On August 23, 2011 the Department of Health and Human Services issued a final rule for financial conflicts of interest (FCOI) among extramural researchers. The new rule, entitled “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” updates the previous FCOI regulations which had been in place since 1995.
Changes in the new rule include a reduction in the de minimis threshold for disclosing significant financial interests (SFI) to $5000 per year. The threshold was $10,000 under the previous rule. The new rule also requires that all SFI related to an investigator’s institutional responsibilities be disclosed. Previously only SFI related to PHS-funded research had to be disclosed. The rule also specifies that certain information about identified FCOI must be made available to the public either via a website or upon written request to the institution. Investigators will be required to complete training on the FCOI regulations prior to engaging in PHS-funded research, and again every four years.
Institutions have until August 24, 2012 to comply with the new regulations.