Bulleit T N, Bonnet S M
Hogan and Hartson L.L.P., Washington, DC 20004-1109, USA.
Acad Med. 1996 Jul;71(7):709-15. doi: 10.1097/00001888-199607000-00001.
Federal involvement in biomedical research has increased significantly in the postwar era, particularly throughout the 1980s and early 1990s. New federal laws and regulations now offer unprecedented opportunities to commercialize federally funded and conducted research, essentially creating a new field of "technology transfer" law. As a result, the biomedical research sector of the health care industry must master a number of relatively new and still developing federal laws, regulations, policies, and concerns that will probably continue to significantly affect its operations. To assist academic medical centers and others in understanding the federal presence in biomedical research, the authors give a short history of technology transfer laws and issues and summarize some of the current main areas of federal interest, including federal oversight of federally funded research, sponsored research agreements, conflict of interest, scientific misconduct, and the prospect of government price control over some biomedical inventions. The authors caution academic medical centers to realize that recent trends favoring deregulation and budget cutting could diminish federal involvement in the future. Thus, research institutions should keep abreast not only of existing rules and policies but of ongoing legislative and regulatory activities that portend possible changes.
