Yesterday, the Department of Health and Human Services (HHS) formally published updates to their Conflict of Interest Rules. The updated regulation will increase financial conflict of interest reporting requirements by federally funded researchers, including those funded by the National Institutes of Health (NIH). Universities and other institutions employing researchers will continue to be responsible for the collection of disclosure data, and institutions will take a greater role in ensuring that the conflict information is available to the public and reported to federal granting agencies.
Major changes to the 1995 regulations include a revised definition of significant financial interest (SFI), the extent of investigator disclosure, the information reported to the awarding entity, the information made accessible to the public, and investigator training on these requirements. 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 awarding entity 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.
The text of the regulations can be found at: http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf.
In a statement on the new rules, Dr. Francis Collins, MD, PhD, Director of the NIH, stated that the "vast majority of researchers" are extremely sensitive and mindful of conflicts of interest, he described the updated rules as "an insurance plan against potential trouble downstream."
Dr. Collins also stated, "The NIH is committed to safeguarding the public's trust in federally supported research that is conducted with the highest scientific and ethical standards. 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."
HHS has allowed for a one-year implementation period for universities and other institutions to set up mechanisms to adhere to the new guidelines. Compliance with the updated rules must occur by August 24, 2012.