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===== The NIH Office of Technology Transfer ~ OTT ===== | ===== The NIH Office of Technology Transfer ~ OTT ===== | ||
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- | The NIH Office of Technology Transfer evaluates, protects, monitors, and manages the wide range of NIH and FDA discoveries, | + | |
To accomplish its mission, OTT oversees patent prosecution and negotiates and monitors licensing agreements. OTT performs similar functions for patenting and licensing activities for the Food and Drug Administration (FDA), another component of the Department of Health and Human Services (HHS). | To accomplish its mission, OTT oversees patent prosecution and negotiates and monitors licensing agreements. OTT performs similar functions for patenting and licensing activities for the Food and Drug Administration (FDA), another component of the Department of Health and Human Services (HHS). | ||
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+ | ==== Cooperative Research And Development Agreements (CRADAs) and Material Transfer Agreements (MTAs) ==== | ||
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+ | === CRADA Overview === | ||
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+ | CRADAs provide an exciting opportunity for NIH investigators to join with their colleagues from industry and academia in the joint pursuit of common research goals. Government scientists can leverage their own research resources, as well as serve the larger mission of NIH, to facilitate the development and commercialization of health-care pharmaceuticals and products. Companies also can leverage their own R&D efforts while collaborating in state-of-the-art NIH research. | ||
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+ | The purpose of a CRADA is to make Government facilities, intellectual property, and expertise available for collaborative interactions to further the development of scientific and technological knowledge into useful, marketable products. | ||
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+ | Each NIH institute has a Technology Development Coordinator (TDC) who should be consulted at an early stage of collaboration by the company and the NIH investigator to assist in identifying and developing the proper documents and obtaining the required approvals. | ||
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+ | === General === | ||
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+ | The intent of Congress in establishing CRADAs was to promote national technological competitiveness and the rapid transfer of the fruits of innovation to the marketplace. CRADA research and development at the NIH should be directed to the development of biological and behavioral technology, products, and processes by transferring relevant knowledge acquired from NIH research efforts to state and local governments, | ||
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+ | Advances in biomedical and [[: | ||
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+ | Although there is **no restriction on the topic of research appropriate** for a CRADA, all CRADA research projects must be highly focussed and delineated and each proposed CRADA must be carefully assessed for its overall research objectives. In considering a proposed CRADA, PHS operating components will determine if the objectives of a proposed collaboration warrant the establishment of a CRADA or if its goals are more appropriately met through a procurement contract, material transfer agreement, cooperative agreement or other contractual mechanism. Also, the proposed collaborator' | ||
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+ | === Prohibition on General Funding === | ||
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+ | A CRADA is not intended to be a general funding mechanism to support directed research in a NIH laboratory. The majority of a laboratory' | ||
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+ | Laboratories must be prepared to address the impact on the ongoing research if a CRADA and related financial support is terminated unexpectedly. The sole purpose of a CRADA cannot be to support post-doctoral fellows and/or technicians, | ||
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+ | === Ensuring Research Freedom === | ||
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+ | NIH investigators generally are free to choose the subject matter of their research, consistent with the mission of their Institute and the research programs of their Laboratories. No CRADA may contravene this freedom. | ||
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+ | CRADAs that explicitly attempt to direct NIH research are not appropriate. Additionally, | ||
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+ | a. the fraction of a laboratory' | ||
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+ | b. the fraction of a laboratory' | ||
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+ | c. the amount of time that any one investigator would give to one or more CRADAs; | ||
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+ | d. the number of CRADAs an investigator or Laboratory/ | ||
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+ | e. the number of CRADAs that any given company might have with the PHS and its operating components. | ||
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+ | === Scientific Communication and Dissemination of Research Results === | ||
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+ | It is fundamental to the mission of NIH that research results be published and discussed at public fora. Further, NIH scientists must operate within an atmosphere of scientific collegiality. Reasonable confidentiality requirements and brief delays in dissemination of research results are permitted under a CRADA, as necessary, in order to protect proprietary materials and intellectual property rights. CRADAs which in any way attempt to unreasonably restrict or constrain scientific interaction or the dissemination of research information will not be approved. In considering any proposed CRADA, consideration must be given to the possibility that the level of confidentiality associated with that CRADA project might, on balance, inappropriately impair the degree of openness necessary to maintain effective scientific communication and to serve the public interest. | ||
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+ | === Requirement of Intellectual Contribution by Collaborator === | ||
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+ | CRADAs are authorized only with collaborators who will make significant intellectual contributions to the research project undertaken or will contribute essential research materials or technical resources not otherwise reasonably available to NIH. CRADAs cannot attempt to direct or restrict research in a NIH laboratory. Sponsored research, such as routine, conventional testing, with no collaborative, | ||
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+ | === Avoidance of Conflict of Interest === | ||
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+ | Pursuant to the CRADA-authorizing statute, every federal laboratory must ensure that there are no conflicts of interest in any CRADA. Extramural NIH staff scientists who administer grants and contracts may have an inherent conflict of interest that would preclude their participation in CRADAs. Intramural NIH scientists also may have conflicts of interest, in that they serve as a project officer on a contract or have authority over funding decisions in the course of their research. In both cases, the employee may have financial interests that would be affected by their proposed CRADA. Therefore, any conflict of interest--actual or apparent--must be addressed in the review and approval of CRADAs. | ||
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+ | === Fair Access to CRADA Opportunities === | ||
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+ | In compliance with the intent of the Federal Technology Transfer Act (FTTA) and the PHS Policy for Promoting Fair Access to CRADA Opportunities, | ||
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+ | === MTA Overview === | ||
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+ | A MTA generally is utilized when any proprietary material is exchanged, and when the receiving party intends to use it for his/her own research purposes. Neither rights in intellectual property nor rights for commercial purposes may be granted under this type of agreement. MTAs define the terms and conditions under which the recipients of materials, provided by either the NIH scientist or the other party, may use the materials. Included in the MTA are the requirements that the materials be used for research purposes only and that the materials cannot be used in human subjects. The NIH also requires that all materials received by their scientists originating from humans be collected under 45 CFR 46, Protection of Human Subjects. ((https:// | ||
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+ | ==== NIH Featured Success Stories ==== ((https:// | ||