Transcript University/Industry Relationships and Conflict of Interest

University/Industry
Relationships and
Conflict of Interest
John Jay Gargus, M.D., PH.D.
Professor, Physiology &
Biophysics/Pediatrics
Chair, Conflict of Interest Oversight
Committee
May 28, 2014
Agenda
 University/Industry
 Conflict
Relationships
of Interest
 Disclosure Requirements
 Conflict of Interest Oversight Committee
 Conflict of Interest and Graduate
Education
 Resources
University/Industry
Relationships
The Bayh-Dole Act or University and Small Business Patent
Procedures Act is United States legislation dealing with
intellectual property arising from federal government-funded
research. Adopted in 1980, it gave US universities, small
businesses and non-profits intellectual property control of their
inventions and other intellectual property that resulted from
such funding.
Birch Evans Bayh II
Dem Senator
Indiana ‘61-’81
Robert Joseph Dole
Rep Senator
Kansas ‘69-’96
University/Industry
Relationships
University vs. Industry
 University
and Industry have fundamental
differences in their motives that can never be
fully reconciled
University
• Educate and
generate knowledge
• Social obligation to
public
Industry
(Pharmaceutical, Device &
Equipment Companies)
• Sell products
• Fiduciary duty to their
stakeholders to make
money
University/Industry
Relationships
University and Industry Overlap

With new knowledge comes new technology
which leads to new products resulting in the
Industry’s need to consult Academic Scientists
for their expertise
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Potential Conflict of Interest since University
researchers have an obligation to put
research integrity and the education of their
trainees and peers first when faced with a
choice between making money or doing their
duty
Positive Interactions:
Significant University Stake in
Research Intellectual Property
 Northwestern
University professor develops IP
 IP sold outright (not licensed) to Pfizer
 Product ultimately marketed as Lyrica
 University
royalties > $700 Million
 Professor endows $95 Million research center
Chicago Tribune…..3/10/08
University/Industry
Relationships
Negative Interactions:
“Drugs and Disclosure”
Reported October 11, 2008
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“Dr. Charles Nemeroff of Emory University—the principal
investigator on a government-financed study of antidepressant
drugs made by GlaxoSmithKline—repeatedly promised to keep
his consulting fees from Glaxo below $10,000 a year in
compliance with federal and university conflict-of-interest
rules…Dr. Nemeroff failed to report some half-million dollars in
fees and expenses from Glaxo while he led the study.”
Dr. Nemeroff had to step down from university research
projects funded by NIH and NIH “froze funds for a $9.3 million
project on depression led by Nemeroff”
NIH also “instituted tighter rules on approving grants for Emory”
Editorial by The New York Times
White, Gayle and Schneider, Craig. “Depression Expert at Emory Pulls out of
Research Projects.” The Atlanta Journal Constitution, October 14, 2008.
University/Industry
Relationships
“University Sues Researcher”
Reported January 3, 2012
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“Craig Thompson, current president of
Memorial Sloan-Kettering Cancer Center, is
being sued by his former employer, the
Leonard and Madlyn Abramson Family
Cancer Research Institute at the University of
Pennsylvania, which he headed for 12 years,
for not disclosing industry activities” for $1
billion dollars
Failed to disclose that he “founded biotech
company called Agios pharmaceuticals”
University claims “it has rights to intellectual
property that the company was founded on”
http://the-scientist.com/2012/01/03/university-sues-researcher/
University/Industry
Relationships
Felony Charges for Failure to Disclose
Financial Interests
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Tatsuya Suda, UCI professor of more than 25 years,
pleaded guilty to failing to disclose his secret
payments from Japanese companies funding his
academic research.
Originally charged with six felony counts for allegedly
receiving $325,000 to $700,000 illegally from a major
Japanese firm from 2006 to 2009.
Owes more than $400,000 in restitution and costs to
the university, and was sentenced to 3 years
probation.
Suda is the first UC professor criminally charged and
convicted for violating the state’s system for
monitoring/preventing conflicts of interest on the 10
UC campuses.
University/Industry
Relationships
Summary

Appropriate disclosure can be very positive
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Articles highlight some serious consequences
of failing to disclose financial interests
Failure to disclose affects the perception of
the researcher’s integrity and work and the
university’s reputation once the undisclosed
financial interests are uncovered
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University/Industry
Relationships
Research Funding
A non-trivial high stakes activity
 NSF
spent $5.5 billion in research and
related activities in FY 2013
 The NIH invests nearly $30.1 billion annually
in medical research.
 America’s biopharmaceutical research
companies invested a record $48.5 billion
in 2012 in research and development of
new medicines and vaccines
http://www.nsf.gov/pubs/2014/nsf14002/pdf/nsf14002.pdf
http://www.nih.gov/about/budget.htm
http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf
University/Industry
Relationships
UCI Statistics
(Year ending June 30, 2012)
 117
invention disclosures
 901 active inventions
 334 active UC patents
 4 startup companies formed
 $7,514,000 total licensing income
UC Technology Transfer Annual Report 2012
http://www.ucop.edu/innovation-alliancesservices/_files/ott/genresources/documents/IASRptFY12.pdf
University/Industry
Relationships
Greater Scrutiny
Revised PHS Regulations
(Final rule published August 25, 2011)
Main changes
 Lower financial disclosure thresholds
 Disclosure requirements broadened to
include financial interests related to
institutional responsibilities not just research
project
 New conflict of interest training requirement
 Disclosure for any reimbursed or sponsored
travel (no lower limit)
 Disclosed information available to public
Implementation began August 24, 2012
http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc
University/Industry
Relationships
Greater Scrutiny
Physician Payment Sunshine Act
(Final Rule Issued February 8, 2013)
Requires all US manufacturers of drug, device,
biologics, and medical supplies covered under
Medicare, Medicaid, or SCHIP to report payments to
physicians and teaching hospitals annually to
Department of Health and Human Services, which
will post information on public website
 Must also disclose physician ownership or investment
interest
 Law exempts payments less than $10 until the
aggregate annual total per company, per covered
recipient, reaches $100, then all retroactive
payments must be disclosed
First report due on March 31, 2014 for payments made
from August 1, 2013 to December 31, 2013.
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http://www.prescriptionproject.org/tools/sunshine_docs/files/Sunshine-fact-sheet-6.07.10.pdf
Conflict of Interest
What is a conflict of interest?
A
situation where an investigator’s outside
financial interest(s) or obligation(s) bias or
have the potential to bias a research
project
Note: Considering the public’s perception is
important when considering a conflict of
interest
Conflict of Interest
What is a financial interest?
Anything of economic value from an
outside entity including:
 Income- salary, consulting fees,
honorarium, stipend
 Equity interests- stock, stock options
 Positions in an outside entity such as
director, officer, partner, consultant, etc.
 Travel payments/reimbursements
 Loans
Conflict of Interest
Important principles about
Conflicts of Interests
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COIs rarely arise from a bad person doing
wrong (illegal, immoral, unethical,
unprofessional) things. They usually arise from
a good person who has two worthy
objectives that conflict with one another
COIs are inevitable for faculty and institutions
engaged in technology transfer
The faculty member or student/trainee is
seldom consciously aware of having a COI
until educated
Disclosure Requirements
COI Disclosure Policies
 State
of California
 Federal Government (PHS, NSF)
 Human Subjects (IRB)
Disclosure Requirements
State
 Required
for non-governmental
sponsored research and research gifts
(i.e. private companies and nonprofit
organizations)
 Principal investigators are required to
disclose financial interests in the nongovernmental sponsor
Disclosure Requirements
State Disclosure Thresholds

If you, the Principal Investigator, have received
one or more of the following from the
nongovernmental sponsor of your research:
Ownership or management interests/position;
consulting/employment relationship
 Income ≥ $500
 Equity ≥ $2,000
 Personal gifts ≥ $50
 Travel payment
 Loan
…. then you would be required to submit a COI
addendum for review
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Disclosure Requirements
Federal (NSF)
 Required
for NSF research contract/grant
including subaward where NSF is the
prime sponsor and funding from
organizations following these federal
disclosure requirements
 All persons involved in design, conduct, or
reporting of research being funded by
NSF are required to disclose their
significant and related financial interests
Disclosure Requirements
NSF Disclosure Thresholds
If you are responsible for design, conduct or
reporting of the NSF funded research and received
one or more of the following from an outside entity
with interests related to the research:
 Income ≥ $10,000
 Equity ≥ $10,000 or 5%
 Director, Officer, Employee, Partner, Trustee,
Consultant, or Management position
 Intellectual Property not owned by UC
…then you would indicate “Yes” on the Federal
Financial Disclosure Form and submit a COI
addendum for review
Disclosure Requirements
Federal (PHS)- Revised in 2011
 Required
for PHS research contract/grant
including subaward where PHS is the
prime sponsor and funding from
organizations following these federal
disclosure requirements
 All persons involved in design, conduct, or
reporting of research being funded by
PHS are required to disclose their
significant financial interests related to
their institutional responsibilities
Disclosure Requirements
Federal Disclosure Thresholds
If you are responsible for design, conduct or reporting of the
PHS funded research and received one or more of the
following from an outside entity with interests related to your
institutional responsibilities:
 For publicly traded entities, total compensation and equity
interest >$5,000;
 For non-publicly traded entities, income >$5,000, or any
equity interest;
 Income received related to intellectual property (not
owned by UC Regents) >$5,000
 Any reimbursed or sponsored travel related to the
institutional responsibilities
…then you would indicate “Yes” for each type of financial
interest on the Form 800
Disclosure Requirements
Human Subjects (IRB)
 Required
for any study involving human
subjects
 All individuals listed in the protocol
application as research personnel must
disclose their financial interests related to
the research
Disclosure Requirements
IRB Disclosure Thresholds
If you are listed as research personnel on the
protocol application and received one or more of
the following from an outside entity with interests
related to the research:
 Income ≥ $10,000
 Equity ≥ $10,000 or 5% in a publicly traded entity
 Any equity in a privately held company
 Director, Officer, Employee, Partner, Trustee,
Consultant, or Management position
 Intellectual Property not owned by UC
…then you would indicate “Yes” on the IRB
application and submit a COI addendum for review
COIOC
Conflict of Interest Oversight
Committee (COIOC)
 Faculty
advisory committee appointed to
3 year terms by the Vice Chancellor for
Research
 Representatives from Office of
Technology Alliances and Research
Administration are non-voting
 Committee meets once a month;
recommendations are forwarded to
Institutional Official for final determination
COIOC
Current Composition of UCI’s COIOC
Faculty (3 year terms; appointed by VC-Research)
School of Biological Sciences – 0
School of Medicine – 5
College of Health Sciences – 0
School of Engineering – 1
School of Physical Sciences – 2
School of Information and Computer Sciences – 0
School of Social Sciences – 1
Merage School of Business – 0
Ex officio
Bruce Morgan – Assistant Vice Chancellor of Research
Kevin Kennan, J.D. – Office of Res-Tech Alliances
Grace Park, J.D. – Principal Subcontract and Research
Compliance Officer
Nadia Wong – COI Administrator
Amy Green – COI Analyst
COIOC
Our function is to protect…
1.Human research subjects.
2.Student researchers.
3.Reputation of the University.
4.Public funds (NIH/NSF), California tax payers.
… by reviewing COI disclosures of research
projects and making recommendation to the
VC-Research for:
(1) approval,
(2) management
(3) disapproval
COIOC
COIOC
 Not
a punitive body
 Protect integrity of research related to
university/industry partnerships, personal
investments, or consulting NOT discourage
those activities
COIOC
COIOC Procedures
 Investigator/Researcher
discloses financial
interests….YOUR RESPONSIBILITY
 COIOC reviews disclosure
 We
review WHAT YOU DISCLOSE
 We are not responsible for DISCOVERING your
conflict
 Determines
whether or not conflict is
manageable
 Send recommendation to Institutional Official
 Implement management plan
COIOC
COI Management Strategies
 Public
disclosure in publications and
presentations
 Monitoring by independent reviewers
 Disqualification from project participation
 Divestiture
 Severance of relationships that create
COI
 Notification of sponsor (NIH, NSF, others)
COIOC
Example of a proper COI disclosure in a
publication.
PNAS 2009 vol. 106 49064911
COIOC
What the COIOC considers…
 Professionalism
 Protection
of human subjects
 Protection against exploitation of
students/trainees
 Integrity of data
 Trust
 Setting standards in education
 Reputations and credibility
COIOC
Potential Risks of a COI
 Compromise
of scientific integrity
 Improper direction of student or
employee’s work
 Inappropriate delay or restriction on
publications
 Unbalanced allocation of faculty
member’s time or effort
 Appearance of impropriety
COI and Graduate Education
How does COI relate to graduate
education?
Scenario 1: A faculty member owns stock in an outside
entity that may or may not be supporting research on which
the faculty is working, but which stands to benefit from that
research. The faculty member directs the student, who is
also working on this project to delay publication of his/her
dissertation and graduation until the faculty member can
complete his research.
Scenario 2: A faculty member establishes a company that
stands to benefit financially from a research or other
project. The company is also supporting the Faculty
member’s research in this area at the university laboratory.
The faculty member pressures a student to work on the
research project of interest to his/her company.
COI and Graduate Education
Graduate Education
COI policy addresses conflicts that might
stem from any financial interest of the
graduate student’s
mentor/thesis/dissertation advisor that has
the potential to harm the student’s
academic interests and degree progress
COI and Graduate Education
When is the best time to raise a concern
about a COI?
When thesis advisor and project are chosen or
anytime student has a concern. School has a form
that must be signed at the end of the first year
when student transfers from the Gateway Program
to a lab.
Who can identify and report a conflict of
interest?
The student, advisor, dept. chair or grad. advisor,
assoc. dean or director of grad program, the
campus COIOC.
COI and Graduate Education
What are the responsibilities of my
academic unit?
• Notify students of the nature of COI and UC
policy.
• Provide students with name of Designated
Resource Person – typically the dept. grad
advisor.
• Ensure faculty are informed about COI policy
and procedures (APM-028), and how these
might affect their relationship with students.
COI and Graduate Education
What is the responsibility of the thesis
advisor?
Disclose any pertinent COIs to student and the
dept. grad. advisor in a timely manner.
Is there COI-related documentation that I
should be aware of?
•
•
Departmental Transfer Agreement: end of 1st
year.
Advancement to Candidacy.
COI and Graduate Education
Graduate Education
1st Year- Gateway Program
2nd Year- Transfer Agreement
If COI, appoint Oversight Member to Thesis
Committee
Advancement to Candidacy
If COI, Oversight Member on Advancement
Committee
Thesis Defense
If COI, Oversight Member on Thesis Committee
COI and Graduate Education
Managing COI when involves
Graduate Students
 Process
may be initiated by student, faculty
mentor, departmental representative, or
COIOC
1.
2.
3.
Report potential COI to Designated Resource
Person (usually departmental graduate advisor) or
Department Chair
If DRP determines COI issue may be harmful to
student, DRP notifies Dean of Graduate Studies
requesting an Oversight Member be appointed
Dean of Graduate Studies selects an Oversight
Member from a list of 3 nominations agreed upon
by the student, faculty research advisor, and DRP
COI and Graduate Education
Oversight Member
 Participates
as a non-voting Ex Officio
Member in all student research advisory
and/or thesis/dissertation committee
meetings.
 Is aware of COI issues and relevant
campus policies
COI and Graduate Education
Oversight Member
 Determine
whether any harmful results from
COI issues
 If no harmful results from COI issues, sign
brief statement to that effect after each
committee meeting and sign
advancement to candidacy and final
exam forms
 If problem arising from COI issues, does not
sign advancement to candidacy or final
exam forms and does inform Dean of
Graduate Studies of problem
 Dean
of Graduate Studies responsible for
determining solution
COI and Graduate Education
COI and Graduate Education
One priority of the COIOC and COI Policies
regarding financial interests is to protect the
academic interests and degree progress of
graduate students
COI Resources
 COI
in Graduate Education FAQs
http://www.grad.uci.edu/forms/facultyand-staff/faq_coi.pdf
 Conflict of Interest Office
 http://www.research.uci.edu/ora/coi/index.htm
 Nadia Wong, COI Administrator [email protected]
 Amy Green, COI Analyst [email protected]
Resources for non-COI
Concerns…
Whistleblower Policy
http://www.evc.uci.edu/whistleblower/
If suspect improper governmental activities (such as
corruption, bribery, theft or misuse of university property,
fraudulent claims, fraud, coercion, willful omission to perform
duty; or economic waste; or gross misconduct, gross
incompetence or gross inefficiency; or any condition that may
significantly threaten the health or safety of employees or the
public). The report can be submitted anonymously by calling
800-403-4744 or submitting a report online at
http://universityofcalifornia.edu/hotline.
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Resources for non-COI
Concerns
Research Misconduct
http://www.research.uci.edu/ora/misconduct_FAQ.html
Research Misconduct is defined by federal law and University
policy as fabrication, falsification, or plagiarism in proposing,
performing, or reviewing research, or in reporting research results.

Office of the Ombudsman
http://www.ombuds.uci.edu/homepage.shtml
The Office of the Ombudsman provides a safe and comfortable
environment to discuss complaints, concerns or problems
confidentially. The office is confidential, informal, and neutral. To
make an in person or telephone appointment, or if you have any
questions, please contact the office at (949) 824-7256 or (714) 4565605.
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