Cooperative Research and Development Agreements (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.
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.
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.
- Technology Development Coordinators (TDC)
- Frequently Asked Questions for CRADAs & MTAs
- CRADA Model Agreements
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, universities, and the private sector.
Advances in biomedical and behavioral research depend on a continuum of research efforts, from those aimed at discovering new knowledge, to those aimed at expanding existing knowledge, to those aimed at developing new procedures and products. There is not always a clear distinction among these research activities to allow a concise definition of which activities are appropriate for a CRADA. All CRADAs must be consonant with the primary biomedical research mission of the PHS and the specific laboratory involved, ensuring that no aspect of that mission is compromised. For example, a proposed CRADA would not be appropriate if the fundamental mission of the NIH is compromised by creating, either explicitly or indirectly, more than minimal constraints on research freedom and communication.
Although there is no restriction on the topic of research appropriate for a CRADA, all CRADA research projects must be highly focused and delineated and each proposed CRADA must be carefully assessed for its overall research objectives. In considering a proposed CRADA, HHS 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's scientific and business capabilities will be assessed.
Prohibition on General Funding
A CRADA is not intended to be a general funding mechanism to support directed research in a NIH laboratory. The majority of a laboratory's resources should not derive from CRADAs. CRADA-derived funds may not supplant appropriated funds in supporting NIH research. They are to be used only to defray the cost of the project specified in the CRADA.
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, to obtain funds, or to purchase equipment and/or supplies. Conversely, the sole justification of a CRADA cannot be for a NIH laboratory to conduct research or tests for the collaborator.
Ensuring Research Freedom
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.
CRADAs that explicitly attempt to direct NIH research are not appropriate. Additionally, in considering any proposed CRADA, attention must be given to whether directed research implicitly will be the net effect. For example, the greater the extent to which a laboratory's resources derive from a CRADA, the less likely it will be that the laboratory will pursue other research opportunities outside of the CRADA; the broader the scope of a CRADA research plan, the less able a laboratory will be to provide fair access and interact with others. The achievement of this balance will be considered in the decision-making process. Thus, consideration should be given to:
a. the fraction of a laboratory's appropriated resources devoted to CRADA research;
b. the fraction of a laboratory's total resources that derive from CRADA support, and the time and scope of work devoted to a given CRADA;
c. the amount of time that any one investigator would give to one or more CRADAs;
d. the number of CRADAs an investigator or Laboratory/Branch has with one company; and
e. the number of CRADAs that any given company might have with the HHS and its operating components.
Scientific Communication and Dissemination of Research Results
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.
Requirement of Intellectual Contribution by Collaborator
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, intellectual contribution, is not appropriate for a CRADA.
Avoidance of Conflict of Interest
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.
Fair Access to CRADA Opportunities
In compliance with the intent of the Federal Technology Transfer Act (FTTA) and the PHS Policy for Promoting Fair Access to CRADA Opportunities, the NIH shall ensure that outside organizations have fair access to collaborative opportunities, the licensing of federal technologies, and NIH scientific expertise, giving special consideration to small business and preference to those that are located in the U.S. and agree to manufacture in the U.S. products developed under the CRADA. Fair access to CRADAs is not to be considered as synonymous with the term "open competition," as defined for contracts and small purchases. Evidence of fair access or discussion of unique resource requirements should be maintained as part of the official NIH Institutes and Centers (IC) CRADA file.