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Data Sharing

Overview

NIH is interested in ensuring that the research resources developed within the Molecular Libraries Roadmap Initiative become readily available to the research community in a timely manner for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public health.The Molecular Libraries Screening Center Network (MLSCN) will provide biomedical researchers with scientific resources that include annotated information (activity in a wide range of biological assays) for compounds in the Molecular Libraries Small Molecule Repository (MLSMR), assay automation, high-throughput screening (HTS), and synthetic chemistry capabilities that can be applied to the discovery and development of innovative chemical tools.

The data and resources generated or developed by the MLSCN are considered to be community resources, and include: assay descriptions, protocols and/or links to published assays implemented in the MLSCN; performance data for assays and compounds; primary data from HTS and data generated in the secondary screen; chemical structures, synthesis protocols, and/or links to published synthesis protocols for chemical analogs of hits, for probes, and the biological activity of analogs and chemical probes. All data generated by the MLSCN will be deposited promptly upon data verification into PubChem.

Technology development resources generated by the MLSCN, such as assay automation or miniaturization, HTS methods or instrumentation, data analysis software, may be patented as determined by law. In such filings, NIH encourages the use of “non-assert” language to ensure that the patent is not enforced against organizations utilizing the technology for research purposes.

Exceptions to prompt disclosure of data will be considered under exceptional circumstances on a case by case basis. Additional, detailed information can be found in the .

History

The policy for data sharing and IP in the MLSCN Program was developed after consultation by NIH staff with a broad range of interested parties, including scientists, university technology transfer officials, and individuals from private foundations, pharmaceutical companies and biotechnology companies. The NIH guidance for data sharing and IP in the MLSCN was proposed in the Request for Applications (RFA-RM-04-017) released on April 21, 2004 and was updated to reflect feedback from the scientific community in an addendum (NOT-RM-04-014) released on July 22, 2004. The NIH MLSCN Project Team issued a concise summary of the data sharing and IP policy for the MLSCN on October 11, 2005. The MLSCN centers have executed a Letter of Agreement to abide by the terms of the . When an assay is selected for implementation within the MLSCN, an unmodified MLSCN Material Transfer Agreement (MTA) is used to facilitate the transfer of assay information and materials from the Assay Provider to the MLSCN. A similar unmodified MLSMR Material Transfer Agreement (MTA) is used to facilitate the transfer of compounds accepted for inclusion in the repository from the Compound Provider to the MLSMR for distribution to the MLSCN.