SPECIAL
MAYO CLINIC’SARTICLE
CONFLICT OF INTEREST POLICY
Principles and Process in the Development of the
Mayo Clinic’s Individual and Institutional Conflict of Interest Policy
MICHAEL CAMILLERI, MD; GAIL L. GAMBLE, MD; STEPHEN L. KOPECKY, MD; MICHAEL B. WOOD, MD;
AND MARIANNE L. HOCKEMA, MA
In 1995, federal regulations required all academic medical cen-
ters to implement policies to manage individual financial conflict
of interest. At the Mayo Clinic, all staff are salaried, and all med-
ically related intellectual property from the staff belongs to the
clinic. Hence, it was necessary to develop a policy for institutional
conflict of interest to complement the policy for individual con-
flicts of interest. This article addresses the principles and process
that led to the development of the Mayo Clinic’s policies that
guide the management of conflict of interest of individuals and of
the institution. Empowered by the Bayh-Dole Act, the Mayo Clinic
participates in technology transfer through its entity Mayo Medi-
cal Ventures. Individual conflicts of interest arising from such
technology transfer are associated with institutional conflicts
because all individual intellectual property belongs to the institu-
tion, per clinic policy. This policy addresses conflicts of interest
that arise in research, leadership, clinical practice, investments,
and purchasing. Associated with the statutory annual disclosure
on personal consulting and other relationships with industry,
which are guided by federal regulations, all research protocols or
grant applications require financial disclosure on initial submis-
sion and in annual progress reports. The clinic’s Conflict of Inter-
est Review Board was established to review each disclosure and
recommend management of individual and institutional conflicts
of interest according to policy.
Mayo Clin Proc. 2005;80(10):1340-1346
T he Bayh-Dole Act of 1980 added a new dimension to
the goals of scientific research as it sought to stimulate
the translation of American scientific discovery to success-
ful commercial activity. This translation has resulted in
patients benefiting from more rapid access to new discov-
eries. Essentially, the Bayh-Dole Act enabled institutions
and their investigators to own patents resulting from feder-
ally funded research. Moreover, it enhanced opportunities
for funding research activities at academic medical centers
at a time when reimbursement from the practice of medi-
cine was dwindling. For the first time, institutions were
permitted to hold intellectual property rights for inventions
disclosed by employees, to license technology to commer-
cial partners, and to share in a royalty stream with the
inventor(s).
The Bayh-Dole Act provided opportunity for the re-
search community to commercialize discovery and innova-
tion. However, it also created inherent conflicts of interest
for academic centers engaging in research and technology
development with industry. New institutional relationships
with industry evolved and extended beyond funded re-
search into strategic alliances, technology licensing,
project partnering, and equipment procurement and testing.
1340 Mayo Clin Proc. • October 2005;80(10):1340-1346
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
When these relationships were created, the risk associated
with the introduction of bias in the conduct of studies was
potentially increased. For individuals, opportunities for
closer relationships with industry also expanded with invi-
tations to provide consulting services and to serve on advi-
sory boards or even corporate boards of directors. Conflicts
of interest and the potential for conflict were inevitable, as
documented in several scholarly reviews and editorials.1-8
Such conflicts became particularly concerning if they were
perceived to influence the conduct of trials involving hu-
man subjects in which patient safety should have been the
principal concern.
Advances in biomedical research originate from both
academic institutions and industry. Translation of these
innovations to clinical practice involves collaborations
that, of necessity, engender formal relationships between
industry and academic centers. Public trust in medical re-
search assumes altruistic motives of academic centers and
medical researchers in the conduct of contracts with indus-
try. In 1995, formalizing years of intense self-examination
and self-regulation within the research community, the
National Institutes of Health and the Department of Health
and Human Services adopted regulations to address indi-
vidual conflicts of interest. Most state laws also require that
tax-exempt entities advance new knowledge in the public
From the Division of Gastroenterology and Hepatology (M.C.), Office of Medi-
cal-Industry Relations (M.C., M.L.H.), Department of Physical Medicine and
Rehabilitation (G.L.G.), and Division of Cardiovascular Diseases (S.L.K.),
Mayo Clinic College of Medicine, Rochester, Minn; and Department of Ortho-
pedic Surgery, Mayo Clinic College of Medicine, Jacksonville, Fla (M.B.W.).
Dr Gamble and Ms Hockema have nothing to disclose. Dr Camilleri has
research grants from Merck KGaA, Johnson & Johnson, and ARYx Pharmaceu-
ticals and has served as a consultant for Salix Pharmaceuticals, Inc,
AstraZeneca, Yamanouchi Pharmaceutical Co, Kosan Biosciences, Inc,
Fulfillium, Inc, Theravance, Inc, Microbia, Inc, Propagate Pharma, Ltd,
GlaxoSmithKline, Novartis Pharmaceuticals, Wilmington Pharmaceuticals,
Takeda Pharmaceuticals America, Inc, Johnson & Johnson Pharma,
AbDiagnostics, Inc, Sanofi-Aventis, Domain Associates, LLC, Vela Pharmaceu-
ticals Inc, Sucampo Pharmaceuticals, Allergan, Inc, Eli Lilly and Company,
Baxter International, Inc, and EnteroMedics Inc. Dr Kopecky has research
grants from AtheroGenics, Inc, and Endomatrix Inc, and has served as a
consultant for Paringenix, Inc, GlaxoSmithKline, Bristol-Myers Squibb Co, and
Hawaii Biotech, Inc. Dr Wood is a member of the Board of Directors of
VisionShare, Inc, Steris Corp, Cubist Pharmaceuticals, Inc, and Assistive
Technology, Inc.
Individual reprints of this article are not available. Address correspondence to
Michael Camilleri, MD, Office of Medical-Industry Relations, Mayo Clinic
College of Medicine, 200 First St SW, Rochester, MN 55905.
© 2005 Mayo Foundation for Medical Education and Research
• www.mayoclinicproceedings.com

interest or risk losing their tax exemption. The key prin-
ciples for protecting the research participant in the context
of individual investigator conflicts of interest were identi-
fied initially as disclosure and informed consent. However,
management of these conflicts has become more complex
with the emergence of institutional conflicts of interest and
the intertwining of conflicts of interest for individual inves-
tigators and their institutions.
On one extreme, conflicts of interest could be managed
by prohibiting contracts and interaction with industry9; on
the other extreme, institutions could simply avoid the issue
entirely or give it minimal attention. Both alternatives ap-
pear unfavorable to the public good; thus, measures must
be devised to facilitate appropriate relationships that posi-
tively affect patient care. Existing policies governing con-
flict of interest at academic centers throughout the United
States reflect a lack of consistency, according to sur-
veys.10,11 Authors have recently recommended measures to
be considered by institutions for managing conflicts of
interest,12,13 but as yet there are no published policies from
academic medical centers. Moreover, policies for employ-
ment and intellectual property at the Mayo Clinic required
the development of customized approaches to individual
and institutional conflicts of interest. Specifically, it is
worth noting that all Mayo Clinic staff are salaried and that
all medically related intellectual property of the staff be-
longs to the Mayo Clinic.
THE NEED FOR AN INSTITUTIONAL POLICY
Conflict of interest, even the appearance of potential con-
flict, has always been a concern for scientists committed to
the integrity of their research. In 1921, Dr William J. Mayo
stated, “Commercialism in medicine never leads to true
satisfaction, and to maintain our self-respect is more pre-
cious than gold.” Early in its history, the Mayo Clinic
developed policies to help individuals manage conflict of
interest. The clinic has considered management of conflict
of interest as the responsibility of the institution because all
physician/scientist staff work as full-time employees and
all intellectual property belongs ultimately to the clinic.
Studies show that patients involved with research
projects are more aware of potential individual conflict of
interest than of institutional conflict of interest.14 Compre-
hensive studies published in the past 3 years indicate that the
potential for institutional conflicts of interest is germane to
most if not all academic medical centers15 including the
National Institutes of Health.16 Relationships among physi-
cians/scientists and their institutions and industry also re-
quire careful management to avoid legal liabilities.17,18
Conflicts of interest for the Mayo Clinic as an institution
are linked almost exclusively to individual conflicts of
Mayo Clin Proc. • October 2005;80(10):1340-1346
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
MAYO CLINIC’S CONFLICT OF INTEREST POLICY
interest. Therefore, we acknowledge that our recommenda-
tions may not apply to conflicts of interest at all medical
centers. However, we believe our deliberations may serve
to stimulate discussion at other medical centers and may
lead eventually to a consensus position for the academic
medical community as a whole.
THE PROCESS LEADING TO THE MAYO CLINIC’S
POLICY ON CONFLICT OF INTEREST
Through ongoing communications with staff, the Mayo
Clinic has noted the staff’s sense of responsibility for con-
flict of interest, but also their confusion regarding what
actually constitutes conflict of interest and how that con-
flict can be managed. Some Mayo Clinic staff perceived
that a potential conflict of interest was associated with a
presumption of wrongdoing. This illustrated a need to edu-
cate the staff about the inevitability of conflicts of interest
and the importance of establishing standards and effective
mechanisms to manage it.
Most guidelines in prior publications tended to address
conflicts of interest related to clinical trials; however, rela-
tionships with industry encompass other everyday func-
tions of academic medical or research centers. Dr David
Korn,2,19 Division of Biomedical and Health Sciences Re-
search, Association of American Medical Colleges, stated,
“Conflicts of interest are ubiquitous and inevitable in aca-
demic life, indeed, in all professional life. The challenge
for academic medicine is not to eradicate them, which is
fanciful and would be inimical to public policy goals, but to
recognize and manage them sensibly and effectively.” Im-
proprieties have been reported at academic medical centers
where institutional and individual conflicts of interest were
not disclosed, reviewed, or managed.
Thus, the Mayo Clinic established a broad-based task
force and intramural review process to develop recom-
mended procedures and policies for handling conflicts of
interest for individuals and for the institution. The clinic
also sought guidance from national leaders, hosted a na-
tional forum to air major issues,20 and reviewed recommen-
dations from learned individuals.19,21 Nonfinancial conflicts
of interest that may affect individual fame rather than for-
tune22 also were recognized but were not addressed in the
first policy because academic self-interest was considered a
legitimate part of the motivation to conduct research, which
is itself a mandate for academics and their institutions.22
GOALS
The goals for the Mayo Clinic Conflict of Interest Policy
are as follows: to safeguard patient safety in all clinical
practice, research, and education efforts; to protect the
• www.mayoclinicproceedings.com 1341
MAYO CLINIC’S CONFLICT OF INTEREST POLICY
TABLE 1. Essential Disclosures
Corporate equity in the form of stock or other ownership
Royalties or rights to receive future royalties on licensed intellectual
property
Consulting fees, honoraria, salary, gifts, or in-kind compensation within
the previous 12 months
Research or education grants within the previous 12 months
Service on advisory boards or boards of directors within the previous
12 months
Current negotiations relating to any of the above relationships
Any other relevant external relationships that could influence the
proposed activity
integrity of the institution and the individual; to support and
not impede research efforts; and to acknowledge and de-
velop guidance for the management of conflicts of interest
for the institution and for the individual. The Mayo Clinic
individual and institutional conflict of interest policy can be
accessed at www.mayoclinic.org/medicalprofs/conflict.pdf.
DEFINITION OF CONFLICT OF INTEREST AT
THE MAYO CLINIC
Mayo Clinic policy focuses on 4 types of activities that
have the potential for financial conflict of interest: purchas-
ing decisions, leadership activities (intramural, including
decisions made in the clinical practice, and extramural),
investments (endowment and pension fund), and research.
Because individual and institutional conflicts of interest at
the Mayo Clinic often are intertwined, the potential for
both is considered for all 4 types of activities.
The operational definition of conflict of interest is as
follows (paraphrased from the Mayo Clinic conflict of inter-
est policy 2004, www.mayoclinic.org/medicalprofs/conflict
.pdf):
A conflict of interest occurs when there is a divergence between
an individual’s or an institution’s private interests and their pro-
fessional obligations either to a patient or to society such that an
independent observer might reasonably question whether actions
taken by the individual or the institution may have been influ-
enced by consideration of significant financial conflict of interest.
A conflict of interest may pertain to research, investment, leader-
ship or purchasing activities; it depends on the situation, and does
not necessarily reflect on the character or actions of an individual.
From the principles outlined in this definition, guidelines
were developed for managing potential conflicts of interest
in purchasing, leadership, investment, and research activi-
ties. Disclosures provide sufficient information to assess
relationships with external entities in matters pertinent to
the proposed activity. Elements of essential disclosures are
listed in Table 1. Such disclosures do not imply unmanage-
able conflicts of interest.
1342 Mayo Clin Proc. • October 2005;80(10):1340-1346
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
Significant financial interest must be defined for each
specific activity. General principles that reflect federal
guidelines for significant conflict of interest23 are listed in
Table 2.
GUIDELINES FOR MANAGEMENT OF
CONFLICT OF INTEREST
There are multiple mechanisms for managing conflict of
interest. The first step is always disclosure. Since 2001, the
Mayo Clinic has mandated annual disclosure by its staff of
all relationships with industry. A statement is signed at the
time of employment, and failure to comply is reported to
the Mayo Clinic Personnel Committee for disciplinary ac-
tion. With such an honor system in place, there is no
attempt to review individual tax returns. In addition, disclo-
sures are updated with each Mayo Clinic Institutional Re-
view Board (IRB) or federal grant application. Apart from
disclosure, current Mayo Clinic policies have discouraged
the development of significant financial conflict of interest
by requiring peer review of all external consulting relation-
ships, prohibiting stock options as payment for consulting
fees, and prohibiting ownership by the professional staff of
medically related companies. The second step is evaluation
or review of the disclosed information by the Conflict of
Interest Review Board to determine whether a significant
conflict of interest is present, according to established cri-
teria. If a conflict of interest situation is identified, the third
step is to institute measures for conflict management. Man-
agement of conflict of interest includes disclosure to pa-
tients and laboratory personnel, including graduate stu-
dents; disclosure in publications and presentations; recusal
from the principal investigator position and/or access to
data management when indicated; escrow of financial
holdings; and rarely, divestiture.
PURCHASING DECISIONS
In a large academic medical center, purchasing departments
often make quality and price-driven decisions removed from
the individual user. However, with many technologies or
devices, the user of the technology with the best knowledge
is often the investigator who invented it or may be funded to
study it. Purchasing decisions include but are not restricted
to the decision to actually purchase a product or technology
(ie, the request that a purchase order be generated); the
selection of a supplier for a product or technology for evalu-
ation, competitive bid, or proposal; and the actual negotia-
tion of a purchasing agreement or contract with a supplier of
a product or technology. Individuals who serve on advisory
boards or boards of directors of vendors or competing ven-
dors being considered in the purchase are said to have a sig-
nificant interest, even if no compensation is involved.
• www.mayoclinicproceedings.com

For purchasing decisions, if a significant conflict of
interest is identified after review by the Conflict of Interest
Review Board, management of the conflict of interest may
require the following: full disclosure of potential conflicts
of interest at the time of purchase discussions; recusal from
chairing or, depending on the level of conflict of interest,
participating in a decision-making process; retention of any
equity ownership until research or purchasing decisions are
completed; and documentation of the recusal in meeting or
purchase decision minutes. The policy also requires that
any purchasing decisions involving sums greater than
$30,000 and institutional conflict of interest must be re-
viewed by the Conflict of Interest Review Board. Purchases
that involve technologies discovered and licensed originally
by the Mayo Clinic to a third party require documentation
that the purchase was based on the best interests of the
patient, such as documentation of best performance in the
literature relative to competing technology. According to
Stark II legislation, the inventors earn no royalty when the
technology is used at the Mayo Clinic. However, the Mayo
Clinic benefits if a sales-based royalty is received.
LEADERSHIP DECISIONS
For leadership decisions made by any employee on behalf
of the Mayo Clinic, management of significant conflict of
interest may require the following: recusal from chairing or
participating in the final decision-making process that
could indirectly affect the relationship of the person with
the company or its competitors and the Mayo Clinic, as
well as documentation of the recusal in the meeting min-
utes that record the leadership decision. The process of
recruiting staff to the Mayo Clinic is not influenced by the
potential to develop intellectual property for income;
rather, search committees consist of academic and clinical
leaders and have no representation from the Office of
Technology Transfer. Incoming staff who own medically
related companies are required to disclose all equity and
intellectual property before employment, and their potential
for conflicts of interest or commitment are monitored by an
independent oversight committee at least twice each year.
For leadership decisions made by non-staff members of
the Mayo Clinic (eg, members of the clinic’s Board of
Trustees), recusal from final decision-making processes
may be required whenever a personal or potential conflict
of interest could directly or indirectly affect the clinic.
Recusal is documented in the institutional minutes that
summarize the decision.
INVESTMENT DECISIONS
Mayo Clinic investment decisions should continue to re-
flect the ethical and responsible stewardship of endow-
ment, pension, and operational funds. Investment decisions
Mayo Clin Proc. • October 2005;80(10):1340-1346
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
MAYO CLINIC’S CONFLICT OF INTEREST POLICY
TABLE 2. Significant Conflict of Interest
Equity greater than 5% in a company or equity with a value of more than
$10,000 (whichever is less) is considered a significant financial interest.
Equity through mutual funds is not considered a significant financial
interest
Rights to receive royalty payments greater than $10,000 per year on
licensed intellectual property are considered a significant financial
interest
Consulting fees, honoraria, salaries, gifts, or in-kind compensation within
the previous 12 months are considered a significant financial interest if
value is greater than $10,000
Research or education grants within the past 12 months that are
unrestricted or provide funds in excess of those required for reasonable
expenses incurred in the performance of the sponsored research or
educational activity are considered a significant financial interest
Current negotiations to initiate or modify the above relationships are
generally regarded as equivalent to a significant financial interest
should be unrelated to any clinical practice, research, or
education activity.
For investment decisions made on behalf of the Mayo
Clinic, the conflict of interest policy specifies that the clinic
should limit its equity holding to 5% or less in any publicly
traded company when the clinic intends to pursue research
or educational activities with that company. The Mayo
Clinic has no limit to investment/equity ownership when
there is no intention to pursue research or educational
activities with a company. Similarly, the clinic has no limit
to equity ownership in privately held companies (including
those that become publicly traded through an initial public
offering) that use the clinic’s intellectual property when no
research is planned with clinic patients or staff. However, if
research activities sponsored by a privately held company
are contemplated, the relationship and research activity
should be reviewed by the IRB to ensure patient safety and
by the Conflict of Interest Review Board to manage poten-
tial institutional conflict of interest if a Mayo Clinic invest-
ment is ongoing or contemplated.
RESEARCH DECISIONS
The literature is replete with examples of societal concerns
about potential conflicts of interest with research results24
and the focus on problems in postmarketing surveillance,25
interpretation of risk-benefit, and the motivation for profit in
the pharmaceutical and device industry. Participation of
Mayo Clinic staff in Food and Drug Administration advisory
review boards is encouraged. Participation in presentations
for new drug or device applications is permitted, although
it requires thorough review by the Medical Industry Rela-
tions Committee, which also appraises individual and
institutional conflicts of interest in each request for par-
ticipation. Clinical research involving new medications
and devices that originate usually in the corporate world
is encouraged.
• www.mayoclinicproceedings.com 1343
MAYO CLINIC’S CONFLICT OF INTEREST POLICY
For research decisions, if the Conflict of Interest Review
Board identifies a significant conflict of interest after re-
view, oversight or possible recusal from research activities
may be required, depending on the level of conflict of
interest and its potential effect on human studies. When
there is institutional conflict of interest pertaining to re-
search being conducted at the Mayo Clinic, this likely
involves individual conflict of interest because all Mayo
Clinic employees are required to disclose and license any
intellectual property through the clinic’s Office of Tech-
nology Transfer. With the current royalty-sharing policy,
the share received by inventors and their research program
or department actually exceeds the royalty received by the
general fund of the Mayo Clinic. Hence, institutional con-
flict of interest can be identified and managed pari passu
with the identification of individual conflict of interest.
Apart from the share of the inventors, such funds are used
to support the research and education missions of the in-
ventors’ research program or department.
Research by or at the Mayo Clinic involving human
subjects or biospecimens and all research requiring IRB
approval require higher levels of management than does
nonhuman research if conflict of interest exists. When
research involves individual or institutional financial con-
flict of interest, the Conflict of Interest Review Board should
be consulted for advice. Typically, financial conflict of inter-
est is determined by virtue of assigned monetary value (that
is, market value) or licensing of a technology and not just
disclosure to the Mayo Clinic’s Office of Technology Trans-
fer (Mayo Medical Ventures). Pursuit of a patent is not a
formal assignment of monetary value, but it presents the
potential for bias; therefore, the Conflict of Interest Review
Board may need to develop management strategies in this
situation.
In general, basic research should be permitted to con-
tinue at the laboratory of the investigator who may have a
conflict of interest, depending on the nature of the work,
the specific expertise available, and the mandate of the
Bayh-Dole Act. Management of conflict of interest in such
situations will include disclosure to laboratory personnel,
disclosure in presentation and publication of data in scien-
tific journals, and disclosure at the point of application for
Public Health Service and/or National Science Foundation
Non-Clinical Research Funding (PHS Final Rule 42 CFR
Part 50 and 45 CFR Part 94; NSF Rule 59 FR 3308 and 60
FR 35820). Management of the conflict of interest will be
reevaluated when the discovery leads to studies in hu-
mans or their medical records or in biospecimens that
would require approval by the IRB. Because there is a
potential for conflict of interest or a potential for the
perception of such a conflict when research results ema-
nate from a laboratory with substantial financial interest,
1344 Mayo Clin Proc. • October 2005;80(10):1340-1346
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
several management guidelines are discussed in the next
section.
OPERATIONAL GUIDELINES FOR THE
CONFLICT OF INTEREST REVIEW BOARD
Practical guidance for the implementation of review and
decision processes was developed for specific situations
that arise commonly in the context of research at the Mayo
Clinic, as indicated subsequently. This is regarded as work
in progress that likely will be refined over time. The Con-
flict of Interest Review Board, which includes intramural
and extramural members, has a direct relationship to Mayo
Clinic leadership for matters related to individual conflict
of interest. In matters pertaining to institutional conflict of
interest, this board reports only to the highest governance
body at the clinic, the Board of Trustees, made up primarily
of public members. The Conflict of Interest Review Board
communicates to the Personnel Committee leadership at
the Mayo Clinic regarding any situations in which policies
and procedures for conflict of interest have not been fol-
lowed by its staff. The Personnel Committee serves as the
disciplinary board.
Mayo Clinic guidelines anticipate that different levels of
conflict of interest may arise that require a tailored or
specific management response by the Conflict of Interest
Review Board. Research studies that may involve conflict
of interest include single-center or multicenter studies with
or without Mayo Clinic equity ownership. Simple disclo-
sure of inventions or intellectual property to the Office of
Technology Transfer does not necessarily constitute a con-
flict of interest. The presence of significant financial con-
flict of interest may require 1 or more management strate-
gies that range from disclosure in the consent form to
recusal from participation.
The Mayo Clinic’s policy for ownership of its staff’s
intellectual property facilitates oversight because all tech-
nology transfer and start-up companies are coordinated
ultimately through 1 office, Mayo Medical Ventures,
whose officers are well aware of the policy. Similarly, the
policy that prohibits independent staff ownership of a
medically related company (whether clinical facilities26 or
biotechnology-based) reduces the risk of undisclosed con-
flicts. Such policies may not apply at other academic medi-
cal centers. In practice, most institutional conflicts of inter-
est at the Mayo Clinic are identified during the review of
individual conflict of interest disclosures, and management
strategies can be recommended at the same review.
For multicenter research studies for which neither the
Mayo Clinic nor the investigator has a conflict of interest,
Mayo Clinic participation and leadership in the study are
strongly encouraged with the usual need for IRB review of
• www.mayoclinicproceedings.com

human studies. However, when single-center or multi-
center research studies involve the investigator and the
Mayo Clinic and both have a conflict of interest, participa-
tion increases the potential of perceived bias in the conduct
of the research or a perceived inability to serve the best
interests of research participants. In these circumstances,
apart from IRB approval, Conflict of Interest Review
Board assessment is needed to determine whether the re-
search may be pursued at the Mayo Clinic and whether the
investigator may participate. In some situations, addressed
in other reports as the “rebuttable presumption,” it may still
be appropriate to pursue the research at the academic medi-
cal center that has a conflict of interest.19 These situations
may include the uniqueness of the patient population or
expertise or facilities that cannot be replicated at other
medical centers. However, in such situations, safeguards
have been developed in conjunction with the Mayo Clinic
IRB to protect the research participant (Table 3). Under
certain circumstances, it may be permissible to enroll more
than 20% of participants in such a study at the Mayo Clinic,
as in early clinical studies (phase 1b or 2a studies) or when
the novel diagnostic or therapeutic procedure is only avail-
able at a few medical centers.
CONSIDERATION OF OTHER RECENTLY PUBLISHED
RECOMMENDATIONS
Recently published articles in the New England Journal of
Medicine12 and the Journal of the American Medical Asso-
ciation13 have proposed 4 important principles, which have
been adopted by Mayo Clinic.
First, institutions and institutional decision makers
should fully disclose industry-related financial interests
and relationships and should divest themselves from these
interests or recuse themselves from responsibility for re-
search oversight or conduct of research, consistent with the
draft recommendations from the Department of Health and
Human Services.27
Second, certain facilities should be physically sepa-
rated, and sharing of information should be restricted be-
tween investment (including endowment and pension
funds) and research staffs.
Third, oversight should be provided by independent
review panels with expertise in intellectual property, fi-
nance, and research, and with no financial or other depen-
dence on the institution.13 The Mayo Clinic Conflict of
Interest Review Board includes external members. How-
ever, a body entirely comprising external members was
considered unlikely to have sufficient understanding of the
mission and governance of the institution and its relation-
ships with industry to serve the needs of the institution or of
society in general.
Mayo Clin Proc. • October 2005;80(10):1340-1346
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
MAYO CLINIC’S CONFLICT OF INTEREST POLICY
TABLE 3. Precautions for Participation in Research When
Investigator and/or Institution Has Significant Financial
Conflict of Interest
Study development is made by a steering committee consisting of Mayo
Clinic (investigator) and non-Mayo Clinic members (including plans for
design, conduct, and analysis)
Mayo Clinic enrolls less than 20% of total participants
Conflicted investigator may not participate in operational aspects of
study, may not enroll patients or gain informed consent, and cannot be
site (Mayo Clinic) principal investigator
Informed consent must be obtained by a nonconflicted investigator who
has no access to the data
Study must be a triple-blind design: patients, investigators, assistants/
technicians must be unaware of randomization groups (if appropriate)
and results
Data management activities may not occur at investigator institution
(Mayo Clinic)
There must be an independent Data Safety Monitoring Board and Clinical
Event Committee with a priori stopping rules for both safety and
efficacy
Central core laboratory must be used when using surrogate end points for
efficacy
Dataset must be given to an independent statistician for comparison at the
end of the study
Data analysis and interpretation monitoring committee must review any
journal or regulatory reports
Individual or institutional conflict of interest must be disclosed to all study
participants in informed consent, and to all study coinvestigators,
fellows, and students working on the project
Fourth, there should be greater oversight of research
involving human participants and the operation of IRB
review and systematic assessment of the outcomes of that
oversight.28 The chair of the Mayo Clinic’s IRB serves as a
member of the Conflict of Interest Review Board, and the
secretaries of the 2 boards coordinate a group of adminis-
trators from the Mayo Clinic’s Research Services Depart-
ment and the Office of Compliance. Mayo Clinic policy
requires an annual progress report of each protocol for
extension of initial IRB approval, which is for 1 year. The
progress report requires disclosure of any change in finan-
cial interest of each investigator listed on the protocol. The
clinic’s internal audit office performs audits of randomly
selected active research protocols.
CONCLUSIONS
29
Blumenthal has written, “Relationships between aca-
demic institutions and industry in the life sciences continue
to fascinate, perplex, trouble, and embarrass academic
investigators, university administrators, industrial compa-
nies, and government policymakers.” However, the com-
mon good of patients requires that the Mayo Clinic and its
staff participate fully in the biomedical research arena and
in the translation of new discoveries to clinical applica-
tion. The Mayo Clinic’s conflict of interest policies re-
garding purchasing, leadership, investment, and research
have been established to allow the relationships to go
• www.mayoclinicproceedings.com 1345
MAYO CLINIC’S CONFLICT OF INTEREST POLICY
forward yet still protect the patient, the individual, and the
institution. The Mayo Clinic has used monetary values
consistent with 1995 Public Health Service regulations to
define significant financial conflicts. Clinic representa-
tives meet with leaders of other academic medical centers
to compare approaches and develop further consensus
regarding identification and management of conflicts of
interest. Currently, we perceive that it is useful to share
with readers at the Mayo Clinic and at other medical
centers the principles and process that were key to the
development of the Mayo Clinic’s policy, which will
continue to evolve and require periodic review to ensure
consistency with federal and state regulations, national
trends, and Mayo Clinic values in order to maintain
the public trust.13 These policies will need to be adapted
to the clinic’s employment policy (of all-salaried staff)
and the policy that all medically related intellectual prop-
erty developed by all–Mayo Clinic staff belongs to the
clinic.
We are grateful to the Mayo Clinic Conflict of Interest task force
members for their contributions to the submitted manuscript: Gail
L. Gamble, MD (Chair), Charles H. Adler, MD, PhD, Nelson S.
Brewer, MD, Michael Camilleri, MD, William P. Cooney III, MD,
Ann E. Decker, JD, Eugene P. DiMagno, MD, James R. Francis,
David L. Hayes, MD, Marianne L. Hockema (secretary), Robert
M. Kisabeth, MD, Stephen L. Kopecky, MD, David E. Larson,
MD, Barbara L. Porter, James A. Rogers, JD, Craig A. Smoldt,
and Richard M. Weinshilboum, MD.
REFERENCES
1. DeAngelis CD. Conflict of interest and the public trust [editorial]. JAMA.
2000;284:2237-2238.
2. Korn D. Conflicts of interest in biomedical research. JAMA. 2000;284:
2234-2237.
3. Martin JB, Kasper DL. In whose best interest? breaching the academic-
industrial wall [published correction appears in N Engl J Med. 2001;344:536].
N Engl J Med. 2000;343:1646-1649.
4. Campbell EG, Louis KS, Blumenthal D. Looking a gift horse in the
mouth: corporate gifts supporting life sciences research. JAMA. 1998;279:995-
999.
5. Lo B, Wolf LE, Berkeley A. Conflict-of-interest policies for investiga-
tors in clinical trials. N Engl J Med. 2000;343:1616-1620.
6. Shalala D. Protecting research subjects—what must be done. N Engl J
Med. 2000;343:808-810.
1346 Mayo Clin Proc. • October 2005;80(10):1340-1346
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
7. Morin K, Rakatansky H, Riddick FA Jr, et al. Managing conflicts of
interest in the conduct of clinical trials. JAMA. 2002;287:78-84.
8. Drazen JM, Koski G. To protect those who serve [editorial]. N Engl J
Med. 2000;343:1643-1645.
9. Rothman KJ. Conflict of interest: the new McCarthyism in science.
JAMA. 1993;269:2782-2784.
10. McCrary SV, Anderson CB, Jakovljevic J, et al. A national survey of
policies on disclosure of conflicts of interest in biomedical research. N Engl J
Med. 2000;343:1621-1626.
11. Cho MK, Shohara R, Schissel A, Rennie D. Policies on faculty conflicts
of interest at US universities. JAMA. 2000;284:2203-2208.
12. Moses H III, Braunwald E, Martin JB, Thier SO. Collaborating with
industry—choices for the academic medical center. N Engl J Med. 2002;347:
1371-1375.
13. Johns MM, Barnes M, Florencio PS. Restoring balance to industry-
academia relationships in an era of institutional financial conflicts of interest:
promoting research while maintaining trust. JAMA. 2003;289:741-746.
14. Kim SY, Millard RW, Nisbet P, Cox C, Caine ED. Potential research
participants’ views regarding researcher and institutional financial conflicts of
interest. J Med Ethics. 2004;30:73-79.
15. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of
interest in biomedical research: a systematic review. JAMA. 2003;289:454-
465.
16. Steinbrook R. Conflicts of interest at the NIH—resolving the problem. N
Engl J Med. 2004;351:955-957.
17. Blumenthal D. Doctors and drug companies. N Engl J Med. 2004;351:
1885-1890.
18. Studdert DM, Mello MM, Brennan TA. Financial conflicts of interest in
physicians’ relationships with the pharmaceutical industry—self-regulation in
the shadow of federal prosecution. N Engl J Med. 2004;351:1891-1900.
19. AAMC. Financial conflicts of interest in clinical research. Available at:
www.aamc.org/members/coitf/start.htm. Accessibility verified August 24,
2005.
20. Holmes DR Jr, Firth BG, James A, et al. Conflict of interest. Am Heart J.
2004;147:228-237.
21. AAU Task Force on Research Accountability. Report on University
Protections of Human Beings Who Are the Subjects of Research. Washington,
DC: Association of American Universities; 2000.
22. Levinsky NG. Nonfinancial conflicts of interest in research. N Engl J
Med. 2002;347:759-761.
23. Department of Health and Human Services. Draft: Financial relation-
ships and interests in research involving human subjects: guidance for human
subject protection. Fed Register. 2003;68:15456-15460.
24. Friedman LS, Richter ED. Relationship between conflicts of interest and
research results. J Gen Intern Med. 2004;19:51-56.
25. Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveil-
lance—lack of vigilance, lack of trust. JAMA. 2004;292:2647-2650.
26. Iglehart JK. The emergence of physician-owned specialty hospitals [pub-
lished correction appears in N Engl J Med. 2005;352:638]. N Engl J Med.
2005;352:78-84.
27. Lipton S, Boyd EA, Bero LA. Conflicts of interest in academic research:
policies, processes, and attitudes. Account Res. 2004;11:83-102.
28. Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human partici-
pants research: identifying problems to evaluate reform proposals. Ann Intern
Med. 2004;141:282-291.
29. Blumenthal D. Academic-industrial relationships in the life sciences. N
Engl J Med. 2003;349:2452-2459.
• www.mayoclinicproceedings.com