possibility of international transfers of samples and data.”
The few studies that have explored how donors feel about international sharing suggest that hesitance or opposition to it is fairly common. In a study of South African donors of blood samples, 10% of those surveyed strongly opposed the export of biological samples, while 75% did not object. In a study of Canadian donors or potential donors, more than 20% preferred that samples be used only by the recipient Canadian institution, 54% would be willing to have their samples and data shared internationally if identifying information was removed, and 24% were undecided.
Donors in the U.S. may be even less likely to support international sharing. While more than 70% of those surveyed in one study would be willing to share data and specimens with U.S. academic researchers and more than 50% would be willing to share with pharmaceutical company researchers, fewer than 40% would be willing to have their data shared with university researchers in other countries. Another recent study may explain why Americans are hesitant to have their data shared internationally. Of more than 1,000 respondents,
“73% were not at all to not very comfortable with their health information being accessed by academic researchers outside the U.S., compared to 53% for academic researchers in the US. Moreover, 49% did not trust academic researchers outside the US to keep their health information private (compared to 25% for academic researchers within the US), and 51% did not trust academic researchers outside the US to keep their health information secure (compared to 26% for US researchers).”
Interestingly, even some international organizations that encourage international sharing of data and biological samples do not address the question of consent. Of the seven international guidelines I examined, three–from Human Genome Organization (HUGO), the International Cancer Genome Consortium, and Organization for Economic Co-operation and Development (OECD)–suggest that donors should be informed that international sharing is possible but do not state that they should be asked to consent to it. The guidelines of the Global Alliance for Genomics & Health refer to consent in the negative by recognizing a right not to share internationally within its consent policy. In contrast, Public Population Project in Genomics and Society (P3G) has written a consent policy that includes consent specifically to international sharing.
The diversity of approaches to international collaborative research raises many questions. Researchers need to better understand and characterize donor hesitance as well as to explore whether asking donors specifically to consent to international sharing would address or minimize this hesitance. Furthermore, researchers need to investigate the most effective ways to ask donors for consent for international sharing of data and specimens and the impact of such consent on internationally collaborative research.
Heather Harrell, MD, JD, is researcher at the University of Louisville Institute for Bioethics, Health Policy and Law. Research for this article was supported by a grant from the National Institutes of Health.