a

GAO

United States General Accounting Office

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

GAO-04-31
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. 

Agencies That Post Research Results on Their Web Sites 

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. 

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. 

Highlights of GAO-04-31, a 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 
Page i GAO-04-31 University Research

Contents

Letter 1

Results in Brief 2

Background 4

Federal Agencies Rely on University Scientists and Agency Web 

Sites to Disseminate Research Results 6

Only NIH and NSF Require Financial Conflict of Interest Standards 

for Grant Recipients 12

Conclusions 16

Recommendations for Executive Action 16

Agency Comments and Our Evaluation 17

Scope and Methodology 18

Appendixes

Appendix I: Agencies’ Actions in Implementing the Shelby Amendment 21

Appendix II: Universities’ Acceptance of Equity in Start-up Companies 26

Appendix III: Comparison of NIH’s and NSF’s Financial Conflict of Interest 

Standards 28

Appendix IV: Comments from the Department of Education 31

Appendix V: Comments from the National Aeronautics and Space 

Administration 32

Appendix VI: Comments from the National Institutes of Health 33

Tables Table 1: Federal Agencies’ Policies on Disseminating Research 

Results 8

Table 2: Agencies That Post Research Results on Their Web 

Sites 10

Table 3: NIH’s and EPA’s Disposition of FOIA Requests Citing the 

Shelby Amendment, as of August 31, 2003 22

Figures Figure 1: The Year Universities First Received Equity in a Start-up 

Company 26
Contents

Page ii GAO-04-31 University Research

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

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. It may be reproduced and distributed in its entirety without further 

permission from GAO. However, because this work may contain copyrighted images or 

other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately.
Page 1 GAO-04-31 University Research

United States General Accounting Office

Washington, D.C. 20548

A

November 14, 2003 Letr

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 longterm, 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 BayhDole 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 
Page 2 GAO-04-31 University Research

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,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 

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 

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. 
Page 3 GAO-04-31 University Research

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 
Page 4 GAO-04-31 University Research

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 2001,2

 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 

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.
Page 5 GAO-04-31 University Research

companies that were formed around university-licensed technology.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-110.4

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.5

 Specifically, the NIH and NSF 

standards require that funding recipients implement policies for 

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.) 
Page 6 GAO-04-31 University Research

(1) scientists to disclose any “significant financial interests”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. 

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.
Page 7 GAO-04-31 University Research

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. 
Page 8 GAO-04-31 University Research

Table 1: Federal Agencies’ Policies on Disseminating Research Results

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.

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 

Agency Policy Citation

Agriculture The principal investigator is expected to publish or otherwise make 

publicly available the results of the work conducted under this award.

Cooperative State Research, Education, 

and Extension Service General Terms 

and Conditions

Defense Publication of results of the research project in appropriate professional 

journal is encouraged as an important method of recording and reporting 

scientific information.

Office of Naval Research

Research Terms and Conditions

The recipient is expected to publish or otherwise make publicly available 

the results of the work conducted under this agreement.

Air Force Office of Scientific Research

Grant Terms and Conditions

Education Grantees are encouraged to publish the results of the work conducted 

under this award.

Individual grant agreementsa

Energy Recipients are encouraged to disseminate results promptly to the 

scientific community. 

Office of Science, Grant Application Guide 

Reporting Requirements

EPA EPA encourages the independent publication of the results of its 

extramural research in appropriate scientific journals.

National Center for Environmental 

Research Terms and Conditions

NASA 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.

Guidebook for Proposers Responding to a 

NASA Research Announcement

NIH [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.

NIH Grants Policy Statement and Final 

NIH Research Tools Policy (Dec. 23, 

1999)

Final NIH Statement on Sharing Research 

Data (Feb. 26, 2003)

NSF 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. 

NSF Grants Policy Manual
Page 9 GAO-04-31 University Research

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.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. 

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).
Page 10 GAO-04-31 University Research

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.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 

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. 

8

The organic statutes for Energy and NASA call for them to widely disseminate the results of 

research that they fund. 

Agency Web-based information system Information posted

Agriculture Current Research Information System Annual and final technical 

reports

Defense Defense Technical Information Center Final technical reports

Energy Information Bridge Final technical reports

EPA National Center For Environmental 

Research

Annual and final report 

summaries

NASA Scientific and Technical Aerospace 

Reports File

Abstract of final technical 

reports
Page 11 GAO-04-31 University Research

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 
Page 12 GAO-04-31 University Research

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.
Page 13 GAO-04-31 University Research

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 nonfederal entity, or funded by the institution itself, should be managed by the 

same conflict of interest process and treated the same.” 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 

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.
Page 14 GAO-04-31 University Research

or NSF, but not to research funded by other federal agencies.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. 

10Universities 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. 
Page 15 GAO-04-31 University Research

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.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 

11S. 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.
Page 16 GAO-04-31 University Research

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.
Page 17 GAO-04-31 University Research

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.
Page 18 GAO-04-31 University Research

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.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 Webbased survey of the 200 universities and colleges that received the most 

federal research funding in fiscal year 2000. The survey contained 42 

12See 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).
Page 19 GAO-04-31 University Research

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 

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 http://www.gao.gov.
Page 20 GAO-04-31 University Research

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
Page 21 GAO-04-31 University Research

Appendix I

Agencies’ Actions in Implementing the Shelby Apendxies

Amendment ApendxiI

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.1

 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 

1

OMB Circular A-110 establishes uniform administrative requirements for grants and 

agreements with institutions of higher education, hospitals, and other nonprofit 

organizations.
Appendix I

Agencies’ Actions in Implementing the 

Shelby Amendment

Page 22 GAO-04-31 University Research

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 Request date Response date Agency disposition

NIH

1 Nov. 4, 1999 Apr. 29, 2002 Request was withdrawn

2 Nov. 5, 1999 Pending Not applicable because the projects for which data are sought were funded 

before the effective date (April 2000)

3 Jan. 20, 2000 July 3, 2000 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

4 Feb. 1, 2000 June 9, 2000 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

5 Feb. 1, 2000 July 18, 2000 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

6 Feb. 1, 2000 Apr. 17, 2000 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

7 Feb. 29, 2000 Aug. 2, 2000 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

8 Mar. 31, 2000 Mar. 31, 2000 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

9 May 16,2000 June 23, 2000 Request was withdrawn

10 June 28, 2000 July 6, 2000 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

11 Aug. 4, 2000 Dec. 14, 2000 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
Appendix I

Agencies’ Actions in Implementing the 

Shelby Amendment

Page 23 GAO-04-31 University Research

12 Dec. 20, 2000 Dec. 26, 2000 Not applicable because the grants for which data were sought were funded 

before April 2000, the effective date of the NIH regulation

13 Jan. 19, 2001 Feb. 28, 2001 Not applicable because requester sought only a copy of the funded grant 

application, not data

14 Aug. 27, 2001 Nov. 15, 2001 Not applicable because requester sought only a copy of the funded grant 

application, not data

15 Oct. 16, 2001 May 30, 2002 Not applicable because the grants for which data were sought were funded 

before April 2000, the effective date of the NIH regulation

16 Oct. 16, 2001 Pending Not applicable because the projects for which data are sought were funded 

before April 2000, the effective date of the NIH regulation

17 Jan. 14, 2002 Feb. 11, 2002 Not applicable because requester sought only a copy of the funded grant 

application, not data

18 Mar. 20, 2002 Apr. 18, 2002 Not applicable because requester sought only a copy of the funded grant 

application, not data

19 Apr. 1, 2002 June 14, 2002 Not applicable because the grants for which data were sought were funded 

before April 2000, the effective date of the NIH regulation

20 June 17, 2002 July 18, 2002 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

21 June 24, 2002 Pending Not applicable because requester sought only copies of funded grant 

applications, not data

22 June 24, 2002 July 22,2002 Not applicable because requester sought only a copy of the funded grant 

application, not data

23 July 2, 2002 Pending Not applicable because requester sought only a copy of the funded grant 

application, not data

24 July 25, 2002 Aug. 21, 2002 Not applicable because requester sought only a copy of the funded grant 

application, not data

25 Aug. 29, 2002 Pending Not applicable because requester sought only a copy of the funded grant 

application, not data

26 Sept. 27, 2002 Oct. 2, 2002 Not applicable because requester sought only copies of funded grant 

applications, not data

27 Oct. 3, 2001 Nov. 7, 2002 Not applicable because requester sought only copies of funded grant 

applications, not data

28 Oct. 28, 2002 Feb. 6, 2003 Not applicable because the grant for which data were sought was funded 

before April 2000, the effective date of the NIH regulation

29 Dec. 12, 2002 Sept. 15, 2003 Not applicable because requester sought only copies of funded grant 

applications, not data

30 Jan. 9, 2003 July 21, 2003 Request was withdrawn

31 Feb. 3, 2003 Feb. 20, 2003 Not applicable because requester sought only a copy of contract records, not 

data

32 June 23, 2003 Aug. 18, 2003 Not applicable because requester sought only a copy of a funded grant 

application, not data

(Continued From Previous Page)

Request Request date Response date Agency disposition
Appendix I

Agencies’ Actions in Implementing the 

Shelby Amendment

Page 24 GAO-04-31 University Research

Sources: NIH and EPA.

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.2

 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.3

 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 

33 June 27, 2003 Sept. 26, 2003 Not applicable because requester sought only a copy of a funded grant 

application, not data

34 July 28, 2003 Not applicable Request was withdrawn

35 July 28, 2003 Aug. 28, 2003 Not applicable because requester sought only copies of funded grant 

applications, not data

36 July 28, 2003 Pending Not applicable because requester sought only copies of funded grant 

applications, not data

37 Aug. 1, 2003 Sept. 5, 2003 Not applicable because requester sought only a copy of a funded grant 

application, not data

38 Aug. 1, 2003 Pending Not applicable because requester sought only a copy of a funded grant 

application, not data

39 Aug. 10, 2003 Pending Not applicable because requester sought only a copy of a funded grant 

application, not data

40 Aug. 19, 2003 Sept. 3, 2003 Not applicable because the grants for which data were sought were funded 

before April 2000, the effective date of the NIH regulation

EPA

1 Dec. 9, 1999 April 24, 2001 Not applicable because the projects for which data were sought were funded 

before the effective date

2 Dec. 9, 1999 April 24, 2001 Not applicable because the projects for which data were sought were funded 

before the effective date

(Continued From Previous Page)

Request Request date Response date Agency disposition

2

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.

3

The proposed guidelines define significant regulatory information to exclude most routine 

statistical and financial information; studies that have already been adequately peerreviewed; and science that is not directed toward regulatory issues, such as most of the 

scientific research conducted by NIH and NSF.
Appendix I

Agencies’ Actions in Implementing the 

Shelby Amendment

Page 25 GAO-04-31 University Research

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.
Page 26 GAO-04-31 University Research

Appendix II

Universities’ Acceptance of Equity in Start-up 

Companies ApendxiI

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 

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 
Appendix II

Universities’ Acceptance of Equity in Startup Companies

Page 27 GAO-04-31 University Research

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.
Page 28 GAO-04-31 University Research

Appendix III

Comparison of NIH’s and NSF’s Financial 

Conflict of Interest Standards ApendxiI

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.
Appendix III

Comparison of NIH’s and NSF’s Financial 

Conflict of Interest Standards

Page 29 GAO-04-31 University Research

• 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.1

• 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.

1

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.
Appendix III

Comparison of NIH’s and NSF’s Financial 

Conflict of Interest Standards

Page 30 GAO-04-31 University Research

• 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.
Page 31 GAO-04-31 University Research

Appendix IV

Comments from the Department of Education ApendxiIV
Page 32 GAO-04-31 University Research

Appendix V

Comments from the National Aeronautics and 

Space Administration ApendxiV
Page 33 GAO-04-31 University Research

Appendix VI

Comments from the National Institutes of 

Health ApendxiVI

(360240)
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