Transcript Conflicts of Interest and Commitment

Conflict of Interest:
Yesterday, Today
and Tomorrow
Sherrie Settle
Assistant Director
Institutional Research Compliance Program
Conflict of Interest Officer
What Is It?
Conflict of interest relates to situations in
which financial or other personal
considerations may compromise, may
involve the potential for compromising, or
may have the appearance of compromising
an employee’s objectivity in meeting
University duties or responsibilities,
including research activities.
- UNC Policy Manual
Conflict is Inherent to
Research Enterprise
COI is a situation, a confluence of
potentially competing factors
Careers, lives, institutions with multiple
facets will have these conflicts
COI is not a reflection of character or
integrity
COI in the Media
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Student Loan Programs
Study Abroad Programs
‘De-Duking’ of the NIEHS
Congressional scrutiny of pharmaceutical
company influence on physicians and
biomedical researchers
Boston Legal episode questions
perceived influence of “unrestricted”
gifts
Who Cares?
 University
and UNC System
 Sponsors
 Federal
 Public
Government
Key Elements
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Federal requirements
UNC-CH policies
Internal Processing Forms
RAMSeS/eCOI
Code of Federal Regulations
CFR Title 42
Each Institution must:
Require that by the time an application is
submitted to PHS each Investigator who is
planning to participate in the PHS-funded
research has submitted to the designated
official(s) a listing of his/ her known
Significant Financial Interests (and those of
his/her spouse and dependent children): (i)
That would reasonably appear to be
affected by the research for which PHS
funding is sought; and (ii) In entities whose
financial interests would reasonably appear
to be affected by the research.
UNC-CH Approach
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Yesterday: Annual disclosure of
everything
Today: Project-specific, event-based
– Screening questions determine if
detailed report is needed
– Screening through IPF and IRB
Application
– PI answers for research team
Assumptions
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PI knows the entire research team’s
circumstances
PI knows what’s on the IPF
Is it Working?
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Good start
Weak correlation between electronic IPF and
paper IRB answers for same project
Missed positives in IPF screening from:
– Inadequate information provided to Research
Administrator
– Project team information not known to PI
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Positive IPF answers don’t prompt next step
Screening is electronic, but disclosures are
not
Introducing eCOI
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Each investigator answers screening
questions for himself/herself
If positive, investigator can continue to
disclosure or complete later
Connects to RAMSeS and IRBIS
Good News and Bad News
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COI questions removed from IPF
All investigators must reply to
screening questions before proposal
can be submitted
How Does it Work?
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Log-in with UserID and ONYEN
Select IPF or IRB record
Select Yes/No for screening questions
If All Replies are “No”
If One or More “Yes” Replies
What Will Research
Administrators See?
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Investigator certification status in
RAMSeS
Review/approval status under
“Compliance” tab
Fit with Federal Reg?
CFR Title 42
Each Institution must:
Require that by the time an application
is submitted to PHS each Investigator
who is planning to participate in the PHSfunded research has submitted to the
designated official(s) a listing of his/ her
known Significant Financial Interests (and
those of his/her spouse and dependent
children)
Does the NIH Mean It?
FY2006 Targeted Site Review Report
 Grant applications submitted prior to
collecting significant financial interests
from investigators
 Grant funds expended prior to
reporting identified financial conflicts
of interest to NIH
Other Changes FYI
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Disclose financial interest of any value
Disclosure may be sufficient to manage
many conflicts in basic research
Presumption that interest of any value
precludes engagement in human studies
research
New modules for technology transfer,
management roles
Tomorrow Brought to You
By:
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Provost’s Task Force
University Counsel
Office of Research Information
Systems
Questions??
[email protected]