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Sneak Preview: The Revised PHS FCOI Regulations

Sneak Preview: The Revised PHS FCOI Regulations. Grace Park, COI Administrator Office of Research. Agenda. Background Highlights Implementation Plan Contact Information Questions. Timeline.

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Sneak Preview: The Revised PHS FCOI Regulations

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  1. Sneak Preview:The Revised PHS FCOI Regulations Grace Park, COI Administrator Office of Research

  2. Agenda Background Highlights Implementation Plan Contact Information Questions

  3. Timeline In 1995, the Public Health Service (PHS)* published regulations to promote objectivity in research The final rule revising the 1995 PHS regulations were issued on August 25, 2011 Implementation of the revised regulations by August 24, 2012

  4. Revisions

  5. Definition of Significant Financial Interest (SFI) - Threshold 1995 Regulations Must disclose if aggregate payments or equity interests are greater than $10,000 2011 Regulations Must disclose if aggregate payments or equity interests are greater than $5,000 Privately held equity interest at zero Travel reimbursements at any amount

  6. What Must Be Disclosed 1995 Regulations Only Significant Financial Interests (SFI) the Investigator deems related to PHS-funded research 2011 Regulations All SFIs related to Investigator’s institutional responsibilities

  7. Definition of Institutional Responsibilities Investigator’s professional responsibilities on behalf of the Institution Research Research consultation Teaching Professional practice Institutional committee memberships

  8. Determination of Relatedness 1995 Regulations Investigator bore the responsibility for determining the relatedness of a SFI to the PHS funded research as part of the disclosure process 2011 Regulations The Institution has the responsibility for determining whether an Investigator’s SFI is related to the PHS funded research

  9. Exclusions 1995 Regulations Income from seminars, lectures, or teaching, and service on advisory committees or review panels, for public or nonprofit entities 2011 Regulations Income from seminars, lectures, or teaching engagements sponsored by and service on advisory or review panels for a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education

  10. New Requirements

  11. FCOI Training 2011 Regulations Investigator must complete FCOI training prior to engaging in PHS-funded research and at least every 4 years

  12. Public Accessibility 2011 Regulations The Institution shall ensure public accessibility of information regarding FCOI of key personnel

  13. Implementation Plan Inform and educate researchers and research administrators about changes Develop and update website with new policies Develop and publicize online training Publicize when UCI will begin following new regulations

  14. Contact Information Grace Park, COI Administrator parkgj@uci.edu (949)824-7218 Nadia Wong, COI Analyst nadiaw@uci.edu (949)824-0012

  15. Resources NIH Summary of Major Changes http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.do NIH Website http://grants.nih.gov/grants/policy/coi/ UCI Conflict of Interest Website http://www.research.uci.edu/ora/coi/index.htm

  16. Questions?

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