BACKGROUND ABOUT THE VA-AFFILIATED NONPROFIT RESEARCH AND EDUCATION CORPORATIONS
In 1988, Public Law 100-322, codified in Title 38, sections 7361-7366, authorized Department of Veterans Affairs (VA) medical centers to establish nonprofit research and education foundations. These organizations are also known as the VA affiliated nonprofit research and education corporations (NPCs).
This statute provides VA medical centers with a flexible funding mechanism to accept and administer private sector and non-VA federal research and education funds. An NPC may accept any funds other than those appropriated to the Department of Veterans Affairs. Each NPC is an independent, state chartered, tax exempt organization under section 501(c)(3) of the Internal Revenue Code.
NPCs accept funds under grants, agreements, and gifts from individuals, for-profit companies, charitable foundations, non-VA federal agencies, state agencies, professional societies, patient advocacy organizations and other nonprofit entities. An NPC may not accept funds appropriated to VA.
Because the statutory purpose of these foundations is to facilitate VA research and education, all funds received or administered must be expended to support VA research and education activities or the business operations of the NPC itself. Contributions and expenditures are subject to the laws and regulations of the state of incorporation and applicable federal laws and regulations.
NPCs are established to serve as flexible funding mechanisms for the conduct of approved research and education, and related activities, at VA medical centers. Research studies supported by NPCs are conducted for the purpose of discovering new or improved treatments for disease and disability.
All research projects administered by NPCs must be approved by the local VA Research and Development (R&D) Committee and applicable subcommittees. The facility's R&D Committee has overall responsibility for the conduct and oversight of all research administered by the NPC, and the research is governed by federal rules and regulations.
Educational programs supported by an NPC must benefit VA personnel or patients and their families. Education activities must be approved by the facility Education Committee.
Federal Tort Claims Act
Subject to certification by the Attorney General actions of NPC employees, including those on WOC status, will generally be protected from personal liability under the Federal Tort Claims Act (FTCA). To qualify, the NPC employee must:
Have a federal appointment (such as a WOC appointment or an Intergovernmental Personnel Act assignment);
Be performing work that is within the scope of government work (such as VA-approved research or education; and
Be working under the supervision of a federal employee.
Cooperative Research and Development Agreements (CRADAs)
CRADAs (Title 15 Commerce and Trade, Chapter 63, Technology Innovation, Section 3710a Cooperative Research and Development Agreements) are the form of contract used by federal agencies to engage in collaborative efforts with non-federal partners to achieve goals of technology transfer. CRADAs are a flexible mechanism that can be adapted to a variety of types of collaborative efforts between federal and non-federal organizations and that can be implemented relatively easily within a relatively short time.
CRADAs may be used at VA research facilities located at VA medical centers throughout the country. CRADAs establish the terms of sponsored collaborative research, generally with non-federal industry partners, and are specifically designed to protect the parties' prior inventions while allowing the government and private sector research partner(s) to negotiate management of any new discovery or intellectual property that may result from the collaboration.
CRADAs are governed by Title 15 Commerce and Trade, Chapter 63, Technology Innovation, Section 3710a Cooperative Research and Development Agreements. Related statutes are found in other parts of Title 15 and Title 35 Patents, Chapter 18, Patent Rights in Inventions Made with Federal Assistance. Selected statutes, regulations, VA policies and model VA CRADAs are accessible in the CRADA Resources section.
From the initial discussions between an investigator and a prospective collaborator through execution of a signed CRADA, coordination among various stakeholders is required. NPCs are prepared to assist potential collaborators with completing CRADA negotiations and all other aspects of VA review and approvals of studies.
Background About NPCs
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