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

Agenda Background Highlights Implementation Plan Contact Information Questions

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.

Revisions

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

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

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

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.

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.

New Requirements

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

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

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

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

Resources NIH Summary of Major Changes NIH Website 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

Questions?