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