February 28, 2015
A review published in Trends in Genetics expresses concern over certain aspects of the new policy governing the use and release of data generated by US National Institutes of Health (NIH)-funded genomic studies, issued in August 2014. The first framework for genetic data by leaders of the Human Genome Project (1996) required the release of all genetic data after 24 hours of generation. This was modified in the NIH 2007 Genome-Wide Association Study (GWAS) policy, in which a 6 month embargo on the data could be permitted. Due to certain embargo violations however, the 2014 Genome Data Sharing (GDS) policy stated that human genomic data must be submitted within 3 months after generation, which may be retained by the NIH for up to 6 months before public release. The policy included non-human and model-organism genetic data for the first time. Under this policy however, these data can be retained by the producers until their initial analyses are published.
The author believes that since scientific advancement is fastest when data are made publicly available rapidly, the provision of these embargos may be misguided. The author believes that the NIH should work on “developing approaches that strengthen the enforceability and monitoring of the embargo rather than making this data unavailable to researchers which would hinder research”. Furthermore, the author argues that even though the inclusion of non-human and model-organism data is a step in the right direction, concessions made by the policy regarding the timing of data-release is disheartening. The author states that the GDS policy is diminished in its effectiveness of pre-empting patents as it relies on the ruling in the Myriad case, which only prohibits the patenting of DNA molecules extracted from the human body but not man-made constructs such as cDNA, even if they duplicate the DNA sequences found in the body.