On August 23, 2011, the U.S. Department of Health and Human Services (“HHS”) issued an updated Final Rule on conflict of interest, providing a framework for identifying, managing, and avoiding investigators’ financial conflicts of interest. See HHS, Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors, 76 Fed. Reg. 53256 (Aug. 23, 2011).
The Final Rule revises regulations adopted by HHS in 1995 that require most applicants for research grants from the Public Health Service (“PHS”) to maintain and enforce a financial conflicts of interest policy, and require investigators working on PHS-funded research to declare “significant financial interests”—including certain compensation, equity interests, and intellectual property rights–to their institutions. The purpose of the 1995 regulations was to reduce the likelihood that the design, conduct, or reporting of HHS-funded research would be biased by significant financial interests of any investigator.
According to HHS, since the 1995 regulations were adopted, industry-funded research in the biomedical sciences has dramatically increased, and relationships between individual academic researchers and industry have proliferated. However, the current “revisions are not designed to prevent or hinder relationships among government, academia, and industry.” Instead, they “are aimed at facilitating such relationships by increasing transparency and accountability so that the resulting research is considered objective and in the interest of the public.”
Among other things, the revised regulations—
- Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.
- Lower the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
- Require institutions to report to the PHS awarding component additional information on identified financial conflicts of interest and how they are being managed.
- Require institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel.
- Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.
All institutions subject to the regulations are required to be in compliance with the revised regulations no later than August 24, 2012.