Guidelines for Grant and Contract Management
302F. Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts
In the Federal Register of November 8, 1994, the NIH published "Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts." Recipients of NIH grants and contracts who are considering developing sponsored research agreements with commercial entities (where such agreements may include activities which are fully or partially funded by NIH) should review this policy statement. A summary of the statement appears below. Copies of the full statement are available in NIH Guide, Volume 23, Number 25, July 1, 1994. - March 1995
The intent of "Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts" is to assist recipients of NIH funding who may develop sponsored agreements with commercial entitites in ensuring that these agreements comply with the requirements of the Bayh-Dole Act and the Public Health Service while upholding basic principles of academic freedom.
The policy statement details several "universal points" which NIH recipients should review as they develop these agreements: maintenance of academic freedom for investigators and institutions; dissemination of research results; utilization; U.S. manufacture; and notification requirements and records. A summary of each follows.
Academic Freedom. Recipients of NIH grants should ensure that agreements with commercial entities preserve their freedom to select projects, collaborate with other scientists, determine the types of sponsored research activities in which they wish to participate, and communicate their research findings at meetings, by publication, and through other means.
Dissemination of Research Results. Recipients must ensure that the timely dissemination of research findings will not be adversely affected by the conditions of a sponsored agreement with a commercial entity.
Utilization. Recipients should consider whether the commercial entity can bring inventions resulting from the research to commercial status in an expedited and efficient manner. Recipients should not enter into sponsored agreements which permit a sponsor to tie up the development of a technology by acquiring exclusive rights to an invention before deciding whether it will actively develop and commercialize that product.
U.S. Manufacture. Recipients must ensure that any agreement requires that products which embody inventions resulting from the research will be manufactured substantially in the U.S. (requirement of the Bayh-Dole Act).
Notification Requirements and Records. Recipients must ensure that PHS invention, patent, and license notification requirements are adhered to in a timely manner.
