Financial Conflict of Interest (FCOI) in Research

The Disclosure of Financial Interests & Management of Conflicts of Interest for Public Health Service (PHS) research Awards Policy will become effective on August 24, 2012. It applies to all investigators and institutions that apply for or receive funding (including renewal/continuation funding) from the National Institutes of Health, Centers for Disease Control and Prevention, Food and Drug Administration, or any other PHS agency on or after August 24, 2012.

The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).

These new requirements apply to ALL investigators involved in research at Los Alamos National Laboratory, regardless of job title, who are responsible for the design, conduct, or reporting of research or research activities. LANS/LANL has the responsibility to identify and manage and reduce or eliminate conflicts of interest that may arise due to financial or other personal interests of the investigator.  Therefore, all personnel named on proposal budgets will be required to disclose significant financial interests related to their institutional responsibilities.

The Work for Others Investigator Statement of Financial Interests Cover Sheet, Disclosure forms, along with instructions for completing the form, can be found at the links below.

Tranining Requirement – for all personnel named on the budget of a PHS proposal

LANS personnel listed on the budget are required to take the LANL FCOI Training (which includes the NIH 2011 FCOI Tutorial), and retain a copy of the certificate available at the end of the tutorial. Non-LANL investigators need to take the NIH 2011 FCOI Tutorial or their institute’s FCOI training course and provide a copy of their certificate. Re-certification is required every four years.

Disclosure of Significant Financial Interests and Management of Financial Conflict of Interests for PHS Awards

Financial Disclosure Forms

• Instructions
• Cover Sheet – lists all personnel named in the budget(s)
• Additional All Persons List – use if more than 15 people are named in the proposal budget(s)
• Disclosure Statement – to be filed by each LANS person named on the budget
• Non-LANL Disclosure Statement – to be filed by each non-LANS person named on sub-budget sheets

Other Resources

• National Institutes of Health (NIH) FCOI Information Page
• NIH FCOI FAQs
• NIH FCOI Tutorial
• Summary of Changes

Please send questions to: fcoi@lanl.gov.

Posted 08/24/2012