COMPLIANCE WITH FINANCIAL CONFLICT OF INTEREST REGULATIONS
New federal regulations on financial conflicts of interest (FCOI) in PHS-funded research took effect on August 24, 2012. The “Final Rule” replaces the 1995 regulations and applies to all researchers at Oakland University who are planning to apply for, or have received, grant funds from the Public Health Service (e.g., NIH) on or after August 24, 2012. The Final Rule affects the definition, thresholds, disclosure and management of Financial Conflicts of Interest (FCOI).
The Final Rule makes it mandatory for investigators with PHS funding to complete required training. This applies to the Principal Investigator or Program Director and all personnel who are responsible for the design, conduct or reporting of the PHS-funded work. “Investigator” includes sub-grantees, contractors, consortium participants, collaborators, and consultants. OU uses the on-line CITI module on FCOI to comply with this training requirement, but the Office of Research Administration can provide additional in-person training sessions upon request.
OU’s research policy and operational guidance on compliance with the FCOI Final Rule is now available. The FCOI disclosure form is included in the research policy, but a fillable form version is available. Disclosures can be e-mailed to FCOI@oakland.edu.
Linda Darga PhD is the contact person in the Office of Research Administration for inquiries about the Final Rule and the OU Research Policy. She can be reached at darga@oakland.edu or 370-2552.
Other helpful information can be found at the NIH website.