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NHGRI Seeks Feedback on ENCODE Data-Release Policy with Nine-Month Publication Moratorium

NEW YORK (GenomeWeb News) – The National Human Genome Research Institute is soliciting comments from the research community on a updated data release and publication policy for the Encyclopedia of DNA Elements, or ENCODE, project.
 
The draft policy, available here, calls for ENCODE data producers to release their data in a “timely” manner, but protects their interests by providing a nine-month period in which users of that information may not publish the results of any research based on the public data without prior consent.
 
“This will provide time for the resource producers to have a protected opportunity to publish initial analyses of the data they have generated,” NHGRI said in the draft policy.
 
NHGRI said in a notice on its website that the updated policy “provides more specificity” than its previous guidelines, which were based on the so-called “Fort Lauderdale agreement,” a general policy drafted in 2003 that called for the rapid release of data produced by “community resource projects.”
 
The updated policy would apply to all data generated under the ENCODE project, a large-scale effort to identify all the functional elements in the human genome that began its second phase last year following a four-year pilot project. The policy also covers data from the modENCODE project, which is focused on the Drosophila melanogaster and Caenorhabditis elegans genomes.
 
According to the revised policy, “ENCODE/modENCODE resource producers will release data, as soon as they have been verified and prior to publication, to public databases.” Prior to publication of the data in a peer-reviewed journal, “NHGRI asks resource users to consider them to be unpublished and to follow standard scientific etiquette regarding the use of unpublished data.”
 
In order to enable the “compromise between unrestricted use of the data and unavailability of the data until publication,” NHGRI recommends a nine-month period during which researchers can freely use the ENCODE and modENCODE data as part of their research, but cannot submit for publication the results of any studies using unpublished ENCODE or modENCODE data without prior consent.
 
NHGRI said that this “publication moratorium” by resource users “ends either at the expiration of the nine-month protected period or when the data have been published, whichever is shorter.”
 
In addition to issues surrounding data release and publication for ENCODE data, the draft policy also addresses intellectual property.
 
Unlike the Human Genome Project and the International HapMap project, which generated raw data that did not have “utility,” from a patenting perspective, “the purpose of the ENCODE and modENCODE Projects is to generate data that identify or define genomic DNA sequence elements that have biological function, and therefore might be considered to have utility and be able to be patented,” the policy states. “Therefore, the use of patents in ways that might restrict access to large amounts or broad categories of data, e.g., all transcription factor binding sites, is an issue that needs to be addressed.”
 
As a result, NHGRI “encourages all ENCODE/modENCODE resource producers to consider placing all information generated from their project-related efforts in the public domain.”
 
In cases where consortium members decide to exercise their IP rights, NHGRI said it “encourages consideration of maximal use of non-exclusive licensing of patents to allow for broad access and stimulate the development of multiple products.” NHGRI’s recommendations for licensing genomic inventions are available here.
 
NHGRI added that it also encourages users of the ENCODE data to “act responsibly.” As an example, the policy states, “if a data user were to incorporate ENCODE/modENCODE data into an invention, the subsequent license should not restrict the access of others to the ENCODE/modENCODE data.”
 
NHGRI said that it is seeking comments on the proposal from the research community before finalizing the policy. Comments should be sent to [email protected] by Oct. 15.
 
Additional information about the ENCODE data-release policy is available here.

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