Priority Issues of Access to Research Resources -- Letter Report (1999) / Chapter Skim
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Priority Issues of Access to Research Resources
Priority Issues of Access to Research Resources
Pages 1-15
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In the near term, the issues of patent policies, material transfer agreements, and access to privately held data are the most time-critical, and should be addressed sooner rather than later, because proposing and adopting solutions to them now is likely to have the greatest chance of
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, which are variations in DNA that provide insight into the genetic basis of disease, among other things. Many research scientists, particularly those in the academic community, consider SNPs to be research tools; like ESTs, SNPs are being identified rapidly and methodically in the genome.
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Material Transfer Agreements and Licensing Research scientists have a Tong tradition of sharing research findings and experimental materials with one another in the interests of collegiality and furthering the scientific research enterprise. However, since the ~ 980 enactment of the Bayh-Dole Act to foster technology transfer, nonprofit organizations like universities have been obliged to promote the utilization, comrnerciaTization, and public availability of inventions that arise from their federally funded research.
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The guidelines note that "restrictive licensing, especially when coupled with indiscriminate use of the patent system, can be antithetical to the goals of the Bayh-Dole Act, such as where these are employed primarily for financial gain" and add that such practices "are likely to thwart, rather than promote utilization and public availability of the invention." The principles and guidelines proposed by NIH seem to be a constructive step in the right direction. The principles emphasize academic freedom and publication, the appropriate treatment of research tools under the Bayh-Dole Act, and the need to minimize administrative impediments to the transfer of research resources.
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~.' The US government has sponsored research aimed at involving biodiversity-rich countries in the development of commercial applications derived from native resources, but its ability to negotiate access to biodiversity resources for academic research is inhibited by the fact that the United States is not a signatory to the convention. The creation of joint, basic research programs in which resources can be shared through material transfer agreements that appropriately restrict their distribution or the scope of their application is one approach to this problem.
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For example, in agricultural research, the private sector is far ahead of the public sector in collecting DNA-sequence information about important field crops. Databases of that information could be a great asset to academic researchers studying plant physiology, growth, and resistance to disease and pests.
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Arguments to support an independent, federal database effort or to rely on private data providers should be developed for a variety of data types; scientific considerations and access must be weighed against cost and other factors, such as the effect of intellectual property rights on the material that underlies the data. Options include the outright purchase of access to the data, perhaps leveraged through a public-private database effort; the creation of public-private consortia to develop bioinformatics tools; and the establishment of incentives to share private data with the public.
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FIRST, University of Wisconsin, Madison, W} DAVID I GALAS, Keck Graduate Institute of Applied Life Sciences, Claremont, CA DAVID V
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A copy of the full Report of the Working Group, with more detailed background information, is available at He NIH web site, www.nih.gov/welcome/forum, or from the NIH Office of the Director. 1 The term "unique research resource" is used in its broadest sense to embrace the full range of tools that scientists use in the l laboratory, including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libranes, clones and cloning tools (such as PCR)
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Recipients should take every reasonable step to streamline the process of transferring their own research tools freely to other academic research institutions using either no formal agreement, a cover letter, the Simple Letter Agreement of the Uniform Biological Materials Transfer Agreement (UE',MTA) , or the UBMTA itself.
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Unique research resources arising from NIH funded research must be made available to the scientific research community. Recipients are expected to manage interactions with third parties that have the potential to restrict Recipients' ability to disseminate research tools developed with NIH funds.
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The RECIPIENT shall refer any request for the BIOLOGICAL MATERIAL to the PROVIDER. To the extent supplies are available, the PROVIDER or the PROVIDER SCIENTIST agrees to make the BIOLOGICAL MATERIAL available, under a separate Simple Letter Agreement, to other scientists (at least those at nonprofit organizations or government agencies)
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In order to safeguard the Licensed Patent Rights, however, Licensor shall consult with Licensee before granting to commercial entities a Research License or providing to them research samples of the materials." "Licensor reserves the right to provide the Biological Materials and to grant licenses under Patent Rights to not-for-profit and governmental institutions for their internal research and scholarly use." 'notwithstanding anything above to the contrary, Licensor shall retain a paid-up, nonexclusive, irrevocable license to practice, and to sublicense other not-for-profit research orgar~tions to practice, the Patent Rights for internal research use." "The grant of rights provided herein is subject to the rights of the United States government and limited by the right of the Licensor to use Patent Rights for its own research and educational purposes and to freely distribute Materials to not-for-profit entities for internal research purposes." "Licensor reserves He right to supply any or all of the Biological Materials to academic research scientists, subject to limitation of use by such scientists for research purposes and restriction from filer distribution." "Licensor reserves the right to practice under the Patent Rights and to use and distribute to third parties the Tangible Property for Licensor's own internal research purposes."
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Unmodified Derivatives are sub seances created by the Recipient which constitute an unmodified functional subunit or product expressed by the original Material, such as subclones of unmodified cell lines, purified or fractionated subsets of the original Material, proteins expressed by DNA/RNA supplied by the Provider, or monoclonal antibodies secreted by a hybridoma cell line." [Source: Uniform Biological Materials Transfer Agreement; terms defined therein] Recipients are expected to avoid signing agreements to import research tools that are likely to restrict Recipients' ability to promote broad dissemination of additional tools that may arise from the research.
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that if an exclusive license is granted, the provider will provide a commercial development plan and agree to benchmarks and milestones for any fields of use granted. It is expected that agreements importing NIH-funded materials from not-for-profit entities for use in NIH funded research will not provide commercialization option rights, royalty reach-through, or product reach-through rights back to the provider.
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