DATA RELEASE POLICY: MICROBIAL GENOME SEQUENCING PROJECTS Release Date: March 17, 1999 P.T. National Institute of Allergy and Infectious Diseases BACKGROUND In its support of large-scale pathogen genome sequencing projects, the National Institute of Allergy and Infectious Diseases (NIAID) seeks to balance the rights of its grantees with the needs of the research community. NIAID recognizes that large-scale genome sequence information is a unique research resource* and that rapid and unrestricted sharing of microbial genome sequence data is essential for advancing research on infectious agents responsible for human disease. Early release of unfinished sequence has proven useful in accelerating the pace of experimental discovery. At the same time, it is also necessary to give investigators time to verify the accuracy of their data and to accomplish the goals proposed in their application, which often includes the assembly and annotation of the sequence data. NIAID POLICY Applications for support of pathogen genome sequencing projects should include a detailed description of the data release plan. Timely release is strongly encouraged and should be implemented in consultation with the NIAID program officer and in recognition of the benefits to the broader research community. Release should be accompanied by appropriate information on the reliability of the data (e.g. level of coverage and extent of assembly, extent of contamination with vector and other sequences, statistical measures of accuracy). At a minimum, it is anticipated that sequence data will be released within one month after 3X coverage of the genome (or chromosome for eukaryotic organisms) is achieved. The released data should be provided as assemblies of equal to, or greater than, one kilobase contigs. Subsequent releases of assembled sequences should be provided on a monthly basis. NIAID expects that users of the released data will appropriately acknowledge their source. Prior to funding, NIAID will review the investigator's proposed data release plan. No award will be made until an acceptable plan has been approved and incorporated into the terms of award. Because the community standard for early data release is presently evolving, plans for data release will be re- assessed at the end of each budget period. In NIAID's opinion, raw genomic sequence, in the absence of additional demonstrated biological information, lacks demonstrated utility and therefore is an inappropriate material for patent filing. NIH is concerned that patent applications on large blocks of primary genomic sequence could stifle future research and the development of future inventions of useful products. However, according to the Bayh-Dole Act, the grantees have the right to elect to retain title to subject inventions and are free to choose to apply for patents should additional biological experiments reveal convincing evidence of utility. NIH Grantees are reminded that the grantee institution is required to disclose each subject invention to the NIH within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. NIAID staff will monitor grantee activity in this area to determine if attempts are being made to patent large blocks of primary genomic sequence. *Public Health Service Policy Relating to Distribution of Unique Research Resources (NIH Guide, Vol. 25, No. 23, July 12, 1996; https://grants.nih.gov/grants/guide/notice-files/not96-184.html
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