University/Industry Relationships and Conflict of Interest

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Dec 6, 2012 (4 years and 9 months ago)

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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 11, 2012

Agenda


University/Industry Relationships


Conflict of Interest


Disclosure Requirements


Conflict of Interest Oversight Committee


Conflict of Interest and Graduate
Education


Resources

Conflict of Interest: An Issue of Ethics

Can ethics be taught?


Can a person become moral and ethical by reading
moral treatises and applying them to case histories?


Aristotle
:

If you need moral guidance seek out a person
who has succeeded in living a moral life rather than
someone who has succeeded in memorizing moral
arguments.


You can memorize the
Metaphysics of Ethics

by the
philosopher
Immanuel Kant

and still be a

moral dunce
.


Kant states that our moral duties are an unconditional
obligation, or an obligation that we have regardless of
our will or desires.



CONFLICT OF INTEREST



A set of conditions in which professional
judgment (such as a patient’s welfare or the
validity of research) tends to be unduly
influenced by a secondary interest (such as
financial gain).

Thompson, NEJM, 1993

WHAT WE SHOULD BE THINKING
ABOUT


Attention should be directed to


professionalism


protection of human subjects


protection against exploitation of students/trainees


integrity of data


trust


setting standards in education


reputations and credibility


“Drugs and Disclosure”

Reported October 11, 2008


“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


“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 $5.6 billion in research and
related activities in FY 2011


NIH awarded $21.3 billion in research
grants in 2011


America’s biopharmaceutical research
companies invested a record $67.4 billion
in 2010 in research and development of
new medicines and vaccines

http://www.nsf.gov/pubs/2012/nsf12001/nsf12001.pdf


http://report.nih.gov/FileLink.aspx?rid=575


http://www.phrma.org/media/releases/rd
-
investment
-
us
-
biopharmaceutical
-
companies
-
reached
-
record
-
levels
-
2010

University/Industry
Relationships

Greater Scrutiny


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

Implementation begins January 1, 2012 with reports
due to HHS by March 31, 2013

University/Industry
Relationships

Physician Payment Sunshine Act

(signed into law on March 23, 2010)


http://www.prescriptionproject.org/tools/sunshine_docs/files/Sunshine
-
fact
-
sheet
-
6.07.10.pdf

Greater Scrutiny

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 begins August 24, 2012


University/Industry
Relationships

Revised PHS Regulations

(Final rule published August 25, 2011)


http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc


What happened?


DNA recombinant technology


1980 U.S. Supreme Court decision
(Diamond
vs

Chakrabarty
) allowing
patenting of “anything under the sun that
is
made by man



1980
Bayh
-
Dole Act


Gave recipients of federal funds the right to
patent federally funded research inventions
and the obligation to spur the translation of
those inventions into public benefit


Declining state support for public
universities


Deregulation of everything financial in the
1990’s through today where we are now
reaping the “fruits” of deregulation


Birch Evans Bayh II

Dem Senator

Indiana ‘61
-
’81

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.

Robert Joseph Dole

Rep Senator

Kansas ‘69
-
’96

WHAT IS THE PROBLEM?

ACADEMIA AND INDUSTRY HAVE
FUNDAMENTAL
DIFFERENCES

IN THEIR MOTIVES THAT CAN
NEVER

BE FULLY RECONCILED.


Pharmaceutical, device, and equipment
companies


DO

want to sell products that benefit patients
and


DO

need and want the expertise and advice
of academic scientists to help them








BUT

WHAT IS THE PROBLEM?


Pharmaceutical, device, and equipment companies
have a fiduciary duty to their shareholders to make
money.


Physicians and scientists have


a fiduciary duty to their universities,


a social obligation to the public,


a professional obligation to their profession and societies, and


a moral and ethical obligation to their patients, peers, and
trainees


Physicians and scientists have an obligation to put
patient care, research integrity, and the education of
their trainees and peers first, when faced with a choice
between making money or doing their
duty……….
CONFLICT
!

University vs. Industry


University and Industry have fundamental
differences in their motives that can never be
fully reconciled


University

Industry

(Pharmaceutical, Device

&
Equipment Companies)


Educate

and
generate knowledge


Social obligation to
public


卥汬⁰S潤畣瑳


䙩摵捩a特r摵d礠y漠瑨敩爠
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



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

FY2010 UCI Snapshot

(Year ending June 30, 2010)


$54.9 million in research funding by
Department of Health & Human Services


$20.6 million in research funding by
Business and For
-
Profit Entities


125 inventions disclosed


302 active US patents


7 startup companies formed


$5.2 million total licensing income

UC Irvine Research Administration Annual Report

http://www.research.uci.edu/ora/sp/reports/09
-
10/New%20&%20Renewal%20Awards%20by%20Funding%20Agency09
-
10.pdf

UC Technology Transfer Annual Report 2010
http://www.ucop.edu/ott/genresources/documents/IASRptFY10.pdf


University/Industry
Relationships

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


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

Conflict of Interest

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
non
-
governmental 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


Disclosure Requirements

State Disclosure Form (700U)

Federal (PHS, NSF)


Required for PHS or NSF research
contract/grant including subaward where
PHS or 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
PHS/NSF are required to disclose their
significant and related financial interests

Disclosure Requirements

Federal Disclosure Thresholds

If you are responsible for design, conduct or
reporting of the PHS/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 Financial Disclosure
Form (FFD)

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


Disclosure Requirements

Addendum Form for All
Positive Disclosures

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

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


COIOC reviews disclosure


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

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

COIOC

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

Graduate Education

COI and Graduate Education

1
st

Year
-

Gate
way Program

2
nd

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

Managing COI when involves
Graduate Students


Process may be initiated by student, faculty
mentor, departmental representative, or COIOC

1.
Report potential COI to Designated Resource
Person (usually departmental graduate advisor)
or Department Chair

2.
If DRP determines COI issue may be harmful to
student, DRP notifies Dean of Graduate Studies
requesting an Oversight Member be appointed

3.
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 and Graduate Education

Resources


COI in Graduate Education
FAQs
http://
www.grad.uci.edu/forms/faculty
-
and
-
staff/faq_coi.pdf




Conflict of Interest Office


http://
www.research.uci.edu/ora/coi/index.htm



Grace Park, COIOC Administrator
parkgj@uci.edu


Nadia Wong, COI Analyst
nadiaw@uci.edu