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
April 24, 2013
Agenda
 University/Industry
 Conflict
Relationships
of Interest
 Disclosure Requirements
 Conflict of Interest Oversight Committee
 Conflict of Interest and Graduate
Education
 Resources
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
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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
University/Industry
Relationships
“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-a-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
Summary
 Articles
highlight some 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
University/Industry
Relationships
Research Funding
A non-trivial high stakes activity
 NSF
spent $5.7 billion in research and
related activities in FY 2012
 NIH awarded $30.9 billion in research
grants in 2012
 America’s biopharmaceutical research
companies invested a record $49.5 billion
in 2011 in research and development of
new medicines and vaccines
http://www.nsf.gov/pubs/2013/nsf13002/pdf/06_chapter1_mannagement_discussion_a
nd_analysis.pdf
http://www.nih.gov/about/budget.htm
http://www.phrma.org/sites/default/files/159/phrma_industry_profile.pdf
University/Industry
Relationships
UCI Statistics
(Year ending June 30, 2011)
 178
invention disclosures
 869 active inventions
 315 active UC patents
 3 startup companies formed
 $7,354,000 total licensing income
UC Technology Transfer Annual Report 2011
http://www.ucop.edu/ott/genresources/documents/IASRptFY11.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
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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
Current Composition
of UCI’s COIOC
Faculty (3 year terms; appointed by VC-Research)
School of Biological Sciences – 0
School of Medicine – 4
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. – COI Administrator
Nadia Wong – COI Analyst
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)
Example of a proper COI disclosure in a publication.
PNAS 2009 vol. 106 4906-4911
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
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
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
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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 COIC.
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.
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What is the responsibility of the thesis advisor?
> Disclose any pertinent COIs to student and the dept.
grad. advisor in a timely manner. (more later!)
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
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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
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Determine whether any harmful results from
COI issues
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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
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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
Research conflicts NOT related
to financial interests
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Whistleblower Policy
http://www.evc.uci.edu/whistleblower/
If you suspect that a UC employee is engaged in 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). (An "improper governmental activity"
has to directly involve the university as either the victim of the improper activity or the perpetrator of the
improper activity via the action of an employee.) The report can be submitted anonymously by calling 800403-4744 or submitting a report online at http://universityofcalifornia.edu/hotline.
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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.
Fabrication is making up data or results and recording or reporting them.
Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results
such that the research is not accurately represented in the research records.
Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate
credit.
If you suspect that research misconduct has occurred, contact the Research Integrity Officer (RIO) at (949)
824-5796 to submit an oral or written complaint. If you are unsure whether a suspected incident falls within the
definition of research misconduct, you may consult with the RIO to discuss the incident informally.
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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) 456-5605.
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
 Grace Park, COIOC Administrator [email protected]
 Nadia Wong, COI Analyst [email protected]