The issue of potential conflicts of interests by those engaged in research is not new. However, within the last twelve months, two Federal agencies have published guidance with respect to disclosures of conflicts of interest by those engaged in clinical research. The following sets forth a summary of the current Food and Drug Administration (“FDA”) requirements with respect to financial conflicts of interest and where noted, incorporates provisions of a draft guidance that was issued by the FDA in 2011. The summary also includes the U.S. Department of Health and Human Services (“HHS”) requirements with respect to financial conflicts of interest held by researchers including new provisions which go into effect on August 24, 2012. The summary should be used only as a guide and is not intended to replace the need for you to review the FDA or HHS regulations in their entirety and/or to seek legal counsel with respect to your set of facts as these rules are subject to agency interpretation.
To download a printable pdf of our summary, click here.