The National Institutes of Health has encouraged international collaboration in the Human Genome Project and other precision medicine research. For example, as approved last year, the 21st Century Cures Act included support for an international pediatric study network.
However, there also is increasing public concern regarding transfer of data about U.S. subjects to international researchers, reports Mary Anderlik Majumder, JD, PhD, an associate professor of medicine in the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston.
Majumder breaks down the legal and ethical issues in a recently published study,1 which follows her 2016 study2 that found a 20% increase in the public’s discomfort with sharing health data with international researchers as opposed to those in the U.S. This distrust appears to stem from a concern that researchers in other countries may not be as bound by regulations or ethical expectations for use of the data.
“That seemed to be the primary factor,” Majumder says. “I think the U.S. public is unfamiliar with the high level of protection in some other countries. Also, I don’t think the U.S. public necessarily is aware of the degree to which U.S. researchers — and, ultimately, all of us — benefit from access to data from other countries.”
There are good examples of how this is currently unfolding in international groups. For example, the Public Population Project in Genomics and Society (P³G) is a consortium dedicated to fostering collaboration between population genomics researchers.
“Of course, that doesn’t mean that there’s no increased risk with data-sharing, and managing risk has been a catalyst for thinking about ways to facilitate use of data for potentially beneficial research without necessarily having the data itself move,” Majumder says. “For example, I think efforts to limit downloads of full data sets while giving researchers access to what they need for their projects, and experiments with distributed data networks, are extremely promising.”
She also cites the work from the Electronic Medical Records and Genomics (eMERGE) Network in the area of informed consent.
“The focus on informed consent seems to me to be appropriate, at least for data-sharing that is occurring through established research consortia and NIH-designated repositories, which have safeguards in place,” she says. “I think it’s appropriate to address international sharing as part of the informed consent process whenever the cross-border sharing of data is contemplated or reasonably foreseeable.”
Whether research is domestic or part of an international group, there are current concerns that deidentified research participant data can be reidentified.
“That’s a larger issue, especially in the context of genomic data-sharing,” Majumder says. “I think of addressing this as part of the informed consent process as preventive ethics. Especially since the revised Common Rule recognizes that risk changes over time.”
1. Majumder MA. United States: law and policy concerning transfer of genomic data to third countries. Human Genetics 2018;137:(8):647–655.
2. Majumder MA, Cook-Deegan R, McGuire AL. Beyond Our Borders? Public Resistance to Global Genomic Data Sharing. PLoS Biol 2016;14(11):e2000206.