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NIH Seeks Public Comment on Genomic Data Sharing Policy

NEW YORK (GenomeWeb News) – The National Institutes of Health is seeking public comments on draft policy proposals for how researchers should share data from human and non-human genomics research projects, NIH said today.

The draft Genomic Data Sharing (GDS) Policy proposed by NIH was developed both to protect the privacy of research participants and of intellectual property, and to help promote the sharing of data, which NIH sees as an important, enabling aspect of genomics research.

NIH said the draft GDS Policy promotes the sharing of genomic data, which allows data from one study to be used to explore a range of other research questions, and enables investigators to combine data from multiple projects, "amplifying the scientific value of data many times," NIH said.

NIH set the background for the GDS Policy in 2007, when it issued a specific policy to promote the sharing of data from genome-wide association studies, and through the creation of the database of Genotypes and Phenotypes (dbGaP). With dbGaP, NIH created a two-tiered system for distributing data — an open access level with no restrictions, and a controlled access level for data that can be used only for research purposes, and which are consistent with the original informed consent under which the data were collected.

Soon after the GWAS policy was in the books, rapid advances in DNA sequencing and other high-throughput technologies led to rapid declines in the costs of DNA sequencing, and NIH said in 2009 that it would plan to extend its policy to encompass data from a wider range of genomics research.

The new draft GDS Policy applies to all research funded by NIH. The policy lays out the responsibilities that researchers and institutions have for the submission of human and non-human genomic data to NIH, how controlled data should be used, and expectations about how to protect intellectual property.

Under the draft policy, privacy protection and confidentiality are paramount in the sharing of human data, NIH said, and it includes a number of provisions to protect research participants.

For example, before data is submitted traditional identifier information such as name, date of birth, address, and social security numbers should be removed and then encoded using a random, unique code.

NIH also will expect that the responsible officials at institutions submitting data will provide an institutional certification to the NIH institute or center providing the funding before it receives the related award. This certification will assure that the data was, or will be, de-identified and collected in a legal and ethically appropriate manner.

Investigators will be expected to address plans for following the policy in their proposals, and any resources required to comply with the policy should be included in their project budgets.

NIH expects that non-human data, including microbial and microbiome data, should be "shared in a timely manner," essentially no later than the date of initial publication.

These data also should be made available through any widely used data repository, whether funded by NIH or not, such as the Gene Expression Omnibus, the Sequence Read Archive, or the Zebrafish Model Organism Database, to name a few.

NIH said it is encouraging the public to provide comments on the draft GDS Policy by Nov. 20, 2013. NIH also said it plans to hold one or more public webinars on the draft policy.