CONFLICTS OF INTEREST IN SPONSORED RESEARCH
June 26-29, 2002
Susan H. Ehringhaus
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
Institutional Conflicts of Interest
I.
II.
“Early” Efforts (mid 1990’s)
A.
"Equity" Policies (Harvard, MIT, Iowa, and others)
B.
Individual COI Policies as applicable to those in administrative roles and to governing
boards; sometimes viewed as "institutional"
C.
State COI Statutes -- applicable to governing boards and senior executives in public
institutions
D.
Commentary
1.
Debate between self policing vs. external regulation
2.
NEJM 332:262-268 (January 26, 1995):
(a)
Clinical research/licensing agreement
(b)
Framework for analysis
i.
Relation between institution’s primary missions and its financial
interest
ii.
Size of financial interest
iii.
Degree of discretion involved in achieving the primary missions
iv.
Seriousness of the harms that might result from the institutional
COI (patient care, teaching, research)
(c)
Safeguards against harm from institutional COI
i.
Disclosure
ii.
Internal monitoring
iii.
External monitoring
(d)
Additional regulation of institutional COI
i.
No reliable data to evaluate incidence
ii.
Necessary to evaluate benefits/burdens of additional regulation
before implementation
AAU Task Force on Research Accountability’s Report on Individual and Institutional Financial
Conflicts of Interest (October 2001)
National Association of College and University Attorneys
1
A.
Definition of Institutional COI
“An institutional financial conflict of interest may occur when the institution, any of its
senior management or trustees, or a department, school, or other sub-unit, or an affiliated
foundation or organization, has an external relationship or financial interest in a company
that itself has a financial interest in a faculty research project.”
1. Categories of such conflicts:
--conflicts involving university equity holdings or royalty arrangements and research
programs;
-- conflicts involving university officials who make decisions with institution-wide
implications (governing board members, presidents, chancellors, deans, department
heads and leaders of laboratories. (These include conflicts between an individual’s
personal financial holdings and their institutional responsibilities; and conflicts
between the individual's responsibilities in a fiduciary or management role of an
entity with a business relationship with the institution and his/her responsbilities to
the institution.)
“A related situation involves senior university officers who serve on governmentappointed boards. Where these boards involve federal or state agencies which provide
research funds to the university, the university official must navigate between the
potential clash of interests between the university and the government agency involved.”
B.
Addressing Potential Institutional COI
“a.
“b.
“c.
disclose always;
manage the conflict in most cases;
prohibit the activity when necessary to protect the public interest or the interest of
the university.
Segregation of decision making about the financial activities and the research activities,
so that they are separately and independently managed
C.
Steps to Consider
1.
2.
3.
4.
5.
6.
7.
8.
D.
Develop and publicize clear policies
Establish administrative processes
Establish a review group on institutional COI
Disclose potential conflicts to review group
Use review group to assess potential conflicts, weigh risks and benefits
Take action regarding institutional conflicts
Strictly scrutinize institutional conflicts involving humans
Strictly scrutinize equity that is not liquid or is less liquid
Methods of Dealing with Institutional Conflicts
National Association of College and University Attorneys
2
“a.
“b.
“c.
“d.
III.
not conducting proposed research at that institution, or halting it if it has
commenced;
reducing or otherwise modifying the financial (equity or royalty) stake involved;
increasing the segregation between the decision-making regarding the financial
and the research activities; and
establishing a research monitoring process, so that the research can be closely
scrutinized to ensure that potential conflicts do not undermine the integrity of the
work (and of the university).”
GAO Report to Senator Bill Frist, Subcommittee on Public Health, Committee on Health,
Education, Labor, and Pensions; U.S. Senate
“Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest”
November 2001 (GAO-02-89: Financial Conflicts in Biomedical Research)
IV.
A.
Focused almost exclusively on individual COI
B.
Institutional COI
1.
Although not required, universities had policies and procedures that addressed
aspects of institutional financial COIs.
2.
Universities managed institutional investments separately from academic units
3.
Some universities tried to minimize potential for institutional conflicts by
separating the Technology Transfer Office from Academic Affairs
4.
Universities placed limits on their equity holdings and roles in start-up companies.
AAMC Task Force on Financial Conflicts of Interest in Clinical Research
Individual conflicts report issued December, 2001. Institutional conflicts report in preparation.
V.
Common Themes
A.
Interests at Stake
1.
2.
3.
4.
5.
6.
B.
Integrity of university
Research objectivity
Fiscal responsibility
Independence of IRB and IACUC review
Research compliance
Primacy of interests of human subjects, where applicable
Key Principles to Observe
1.
Accountable separation of responsibility
(a)
Research
(b)
Compliance
National Association of College and University Attorneys
3
(c)
(d)
2.
C.
D.
Financial
The closer the proximity to research, the more absolute the firewall needed
External credibility
(a)
Review by persons from outside university
(b)
Transparency
Key Processes Necessary
1.
Clear assignment of institutional responsibility
2.
Interactive, searchable databases
(a)
Donors
(b)
Research sponsors
(c)
Inventors
(d)
Start-ups
(e)
IRB
(f)
IACUC
(g)
Equity holdings not in endowment
(h)
Licensees
3.
Review committees
(a)
Advisory vs. decision making
(b)
Outside members
(c)
Disclosure?
(d)
BOT?
Workable Review Mechanisms

potential for
institutional COI






degree of scrutiny
(burden on the process vs. yield rate of serious conflicts)
*
1.
2.
3.
4.
5.
Equity in a start-up sponsoring research at the institution
Major research contracts over x years from one sponsor
Major gifts over x years from a research sponsor
Patent royalties from licensee who sponsors research
Endowment position and licensee or research
National Association of College and University Attorneys
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*
types of potentially
compromising events
6.
E.
Venture activity and research
Institutional Response to Institutional COI
1.
2.
3.
4.
5.
6.
7.
8.
Not doing research
External monitoring via review group
Internal monitoring
Modifying or giving up financial interest
Increasing segregation between financial interest and research
Recusal of senior officials
External IRB review
Multi-center clinical trials
National Association of College and University Attorneys
5