This article is more than 5 years old. Information may no longer be current.
HHS revises financial conflict of interest rules for researchers
The changes are aimed at updating and enhancing objectivity, and the integrity of the research process.
Click Here to Manage Email Alerts
The U.S. Department of Health and Human Services has issued an updated final rule on conflict of interest — a move the Department says will provide a framework for identifying, managing and ultimately avoiding financial conflicts of interest among investigators and researchers.
The update was constructed by staff from the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS). It revises regulations originally enacted in 1995.
“In the intervening years, biomedical and behavioral research and the resulting interactions among government, research institutions and the private sector has become increasing complex,” the NIH wrote in a summary of the changes. “This complexity, as well as increased public scrutiny and a need to strengthen transparency and accountability have led HHS to propose a more rigorous approach to investigator disclosure, management of financial conflicts and federal oversight.”
According to HHS Secretary Kathleen Sebelius, making the regulatory changes is a critical step in to ensure that scientific research stays current and relevant.
“The medical research conducted and funded by the federal government has long been the gold standard of scientific investigation,” Sebelius stated in an HHS release. “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.”
Changes to disclosure
According to the release, changes to the regulations include alterations to the definition of significant financial interest and the extent of investigator disclosure, information reported to the Public Health Service (PHS) awarding component, information made accessible to the public and investigator training.
Additional changes include a new requirement wherein investigators must disclose to their institutions all significant financial interests related to their responsibilities at the institution, a lowering of the monetary threshold — from $10,000 to $5,000 — at which significant financial interests require disclosure, and a requirement wherein institutions must report to the PHS awarding component any additional information on financial conflicts of interest that have been identified, as well as information on how these conflicts are being managed.
According to the release, further requirements will ensure that institutions will make information regarding significant financial interests of key or senior personnel available to the public. Investigators will also be required to complete training related to the regulations, as well as their institution’s financial conflict of interest policy.
Promoting objectivity
Institutions who want to apply for or receive NIH funding must comply with the new requirements by Aug. 24, 2012, according to HHS rules and regulations. Until the new regulations are put in place, institutions have been instructed to comply with the 1995 financial conflict of interest regulations.
“The NIH is committed to safeguarding the public’s trust in federally supported research that is conducted with the highest scientific and ethical standards,” NIH Director Francis S. Collins stated in the release. “Strengthening key provisions of the regulations with added transparency will send a clear message that NIH is committed to promoting objectivity in the research it funds.”
Reference: