The policy follows on from the 2008 policy for NIH-funded genome-wide association studies (GWAS) studies, and is intended to promote the sharing of large-scale human and nonhuman genomic data arising from NIH-funded research. It is argued that this will accelerate further research, especially by allowing the combination of multiple datasets, and is ‘essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health’.
The draft GDS policy is intended to uphold the NIH’s commitment to ‘responsible data stewardship’, which is said to be essential in order to maintain public trust in biomedical research. To this end it includes measures to protect the privacy and confidentiality of research participants, as well as requirements for appropriate informed consent. For studies taking place after the policy becomes effective, informed consent is to involve a clear understanding that genomic and phenotypic data may be shared broadly for future research purposes
Open-access datasets are to be made publicly available without restriction, whereas controlled-access data will necessitate approval for use by other researchers. The NIH emphasises that it ‘discourages the use of patents to prevent the use of or block access to genomic or genotype-phenotype data’ developed with their financial support, and stipulates that data may not have any licensing requirements attached to them; however, the development and patenting of downstream technologies and products that may address public needs is encouraged.
The consultation runs for sixty days from 20th September 2013, and the policy is expected to take effect sixty days after the final version is made public.