<< Previous Section | < Previous Page | Next Page > | Next Section >> Government intervention The Bayh-Dole act of 1980 made it possible for institutions and individuals to recover substantial financial rewards for their intellectual property as royalties and as equity. Furthermore, the reliance of research sponsors on the expertise of faculty to support a trial agent encouraged substantial payments to accrue to faculty as consultants, often on a continuing basis. Optimizing these financial interests produces a COI situation in relation both to the conduct of the research and to the welfare of trial subjects. Responding to these realities, the NIH, FDA and individual institutions developed rules for investigators to limit the impact of investigator COIs under Federal rules. A reminder follows http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-013.html The actual rules can be found at this URL http://grants.nih.gov/grants/guide/notice-files/not95-179.html The key provisions are, redacted: "Investigators are required to disclose to an official(s) designated by the institution a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that would reasonably appear to be affected by the research proposed for funding by the PHS. The institutional official(s) will review those disclosures and determine whether any of the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research and, if so, the institution must, prior to any expenditure of awarded funds, report the existence of such conflicting interests to the PHS Awarding Component and act to protect PHS-funded research from bias due to the conflict of interest. The definition of "Significant Financial Interest" in 50.603 has been changed in several respects. The exception for financial interests in business enterprises includes salary, royalties or other payments not reasonably expected to exceed $10,000 per annum. Alternative measures of $10,000 in value include stock or no more than five percent ownership interest." In my view, $10,000 or an ownership position even if it has no cash value constitutes a significant COI and should be at least disclosed. Disclosure requirements are very poor in that the statute limits them to the institutional administrators and the COI committee. They should be required to disclose every time they present or publish research. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 4 Quick Links Conflicts of Interest (COI) Definitions Consequences of a COI Government Intervention Industry Sponsorship Professional Societies Clinical Practice Guidelines Other Initiatives COI in Financial Consulting Cases Bibliography Chapter 4 Download (PDF)