University Research
Most Federal Agencies Need to Better Protect against Financial Conflicts of Interest Gao ID: GAO-04-31 November 14, 2003In fiscal year 2001, federal agencies provided $19 billion for university research, a vital part of the nation's research and development effort. GAO was asked to examine federal agencies' actions to ensure that (1) the results of the university research grants they fund are made available to the public and (2) universities receiving such grants implement policies for identifying and managing possible financial conflicts of interest. GAO reviewed the actions of eight federal agencies and conducted a Web-based survey of 200 leading research universities (refer to GAO-04-223SP). GAO also met with officials in the Office of Science and Technology Policy (OSTP) to discuss the National Science and Technology Council's role in coordinating federal science policy.
Each of the eight federal agencies GAO examined relies on university scientists who receive federally funded research grants to make the results available to the public. Although university scientists customarily seek to publish their research results in peer-reviewed journals, agencies cannot require such publication as a condition for funding because it is impossible to ensure in advance that the results will be accepted for publication. Agencies do, however, explicitly encourage funding recipients to make results public. The Departments of Agriculture, Defense, and Energy; the Environmental Protection Agency (EPA); and the National Aeronautics and Space Administration (NASA) also disseminate the results of their funded research by posting them on their Web sites. Officials from these agencies said that posting the results is an effective way to share information among scientists, as well as with the public. In contrast, the National Institutes of Health (NIH) and the National Science Foundation (NSF) do not post research results on their Web sites. According to NIH officials, the risk associated with posting researchers' final reports before they have been validated by peer review is too great in the biomedical field. The Department of Education is considering how best to widely disseminate the results of research it funds. NIH and NSF are the only federal agencies that require universities to implement policies for identifying and managing possible financial conflicts of interest for the research they fund. The other six agencies do not have financial conflict of interest standards for university research grants. Of the 171 universities that responded to the GAO survey, 148 (87 percent) reported that all of their federally funded research is covered by financial conflict of interest policies that are consistent with either NIH's or NSF's standards. However, 17 universities reported that they do not extend either agency's requirements to cover research grants from other federal agencies. Unless federal agencies uniformly require that universities implement conflict of interest policies, the government cannot properly safeguard against financial conflicts of interest that might bias federally funded research.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-04-31, University Research: Most Federal Agencies Need to Better Protect against Financial Conflicts of Interest
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Report to the Honorable Richard C. Shelby, U.S. Senate:
November 2003:
UNIVERSITY RESEARCH:
Most Federal Agencies Need to Better Protect against Financial
Conflicts of Interest:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-04-31] GAO-04-31:
GAO Highlights:
Highlights of GAO-04-31, a report to the Honorable Richard C. Shelby,
U.S. Senate
Why GAO Did This Study:
In fiscal year 2001, federal agencies provided $19 billion for
university research, a vital part of the nation‘s research and
development effort. GAO was asked to examine federal agencies‘ actions
to ensure that (1) the results of the university research grants they
fund are made available to the public and (2) universities receiving
such grants implement policies for identifying and managing possible
financial conflicts of interest. GAO reviewed the actions of eight
federal agencies and conducted a Web-based survey of 200 leading
research universities. GAO also met with officials in the Office of
Science and Technology Policy (OSTP) to discuss the National Science
and Technology Council‘s role in coordinating federal science policy.
What GAO Found:
Each of the eight federal agencies GAO examined relies on university
scientists who receive federally funded research grants to make the
results available to the public. Although university scientists
customarily seek to publish their research results in peer-reviewed
journals, agencies cannot require such publication as a condition for
funding because it is impossible to ensure in advance that the results
will be accepted for publication. Agencies do, however, explicitly
encourage funding recipients to make results public. The Departments
of Agriculture, Defense, and Energy; the Environmental Protection
Agency (EPA); and the National Aeronautics and Space Administration
(NASA) also disseminate the results of their funded research by
posting them on their Web sites (see table below). Officials from
these agencies said that posting the results is an effective way to
share information among scientists, as well as with the public. In
contrast, the National Institutes of Health (NIH) and the National
Science Foundation (NSF) do not post research results on their Web
sites. According to NIH officials, the risk associated with posting
researchers‘ final reports before they have been validated by peer
review is too great in the biomedical field. The Department of
Education is considering how best to widely disseminate the results of
research it funds.
NIH and NSF are the only federal agencies that require universities to
implement policies for identifying and managing possible financial
conflicts of interest for the research they fund. The other six
agencies do not have financial conflict of interest standards for
university research grants. Of the 171 universities that responded to
the GAO survey, 148 (87 percent) reported that all of their federally
funded research is covered by financial conflict of interest policies
that are consistent with either NIH‘s or NSF‘s standards. However, 17
universities reported that they do not extend either agency‘s
requirements to cover research grants from other federal agencies.
Unless federal agencies uniformly require that universities implement
conflict of interest policies, the government cannot properly
safeguard against financial conflicts of interest that might bias
federally funded research.
What GAO Recommends:
GAO recommends that the Department of Education post the final
technical reports of the research it funds on its Web site. GAO also
recommends that the National Science and Technology Council coordinate
the development of a uniform federal requirement for identifying and
resolving financial conflicts of interest in federally funded
research. In commenting on the draft report, Education agreed with the
recommendation to post research results on its Web site. OSTP agreed
with the recommendation for developing a federal requirement.
www.gao.gov/cgi-bin/getrpt?GAO-04-31.
To view the full product, including the scope and methodology, click
on the link above. For more information, contact Robin Nazzaro at
(202) 512-3841or nazzaror@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Federal Agencies Rely on University Scientists and Agency Web Sites to
Disseminate Research Results:
Only NIH and NSF Require Financial Conflict of Interest Standards for
Grant Recipients:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Scope and Methodology:
Appendixes:
Appendix I: Agencies' Actions in Implementing the Shelby Amendment:
Appendix II: Universities' Acceptance of Equity in Start-up Companies:
Appendix III: Comparison of NIH's and NSF's Financial Conflict of
Interest Standards:
Appendix IV: Comments from the Department of Education:
Appendix V: Comments from the National Aeronautics and Space
Administration:
Appendix VI: Comments from the National Institutes of Health:
Tables:
Table 1: Federal Agencies' Policies on Disseminating Research Results:
Table 2: Agencies That Post Research Results on Their Web Sites:
Table 3: NIH's and EPA's Disposition of FOIA Requests Citing the Shelby
Amendment, as of August 31, 2003:
Figures:
Figure 1: The Year Universities First Received Equity in a Start-up
Company:
Abbreviations:
EPA: Environmental Protection Agency:
FDP: Federal Demonstration Partnership:
FOIA: Freedom of Information Act:
NARA: National Archives and Records Administration:
NASA: National Aeronautics and Space Administration:
NIH: National Institutes of Health:
NSF: National Science Foundation:
OMB: Office of Management and Budget:
OSTP: Office of Science and Technology Policy:
Letter November 14, 2003:
The Honorable Richard C. Shelby:
United States Senate:
Dear Senator Shelby:
University research is a vital part of the nation's research and
development efforts. Because there is broad consensus that university
research is a long-term, national investment in the future, the federal
government has been the primary source of funding for this research. In
fiscal year 2001, federal agencies provided $19 billion, or about 60
percent of all funding for university research. Eight agencies--the
Departments of Agriculture, Defense, Education, and Energy; the
Environmental Protection Agency (EPA); the National Aeronautics and
Space Administration (NASA); the National Institutes of Health (NIH),
within the Department of Health and Human Services; and the National
Science Foundation (NSF)--obligated 97 percent of the university
research funding, with NIH and NSF alone accounting for $14.2 billion.
The Office of Science and Technology Policy (OSTP) coordinates the
development of standard practices among federal agencies through the
National Science and Technology Council. For example, the Council is
undertaking a review of policies, procedures, and plans relating to the
business relationship between federal agencies and research performers
with the goal of improving the performance and management of federally
funded research.
Historically, the primary return on the federal government's investment
in university research was the advancement of scientific knowledge.
Science progresses through open communication among scientists and the
sharing of research results. Publication of research results in peer-
reviewed scientific journals is an academic tradition that both
validates and disseminates these results.
More recently, the federal investment in university research not only
has advanced scientific knowledge but also has yielded thousands of
inventions each year that have fostered the development of new
technologies, stimulated the creation of new jobs, and improved the
quality of life. For some universities, it has also yielded new streams
of income that helped to support their research and education missions.
The Bayh-Dole Act of 1980 has facilitated commercialization of
university technology by giving universities, among others, the right
to own their federally funded inventions and license them to
businesses. As the importance of university research to technological
innovation has increased, partnerships between universities and
businesses have also grown, giving rise to concerns that financial
conflicts of interest might restrict the dissemination of research
results or bias the conduct or results of federally funded research.
Industry groups and others have also expressed concerns about the need,
in certain instances, for access to the scientific data that underlie
the published results of federally funded research. In response, in
November 1999, the Congress enacted a provision, commonly called the
Shelby Amendment, requiring the Director of the Office of Management
and Budget (OMB) to amend Circular A-110 for universities, hospitals,
and other nonprofit organizations. Under this amendment, federal
agencies are directed to provide scientific data in response to a
Freedom of Information Act (FOIA) request if the published results of
federally funded research are used in developing a federal agency
action that has the force and effect of law.
You requested that we examine federal agencies' actions to ensure that
(1) the results of the university research grants they fund are made
available to the public and (2) universities receiving such grants
implement policies for identifying and managing possible financial
conflicts of interest. In addition, as agreed with your office,
appendix I provides information on agencies' actions in implementing
the Shelby Amendment. Our review focused on the Departments of
Agriculture, Defense,[Footnote 1] Education, and Energy; EPA; NASA;
NIH; and NSF. As part of our review, we conducted a Web-based survey of
the 200 universities that received the most federal funding for
research and development in fiscal year 2000. We received responses
from 171 universities, an 86 percent response rate. The universities'
aggregated responses are available at [Hyperlink, http://www.gao.gov/
special.pubs/gao-04-223sp.] http://www.gao.gov/special.pubs/gao-04-
223sp.
Results in Brief:
Each of the eight federal agencies we examined relies on university
scientists who receive federally funded research grants to make the
results available to the public; five of these agencies also
disseminate results by posting them on their Web sites. Although
university scientists customarily seek to publish their research
results in peer-reviewed journals, agencies cannot require such
publication as a condition for funding because it is impossible to
ensure in advance that the results will be deemed by peer review to be
acceptable for publication. Agencies do, however, explicitly encourage
funding recipients to make results available to the public, and they
consider scientists' publication records in reviewing grant
applications. Agriculture, Defense, Energy, EPA, and NASA also
disseminate the results of the research they fund by posting
researchers' final reports on their Web sites because, according to
officials at these agencies, Web sites offer an effective way to share
information among scientists, as well as with the public. In contrast,
NIH officials told us that they do not post researchers' final reports
because, in the biomedical field, the risks associated with posting
results that have not been scrutinized and validated by peer review are
too great. Similarly, NSF officials said that NSF does not post
results, partly because some scientific journals reject manuscripts if
the results have already been posted on the Web. Education currently is
considering how best to respond to the directive in the Education
Sciences Reform Act of 2002 to widely disseminate the findings and
results of scientifically valid research in education. We are
recommending that Education post the results of the research it has
funded on its Web site to facilitate access to and maximize the
benefits of its research investment. Education agreed with our
recommendation.
NIH and NSF are the only federal agencies that require universities to
implement policies for identifying and managing possible financial
conflicts of interest for the research they fund; the other agencies do
not have any standards to protect against financial conflicts of
interest in university research. The NIH and NSF standards, promulgated
in July 1995, place primary responsibility on universities to institute
appropriate policies and procedures for identifying and managing
potential conflicts of interest. Under these standards, a financial
conflict of interest might be resolved by eliminating or reducing the
conflict or it might be managed by establishing an oversight committee
to monitor the conduct and the reporting of the research. The other six
agencies do not have financial conflict of interest standards for
universities, in part because some of the agencies believe that
identifying and managing conflicts of interests is the responsibility
of the universities. Of the 171 university respondents, 148 (87
percent) reported that all of their federally funded research is
covered by financial conflict of interest policies that are consistent
with NIH's and/or NSF's standards. However, 17 university respondents
reported that they do not extend either the NIH nor the NSF financial
conflicts of interest requirements to cover research grants funded by
other federal agencies. Unless federal agencies uniformly require that
universities implement financial conflict of interest policies, the
government cannot properly safeguard against conflicts of interest that
might bias federally funded research. We are recommending that the
National Science and Technology Council coordinate the development of
uniform federal requirements for universities and other funding
recipients to identify and resolve financial conflicts of interest that
might bias the design, conduct, or reporting of federally funded
research. OSTP officials agreed with the thrust of our recommendation
that uniform federal requirements be developed to identify and resolve
financial conflicts of interest. However, the OSTP officials noted that
recent experience in developing a common rule for research misconduct
has demonstrated that the process of reaching consensus among federal
agencies can be difficult and prolonged.
Background:
The Bayh-Dole Act of 1980 (Pub. L. No. 96-517, Dec. 12, 1980) has
fostered linkages between universities and businesses by giving
universities, other nonprofit organizations, and small businesses the
option to retain title to the inventions they make in the course of
federally funded research. Before 1980, federal agencies generally
retained title rights to any inventions made in the course of the
research they funded. Funding recipients seeking to commercialize such
inventions often faced long delays and uncertainty when they asked the
funding agencies to waive their rights. Since 1980, universities have
upgraded and expanded their technology licensing efforts, particularly
in such fields as biomedicine and computer technology. Federal agencies
and industry also substantially increased their funding of university
research--federal funding grew from $8 billion (in 2001 dollars) in
fiscal year 1980 to $19.2 billion in fiscal year 2001, and industry
funding grew from $461 million (in 2001 dollars) to $2.2 billion during
this period. For the Association of University Technology Managers'
survey for fiscal year 2001,[Footnote 2] U.S. university respondents
reported that they (1) executed 3,282 technology licenses and options,
(2) received $852 million in gross license income, and (3) held equity
in 348, or 70 percent, of the 494 start-up
companies that were formed around university-licensed
technology.[Footnote 3] (See app. II for information from our survey
about universities' licensing activities with start-up companies.):
OMB Circular A-110 establishes uniform requirements for the
administration of federal grants and cooperative agreements with
institutions of higher education, hospitals, and other nonprofit
organizations. For example, the circular requires that funding
recipients submit performance reports to the funding agency at least
annually, with a final technical report normally due within 90 days
after the grant's termination or expiration. However, the circular
provides flexibility by allowing the agencies to specify the content of
these reports or to waive the final technical report. The National
Science and Technology Council, established by Executive Order 12881 in
November 1993, coordinates the development of governmentwide science
and technology policies. For example, the Council's Subcommittee on
Research Business Models is examining the effects of the changing
nature of scientific research on business models for conducting
federally funded research. In addition, 7 federal agencies, 84 research
universities, and 6 other research institutions participate in the
Federal Demonstration Partnership (FDP), which seeks to streamline the
administrative processes for implementing OMB Circular A-110.[Footnote
4]
In July 1995, the Department of Health and Human Services, which
includes NIH, promulgated regulations on Objectivity in Research and
NSF revised its Investigator Financial Disclosure Policy to establish
consistent requirements for universities and most other grantees to
identify and manage financial conflicts of interest.[Footnote 5]
Specifically, the NIH and NSF standards require that funding recipients
implement policies for
(1) scientists to disclose any "significant financial
interests"[Footnote 6] to an official designated by the institution and
(2) institutions to determine whether a real or apparent conflict
exists and, if so, take appropriate actions to manage, mitigate, or
eliminate the identified conflict. Under these regulations, a conflict
of interest exists when the institution's designated official
determines that a significant financial interest could directly and
significantly affect the research design, conduct, or reporting. The
financial benefit may result, for example, from an investigator owning
stock in a company providing the research funding, or from an
investigator having ownership interest in a company that may profit
from a university invention. Conflicting interests are not necessarily
unacceptable, and many can be managed through disclosure and oversight.
The NIH regulation exceeds the scope of NSF's policy in some areas. For
example, it requires that universities and other funding recipients
report every identified possible conflict of interest, while NSF
requires that institutions report only those conflicts that have not
been resolved. (See app. III for a more detailed comparison of the NIH
and NSF requirements.):
Federal Agencies Rely on University Scientists and Agency Web Sites to
Disseminate Research Results:
Federal agencies rely primarily on the university scientists who
receive research grants to make their research results available to the
public. Each agency encourages grantees to publish research results in
the scientific literature, a practice that is steeped in academic
tradition. Agriculture, Defense, Energy, EPA, and NASA also disseminate
the results of the research they fund by posting scientists' final
technical reports on their Web sites, and Education is considering
whether to post research results. While NIH, NSF, and Education do not
post research results on their Web sites, they post certain grant
information, including abstracts submitted at the time of the award.
Agencies Rely on and Encourage Grant Recipients to Make Research
Results Available:
The eight agencies we examined rely on university scientists to
disseminate the results of the research they fund, and their policies
explicitly encourage principal investigators and universities to
disseminate those results through presentations at scientific
conferences and publishing in scientific journals. (See table 1.)
Similarly, FDP's model terms and conditions for research grants state,
"The recipient is expected to publish or otherwise make publicly
available the results of the work conducted under the award."
Publishing federally funded research results also is vital to
university scientists because research publications are key to
obtaining future grant awards, gaining professional recognition, and
achieving tenure.
Table 1: Federal Agencies' Policies on Disseminating Research Results:
Agency: Agriculture; Policy: The principal investigator is expected to
publish or otherwise make publicly available the results of the work
conducted under this award; Citation: Cooperative State
Research, Education, and Extension Service General Terms and
Conditions.
Agency: Defense; Policy: Publication of results of the research project
in appropriate professional journal is encouraged as an important
method of recording and reporting scientific information;
Citation: Office of Naval Research; Research Terms and Conditions.
Policy: The recipient is expected to publish or otherwise make publicly
available the results of the work conducted under this agreement;
Citation: Air Force Office of Scientific Research; Grant Terms
and Conditions.
Agency: Education; Policy: Grantees are encouraged to publish the
results of the work conducted under this award; Citation:
Individual grant agreements[A].
Agency: Energy; Policy: Recipients are encouraged to disseminate
results promptly to the scientific community; Citation:
Office of Science, Grant Application Guide Reporting Requirements.
Agency: EPA; Policy: EPA encourages the independent publication of the
results of its extramural research in appropriate scientific journals;
Citation: National Center for Environmental Research Terms and
Conditions.
Agency: NASA; Policy: NASA requires prompt public disclosure of the
results of its sponsored research and, therefore, expects significant
findings from supported research to be promptly submitted for peer
reviewed publication; Citation: Guidebook for Proposers
Responding to a NASA Research Announcement.
Agency: NIH; Policy: [P]rincipal investigators and grantee
organizations are expected to make the results and accomplishments of
their activities available to the research community and to the public
at large; Starting with the October 1, 2003, receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why data sharing is not possible; Citation:
NIH Grants Policy Statement and Final NIH Research Tools Policy (Dec.
23, 1999); Final NIH Statement on Sharing Research Data (Feb. 26,
2003).
Agency: NSF; Policy: Investigators are expected to promptly prepare and
submit for publication — all significant findings from work conducted
under NSF grants; Investigators are expected to share with other
researchers — materials created or gathered in the course of work under
NSF grants. Grantees are expected to encourage and facilitate such
sharing; Citation: NSF Grants Policy Manual.
Sources: Agriculture, Defense, Education, Energy, EPA, NASA, NIH, and
NSF.
[A] Education currently is revising its research dissemination policies
in response to the Education Sciences Reform Act of 2002.
[End of table]
Agencies also indirectly encourage the dissemination of research
results through their grant award practices. Officials at each agency
said that peer review panels consider the publication record of the
applicant (usually the principal investigator) in assessing the grant
proposal. NSF, for example, requires that principal investigators
requesting grant renewals include a list of publications generated with
NSF's prior support. Agriculture officials told us that they are less
likely to recommend renewal applications for continued funding if the
funded project's results have not been published. Publications indicate
to the agencies that the principal investigator has made progress in
his/her research and that the results are available to other scientists
in the field. However, a research project may not generate publishable
results because leading scientific journals require that manuscripts be
reviewed by other experts in the field to validate the research
findings prior to publication. The scientific journal may reject a
manuscript because, for example, the reviewers conclude that the work
adds little value to the field of study, the results are inadequately
supported, or the research failed.
All but five of the university respondents reported that they have a
policy or standard operating procedure that addresses whether sponsors
are allowed to delay the publication of research results under certain
circumstances, such as reviewing a manuscript for possible proprietary
information or for intellectual property. Three universities--the
California Institute of Technology, Howard University, and Iowa State
University--reported that they do not permit any publication delays,
while 160 universities allow a sponsor to review a manuscript prior to
publication--typically from 30 to 90 days.[Footnote 7] However, 10
universities allow a longer period of up to either 120 days or 180
days, and 1 university allows up to 365 days for the sponsor to review
a manuscript for proprietary information.
Generally, research sponsors appear to adhere to the universities' time
frames for reviewing manuscripts. Administrators reported the
following:
* Fourteen universities were aware of one or more cases during the past
3 years of a sponsor delaying the publication of unclassified and
nonsensitive research beyond the university's time limits.
* Three universities were aware of one or more cases during the past 3
years of a federal sponsor delaying the publication of research
involving sensitive, but not classified, information beyond the
university's time limits.
* Thirteen universities were aware of one or more cases during the past
3 years of a federal sponsor blocking, or attempting to block,
publication of research involving sensitive, but not classified,
information.
However, several university administrators noted during the pretest of
our survey instrument that publication delays can occur without the
university's knowledge if the sponsor and the research team reach an
accommodation without notifying university administrators.
Five Agencies Disseminate Research Results on Their Web Sites:
As shown in table 2, Agriculture, Defense, Energy, EPA, and NASA use
their Web sites to post research results, in some form, for grants that
they issue.[Footnote 8] For example, EPA posts summaries of annual and
final technical reports on its National Center for Environmental
Research Web site. These summaries include research accomplishments or
findings, the reporting date, EPA agreement number, title,
investigators, institution, research category, project period,
objective of research, progress summary, conclusions (if applicable),
publications/presentations, future activities, supplemental keywords,
and other relevant Web sites. EPA's Web site also allows users to
search for publications associated with a particular grant. NASA
primarily posts abstracts of final technical reports on its Web site,
although NASA plans to post mainly full technical reports in 2004.
Table 2: Agencies That Post Research Results on Their Web Sites:
Agency: Agriculture; Web-based information system: Current Research
Information System; Information posted: Annual and final technical
reports.
Agency: Defense; Web-based information system: Defense Technical
Information Center; Information posted: Final technical reports.
Agency: Energy; Web-based information system: Information Bridge;
Information posted: Final technical reports.
Agency: EPA; Web-based information system: National Center For
Environmental Research; Information posted: Annual and final report
summaries.
Agency: NASA; Web-based information system: Scientific and Technical
Aerospace Reports File; Information posted: Abstract of final technical
reports.
Sources: Agriculture, Defense, Energy, EPA, and NASA.
Note: Some agencies use their Intranet sites to provide greater access
to research results for organizations with which they have a business
relationship. For example, Defense's Scientific and Technical
Information Network uses a customer registration and information
release process to provide access to eligible contractors, academic
institutions, and certain other federal agencies.
[End of table]
While Education, NIH, and NSF do not post research results on their Web
sites, they post a project abstract written at the time of award
stating how the research will be conducted and what researchers hope to
accomplish. In November 2002, the Education Sciences Reform Act of 2002
(Pub. L. No. 107-279) established the Institute of Education Sciences
and directed it to widely disseminate the findings and results of
scientifically valid research in education. An Education official told
us that after the members of the Institute's National Board of
Educational Sciences have been appointed and confirmed, Education will
consider how best to fulfill this requirement, particularly for the
results of Institute-funded research that have not been peer reviewed.
The official noted that the Institute's National Center for Education
Evaluation currently disseminates the results of research performed
under contract either through research publications or through its Web
site after the results have been peer reviewed.
In addition to using their own Web sites, several agencies participate
in collaborative Web-based efforts to share information, including
research results. For example, Energy's Office of Scientific and
Technical Information maintains Federal R&D Project Summaries, a Web-
based portal to summary and award information for Energy, NIH, and NSF
research grants. The office also maintains GrayLIT Network, a portal to
full-text reports located on the Energy, Defense, EPA, and NASA
information systems. In addition, an interagency working group from 11
major science agencies recently initiated the science.gov Web site,
which provides a gateway to federal research and development results
and other scientific information.
Officials at the eight agencies identified both advantages and
disadvantages to posting all funded research results on agencies' Web
sites. Most of the agency officials told us that posting technical
reports on agencies' Web sites is an effective way to share information
among scientists in the field of research, as well as with the public.
In explaining why they have chosen not to post all results on their Web
site, NIH and NSF officials cited concerns that grant results posted
prior to peer review and publication may be incomplete or incorrect and
could mislead other researchers or the public. According to NIH
officials, the risk associated with posting results that have not been
scrutinized and validated by peer review is simply too great in the
biomedical field. In addition, NSF officials were concerned that a
scientific journal would reject a manuscript because it views reports
posted on the Web as publications. Some agency officials also expressed
concern that a final technical report might be posted before the
university files a patent application for an invention, thereby
preventing it from obtaining a patent.
Among the 171 university respondents to our survey, 91 universities (53
percent) supported posting the grantee's final technical reports on the
agency's Web site, and 31 universities (18 percent) opposed posting the
final technical report, while 49 universities (29 percent) either were
uncertain or did not respond. Primary advantages that universities
cited for posting final technical reports on an agency's Web site
include facilitating the access of other scientists to research
results, facilitating collaboration among scientists, providing prompt
dissemination of research results, and providing a public record if the
results of a research project are not published. Primary disadvantages
that universities cited for posting final technical reports are the
potential for (1) an invention to be prematurely disclosed, (2) a
scientific journal to reject a manuscript because it views posted
reports as publications, (3) proprietary information to be disclosed,
(4) research results to be prematurely disclosed, (5) incomplete or
misleading report results to be prematurely disseminated, (6) an
investigator to be to harassed by opponents to the research, and (7)
universities to incur added administrative costs in complying with
agency requirements.
Only NIH and NSF Require Financial Conflict of Interest Standards for
Grant Recipients:
NIH and NSF, the two largest federal supporters of university research,
are the only federal agencies we examined that have adopted standards
intended to protect against financial conflicts of interest among
university grantees. The other six agencies do not require universities
and other grantees to identify and manage possible financial conflicts
of interest involving their research. According to officials from these
agencies, it is the universities' responsibility to protect against
conflicts of interest in university research. While 87 percent of our
survey respondents reported that all of their federally funded research
is covered by financial conflict of interest policies that are
consistent with either NIH's or NSF's standards, 17 universities--
including 5 universities in the University of California system--
reported that they do not extend either the NIH or the NSF financial
conflicts of interest requirements to cover research grants funded by
other federal agencies.
Agencies without Financial Conflict of Interest Standards Believe
Universities Should Take the Lead in Implementing Policies:
While both NIH and NSF promulgated regulations in 1995 that require
universities to implement financial conflict of interest policies, the
other six federal agencies do not require that their grantees have
similar standards. According to Agriculture and Energy officials,
universities should take responsibility for developing and implementing
policies for identifying and managing financial conflicts of interest
involving their scientists. Defense and NASA officials told us that
they have not experienced enough problems to justify adopting financial
conflict of interest standards for universities and other grantees.
These officials added that the potential for financial conflicts of
interest in the scientific fields that they fund is generally lower
than in the biomedical field. However, NSF supports research in many of
the same fields of research as these agencies.
Most Universities Report That Their Financial Conflict of Interest
Policies Are Consistent with NIH and/or NSF Standards:
All of the 171 university respondents to our survey reported that they
had one or more policies for addressing possible financial conflicts of
interest by research investigators. Of the respondents, 148
universities (87 percent) reported having financial conflict of
interest policies consistent with either NIH's or NSF's regulations
that apply to all federally funded research. More specifically, 135
universities (79 percent) reported that they have a single conflict of
interest policy that applies to all of their research. These
universities' policies are consistent with one of the 10 guidelines
that the Association of American Universities' Task Force on Research
Accountability proposed for managing individual conflicts of interest:
"Treat research consistently, regardless of funding source--all
research projects at an institution, whether federally funded, funded
by a non-federal entity, or funded by the institution itself, should be
managed by the same conflict of interest process and treated the
same."[Footnote 9]
In contrast, 17 universities reported that some of the federally funded
research they perform is not covered by financial conflict of interest
policies that are consistent with either NIH's or NSF's regulations.
For example, 5 universities in the University of California system
reported that their financial conflict of interest policies apply to
research funded by NIH
or NSF, but not to research funded by other federal agencies.[Footnote
10] The Massachusetts Institute of Technology and Yale University
reported that they have specific policies that cover research funded by
NIH and NSF, while their institutional policies cover all other funded
research. Six other universities did not provide a response.
Overall, 124 universities strongly supported, and 25 universities
somewhat supported, creating a single financial conflict of interest
policy for all federally funded research. Among the other respondents,
19 universities either did not have a strong opinion or did not respond
to the question, while only 3 universities either strongly or somewhat
opposed a single financial conflict of interest policy for all
federally funded research. The university respondents did not agree,
however, on which agency's standards should serve as the basis for a
single federal policy: among the 133 universities that expressed an
opinion, 72 preferred the NIH regulation, 56 preferred the NSF
regulation, while 5 stated that either would be acceptable.
To implement their financial conflict of interest policies, 140 of the
171 universities (82 percent) reported that they require scientists to
indicate whether or not a conflict may exist when a grant proposal is
submitted; 108 universities (63 percent) require scientists to annually
submit financial disclosure forms to appropriate institution officials;
and 139 universities (81 percent) require scientists to update
financial disclosure forms during the year if new possible financial
conflicts of interest are identified. A policy that incorporates all
three of these requirements is consistent with the Association of
American Universities' Task Force on Research Accountability guideline:
"Disclose financial information to the institution--individuals
engaged in research should disclose on an annual basis all financial
interests related to university research, and provide updated
information when new financial circumstances may pose a conflict of
interest and when grant applications are submitted." All but 6 of the
171 universities reported that they require at least one of these three
types of financial disclosure.
In addition, 56 universities reported that their policy requires that
the federal funding agency be notified whenever a financial conflict of
interest is identified. In comparison, 62 universities reported that
their policies require that only certain federal funding agencies be
notified, 49 universities do not have a policy for notifying federal
funding agencies about identified financial conflicts of interest, and
4 universities did not respond about their notification policies.
Our survey results indicate that several universities have tightened
their policies for financial conflicts of interest in recent years to
comply with the NIH and NSF requirements. Specifically, all of our 171
respondents reported that they have financial conflict of interest
policies, while a survey reported in the November 2000 issue of the New
England Journal of Medicine found that 15 of the 250 institutional
respondents (6 percent) did not have a policy on conflicts of
interest.[Footnote 11] In response to the November 2000 survey, NIH
reviewed the financial conflict of interest policies of a
representative sample of more than 100 universities and other
institutions. NIH found that, generally, the institutions had developed
policies that reflected a serious desire to inform and assist their
investigators in complying with NIH's regulation. However, NIH found
several specific areas of noncompliance and identified four major areas
of concern that the institutions' financial conflicts of interest
policies need to address: (1) many policies are not separated from
other institutional policies through a distinct part, appendix, or
document; (2) investigators face an increased burden because the many
policies do not provide electronic links to supporting information; (3)
many policies are confusing because their applicability and terminology
are unclear; and (4) many policies include numerous examples of vague
language or statements.
Upon review of our university survey results, officials at Agriculture,
Energy, EPA, and NASA told us that OMB should take the lead in
developing a uniform, governmentwide requirement for addressing
possible financial conflicts of interest that is consistent with NIH's
and NSF's standards. NIH and NSF officials also supported developing a
uniform requirement that is consistent with their standards. Defense
officials said they were ready to work with other federal agencies on
governmentwide regulations, if regulations are warranted. OMB and OSTP
officials believe that the National Science and Technology Council,
which OSTP coordinates, is in the best position to develop a uniform
financial conflict of interest standard for federally funded research.
Conclusions:
A fundamental principle of scientific research is that wide
dissemination of research results is vital for validating these results
and advancing the field of science. Posting final research reports, or
similar information, on federal agencies' Web sites can advance
scientific research by providing other scientists with timely access to
research results and facilitating collaboration. Posting this
information also provides access to members of the public interested in
the research and a public record if the results of agency-funded
research are not published, thus maximizing the benefit of the federal
investment. For these reasons, five federal agencies, including Energy
and NASA, already routinely disseminate research results through their
Web sites. While posting research results might create concerns in some
fields, such as biomedical research, these concerns are less applicable
for Education, which like Energy and NASA, has a specific statutory
requirement to widely disseminate research results.
The growing relationship between universities and businesses since
passage of the Bayh-Dole Act has led to an increase in possible
financial conflicts of interest, as businesses have increased their
funding of university research and some universities have collected
more than $10 million in royalties in a given year for technologies
they have developed. In response to the NIH and NSF requirements, all
of the universities we surveyed have implemented policies for
identifying and managing possible conflicts of interest. However, some
universities have not extended their policies to cover research funded
by other agencies, which also provide substantial amounts of research
funding, and OMB Circular A-110 does not address financial conflicts of
interest. Unless all federal agencies require that universities have
appropriate conflict of interest policies, the government cannot ensure
that safeguards are in place to protect the integrity of scientific
research, and the public's investment.
Recommendations for Executive Action:
To better ensure that the findings and results of scientifically valid
research in education are widely disseminated, we recommend that the
Secretary of Education direct the new Institute of Education Sciences
to post the final technical reports of the research it funds on its Web
site.
To safeguard against bias in the design, conduct, or reporting of
federally funded research, we recommend that the National Science and
Technology Council coordinate the development of uniform federal
requirements for universities and other funding recipients to identify
and resolve financial conflicts of interest. The NIH and NSF standards
provide a useful starting point for this requirement.
Agency Comments and Our Evaluation:
We provided Education, OSTP, Agriculture, Defense, Energy, EPA, NASA,
NIH, and NSF with a draft of this report for their review and comment.
Education agreed with our recommendation to post the results of the
research it has funded on its Web site, stating that the department is
currently exploring how to best implement the Education Sciences Reform
Act's provisions while not discouraging grantees from having their work
published in scientific journals. (See appendix IV for Education's
written comments.) We met with OSTP officials, including the Associate
Director for Science, who agreed with the thrust of our recommendation
that the National Science and Technology Council coordinate the
development of uniform federal requirements to identify and resolve
financial conflicts of interest. However, the OSTP officials noted that
recent experience in developing a common rule for research misconduct
has demonstrated that the process for reaching consensus among federal
agencies can be difficult and prolonged. We continue to believe that
federal agencies should develop a single, uniform requirement for
financial conflicts of interest. Through their experiences in
implementing standards since 1995, NIH and NSF can provide important
insights into the benefits and costs of alternative approaches in areas
where their requirements differ.
The Deputy Administrator for Extramural Programs within Agriculture's
Cooperative State Research, Education, and Extension Service stated, in
oral comments, that the Service agreed with our recommendation and
will, where appropriate, implement financial conflict of interest
standards similar to those of NIH and NSF. Defense, Energy, EPA, NASA,
NIH, and NSF agreed with the factual presentation of the report. (See
app. V for NASA's written comments, and app. VI for NIH's written
comments.) Several agencies also provided specific comments to improve
the report's technical accuracy, which we incorporated as appropriate.
Scope and Methodology:
To assess the actions that federal agencies have taken to ensure the
public's access to authoritative and unbiased scientific research at
universities, we examined the policies and procedures of the eight
federal agencies that primarily fund university research--Agriculture,
Defense, Education, Energy, EPA, NASA, NIH, and NSF. Specifically, we
performed the following audit steps:
* To assess agencies' actions to ensure that the results of the
university research they fund are made available to the public, we
reviewed each agency's policies and procedures for disseminating
research results and interviewed agency officials. We also accessed the
final technical reports for several university grant projects from the
Web sites of the five agencies that post research results.
* To assess agencies' actions to ensure that universities implement
policies for identifying and managing possible financial conflicts of
interest, we examined whether each agency has regulations or policies
requiring that universities identify and manage possible financial
conflicts of interest. We also interviewed cognizant officials about
their procedures for ensuring that universities are implementing
financial conflict of interest policies. We did not examine the extent
to which agencies have taken additional actions to protect against
financial conflicts of interest for research involving human subjects,
a topic examined in a November 2001 GAO report.[Footnote 12]
* To assess agencies' actions to implement the Shelby Amendment, we
examined the 1999 legislation; OMB's revisions to Circular A-110; and
the actions each agency has taken to implement the circular's
revisions. We also discussed these actions with cognizant agency
officials, asked them whether they had received any FOIA requests that
cited the Shelby Amendment, and, if so, asked them to provide
information about each such request. We then reviewed the agency's
disposition of these FOIA requests.
In addition to our review of federal agencies' actions, we conducted a
Web-based survey of the 200 universities and colleges that received the
most federal research funding in fiscal year 2000. The survey contained
42 questions that asked about (1) their policies and procedures for
ensuring that federally funded research results are made available to
the public, (2) their views of the advantages and disadvantages of
posting a grant's final technical report to the agency's Web site, (3)
their conflict of interest and financial disclosure policies, (4) any
FOIA requests federal agencies had received that asked for access to
research data, and (5) data on their research funding and technology
transfer activities.
We pretested the content and format of the questionnaire with research
office administrators at the Georgia Institute of Technology, Emory
University, Washington University, the University of Missouri, the
University of Colorado, the Colorado School of Mines, George Washington
University, and the University of Maryland. During the pretest, we
asked the administrators to determine whether the survey questions were
clear, the terms used were precise, and the questions were unbiased. We
also assessed the usability of the Web-based format. We made changes to
the content and format of the final questionnaire based on pretest
results.
We received responses from 171 of the 200 universities surveyed, for a
response rate of 86 percent. Respondents included 44 of the 50
universities that received the most federal funding in fiscal year
2000. We performed analyses to identify inconsistencies in the data and
resolved them. The universities' aggregated responses are available at
[Hyperlink, http://www.gao.gov/special.pubs/gao-04-223sp] http://
www.gao.gov/special.pubs/gao-04-223sp.
We conducted our review from August 2002 through September 2003 in
accordance with generally accepted government auditing standards.
:
We are sending copies of this report to the appropriate House and
Senate Committees, the Director of OSTP, the Secretary of Agriculture,
the Secretary of Defense, the Secretary of Education, the Secretary of
Energy, the Administrator of EPA, the Administrator of NASA, the
Director of NIH, the Director of NSF, and the Director of OMB. We also
will make copies available to others upon request. In addition, the
report will be available at no charge on the GAO Web site at
[Hyperlink, http://www.gao.gov] http://www.gao.gov.
If you or your staff have any questions about the report, please
contact me at (202) 512-3841. Key contributors to this report were
Richard Cheston, Vondalee Hunt, Ulana Bihun, Donald Pless, and Lynn
Musser.
Sincerely yours,
Robin Nazzaro:
Director, Natural Resources and Environment:
Signed by Robin Nazzaro:
[End of section]
Appendixes:
[End of section]
Appendix I: Agencies' Actions in Implementing the Shelby Amendment:
The Omnibus Consolidated and Emergency Supplemental Appropriations Act,
1999, (Pub. L. No. 105-277) required the Director of the Office of
Management and Budget (OMB) to amend Circular A-110 by incorporating a
provision known as the Shelby Amendment.[Footnote 13] Among other
things, the Shelby Amendment requires that (1) federal awarding
agencies ensure that all data produced under an award will be made
available to the public through the procedures established under the
Freedom of Information Act (FOIA) and (2) if the agency obtaining the
data does so solely at the request of a private party, the agency may
charge a reasonable user fee equaling the incremental cost of obtaining
the data. The Shelby Amendment grew out of a controversy that arose
over the Environmental Protection Agency's (EPA) proposal to tighten
Clean Air Act standards for small airborne particulates in 1997. EPA's
proposed rule cited the published results of a 30-year epidemiological
study funded by the National Institutes of Health (NIH) and conducted
by Harvard University. Various industry groups that opposed EPA's
proposed regulation asked to review original data of the study.
However, Harvard denied the requests, citing both confidentiality
agreements with human subjects and the volume of data accumulated.
On November 6, 1999, OMB published revisions to Circular A-110 in the
Federal Register in response to the Shelby Amendment. Under the
revision, a subject institution must provide the research data to the
funding agency in response to a FOIA request if a federal agency has
used the published research findings in developing an agency action
that has the force and effect of law. In March 2000, 15 federal
agencies published an interim final rule in the Federal Register that
codified the OMB Circular A-110 revision. These agencies included
Agriculture, Defense, Energy, Education, EPA, the National Aeronautics
and Space Administration (NASA), and NIH. National Science Foundation
(NSF) officials told us that NSF incorporated the revision by reference
to OMB Circular A-110 in its grant agreements.
Only NIH and EPA have received FOIA requests citing the Shelby
Amendment. In reviewing the requests, both agencies determined that the
requests did not meet the OMB Circular A-110 criteria. (See table 3.)
Of the 40 requests received by NIH, 20 requested copies of either
funded grant applications or contract records, not research data; 9
requested data generated from grants funded prior to the effective date
of the NIH regulation implementing the Shelby Amendment; and 4 were
withdrawn. NIH officials told us that NIH determined that the remaining
seven requests were not applicable to the Shelby Amendment; however,
information on the basis for this decision was unavailable because NIH
had destroyed the FOIA files 2 years after its final response, in
accordance with the National Archives and Records Administration's
(NARA) records retention schedule. EPA denied both requests it received
because the requested data were generated by projects funded prior to
the effective date of its regulation implementing the revision to OMB
Circular A-110.
Table 3: NIH's and EPA's Disposition of FOIA Requests Citing the Shelby
Amendment, as of August 31, 2003:
Request: NIH:
Request: 1; Request date: NIH: Nov. 4, 1999; Response date: NIH: Apr.
29, 2002; Agency disposition: NIH: Request was withdrawn.
Request: 2; Request date: NIH: Nov. 5, 1999; Response date: NIH:
Pending; Agency disposition: NIH: Not applicable because the projects
for which data are sought were funded before the effective date (April
2000).
Request: 3; Request date: NIH: Jan. 20, 2000; Response date: NIH: July
3, 2000; Agency disposition: NIH: Not applicable. Information on the
basis for NIH's decision is unavailable because the FOIA file had been
destroyed in accordance with NARA's records retention schedule.
Request: 4; Request date: NIH: Feb. 1, 2000; Response date: NIH: June
9, 2000; Agency disposition: NIH: Not applicable. Information on the
basis for NIH's decision is unavailable because the FOIA file had been
destroyed in accordance with NARA's records retention schedule.
Request: 5; Request date: NIH: Feb. 1, 2000; Response date: NIH: July
18, 2000; Agency disposition: NIH: Not applicable. Information on the
basis for NIH's decision is unavailable because the FOIA file had been
destroyed in accordance with NARA's records retention schedule.
Request: 6; Request date: NIH: Feb. 1, 2000; Response date: NIH: Apr.
17, 2000; Agency disposition: NIH: Not applicable. Information on the
basis for NIH's decision is unavailable because the FOIA file had been
destroyed in accordance with NARA's records retention schedule.
Request: 7; Request date: NIH: Feb. 29, 2000; Response date: NIH: Aug.
2, 2000; Agency disposition: NIH: Not applicable. Information on the
basis for NIH's decision is unavailable because the FOIA file had been
destroyed in accordance with NARA's records retention schedule.
Request: 8; Request date: NIH: Mar. 31, 2000; Response date: NIH: Mar.
31, 2000; Agency disposition: NIH: Not applicable. Information on the
basis for NIH's decision is unavailable because the FOIA file had been
destroyed in accordance with NARA's records retention schedule.
Request: 9; Request date: NIH: May 16,2000; Response date: NIH: June
23, 2000; Agency disposition: NIH: Request was withdrawn.
Request: 10; Request date: NIH: June 28, 2000; Response date: NIH: July
6, 2000; Agency disposition: NIH: Not applicable. Information on the
basis for NIH's decision is unavailable because the FOIA file had been
destroyed in accordance with NARA's records retention schedule.
Request: 11; Request date: NIH: Aug. 4, 2000; Response date: NIH: Dec.
14, 2000; Agency disposition: NIH: Request did not identify the grants
for which data were sought; However, given the date of publications
cited, the projects were funded before April 2000, the effective date
of the NIH regulation.
Request: 12; Request date: NIH: Dec. 20, 2000; Response date: NIH: Dec.
26, 2000; Agency disposition: NIH: Not applicable because the grants
for which data were sought were funded before April 2000, the effective
date of the NIH regulation.
Request: 13; Request date: NIH: Jan. 19, 2001; Response date: NIH: Feb.
28, 2001; Agency disposition: NIH: Not applicable because requester
sought only a copy of the funded grant application, not data.
Request: 14; Request date: NIH: Aug. 27, 2001; Response date: NIH: Nov.
15, 2001; Agency disposition: NIH: Not applicable because requester
sought only a copy of the funded grant application, not data.
Request: 15; Request date: NIH: Oct. 16, 2001; Response date: NIH: May
30, 2002; Agency disposition: NIH: Not applicable because the grants
for which data were sought were funded before April 2000, the effective
date of the NIH regulation.
Request: 16; Request date: NIH: Oct. 16, 2001; Response date: NIH:
Pending; Agency disposition: NIH: Not applicable because the projects
for which data are sought were funded before April 2000, the effective
date of the NIH regulation.
Request: 17; Request date: NIH: Jan. 14, 2002; Response date: NIH: Feb.
11, 2002; Agency disposition: NIH: Not applicable because requester
sought only a copy of the funded grant application, not data.
Request: 18; Request date: NIH: Mar. 20, 2002; Response date: NIH: Apr.
18, 2002; Agency disposition: NIH: Not applicable because requester
sought only a copy of the funded grant application, not data.
Request: 19; Request date: NIH: Apr. 1, 2002; Response date: NIH: June
14, 2002; Agency disposition: NIH: Not applicable because the grants
for which data were sought were funded before April 2000, the effective
date of the NIH regulation.
Request: 20; Request date: NIH: June 17, 2002; Response date: NIH: July
18, 2002; Agency disposition: NIH: The study referenced in the request
could not be identified. In addition, according to information provided
by the requester, if the study existed, it predated the effective date
of the NIH regulation.
Request: 21; Request date: NIH: June 24, 2002; Response date: NIH:
Pending; Agency disposition: NIH: Not applicable because requester
sought only copies of funded grant applications, not data.
Request: 22; Request date: NIH: June 24, 2002; Response date: NIH: July
22,2002; Agency disposition: NIH: Not applicable because requester
sought only a copy of the funded grant application, not data.
Request: 23; Request date: NIH: July 2, 2002; Response date: NIH:
Pending; Agency disposition: NIH: Not applicable because requester
sought only a copy of the funded grant application, not data.
Request: 24; Request date: NIH: July 25, 2002; Response date: NIH: Aug.
21, 2002; Agency disposition: NIH: Not applicable because requester
sought only a copy of the funded grant application, not data.
Request: 25; Request date: NIH: Aug. 29, 2002; Response date: NIH:
Pending; Agency disposition: NIH: Not applicable because requester
sought only a copy of the funded grant application, not data.
Request: 26; Request date: NIH: Sept. 27, 2002; Response date: NIH:
Oct. 2, 2002; Agency disposition: NIH: Not applicable because requester
sought only copies of funded grant applications, not data.
Request: 27; Request date: NIH: Oct. 3, 2001; Response date: NIH: Nov.
7, 2002; Agency disposition: NIH: Not applicable because requester
sought only copies of funded grant applications, not data.
Request: 28; Request date: NIH: Oct. 28, 2002; Response date: NIH: Feb.
6, 2003; Agency disposition: NIH: Not applicable because the grant for
which data were sought was funded before April 2000, the effective date
of the NIH regulation.
Request: 29; Request date: NIH: Dec. 12, 2002; Response date: NIH:
Sept. 15, 2003; Agency disposition: NIH: Not applicable because
requester sought only copies of funded grant applications, not data.
Request: 30; Request date: NIH: Jan. 9, 2003; Response date: NIH: July
21, 2003; Agency disposition: NIH: Request was withdrawn.
Request: 31; Request date: NIH: Feb. 3, 2003; Response date: NIH: Feb.
20, 2003; Agency disposition: NIH: Not applicable because requester
sought only a copy of contract records, not data.
Request: 32; Request date: NIH: June 23, 2003; Response date: NIH: Aug.
18, 2003; Agency disposition: NIH: Not applicable because requester
sought only a copy of a funded grant application, not data.
Request: 33; Request date: NIH: June 27, 2003; Response date: NIH:
Sept. 26, 2003; Agency disposition: NIH: Not applicable because
requester sought only a copy of a funded grant application, not data.
Request: 34; Request date: NIH: July 28, 2003; Response date: NIH: Not
applicable; Agency disposition: NIH: Request was withdrawn.
Request: 35; Request date: NIH: July 28, 2003; Response date: NIH: Aug.
28, 2003; Agency disposition: NIH: Not applicable because requester
sought only copies of funded grant applications, not data.
Request: 36; Request date: NIH: July 28, 2003; Response date: NIH:
Pending; Agency disposition: NIH: Not applicable because requester
sought only copies of funded grant applications, not data.
Request: 37; Request date: NIH: Aug. 1, 2003; Response date: NIH: Sept.
5, 2003; Agency disposition: NIH: Not applicable because requester
sought only a copy of a funded grant application, not data.
Request: 38; Request date: NIH: Aug. 1, 2003; Response date: NIH:
Pending; Agency disposition: NIH: Not applicable because requester
sought only a copy of a funded grant application, not data.
Request: 39; Request date: NIH: Aug. 10, 2003; Response date: NIH:
Pending; Agency disposition: NIH: Not applicable because requester
sought only a copy of a funded grant application, not data.
Request: 40; Request date: NIH: Aug. 19, 2003; Response date: NIH:
Sept. 3, 2003; Agency disposition: NIH: Not applicable because the
grants for which data were sought were funded before April 2000, the
effective date of the NIH regulation.
Request: EPA:
Request: 1; Request date: NIH: Dec. 9, 1999; Response date: NIH: April
24, 2001; Agency disposition: NIH: Not applicable because the projects
for which data were sought were funded before the effective date.
Request: 2; Request date: NIH: Dec. 9, 1999; Response date: NIH: April
24, 2001; Agency disposition: NIH: Not applicable because the projects
for which data were sought were funded before the effective date.
Sources: NIH and EPA.
[End of table]
More recently, OMB published a proposed bulletin and guidelines to
ensure that agencies conduct peer reviews of the most important
scientific and technical information relevant to regulatory policies
that they disseminate to the public, and that the peer reviews are
reliable, independent, and transparent.[Footnote 14] The guidance would
supplement the requirements that many agencies have for peer review of
"significant regulatory information," which is scientific or technical
information that qualifies as "influential" under OMB's information
quality guidelines and is relevant to regulatory policies.[Footnote 15]
Specifically, the proposed guidelines state that, to the extent
permitted by law, an agency shall have an appropriate and
scientifically-rigorous peer review conducted on all significant
regulatory information that the agency intends to disseminate. In
addition, the proposed guidelines state that, to the extent permitted
by law, an agency shall have formal, independent, external peer review
conducted for so-called "especially significant regulatory
information" which would apply to significant regulatory information if
(1) the agency intends to disseminate the information in support of a
major regulatory action, (2) the dissemination of the information could
otherwise have a clear and substantial impact on important public
policies or important private sector decisions with a possible impact
of more than $100 million in any year, or (3) the Administrator of the
Office of Information and Regulatory Affairs determines that the
information is of significant interagency interest or is relevant to an
administration policy priority.
[End of section]
Appendix II: Universities' Acceptance of Equity in Start-up Companies:
Among the 171 respondents to our survey, 155 universities reported that
they, or their affiliates, have the option to accept equity as a means
of payment for licensed technology. As shown in figure 1, since the
enactment of the Bayh-Dole Act in December 1980, these universities
have increasingly begun receiving equity in start-up companies in lieu
of receiving license fees and royalties. Prior to the act, only 10
universities accepted equity in start-up companies.
Figure 1: The Year Universities First Received Equity in a Start-up
Company:
[See PDF for image]
[End of figure]
As of March 2003, 123 universities reported that they held equity in at
least one start-up company, and 44 of these universities reported that
they held equity in at least 10 start-up companies. The Massachusetts
Institute of Technology held equity in 116 start-up companies at that
time. Furthermore, 93 universities reported that they held, on average,
less than 10 percent of the start-up companies' equity, and 31
universities reported that they held, on average, 10 percent or more of
the start-up companies' equity. While 16 universities limit equity
ownership to at most 10 percent, 116 universities reported that their
institutional policy does not restrict the percentage of equity
ownership they can hold in a start-up company.
[End of section]
Appendix III Comparison of NIH's and NSF's Financial Conflict of
Interest Standards:
On July 11, 1995, the Department of Health and Human Services, which
includes NIH, promulgated regulations and NSF revised its Investigator
Financial Disclosure Policy to establish consistent requirements for
universities and other grantees, with certain exceptions, to identify
and manage real or apparent financial conflicts of interest. The stated
purpose of these requirements is to ensure a reasonable expectation
that the design, conduct, and reporting of research will be unbiased by
any conflicting financial interest of the investigator. The effective
date of these standards was October 1, 1995.
Both NIH and NSF define a "significant financial interest" as anything
of monetary value with the following exceptions:
* salaries, royalties, and remuneration from the applicant institution;
* any ownership interest in the institution, if the institution is an
applicant under the Small Business Innovation Research program;
* income from seminars, lectures, teaching engagements, and service on
advisory committees or review panels;
* an equity interest that--when aggregated for the investigator,
spouse, and dependent children--does not exceed $10,000 and does not
represent more than 5 percent ownership interest in a single entity;
or:
* salary, royalties, or other payments that--when aggregated for the
investigator, spouse and dependent children--do not exceed $10,000 over
the next 12 months.
The NIH regulations (42 C.F.R. Part 50 and 45 C.F.R. Part 94) require
that each institution, except Phase I applicants for the Small Business
Innovation Research program, takes the following actions:
* Maintains a written, enforced policy on conflict of interest
complying with the regulations, and inform investigators of the policy.
The institution must take reasonable steps to ensure that subgrantees
comply with its policy.
* Designates an institutional official who will review financial
disclosure statements.
* Requires that each investigator submit to the institutional official,
by the time the application is submitted for funding, a listing of
significant financial interests that would reasonably be affected by
the research.[Footnote 16]
* Provides guidelines for designated officials to identify conflicts of
interest and take necessary action to manage, reduce, or eliminate
those conflicts. Under the regulations, a conflict of interest exists
when the designated official reasonably determines that a significant
financial interest could directly and significantly affect the design,
conduct, or reporting of the funded research.
* Maintains records for 3 years after the date of the submission of the
final report of expenditures.
* Establishes adequate enforcement mechanisms and provide for
appropriate sanctions.
* Certifies in each application for funding that the institution has an
administrative process to manage conflicts of interest and that, prior
to any expenditure of funds, the institution will report the existence
of a conflict and assure that it is being managed, reduced, or
eliminated.
If an investigator fails to comply with the institution's policies and
has, thereby, biased the research, the institution must report the
noncompliance immediately to NIH and inform NIH of the action that has
been, or will be, taken. If this failure occurs in a project whose
purpose is to evaluate the safety or effectiveness of a drug, medical
device, or treatment, the institution must require that it be disclosed
in each public presentation of the results of the research.
NSF's policies were developed in close conjunction with the NIH
regulations but differ in the following significant respects:
* NSF has no conflict of interest requirement governing subgrantees.
* NSF exempts all entities with less than 50 employees from its
standard.
* NSF requires that records be retained for 3 years after the
termination of the award instead of 3 years after the last financial
statement has been submitted.
* NSF requires that the institution provide notification of a conflict
of interest only if the institution is unable to resolve the conflict.
* NSF permits research to proceed, in spite of disclosed conflicts, if
the review determines that restrictions would be ineffective or that
the benefits of proceeding outweigh the consequences of any negative
impact. NIH does not address this issue in its policy.
[End of section]
Appendix IV: Comments from the Department of Education:
UNITED STATES DEPARTMENT OF EDUCATION:
INSTITUTE OF EDUCATION SCIENCES:
THE DIRECTOR:
OCT 31 2003:
Mr. Richard Cheston:
Assistant Director, Natural Resources and Environment:
U.S. General Accounting Office:
Washington, DC 20548:
Dear Mr. Cheston:
Thank you for the opportunity to review and comment on your draft
report entitled University Research: Federal Agencies Need to Better
Protect against Financial Conflicts ofInterest (GAO-04-31).
The GAO recommends that the Secretary of Education direct the Institute
of Education Sciences (the Institute) to post the final technical
reports of the research the Institute funds on the Institute's Web
site. The Education Sciences Reform Act (ESRA) provides that all
research, statistics and evaluation reports conducted by, or supported
through, the Institute must undergo rigorous peer review before the
Institute can publish them or otherwise make them available to the
public. See Pub. L. 107-279, section 186(c).
Consistent with this provision, the Institute intends to post on its
web site final reports generated by contractors after the reports have
gone through peer review. As for reports generated under a grant or
cooperative agreement, section 134 (b)(1) of the ESRA states that the
Director shall establish a peer review process for evaluating and
assessing the products of research from grant and cooperative agreement
recipients. The Institute is currently exploring how to best implement
this provision while not discouraging grantees from having their work
published in scientific journals.
Any questions about this response should be directed to Dr. Lynn
Okagaki at 202-219-2006 or lynn.okagaki@ed.gov.
Sincerely,
Grover J. Whitehurst:
Signed by Grover J. Whitehurst:
[End of section]
Appendix V: Comments from the National Aeronautics and Space
Administration:
National Aeronautics and Space Administration:
Office of the Administrator:
Washington, DC 20546-0001:
October 27, 2003:
Ms. Robin Nazzaro Director:
Natural Resources and Environment United States General Accounting
Office Washington, DC 20548:
Dear Ms. Nazzaro:
Thank you for the opportunity to review the draft GAO report titled
"University Research: Federal Agencies Need to Better Protect against
Financial Conflicts of Interest" (GAO-04-31). We were pleased that the
report included no recommendations for NASA. We were also pleased that
you recognized the fact that we post abstracts of final technical
reports on our Web site. Although we do post some technical reports
now, we plan to increase the number offered in calendar year 2004.
The report included a recommendation that the National Science and
Technology Council develop uniform federal requirements for
universities and other federal funding recipients to identify and
resolve financial conflicts of interest. NASA would certainly comply
with any uniform federal requirements developed to identify and resolve
such concerns.
If you have any questions or require additional information, please
contact Thomas S. Luedtke, Assistant Administrator for Procurement, at
(202) 358-2090.
Cordially,
Frederick D. Gregory:
Deputy Administrator:
Signed by Frederick D. Gregory:
[End of section]
Appendix VI: Comments from the National Institutes of Health:
DEPARTMENT OF HEALTH & HUMAN SERVICES:
Public Health Service:
National Institutes of Health:
Bethesda, Maryland 20892:
www.nih.gov:
OCT 30 2003:
Ms. Robin Nazzaro:
Director, Natural Resources and Environment:
U.S. General Accounting Office:
441 G Street, N.W. Washington, D.C. 20548:
Dear Ms. Nazzaro:
We appreciate the opportunity to review this draft report. The report
addresses your review objectives and provides a clear perspective of
the uniqueness of NIH research grants and the challenges of providing
the valuable results to the public.
In our comments we offer several technical suggestions and corrections
for your consideration. We believe that incorporation of these will
correct some inaccuracies and enhance the clarity of the final report.
Sincerely,
Signed by: Elias A. Zerhouni, M.D.: Director:
Enclosure:
[End of section]
(360240):
FOOTNOTES
[1] Within Defense, we generalized the research grant terms and
conditions of the Office of Naval Research and the Air Force Office of
Scientific Research to the entire department. The Army does not have
standard research grant terms and conditions because each of its
awarding offices is responsible for its own unique terms and
conditions.
[2] Beginning in 1993, the Association of University Technology
Managers has annually surveyed U.S. and Canadian institutions on their
patenting and licensing activities. The participants in the fiscal year
2001 survey were 142 U.S. universities, 28 U.S. hospitals and research
institutes, 27 Canadian institutions, and 1 patent management firm.
[3] According to the Association of University Technology Managers,
taking equity in a start-up company, partially in lieu of cash fees, is
an important licensing approach because start-up companies rarely have
a positive cash flow during their first years of operation and,
therefore, need to conserve cash for investing in product development.
[4] FDP is an outgrowth of the Florida Demonstration Project formed in
1986. All of the federal agencies we reviewed, except Education, and 64
of our 171 university respondents participate in FDP and incorporate
the FDP terms and conditions in their grant agreements.
[5] NIH funds almost all of the university research within Health and
Human Services. The department also has promulgated regulations to
protect human research subjects. (See 45 C.F.R. Part 46.)
[6] Significant financial interests are defined, among other things, to
include (1) the holdings of the investigator, the investigator's
spouse, and any dependent children that exceed a $10,000 equity
interest or a 5-percent ownership interest in a single entity and (2)
salary, royalties, or other payments for the investigator and the
investigator's spouse and dependent children that exceed $10,000 over
the next 12-month period.
[7] According to NIH, a 30-to 60-day delay to secure intellectual
property rights is generally viewed as reasonable. See "Developing
Sponsored Research Agreements: Considerations for Recipients of NIH
Research Grants and Contracts," (59 fr 55674).
[8] The organic statutes for Energy and NASA call for them to widely
disseminate the results of research that they fund.
[9] Association of American Universities, Task Force on Research
Accountability: Report on Individual and Institutional Financial
Conflict of Interest, October 2001. In asserting that universities are
accountable for the research they perform, the task force provided 10
guidelines for managing individual conflicts of interest and
recommended a three-step approach for addressing institutional
conflicts of interest.
[10] Universities in the University of California system also must
comply with state requirements under the Political Reform Act of 1974.
The act established a lower income and equity threshold than the NSF
and NIH regulations for disclosing financial interests, but the
relationship between the university scientist and an affected company
is more tightly limited to only those companies directly supporting the
research through gifts, grants, or contracts.
[11] S. Van McCrary et al., "A National Survey of Policies on
Disclosure of Conflicts on Interest in Biomedical Research," The New
England Journal of Medicine 343, No. 22 (2000): 1621-1626. The authors
surveyed 297 medical schools and other research institutions that
received more than $5 million in total grants annually from NIH or NSF
to analyze their policies on conflicts on interest.
[12] See U.S. General Accounting Office, Biomedical Research: HHS
Direction Needed to Address Financial Conflicts of Interest, GAO-02-89
(Washington, D.C.: Nov. 26, 2001).
[13] OMB Circular A-110 establishes uniform administrative requirements
for grants and agreements with institutions of higher education,
hospitals, and other nonprofit organizations.
[14] OMB published a notice in the Federal Register on September 15,
2003, announcing a proposed OMB bulletin under Executive Order No.
12866 and supplemental information quality guidelines.
[15] The proposed guidelines define significant regulatory information
to exclude most routine statistical and financial information; studies
that have already been adequately peer-reviewed; and science that is
not directed toward regulatory issues, such as most of the scientific
research conducted by NIH and NSF.
[16] The investigator is the principal investigator and any other
person responsible for the design, conduct, or reporting of research
funded by NIH. For financial interest purposes, the term also includes
the investigator's spouse and dependent children.
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