NIH Seeks Comments on Plan to Share Genomic Data
The National Institutes of Health (NIH) is accepting public comments until November 20 on a draft Genomic Data Sharing Policy “that promotes sharing, for research purposes, of large-scale human and nonhuman genomic data generated from NIH-supported and NIH-conducted research.” NIH provides an easy online form to fill out if you’d like to share your thoughts.
According to the blog of the Presidential Commission for the Study of Bioethical Issues, the NIH policy guidelines are similar to those in its 2012 report Privacy and Progress in Whole Genome Sequencing. The goal of that document was to “help craft policies that are flexible enough to ensure progress and responsive enough to protect privacy.”
And therein lies the fundamental struggle facing genetic research. Genomic data is an extremely valuable resource; open access to large amounts of it could lead to improved understanding of the human genome and better ways to diagnose, treat, and prevent disease. But it could also pose risks to the individuals whose genetic information will be freely available. The NIH draft policy assures that provisions to protect privacy are included; for example, information will be connected not to a person’s name or date of birth, but to a random unique code. Research participants will also have some say over whether their data is available through open or controlled access.
However, a series of high-profile database hacks has shown that complete privacy or control is probably impossible. In June, Steven E. Brenner wrote an in-depth article in Nature warning, “It seems inevitable that there will be a major leak of genome information in the near future.”
Moreover, it doesn’t sound as though there will be much room for wary researchers to get around the NIH policy. It will apply to all projects involving large-scale genomic data funded in any way by the NIH, and failure to comply could lead to the withholding of funding. This may cause researchers to encourage participants to agree to share their data broadly, and could limit the likelihood that participants will choose to evade this pressure. The NIH says it will accept data derived before the policy goes into effect, and require any studies initiated afterward to inform participants that their genomic and phenotypic data will be shared broadly.
This policy could mark a critical shift in the landscape of genomic research. Importantly, it’s a move away from private efforts to monetize genomic data by limiting access. The NIH document emphasizes the Supreme Court decision that naturally occurring DNA sequences are not patentable and states that, “the NIH discourages the use of patents to prevent the use of or block access to genomic or genotype-phenotype data developed with NIH support.”
However, if genomic information does lead to the creation of drugs, tests, and treatments that are patentable, the people who provided the raw material will surely not be receiving any thanks. Furthermore, people giving away their genetic data should be aware that it is not only their personal privacy that is at stake; genetic information implicates entire families.
Not to disparage the lofty intentions of the NIH or genetic researchers, but the extent to which various organizations and companies are now vying for my DNA makes me somewhat uncomfortable. If the “open-access” model really does spread globally, people may feel that they’re a part of something important, even revolutionary, as the Personal Genome Project founder George Church likes to say. But, to me, it's all starting to feel a bit like a corporate colonization of our bodies, at the most intimate level.
Previously on Biopolitical Times: