Cho MK, Shohara R, Schissel A, Rennie D. Policies on Faculty Conflicts of Interest at US Universities. JAMA. 2000;284(17):2203-2208. doi:10.1001/jama.284.17.2203
Author Affiliations: Stanford University Center for Biomedical Ethics, Stanford, Calif (Dr Cho); University of California, San Francisco, Institute for Health Policy Studies (Mr Shohara and Dr Rennie); and New York University School of Law, New York, NY (Ms Schissel). Dr Rennie is also Deputy Editor, JAMA.
Context Despite federal regulations on faculty conflicts of interest in federally
funded research, academic-industry ties are common, and evidence exists that
financial considerations bias the research record. Public scrutiny of these
ties is increasing, especially in cases where researchers have financial interests
in the corporate sponsors of their clinical research.
Objective To review policies on conflict of interest at major biomedical research
institutions in the United States.
Design Cross-sectional survey and content analysis study conducted from August
1998 to February 2000.
Setting and Participants The 100 US institutions with the most funding from the National Institutes
of Health in 1998 were initially sampled; policies from 89 institutions were
available and included in the analysis.
Main Outcome Measures Process for disclosure, review, and management of conflicts of interest
and specified management strategies or limitations, according to the institutions'
faculty/staff conflict of interest policies.
Results Content of the conflict of interest policies varied widely across institutions.
Fifty-five percent of policies (n = 49) required disclosures from all faculty
while 45% (n = 40) required them only from principal investigators or those
conducting research. Nineteen percent of policies (n = 17) specified limits
on faculty financial interests in corporate sponsors of research, 12% (n =
11) specified limits on permissible delays in publication, and 4% (n = 4)
prohibited student involvement in work sponsored by a company in which the
faculty mentor had a financial interest.
Conclusions Most policies on conflict of interest in our sample of major research
institutions in the United States lack specificity about the kinds of relationships
with industry that are permitted or prohibited. Wide variation in management
of conflicts of interest among institutions may cause unnecessary confusion
among potential industrial partners or competition among universities for
corporate sponsorship that could erode academic standards. It is in the long-term
interest of institutions to develop widely agreed-on, clear, specific, and
credible policies on conflicts of interest.
In the 20 years since the Bayh-Dole Act was passed,1
US academic institutions have developed a variety of relationships with industry.
In fulfilling its intended goal of encouraging transfer of technology from
universities to the private sector, this act and associated legislation have
fostered the rapid growth of patents held by nonprofit institutions, such
as universities, and the licensing of these patents to for-profit companies.
The number of university-generated patents increased from approximately 250
per year prior to the Bayh-Dole Act2 to more
than 4800 (and >3000 licenses) in 1998.3 This
new pathway of technology transfer has resulted in development by private
companies of technologies such as the cancer drug paclitaxel and the Lycos
Internet search engine.3 It also has created
opportunities for conflict of interest for university faculty members because
academic-industry partnerships can offer direct financial rewards to individual
faculty members in the form of consulting fees, royalties, and equity in companies
while simultaneously funding these faculty members' research. These financial
interests are now prevalent: Krimsky et al4
found that 34% of articles published in 14 leading biology and medical journals
in 1992 had at least 1 lead author with a financial interest in a company
with activities related to the published research, although virtually all
of these interests were undisclosed in the articles.
Conflicts of interest are of concern because of their potential effect
on the quality, outcome, and dissemination of research,5
as well as their effects on the public's perception of and trust in researchers
and universities. We define conflicts of interest
as situations in which primary and secondary interests coexist,6
rather than as situations in which the coexisting interests have led to an
undesirable outcome, such as research misconduct. There is a growing body
of literature showing that faculty who have industry ties are more likely
to report research results that are favorable to a corporate sponsor,7- 10 are
more likely to conduct research that is of lower quality,11,12
and are less likely to disseminate their results to the scientific community.13,14 Other findings suggest that faculty
with some research support from industry may publish at higher rates than
faculty without such support. However, faculty who receive more than two thirds
of their research support from industry publish less than faculty with lower
levels of industry support.15 The extent to
which conflicts of interest are directly responsible for these outcomes is
The US government has attempted to address the concern over conflicts
of interest by implementing a federal regulation mandating the disclosure
of financial interests of individuals who apply to the Public Health Service
(PHS) or the National Science Foundation (NSF) for research funding.16 This regulation is limited in scope because it requires
disclosure only to institutional officials, not to the public. Furthermore,
disclosure is required only for financial interests related to research proposed
for PHS or NSF funding. Thus, faculty members with financial interests related
to research funded solely by private companies are not necessarily affected
by these regulations; therefore, grants for which one might expect the greatest
conflict may be excluded from regulation. However, the federal regulation
also requires institutions that apply for PHS or NSF funding to have institutional
policies for reviewing and managing the financial interests of their researchers.
This leaves the specifics of policy making up to individual institutions.
However, the institutions themselves are also in a situation of conflicting
interests to the extent that institutions also collect a share of industry
research grants and royalties from patents generated by their faculty.
Institutional policies, and the variation among them, are of increasing
interest for 3 reasons. First, institutions have changed their policies in
recent years because of the increasing frequency and complexity of academic-industry
ties and the implementation of the aforementioned federal regulation regarding
conflicts of interest. Second, public awareness of academic-industry ties
is increasing, as is interest in how universities set limits on, or otherwise
manage, conflicts of interest.17 Third, the
institutional stance toward academic-industry ties may be a factor in faculty
members' willingness to work at the institution. For example, Harvard University
reviewed its policy limiting faculty financial interests in companies that
sponsor their research, presumably because some faculty felt that the limits
are too restrictive.18 For these reasons, we
performed a comprehensive review of institutional conflict of interest policies
at 100 major US research institutions.
We performed a content analysis of conflict of interest policies from
100 US research institutions, collected between August 1998 and February 2000.
These institutions had the highest levels of funding from the National Institutes
of Health (NIH) in 1998 (as a proxy for PHS/NSF funding) as determined from
lists publicly available from the NIH Office of Extramural Research (available
at: http://grants.nih.gov/grants/index.cfm). We collected
policies from institutional Web sites or from institutional officials. At
institutions where a Web site was not available, we attempted to contact institutional
officials up to 5 times by telephone and letter. These policies were generally
available from institutional offices of research administration. Because we
were also interested in clinical research and publication, we requested a
variety of policies, including those regarding faculty conflict of interest,
conflict of commitment, or external activities; intellectual property; clinical
research; and academic freedom. If policies were updated during the period
of data collection, we used the updated version. We included policies on faculty
conflict of interest where available, otherwise we included policies on staff
conflict of interest.
We developed a 22-item data abstraction instrument covering several
topics including the process for disclosure, review, and management of faculty
conflicts of interest and any specified management strategies or limitations
(Table 1). If we could not find
information pertaining to an instrument item in the published policy, we classified
it as "unspecified." We pilot tested the instrument using 10 policies. One
author (R.S.) abstracted data from all policies, and another (M.K.C.) independently
abstracted a subsample of 10 policies to determine interrater reliability
of the abstraction. For those policies, the agreement of each instrument item
ranged from 80% to 100%. The average agreement for all items was 93.7%. All
but 1 disagreement was due to abstractor oversight of the item in the policy.
Of 100 institutions selected from the NIH ranking, 3 were excluded because
the institution no longer existed or had conflict of interest policies identical
to a parent institution in our sample. Of the 97 remaining institutions, we
obtained a total of 89 policies (92% response rate): 54 (61%) from institutional
Web sites and 35 (39%) from institutional officials. The effective dates of
the 72 policies for which a date could be determined ranged from 1984 to 2000.
Of the 72 policies, 29 (40%) were established in 1995 (the year that the federal
regulation was introduced),16 17 (24%) were
dated prior to 1995, and 26 (36%) were dated after 1995. Those dated during
or after 1995 could have been established before 1995 and subsequently modified.
All policies addressed financial conflicts of interest, 36 (40%) addressed
conflicts of commitment, and 47 (53%) addressed issues related to the effects
of either conflicts of interest or conflicts of commitment on trainees or
Forty-nine policies (55%) required disclosures from all faculty, while
40 (45%) required disclosures only from those conducting research or serving
as principal investigators. Seven (8%) also required disclosure about financial
interests of trainees and 78 (88%) required disclosure about financial interests
of family members. Sixty-two institutions (70%) asked for disclosure of all
interests related to professional activities (including research and teaching),
while 24 (27%) asked for disclosure only of interests related to research
or sponsored research. Only 2 institutions asked for disclosure of all financial
Seventy-five institutions (84%) asked for disclosure either annually
and/or when conflicts of interest arose. Six (6.7%) asked for disclosure only
when conflicts of interest arose in the context of external funding for research.
The administrative processes for review and decision making about disclosed
conflicts of interest are summarized in Table 2.
Forty-seven institutional policies (53%) specifically stated that there
was a process by which faculty could appeal decisions about conflict of interest,
and 62 (70%) specified sanctions for faculty who did not comply with the policies.
Many policies listed methods by which institutions could potentially
manage disclosed conflicts of interest. Institutions were not necessarily
limited to these methods, and the situations in which the methods would be
used were generally not specified. The frequencies with which these methods
were described in policies are listed in Table 3. The method most frequently stated was disclosure to institutions,
followed by disclosure to the public, monitoring or oversight of research
activities, and divestiture or prohibition of financial interests. Disclosure to the public included statements requiring disclosure in
public presentations or publication of research and did not include disclosure
that might have been required by state laws on public access to information
at public institutions. Other methods included assigning another investigator
to lead a research project or asking the faculty member to take a leave of
absence from the university.
Activities Specifically Allowed by Policies. Thirty-two policies (36%) specifically described activities that were
allowed and generally not considered conflicts of interest. These included
paid or unpaid directorships or similar roles in organizations unrelated to
professional responsibilities; receiving royalties, honoraria, or prizes for
scholarly work; paid consulting for private or nonprofit organizations (within
institutional limits); membership on professional review panels or societies,
and providing expert testimony for judicial or legislative bodies.
Activities Specifically Prohibited by Policies. Institutional policies typically described several kinds of activities
that were specifically prohibited. Many of these activities were not specific
to academic research or teaching activities but applied to external activities
related to professional roles, such as consulting, or to nonacademic activities
conducted on behalf of the university, such as purchasing equipment or negotiating
agreements. Prohibited activities typically included excessive consulting,
using university facilities or the university name in consulting, employment
by outside entities, using confidential information for personal benefit,
accepting personal gifts from companies with which the university does business,
and negotiating agreements with companies in which the individual has a financial
We searched the policies for specific prohibitions or limits on activities
related to research and teaching (Table
4). We found such activities in only 17 policies (19%). The activity
that was most often specifically prohibited or limited was a faculty member
having financial interests in a company sponsoring their research. Other prohibited
activities included involvement of students in work sponsored by a company
in which the student's advisor had a financial interest, faculty membership
on the board of directors of a company sponsoring the faculty's research or
giving gifts to the institution, and students being hired by companies as
paid consultants. The remaining 81% of policies made no mention of prohibitions
on such activities in the context of research.
We also searched policies for any mention of considerations of conflicts
of interest particular to clinical research. Of the 17 policies (19%) with
such language, 8 included faculty limits on equity holdings in companies sponsoring
their research. Five had other policies specific to clinical research, including
requiring disclosure of financial interests in published work, having a "zero
threshold" for disclosure of financial interests in company sponsors, using
oversight committees to monitor research sponsored by companies in which faculty
have financial interests, and requiring the institution to inform the human
subjects review committee of identified conflicts of interest. The remainder
of the policies had a general statement that clinical research required more
stringent limitations or management strategies than nonclinical research.
None included a requirement for disclosing faculty financial interests in
informed consent forms for human subjects.
Only 11 policies (12%) specified a time limit for delay of publication
or presentation of research results to allow review by corporate sponsors
or to allow patents to be filed. The specified time limits ranged from 0 to
12 months, with 8 institutions limiting delays to 3 months or less. The other
78 policies (88%) did not mention delay of publication or presentation or
included a nonspecific statement that academic activities should not be delayed
longer than needed to obtain intellectual property protection. Twenty-four
institutions (27%) had a separate policy that pertained only to PHS/NSF-funded
research (mirroring the federal guidelines).
Forty-six policies (52%) were from private institutions and 43 (48%)
were from public institutions. Approximately twice as many private as public
institutions had specific limits on publication delay and limits on financial
interests in corporate sponsors of research (Table 5), but these differences were not statistically significant.
The vast majority of the institutions in our sample had written conflict
of interest policies that pertained to research activity of its faculty or
staff, in compliance with federal regulations. We do not know whether the
8 institutions that did not respond to our request lacked a policy or were
merely nonresponders. Three quarters of the policies we analyzed were established
or modified around the time that federal regulations on researchers' conflict
of interest were introduced in 1995, suggesting that most research institutions
have recently established or changed the way they handle conflict of interest.
More than 70% of institutions have policies that cover situations beyond those
mandated by the federal regulations (researchers applying for funding from
PHS or NSF), suggesting that the federal policies have had an influence well
beyond federally funded research.
The processes for disclosing, reviewing, and managing conflicts of interest
varied widely among institutions, as described by the policies. A survey of
academic institutions published earlier also found that academic conflict
of interest policies varied widely.19 Then
and now, this variation probably reflects overall differences among institutional
administrative processes. However, a typical institution solicits disclosure
of faculty financial interests annually and/or when new interests arise. Institutions
rely on faculty to fully disclose all relevant financial interests. These
disclosures are typically reviewed by a university-level committee, and final
decisions on the handling of the disclosed cases typically are made by a designated
institutional official, such as a provost or dean of research. Only 38% of
universities appear to have established institutional committees (almost always
made up of the institution's faculty members) specifically to review conflicts
of interest, and many of these committees require the involvement of faculty
at the department, school, and university levels as well. This suggests that
while some institutions have felt the need to develop elaborate infrastructures
to comply with conflict of interest regulations, the majority have not.
Most institutional policies did not specifically limit or prohibit particular
kinds of activities, but many outlined the kinds of activities that would
require disclosure and review and a broad range of methods that might be used
to mitigate any conflicts of interest. Less than a fifth of institutions specified
limits or prohibitions on faculty activities in their written policies. Other
institutions might, in practice, also place similar limits on faculty, but
have not codified such limits. Whereas more than half the policies suggested
that conflicts of interest might be mitigated by disclosure of financial interests
to the public, monitoring or oversight of research, or divestiture of financial
interests, the extent to which these strategies are actually used is not known.
Krimsky et al4 found that a third of articles in 14 leading biomedical
journals analyzed had a lead author with financial interest in a company whose
activities were related to the field represented in the published work, but
that only 1 of 267 articles analyzed disclosed any financial interest. Their
findings suggest that public disclosure in publications may often not be required
(we did not find this requirement in 42% of policies) or is weakly enforced.
Alternatively, faculty members might be disclosing conflicts of interest to
journals, but the disclosures might not be published and thus would not be
communicated to journal readers. If institutions are relying on public disclosure
through publication, better policy coordination with journals may be needed.
Although most of the institutions in our sample conduct clinical research,
few made any policy distinctions between conflicts of interest in clinical
vs nonclinical studies. However, clinical research carries unique considerations
because there is a growing body of evidence that financial interests may have
an effect on the quality and outcome of certain kinds of clinical studies,
and because there is an added ethical obligation to protect the safety and
well-being of human research participants. Thus, for clinical research, policies
that encourage clear disclosure to patients and the public and more limits
on investigators having financial interests in research are warranted. For
example, the death last year of Jesse Gelsinger,20
a participant in a clinical trial of gene therapy, led at least 2 professional
organizations to call for their members to abstain from having financial interests
in their sponsors,21,22 suggesting
that these organizations recognized that financial considerations might diminish
the protections afforded to research participants.
Few of the policies we analyzed included specific limits on the amount
of delay that would be permitted for publication of research results for purposes
of securing intellectual property rights or allowing review by sponsors. Such
limits may have been specified in other policies, but they were generally
not mentioned or referred to in the conflict of interest policies we studied.
Dissemination of knowledge for the public good is the main mission of universities,
especially institutions that receive large amounts of public funding. The
finding that faculty participating in research relationships with industry
are more likely to delay publication, at least among life science faculty,13 suggests that universities should be more active
in ensuring that dissemination of knowledge is not unduly delayed by faculty
ties with industry. This would include developing more specific policies on
limits to any delay of publication of research results and shorter limits
to such delay. Although relatively few institutions specified limits on permissible
delays of publication or on financial interests with corporate research sponsors,
private institutions were more likely to have such limits than public institutions,
although this difference was not statistically significant. Public institutions
might be less willing to specify limits on industry relationships if they
must also fulfill state mandates to enhance technology transfer and to encourage
local businesses or particular industries important to the state.
Few policies specifically addressed the role of trainees in research
or educational activities sponsored by companies in which their faculty advisors
had a financial interest. The effect of such arrangements on trainees is not
known, but given the central role of training and education in the university
mission, it is striking that so few policies mentioned them in contrast to
the implicit or explicit concern about integrity of the research addressed
by the policies. Although the policies analyzed in this study applied specifically
to conflicts of interest of individual faculty, as institutional policies
they reflect institutional values. To the extent that institutions also have
financial interests stemming from ties with industry, care must be taken not
to be unduly influenced in the development and implementation of faculty policies
on conflict of interest.
This study has several limitations. First, policies pertinent to the
specific items we sought might have been contained in policies other than
those we analyzed. Although in addition to policies that specifically addressed
conflict of interest we requested policies on intellectual property, clinical
research, and academic freedom (where available), statements relevant to our
study might have been contained in institutional policies that we did not
locate. Furthermore, other relevant regulations, such as state or local laws
pertaining to conflict of interest of state employees, might not have been
included in institutional policies and therefore would not have been reflected
in our data. Second, written institutional policies do not necessarily fully
reflect practice. Especially in the area of conflict of interest, many institutions
review situations and make decisions about how to manage them on a case-by-case
basis. The lack of specified prohibitions does not necessarily mean that all
activities are allowed. Third, our sample was drawn from institutions with
the highest amount of NIH funding, so we do not know whether smaller institutions
or those that are primarily industry-supported would have had different policies.
Fourth, policies on institutional conflict of interest were not included in
this study. However, in the case of industry funding, the short-term interests
of researcher and institution may be similar. Therefore, we believe that our
analysis provides important information that reflects the academic institutional
view of its own mission and its stance toward its relationship with industry.
Most policies on conflict of interest at major US research institutions
lack specificity about the kinds of relationships with industry that are permitted
or prohibited. Such lack of specificity enhances the flexibility of institutions
to address complex and rapidly evolving academic-industry ties. However, it
would be to the long-term benefit of faculty, institutions, and companies
to develop clear and specific policies based on agreed-on principles that
protect universities' primary missions of education, research, and dissemination
of knowledge. Wide variation in management of conflicts of interest among
institutions may cause unnecessary confusion among potential industrial partners
or competition among universities for corporate sponsorship that could erode
academic standards and lessen public confidence in university research. Further
research on the actual practices of all institutions is necessary to form
a more complete picture of academic-industry ties.