for clinical research sponsors


BACKGROUND ABOUT THE VA-AFFILIATED NONPROFIT
RESEARCH AND EDUCATION CORPORATIONS

In 1988, Title 38, sections 7361-7368, authorized Department of Veterans Affairs 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 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 the Internal Revenue Code section 501(c)(3).

NPCs are established solely to advance medical knowledge through the support of VA research and research related activities as well as medical education. All studies supported by NPCs are VA research conducted for the purpose of discovering new or improved treatments for disease and disability.  Educational programs supported by NPC must benefit VA personnel or patients and their families.

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. 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. Contributions and expenditures are subject to the laws of the state of incorporation and applicable federal law.

All research projects administered by the VA-affiliated nonprofit research corporations must be approved by the local VA Research and Development (R&D) Committee and the facility institutional review board (IRB). The facility's R&D Committee has overall responsibility for the conduct of all research administered by the corporation, and the research is governed by federal rules and regulations. Education activities must be approved by the facility Education Committee.

Most activities supported by NPCs are conducted in VA facilities and are likely to involve VA employees and VA patients. As a result, federal regulations and federal laws govern access to patient records and treatment for research related injuries as well as intellectual property and patent rights. Also, subject to certification by the Attorney General that an employee was performing services within the scope of government employment, actions of corporation employees, whether working on a full time, part time or without compensation (WOC) basis, generally will be protected from personal liability under the Federal Tort Claims Act.

 

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last updated: 01/31/08

 

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