Transcript lecture 20.ppt

Crisis And Conflict Management
Conflicts of Interest
Lecture 20
2
Conflict of Interest
3
DEFINITIONS
1. COIs are the “temporal existence of conflicting
primary and secondary interests.”
2. COIs occur “whenever financial considerations may
compromise or have the appearance of compromising an
investigator’s professional judgment and independence in
designing, conducting, or reporting research.”
4
“REASONABLE PERSON” TEST FOR COIs
•
If a reasonable person concludes that it is
likely that an individual might emphasize
personal interests over other interests for which
he/she has responsibility
Sponsored Programs
5
COIs REQUIRE PRESENCE OF THREE ELEMENTS
1. Acting in a professional or official capacity
or in a position of trust
2. While having a personal interest (usually
financial)
+
+
3. That interferes with objective decision
making (or gives the impression that
decision making is compromised)
6
Having a conflict of interest is not necessarily
a problem or a “bad thing”.
+
+
Having a conflict of interest and doing nothing
about it is a problem!
7
INTERESTS COME IN TWO BASIC FORMS
Financial (tangible)
Non-Financial (intangible)
• Money
• Professional
• Employment
 Personal
• Property/Stock Ownership
• Physical
 Psychological
8
TYPICAL COIs
• Maintaining roles that conflict
• Accepting personal gratuities
• Influence Peddling
• Use of public property to fulfill private obligations
• Using or disclosing confidential information
• Conflicting outside employment or other
allegiances (i.e., boards)
9
MOST COMMON FACULTY COI SITUATIONS
• Consulting
• Licensing University technology
• Studies involving risk to human
subjects
• Procurement
• Mentoring
10
TO WHOM DO FACULTY RESEARCHERS HAVE A
RESPONSIBILITY?
• Students/Trainees
• Employees
• Employers
• State Taxpayers
• Society (“Public Trust”)
11
HOW UNIVERSITIES HANDLE COIs
Step One:
• Always disclose!
• Apply the “Front Page of the Atlanta
Journal Constitution” test
12
HOW UNIVERSITIES HANDLE COIs
Step Two:
• Mitigate and manage, where possible
• Modify research design
• Monitor research by independent
reviewers
13
HOW UNIVERSITIES HANDLE COIs
Step Three:
If monitoring is not feasible, you
may be required to:
• Discontinue the compensated activity
• Divest self of the financial interest
• Terminate the research
14
FACULTY COI SITUATIONS
Consulting
Must balance the researcher’s
responsibility to the institution, to
students, and to the company.
15
FACULTY COI SITUATIONS
Common Consulting Mistakes
• Limiting publication rights
• Creating the impression your University has
sanctioned the consulting
• Taking time away from primary University
duties
• Giving away or bartering ownership and
intellectual property (IP) rights
16
FACULTY COI SITUATIONS
Consulting at UGA
• UGA requires disclosure and prior
approval of all consulting relationships
• Each college/school has its own
consulting request/approval form
• Other USG institutions have their own
consulting policies
17
FACULTY COI SITUATIONS
Consulting Cautions
• Do not consult for a company that requires you to devote time and
effort already committed to the university
• Be cautious when entering into relationships that limit publication
• Refrain from creating any impression that the university has
sanctioned the outside activity, if it hasn’t
• Do not use any university resources for your consulting without
written permission.
• Do not use students to support your consulting activities
• Seek advice from your dean or Sponsored Programs representative
before accepting consulting agreements that may limit future
sponsored activities
18
FACULTY COI SITUATIONS
Licensing Intellectual Property
Licensing transactions present many
potential COIs, especially those involving
start-up companies where your institution
and inventors have a continuing
relationship.
19
FACULTY COI SITUATIONS
Licensing Issues
• Establishing a company based on a license of institution-owned
technology
• Distributing equity in that company to the inventor and
the University and managing it
• Providing sponsored research from the company back to the
University
• Managing research in areas closely related to the licensed
technology
• Supervising students and other University employees in the
context of the relationship between the university and the startup
20
FACULTY COI SITUATIONS
Licensing Cautions
• Simultaneously wearing a faculty hat and a company hat creates
a COI; if the company also funds your faculty research, your COI
just grew exponentially!
• Be careful about involving students and other University staff
in research for which you have a COI
• Stay out of negotiations between your University and your
company---if you can!
• If your commitment to your academic job suffers because of
your company activities, consider taking a leave of absence
21
FACULTY COI SITUATIONS
Research
It is critical that humans who volunteer as
participants be assured that no bias is influencing the
study
Potential Places for Bias
1.
2.
3.
4.
5.
Study design
Subject recruitment
Gathering data
Interpreting data
Reporting data
22
FACULTY COI SITUATIONS
Clinical Research
• If real financial COIs exist, they must be
addressed in the most conservative manner
• Scientific objectivity and ethics are at stake!
• The utmost attention must be paid to avoid COIs
involving human subjects
• Your IRB approval is contingent upon resolution
of COIs
23
FACULTY COI SITUATIONS
Research Cautions
• Disclose all financial relationships
• The greater the risk to volunteers, the more likely an institution will be to
limit or bar faculty with significant financial interests from participating in
the study
• The more complex and closer the activities of the faculty
member are to the business interests of the company, the more likely the
institution will be to restrict the faculty members’ multiple roles
• Avoid conducting clinical trials when both the institution and the investigator
have financial interests in the outcome of clinical studies
24
FACULTY COI SITUATIONS
Procurement
In Georgia, investigators can’t acquire
goods and services from companies in
which they have an interest, except under
certain circumstances (i.e., unless the COI is
managed, mitigated, or eliminated)
25
FACULTY COI SITUATIONS
Procurement Cautions
• Disclose the same for family members
26
FACULTY COI SITUATIONS
Mentoring
• Graduate Students
• Post-Docs
• Junior Faculty Colleagues
27
FACULTY COI SITUATIONS
Mentoring
• Special relationship of trust
• Unequal distribution of power
• Potential for damage to mentee’s training or
career development
28
FACULTY COI SITUATIONS
Mentoring Cautions
• Protection of mentee’s rights to publish must be
paramount
• Mentees have the “right to know” about mentors’ COIs
• COIs involving mentoring should be monitored
A. Assign mentoring responsibilities to
another colleague
B. Use Ombudsman oversight or other
management strategies
C. Eliminate COI
29
REALITY CHECK
• Many people believe that they are too moral
or too wise to have conflicts.
• Too many people believe they have the
wisdom and virtue to manage their own
conflicts of interest.
30
Summary
•
•
•
•
•
Conflict of interest
Typical Conflict of Interest
Steps how university handle COI.
Faculty Conflict
Reality Check
31
Thank you
32