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NIH Considering New Genomic Data Sharing Policies

NEW YORK (GenomeWeb News) – The National Institutes of Health plans to update its policies on sharing genomic and sequence-related data, and is now discussing changes that could affect how data sets are used, organized, and prioritized, how they are made available, and how privacy is protected.

The plans were spurred by the NIH's conclusion that the value of sequence-based genomic data can be realized by making sequence and other genomic and phenotypic data "available as broadly as possible to a wide range of scientific investigators," NIH said this week in a notice to the genomics research community.

One of NIH's aims is to encourage investigators who are funded by the institutes and internal review boards to consider adopting broad sharing of sequence and related data as they develop informed consent processes and documents for studies using human sequence data.

It also wants to develop a policy to place large data sets into centralized databases, such as the Database of Genotypes and Phenotypes, so they are available "as broadly and rapidly as possible to a wide range of scientific investigators," NIH said.

Policy discussions that NIH plans to focus on include how to get the maximum utility from genomic data by providing access for research and computational analysis that could lead to prognostic, preventative, and therapeutic approaches to human disease.

Several issues are central to the NIH discussion of what data sets will be subject to the new policy including the broad utility of a data set to the wider community for analyses and validations; the uniqueness of the data set in terms of its size and the genomic region to be analyzed, as well as the number of samples to be analyzed; the quality of the available associated non-sequence data, such as phenotype and exposure data; as well as issues related to protecting participants' privacy, and confidentiality and consent issues related to using human data.

NIH also will consider the importance of the timing of broad data release, including potential pre-publication release. It also will review the types of primary and processed data that should be released, such as accompanying metadata and annotation like phenotype and epigenetic data, and it will consider the costs borne by investigators of implementing any proposed policies.

In a separate effort, the Secretary's Advisory Committee on Genetics, Health, and Society two weeks ago began addressing data-sharing issues by agreeing to take two steps to start studying these issues.

The committee decided to form a steering group that will host a session at a meeting this winter to explore models of genomic data sharing and usage. It also plans to look at sharing data collected by companies providing direct-to-consumer genetic tests, how research participants feel about their data being shared, systems for data sharing, what other agencies are doing in this area, and the range of social and clinical implications of genomic data sharing.

SACGHS also agreed to provide information to the Lewin Group, a health care research company, to study important policy questions in these areas.