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
The 1995 regs make up the financial interest disclosure policy for PHS funded research. By PHS, we really mean NIH. As some of you know, the National Science Foundation adopted these regs to apply to all investigators with research funded by the NSF. Define Investigator – anyone responsibility for the design, conduct or reporting of the funded research. This definition is not limited to PIs or project directors and may go beyond key personnel.
Now, 16 years later, DHHS issued a revised regulation. The issuance was a culmination of two and a half years of issuing notice or drafts of the changes, calling for comments, etc.
PHS has given all institutions receiving PHS funding for research 365 days to implement the changes.

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
This is a change in the definition of significant financial interest (SFI)
Travel reimbursement:
Purpose of trip
Identity of sponsor
Destination
Duration

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
Related if the SFI could be affected by the PHS funded research or is in an entity whose financial interest could be affected by the research
Institution can involve the Investigator in the determination process.

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
Federal, state and local agencies
Institution of higher education
Academic teaching hospitals
Medical center or research institute 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
(949)
Nadia Wong, COI Analyst
(949)

15. Resources NIH Summary of Major Changes NIH Website
NIH Website
UCI Conflict of Interest Website

16. Questions?