Transcript Conflict of Interest Mary Evelyn Armstrong MA, CRA Conflict of Interest Officer.

Conflict of Interest
Mary Evelyn Armstrong MA, CRA
Conflict of Interest Officer
What is a conflict of interest?
Personal financial benefit or economic interest
from one’s position that may inappropriately:
• influence the employee’s judgment
• compromise the employee’s ability to carry
out their responsibilities
• be a detriment to the integrity of the organization
Evolution of COI in Academia
• 1980: Bayh-Dole Act passed by Congress – allows
universities to patent rights for discoveries made at
their institutions
• Patents are licensed to a commercial entity
(industry) and products delivered (sold) to patients
• 1982: NIH developed SBIR and STTR funding
mechanisms to help to assist with the transfer of
technology and development of bio-tech companies
• 1988: MUSC established the Foundation for
Research Development to interface with Industry
and further technology transfer
Evolution of COI in Academia
• Industry Relationships - Academic researchers
and their institutions partner in a variety of
ways with private industry
– Researchers and universities:
• Own patents
• Are forming and have equity ownership in
biotechnology companies
• Are consulting with industry for protocol and
product development
Jesse Gelsinger
June 18, 1981 – September 17, 1999
What are the institution’s concerns?
• Patient safety
• Influence on the integrity of MUSC operations
(vendor selection, academic experience of
students)
• Proper use of University property, facilities,
equipment or other resources
• Protecting MUSC’s intellectual
proprietary information
property
or
• Ensuring public trust
– The Physician Payment Sunshine Act will increase
transparency, emphasizing the need to evaluate the nature
and value of individual relationships
MUSC Strategic Plan 2010-2015
Entrepreneurialism and Industry Partnerships
– Contribute
to
public
welfare,
economic
development in SC and successful application of
University research to healthcare needs.
– Promote a culture of ethical entrepreneurialism
to facilitate innovation and technological advances
while maintaining fairness, teamwork, core values
and ethical principles.
Measures to manage COI
• Examples:
– Disclosure to patients and research
subjects about relationships
– Disclosure to students and trainees about
relationships
– Disclosure in publications and
presentations
– Recusal from decision making
– Independent or outside periodic reviews
Conflict of Interest in Graduate
and Postgraduate Education
• Issue
• Outside financial interests that may
have the potential to harm the
academic interests and/or career
advancement of the student or fellow
• Mentor/advisor should disclose any
COI related to the project
Scenarios
1. A faculty member has an ownership interest in an outside entity
which stands to benefit from the results of the research. The
faculty member directs the student or fellow to delay publication
until the faculty member can complete the research.
2. A faculty member owns a biotech company, which is sponsoring
research at the University and stands to benefit from the results of
the research. The student or fellow is pressured to work on the
project of interest to the faculty member’s company.
3. A faculty member has a financial interest in a product being
evaluated in a research project. A student or fellow generates data
from the research project which is not favorable to the product and
the faculty member pressures the student not to publish the data.
Case study - Dr. Galloway and Drug Inc.
• Drug Inc. approaches Dr. Galloway about doing a
study in his lab on a natural compound.
• Dr. Galloway is well-respected in his field.
However, he is struggling to obtain research
funding in this economy.
• Drug Inc. offers to pay 100% of costs associated
with this study, and the company rep hints that if
the outcome is positive, the company would be
willing to fund future studies in Dr. Galloway’s lab.
• Dr. Galloway happens to carry stock in the
company.
Case study - Dr. Galloway and Drug Inc.
• Dr. Galloway decides to do the study, and he
assigns a postdoc to serve as PI.
• Dr. Galloway is still involved with some of the
data analyses.
• Results are positive,
publishes these results.
and
Dr.
Galloway
• Drug Inc. subsequently funds several other
studies in Dr. Galloway’s lab.
Case study - Dr. Galloway and Drug Inc.
• Does Dr. Galloway have a conflict of
interest that should have been disclosed?
• Is Dr. Galloway avoiding this COI by
assigning a different PI?
• Was it wrong for the Drug Inc. rep to
suggest that positive results would lead to
future funding?
Contact us
Mary Evelyn Armstrong MA, CRA
2-5907
[email protected]