DATE: 24 July 2012 FROM: R.W. Trewyn TO: Deans and Department Heads SUBJECT: New Financial Conflict Of Interest (FCOI) Regulations for Public Health Service (PHS)Supported Researchers There are significant new federal Financial Conflict of Interest (FCOI) rules and regulations taking effect on the 24th of August 20102 that will require new levels of disclosure, review, training and reporting for FCOI for those in your administrative unit who are supported by Public Health Service (PHS) funds. The U.S. Department of Health and Human Services (HHS) has issued a final rule that amends FCOI regulations for investigators, contractors, and organizations seeking PHS-funded support. (42 C.F.R. Part 50, Subpart F, and Responsible Prospective Contractors, 45 C.F.R. Part 94). The revised regulations will substantially impact investigators who have personal financial interests in the sponsor of their research activities, or in companies providing investigational drugs, services, devices or other financial support to their U.S. Department of Health and Human Services (HHS) funded projects. For clarification, PHSsupported means any person who works in a laboratory or program supported by PHS funds. The new regulations take effect on the 24th of August 2012, so there are several important things that applicable personnel in your unit need to do in the next several months. All PHS-supported personnel must: Complete institutional online FCOI training by the 24th of August on the URCO webpage at http://www.kstate.edu/research/comply/index.htm. (need real link) Update their FCOI information by the 24th of September. The forms are at http://www.kstate.edu/conflict/forms/ . Update their annual COI disclosure within thirty days of acquiring a new significant financial interest (SFI) at http://www.k-state.edu/conflict/forms/ . As needed, submit any reimbursed or sponsored travel on the form provided at the following link (http://www.k-state.edu/conflict/forms/). Responsibilities For PIs: PIs will be ultimately responsible for ensuring that all personnel supported by - or working on a PHS grant are aware of, and comply with these new requirements. This includes graduate students and post-docs. For your information, please note the brief overview of the new changes below: Different Monetary FCOI Threshold: A significant change in the regulation for PHS-supported personnel is a reduction in the monetary amount considered to be a “significant” financial interest for PHS-supported researchers – the current $10,000 threshold will be reduced to $5,000 received from an entity within a twelve month period. Under the new regulations, receipt of $5,000 or more from a research sponsor in consulting income, honoraria, stock or equity ownership, or personal payment of travel expenses by a sponsor will now be considered Significant, and will require formal disclosure of the supported person’s interest to K-State and HHS, and require the development of a FCOI management plan. Expanded Financial Interests Sources and Disclosure Requirements: The new regulation for PHS-supported personnel now covers financial interests received from any source (with the exception of federal and state agencies, U.S. colleges and universities, and academic medical centers), which may relate to all professional activities of an investigator – not just his/her research-related activities. The new regulation also requires that PIs, co-investigators and key research personnel update their annual COI disclosures within thirty days of acquiring a new significant financial interest. New Travel Disclosures: PHS-supported investigators, co-investigators, and key research personnel will be required to disclose the occurrence of any reimbursed travel or sponsored travel related to his/her institutional responsibilities – not just research (http://www.k-state.edu/conflict/forms/). The only reimbursed travel that is excluded from disclosure is that which is sponsored by a federal, state or local government agency or by a U.S. institution of higher education (an accredited college or university). This disclosure must be filed within 30 days of the travel, and includes: the purpose of the trip, the sponsor/organizer, the destination and the duration of the travel. New FCOI Training Requirements: There are new FCOI training requirements mandated. All personnel currently supported by PHS funds - investigators, co-investigators and key research personnel – are required to complete formal FCOI training by the 24th of August, and subsequently at least once every four years. New personnel must take COI training within 30 days of PHS-support. Institutional COI training is available online at the University Research Compliance Office (URCO) webpage at http://www.kstate.edu/research/comply/index.htm. New Public Accessibility Requirements for FCOI Information: For PHS-supported activities, the revised regulations have a significant public accessibility requirement. When appropriate, K-State will make certain information concerning identified FCOI publically available. The information required will include: the name of the faculty member (or key research personnel), his/her position with respect to the research, the nature of the significant financial interest, and the range of the financial interest. Timeline: The new regulations take effect on the 24th of August 2012. All personnel supported by PHS funds will be required to: Update their FCOI information by the 24th of September http://www.k-state.edu/conflict/forms/ , and Complete institutional online FCOI training by the 24th of August at: http://www.kstate.edu/research/comply/index.htm. The Institutional Policy on Conflict of Interest and Time can be found at: http://www.kstate.edu/academicpersonnel/fhbook/fhxs.html. We have sent individual email notification to all personnel our records indicate are PHS supported. As an administrator in a unit with personnel supported by NIH funding, we need your support in ensuring that they know about, and comply with these new regulations. Additionally, as a senior administrator with review and oversight responsibilities in the conflict of interest program, I strongly recommend that you and your key administrative staff take the Institutional COI training available at http://www.k-state.edu/research/comply/index.htm. Please contact Susana Valdovinos (532-4392), Paul Lowe (532-3231), Jerry Jaax (532-3233), or Jim Guikema (5323216) if you have questions or need clarification on the new financial Conflict of Interest regulations.