HHS tightens rules on financial conflicts of interest

The U.S. Department of Health and Human Services (HHS) has released updated regulations on financial conflicts of interest for investigators and institutions that apply for Public Health Service (PHS) funding. The update is designed to provide a framework for identifying, reporting and managing financial conflicts of interest in an effort to enhance transparency and avoid conflicts that may bias research results and threaten credibility and public trust.

“The medical research conducted and funded by federal government has long been the gold standard of scientific investigation,” HHS Secretary Kathleen Sebelius said in a statement. “Our financial conflict of interest rules must keep up with the times if we are to maintain our leadership role in the global scientific community.”

Major changes in the regulations include the definition of a significant financial interest and reporting mechanisms. Among the revisions:

• Amending the definition of a significant financial interest generally to $5,000 from the previous threshold of $10,000 for disclosures of payments, equity interests and equity interests in non-publicly traded equities;

• Expanding investigators’ disclosure requirements to include significant financial interests related to institutional responsibilities, placing the responsibility on the institution to determine if the disclosure constitutes a conflict with PHS-funded research;
• Excluding income from government agencies or higher education institutions for lectures, seminars, teaching or participation on advisory or review panels;
• Requiring institutions to report identified financial conflicts of interest and a plan for managing the conflicts to the PHS awarding agency;
• Making disclosures of significant financial interests publicly available;
• Requiring investigators to complete training in financial conflicts of interest; and
• Including SBIR/STTR Phase I applications under the revised regulations.

The estimated 3,000 institutions that apply for PHS funding annually will be subject to the regulations. Institutions may be able to offset some of the cost of implementing the updated regulations under facilities and administrative costs on PHS-funded grants, cooperative agreements and contracts, according to the final rule.

The updated final rule is available here. It is effective Sept. 26, with a compliance date of no later than Aug. 24, 2012.