Federal Research
NIH and EPA Need to Improve Conflict of Interest Reviews for Research Arrangements with Private Sector Entities Gao ID: GAO-05-191 February 25, 2005An institute at the National Institutes of Health (NIH) and an office in the Environmental Protection Agency (EPA) entered into collaborative arrangements with the American Chemistry Council (ACC) to support research on the health effects of chemical exposures. NIH accepted a gift from ACC to help fund the research. EPA and ACC funded their proposals separately. The arrangements raised concerns about the potential for ACC to influence research that could affect the chemical industry. GAO determined the agencies' legal authorities to enter into the arrangements; the extent to which the agencies evaluated and managed potential conflicts of interest resulting from these arrangements; the extent to which the NIH institute complied with NIH's gift acceptance policy; and the extent to which NIH, EPA, and other agencies have similar arrangements.
NIH's National Institute of Environmental Health Sciences (NIEHS) used the authorities granted to NIH's institutes and centers under sections of the Public Health Service Act to enter into its arrangement with ACC. Similarly, EPA's Office of Research and Development (ORD) relied on authorities granted to EPA under sections of the Clean Air Act, the Clean Water Act, and the Solid Waste Disposal Act to enter into its research arrangement. Nothing in these statutes appears to prohibit either agency from entering into research arrangements with nonprofit organizations such as ACC. NIEHS and ORD did not formally evaluate the potential for conflicts of interest with ACC before they entered into the arrangements, but both agencies took steps to manage the potential as the arrangements were implemented. NIH and EPA had no specific policies requiring officials to evaluate or manage potential conflicts of interest when they entered into the ACC arrangements, nor do they currently have such policies. Although no formal evaluation occurred, agency officials managed the arrangements through their existing research management processes. Both agencies believe these actions helped mitigate the potential for undue influence by ACC and adequately protected the integrity of the scientific research conducted under the arrangements. Because the agencies' research management processes were not designed to address conflict of interest issues they are not a substitute for a formal evaluation of such conflicts. Without policies requiring a formal evaluation and management of conflicts, there is no assurance that similar arrangements will be appropriately evaluated and managed for such conflicts in the future. NIEHS officials complied with portions of NIH's gift acceptance policy that guide the acknowledgement and administration of gifts. However, the policy's guidance on evaluating and managing potential conflicts is extremely broad, and it lacks clarity and consistency. As a result, the policy gives officials wide discretion in this area. In addition, the policy does not require the agency to document the basis for its decisions. Consequently, the policy does not provide sufficient assurance that potential conflicts of interest between NIH and donor organizations will be appropriately considered. While some institutes and centers at NIH had arrangements somewhat similar to the ACC arrangements, GAO did not find any similar arrangements at other program offices at EPA or at the Food and Drug Administration and the Federal Aviation Administration--two other agencies with significant research budgets. None of the nine research arrangements GAO found at NIH institutes and centers involve organizations that represent industry in the same direct manner that ACC represents the chemical industry.
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-05-191, Federal Research: NIH and EPA Need to Improve Conflict of Interest Reviews for Research Arrangements with Private Sector Entities
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Report to Ranking Members, Subcommittee on Environment, Technology and
Standards and Subcommittee on Research, Committee on Science, House of
Representatives:
February 2005:
Federal Research:
NIH and EPA Need to Improve Conflict of Interest Reviews for Research
Arrangements with Private Sector Entities:
GAO-05-191:
GAO Highlights:
Highlights of GAO-05-191, a report to congressional requesters:
Why GAO Did This Study:
An institute at the National Institutes of Health (NIH) and an office
in the Environmental Protection Agency (EPA) entered into collaborative
arrangements with the American Chemistry Council (ACC) to support
research on the health effects of chemical exposures. NIH accepted a
gift from ACC to help fund the research. EPA and ACC funded their
proposals separately. The arrangements raised concerns about the
potential for ACC to influence research that could affect the chemical
industry. GAO determined the agencies‘ legal authorities to enter into
the arrangements; the extent to which the agencies evaluated and
managed potential conflicts of interest resulting from these
arrangements; the extent to which the NIH institute complied with NIH‘s
gift acceptance policy; and the extent to which NIH, EPA, and other
agencies have similar arrangements.
What GAO Found:
NIH‘s National Institute of Environmental Health Sciences (NIEHS) used
the authorities granted to NIH‘s institutes and centers under sections
of the Public Health Service Act to enter into its arrangement with
ACC. Similarly, EPA‘s Office of Research and Development (ORD) relied
on authorities granted to EPA under sections of the Clean Air Act, the
Clean Water Act, and the Solid Waste Disposal Act to enter into its
research arrangement. Nothing in these statutes appears to prohibit
either agency from entering into research arrangements with nonprofit
organizations such as ACC.
NIEHS and ORD did not formally evaluate the potential for conflicts of
interest with ACC before they entered into the arrangements, but both
agencies took steps to manage the potential as the arrangements were
implemented. NIH and EPA had no specific policies requiring officials
to evaluate or manage potential conflicts of interest when they entered
into the ACC arrangements, nor do they currently have such policies.
Although no formal evaluation occurred, agency officials managed the
arrangements through their existing research management processes. Both
agencies believe these actions helped mitigate the potential for undue
influence by ACC and adequately protected the integrity of the
scientific research conducted under the arrangements. Because the
agencies‘ research management processes were not designed to address
conflict of interest issues they are not a substitute for a formal
evaluation of such conflicts. Without policies requiring a formal
evaluation and management of conflicts, there is no assurance that
similar arrangements will be appropriately evaluated and managed for
such conflicts in the future.
NIEHS officials complied with portions of NIH‘s gift acceptance policy
that guide the acknowledgement and administration of gifts. However,
the policy‘s guidance on evaluating and managing potential conflicts is
extremely broad, and it lacks clarity and consistency. As a result, the
policy gives officials wide discretion in this area. In addition, the
policy does not require the agency to document the basis for its
decisions. Consequently, the policy does not provide sufficient
assurance that potential conflicts of interest between NIH and donor
organizations will be appropriately considered.
While some institutes and centers at NIH had arrangements somewhat
similar to the ACC arrangements, GAO did not find any similar
arrangements at other program offices at EPA or at the Food and Drug
Administration and the Federal Aviation Administration”two other
agencies with significant research budgets. None of the nine research
arrangements GAO found at NIH institutes and centers involve
organizations that represent industry in the same direct manner that
ACC represents the chemical industry.
What GAO Recommends:
GAO recommends, among other things, that NIH and EPA develop formal
policies for evaluating and managing conflicts of interest when
entering into research arrangements with nongovernmental partners,
particularly those representing a regulated industry, and that NIH
revise its gift policy to require conflict of interest evaluations and
documentation of decisions.
www.gao.gov/cgi-bin/getrpt?GAO-05-191.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Anu Mittal at (202)
5123841or Mittala@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
NIEHS and ORD Used Broad Legal Authority to Support Their Arrangements
with ACC:
NIEHS and ORD Did Not Formally Evaluate, but Took Steps to Manage, the
Potential for Conflicts of Interest in Their Arrangements with ACC:
NIEHS Generally Complied with NIH's Gift Acceptance Policy, but the
Policy Cannot Provide Assurance that Conflicts of Interest Are
Evaluated and Managed:
Research Arrangements Such as Those with the American Chemistry Council
Are Not Widely Used:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendixes:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Comments from the Environmental Protection Agency:
Appendix III: Comments from the National Institutes of Health:
Appendix IV: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Staff Acknowledgments:
Table:
Table 1: NIH Arrangements with Nonprofit Partners for Cosponsoring
Research, 1999-2004:
Figure:
Figure 1: Four Agencies' Funding Devoted to Intramural and Extramural
Research, Fiscal Year 2002:
Abbreviations:
ACC: American Chemistry Council:
EPA: Environmental Protection Agency:
FAA: Federal Aviation Administration:
FDA: Food and Drug Administration:
NIEHS: National Institute of Environmental Health Sciences:
NIH: National Institutes of Health:
ORD: Office of Research and Development:
Letter February 25, 2005:
The Honorable Mark Udall:
Ranking Member:
Subcommittee on Environment, Technology and Standards:
Committee on Science:
House of Representatives:
The Honorable Eddie Bernice Johnson:
Ranking Member, Subcommittee on Research:
Committee on Science:
House of Representatives:
In fiscal year 2002, the federal government devoted an estimated $45
billion to research, $35 billion of which funded research conducted by
universities, industry, nonprofit organizations and state and local
governments.[Footnote 1] Some agencies fund this extramural research
through direct federal grants to or contracts with researchers, which
are generally considered an effective way to encourage federal and
nonfederal research partnerships. Other agencies collaborate with
governmental and nongovernmental organizations to solicit and/or fund
extramural research proposals, and in some cases have the authority to
accept money from their partners to support the research.[Footnote 2]
These collaborative arrangements have taken the form of cooperative
agreements or memorandums of understanding with external research
partners. The American Chemistry Council (ACC)--a nonprofit
organization that represents the chemical industry--has entered into
two such research arrangements; one with the National Institute of
Environmental Health Sciences (NIEHS) in the National Institutes of
Health (NIH), and the other with the Office of Research and Development
(ORD) in the Environmental Protection Agency (EPA). Since ACC
represents chemical companies that are regulated by the federal
government, these arrangements have raised concerns that ACC or its
members could potentially influence, or appear to influence, the
scientific results that may be used to make future regulatory
decisions.[Footnote 3]
In 2001, ACC entered into an arrangement with NIEHS to solicit and fund
research on the effects of environmental chemicals on human
reproduction and development. Under the arrangement, NIEHS, which has
authority to accept gifts from external organizations, accepted funds
from ACC to support the research.[Footnote 4] In 2003, ACC entered into
a similar arrangement with ORD to solicit and fund research; under this
arrangement the first solicitation for research proposals focused on
novel approaches to analyzing existing data on human exposure to
chemicals.[Footnote 5] In the absence of authority allowing EPA to
accept gifts, ORD and ACC solicited proposals jointly but funded
selected research proposals separately. A goal of both research
arrangements is to provide scientific tools or knowledge that will
ultimately help improve the effectiveness of human health and
ecological risk assessments.
In the context of these two arrangements, you asked us to determine the
(1) legal authority NIEHS and ORD used to enter into the arrangements
with ACC; (2) extent to which NIEHS and ORD evaluated and managed the
possibility that conflicts of interest could result from their
arrangements with ACC; (3) extent to which NIEHS complied with NIH's
gift acceptance policy when accepting ACC's funds; and (4) extent to
which similar research arrangements exist within other offices and
programs of NIH and EPA, as well as other regulatory agencies.
To identify the legal authority each agency used to enter into
collaborative research arrangements with ACC, we reviewed the
authorities cited in each agency's arrangement, as well as the related
legislative histories and policies at NIH and EPA. We also interviewed
program and legal staff at the agencies. To ascertain the extent to
which NIEHS and ORD evaluated and managed the potential that conflicts
of interest could result from their research arrangements with ACC, we
reviewed agency policy and documents relevant to the ACC arrangements
and interviewed senior officials. To determine the extent to which
NIEHS complied with the NIH gift acceptance policy, we reviewed the
policy and related documentation and interviewed senior NIEHS officials
and NIH legal advisors. To determine the prevalence of similar research
arrangements, we interviewed officials within NIH and EPA. In addition,
we contacted officials at the Food and Drug Administration (FDA) and
the Federal Aviation Administration (FAA), both of which, like EPA, are
regulatory agencies that have significant extramural research budgets.
We interviewed officials responsible for 96 percent or more of each
agency's extramural research dollars and reviewed research arrangements
that have been signed since January 1999. We conducted our review from
March 2004 through February 2005 in accordance with generally accepted
government auditing standards. The details of our scope and methods can
be found in appendix I.
Results in Brief:
NIEHS used the authorities granted to NIH's institutes and centers
under sections of the Public Health Service Act to enter into its
arrangement with ACC. Similarly ORD relied on authorities granted to
EPA under sections of the Clean Air Act, the Clean Water Act, and the
Solid Waste Disposal Act to enter into its research arrangement with
ACC. These statutes, among other things, provide broad authority to
both agencies to collaborate with external organizations in support of
research. For example, the Public Health Service Act, as amended,
authorizes NIH and its institutes and centers to cooperate in, assist,
and promote the coordination of research on the causes, diagnosis,
treatment, control, and prevention of physical and mental diseases.
Similarly, the Clean Air Act, as amended; the Clean Water Act, as
amended; and the Solid Waste Disposal Act, as amended, authorize EPA to
promote the coordination and acceleration of research on the causes,
effects, extent, prevention, reduction, and elimination of pollution.
Nothing in these statutes appears to prohibit either agency from
entering into research arrangements with nonprofit organizations such
as ACC.
NIEHS and ORD did not formally evaluate the potential for conflicts of
interest with ACC before they entered into the arrangements, but both
agencies took several steps to manage the potential for conflicts of
interest that could occur as the arrangements were implemented. Neither
NIH nor EPA had formal policies that required officials to evaluate or
manage potential conflicts of interest when they entered into the
collaborative research arrangements, nor do they currently have such
policies. As a result, no formal evaluation occurred. In the absence of
formal policies to manage potential conflicts of interest, officials at
both agencies relied on their existing research management processes to
implement these research arrangements. According to these officials,
the agencies' existing research management processes helped mitigate
the potential for undue influence by ACC and helped protect the
integrity of the scientific research to be carried out under these
arrangements. For example, agency officials told us that NIEHS and ORD
established the scientific topics that would be the focus of the
research through routine agency planning processes before they entered
into the ACC arrangements. These processes involved significant input
from a range of stakeholders, and the agency-established research
priorities did not change after the arrangements with ACC were
implemented. Similarly, the opportunity to apply for funding under the
research arrangements was widely announced within the research
community, and the funding of research proposals was competitively
awarded only after the proposals had been independently peer reviewed
for their scientific merit. Furthermore, ORD officials told us that
they took additional steps that they believe helped manage the
potential for conflicts of interest. For example, ORD sought public
input on the terms and conditions of its research arrangement with ACC.
The processes that the agencies used to mitigate potential conflicts of
interest were appropriate for managing and implementing the research
arrangements with ACC but cannot substitute for a formal conflict of
interest evaluation. This is because these processes were not designed
to specifically address conflict of interest issues. Formal policies
requiring the evaluation and management of conflicts of interest would
help the agencies ensure that potential conflicts in future research
arrangements will be appropriately addressed. Therefore, we are
recommending that NIH and EPA establish formal policies for evaluating
potential conflicts of interest when entering into research
arrangements with nongovernmental partners (particularly those that
represent regulated industry), and for managing these conflicts as the
agencies implement these arrangements.
NIEHS officials complied with sections of NIH's gift acceptance policy
for acknowledging and administering gifts, but the policy's guidance on
evaluating and managing potential conflicts of interest is so broad
that it allows officials to satisfy its requirements with a wide array
of actions. As a result, the policy does not provide sufficient
assurance that potential conflicts of interest between NIH and donor
organizations will be appropriately considered before a gift is
accepted. Specifically, the policy is inconsistent on whether and how
to evaluate potential conflicts of interest. As a result, agency
officials have wide discretion in deciding how to comply with the
policy. In addition, the policy does not require the agency to document
any conflict-of-interest evaluations or the basis for deciding whether
to accept or reject a gift. For example, the NIEHS official who decided
to accept the ACC gift stated that he was concerned that accepting
funds from ACC might create an apparent conflict of interest. However,
he believed that his informal and undocumented consultations with other
NIH officials and two representatives from external organizations
satisfied the NIH policy. Other senior NIEHS officials also told us
they had concerns about accepting funds from ACC. However, in referring
the arrangement to the NIH Legal Advisor's Office for review, these
officials said they did not specifically request a determination of
whether the gift would constitute a conflict of interest because the
policy did not require them to do so. Consequently, the NIH counsel
conducted a more general legal review. Since NIEHS entered into the ACC
arrangement, NIH has revised its gift acceptance policy. However, these
revisions have not eliminated the inconsistency nor do they require
agency officials to document the basis for their decisions. We are
recommending that NIH further revise its gift acceptance policy to
clarify how officials are to evaluate gifts for potential conflicts of
interest, particularly from organizations that represent regulated
industry, and require the officials to document the basis for their
decisions, including what, if any, steps are needed to manage potential
conflicts of interest.
While some institutes and centers at NIH had arrangements somewhat
similar to the ACC arrangements, we did not find any similar
arrangements at the regulatory agencies we reviewed: EPA, FDA, and FAA.
We found nine signed research arrangements at NIH institutes and
centers that share some, but not all, of the characteristics of the ACC
arrangements. For example, all nine are formal arrangements with
nonprofit organizations to jointly sponsor extramural research.
However, none of the arrangements involve organizations that represent
a regulated industry in the same direct manner that ACC represents the
chemical industry, although several of the nonprofit partners have at
least some corporate sponsorship. For example, the Juvenile Diabetes
Research Foundation has a research arrangement with the National
Institute of Neurological Disorders and Stroke to support extramural
research into the neurobiology of diabetic complications. One of the
corporate sponsors of the Juvenile Diabetes Research Foundation is an
airline company, not an entity with any material connection to the
outcome of the research.
In commenting on a draft of this report, EPA did not indicate whether
it agreed or disagreed with our recommendation but provided technical
comments that we have incorporated as appropriate. NIH agreed to
implement our recommendations and also provided technical comments that
we have incorporated as appropriate. EPA's comments are provided in
appendix II, and NIH's comments are provided in appendix III.
Background:
Many federal agencies fund research to serve their goals and
objectives. For example, NIH, the largest source of federal support for
nondefense research, is the federal focal point for medical and
behavioral research to help extend healthy life and reduce illness and
disability. Each of the 27 institutes and centers that constitute NIH
has an explicit mission focused on a particular disease, organ system,
stage of development, or a cross-cutting mission, such as developing
research tools. Other agencies, such as EPA, FDA, and FAA, support
research, in part, to further scientific understanding that may in the
future better inform their regulatory decisions. Nineteen offices
within EPA conduct and/or support research to help carry out the
regulatory aspect of the agency's mission to protect human health and
the environment and to implement environmental laws.[Footnote 6]
Similarly, FDA relies on research to help identify and assess risks and
to serve as the basis for regulatory decisions about such issues as
human and veterinary drugs, medical devices, and the nation's food
supply. Finally, FAA, which enforces regulations and standards for the
manufacture, operation, and maintenance of aircraft, conducts research
to help ensure a safe and efficient system of air navigation and air
traffic control.
Federal research can be conducted by scientists in government
laboratories--called intramural research--or by scientists at
universities, in industry, or at nonprofit organizations--called
extramural research. In fiscal year 2002, NIH, EPA, FDA, and FAA
devoted a total of about $23 billion to intramural and extramural
research. (See fig. 1.) Together, these four agencies accounted for
about 50 percent of the federal funds devoted to research.
Figure 1: Four Agencies' Funding Devoted to Intramural and Extramural
Research, Fiscal Year 2002:
[See PDF for image]
[End of figure]
Federal laws have created an environment conducive to a full range of
joint ventures between government and industry, or between industry and
universities, as well as among companies. Specifically, through
collaboration, federal and nonfederal partners attempt to share the
costs, risks, facilities, and expertise needed for research and to
promote the movement of ideas and technologies between the public and
private sectors. This cooperation between federal and private sector
researchers may take many forms. Through informal cooperation, for
example, federal agencies and industry may coordinate and share
research agendas to prevent duplication of effort, or agency and
private sector scientists may consult one another. Through formal
cooperation, federal and nonfederal partners use written agreements,
such as contracts or memorandums of understanding, to define the roles
and responsibilities of each party. However, each type of arrangement
differs in the extent of federal involvement in the research conducted
under the agreement. Generally, work conducted under contracts is
directed and overseen by federal agencies that do not participate in
the work. In contrast, memorandums of understanding allow great
flexibility in terms of participation by federal agencies and may also
allow for sharing of resources or the funding of research by nonfederal
partners.
Congress may provide federal agencies the authority to accept gifts
from external sources. For example, under the Public Health Service
Act, certain agencies, such as NIH, may accept funds or nonmonetary
gifts to support their research efforts or other agency functions.
Under the act, donors may stipulate how agencies may use their gifts,
for example, to only support research on a specific disease or
condition, or they may allow the agency to use the gift for the benefit
of any effort without stipulations. An agency's statutory authority to
accept donations is called its "gift acceptance authority."
In 2001 and 2003, NIEHS and ORD, respectively, entered into research
arrangements with ACC to solicit and fund extramural research
proposals. These arrangements specified how research proposals would be
solicited, reviewed, funded, and overseen. Specifically, under the
NIEHS-ACC arrangement, ACC and NIEHS agreed to support a 3-year
research program to study the effects on reproduction and development
of exposure to chemicals in the environment. ACC provided a gift of
$1.05 million to NIEHS to fund this research, and NIEHS contributed
$3.75 million to the project. Using the combined funds, NIEHS awarded a
total of 17 research proposals from among the 52 it received. The
program ended in 2004. Under the ORD-ACC arrangement, ACC and ORD
agreed to support and fund research, with the first solicitation for
research proposals focusing on novel approaches to analyzing existing
human exposure data. In response to this first announcement of funding
availability, issued in July 2003, 36 research proposals were
submitted. ORD funded four research proposals, for a total of about
$1.7 million, and ACC funded two proposals, for a total of about $1
million. ORD and ACC separately funded the research proposals that each
had selected under this arrangement because EPA does not have the
authority to accept contributions from outside sources. Researchers
could specify whether they wanted their proposals considered for
funding solely by ORD or by either ORD or ACC.[Footnote 7]
ACC is a nonprofit trade organization representing most major U.S.
chemical companies.[Footnote 8] It represents the chemical industry on
public policy issues, coordinates the industry's research and testing
programs, and leads the industry's initiative to improve participating
companies' environmental, health, and safety performance. In 1999, ACC
launched a $100 million research initiative to study the potential
impacts of chemicals on human health and the environment and to help
improve screening and testing methods. A primary goal of the initiative
is to focus on projects or programs that might take advantage of work
planned or conducted by EPA, NIEHS, and other laboratories to stimulate
collaboration and/or to prevent unnecessary duplication.
Individuals or organizations can have conflicts of interest that arise
from their business or financial relationships. Typically, federal
conflict-of-interest laws and regulations govern the actions of
individual federal employees, including their financial interests in,
and business or other relationships with, nonfederal organizations.
Conflict-of-interest concerns about individual federal employees
typically arise when employees receive compensation from outside
organizations; such arrangements often require prior approval from the
federal employer. When a federal agency enters into a relationship
with, or accepts a gift from, a regulated company or industry, concerns
may arise about the agency's ability to fulfill its responsibilities
impartially.
NIEHS and ORD Used Broad Legal Authority to Support Their Arrangements
with ACC:
The statutory provisions that NIEHS and ORD relied upon to enter into
their arrangements with ACC grant the agencies broad authority to
collaborate with external organizations in support of research. Nothing
in these statutes appears to prohibit either agency from entering into
research arrangements with nonprofit organizations such as ACC.
NIEHS used the authorities granted to NIH's institutes and centers
under sections of the Public Health Service Act, as amended, to enter
into its arrangement with ACC (sections 301 and 405). The act
authorizes NIH and its institutes and centers to cooperate, assist, and
promote the coordination of research into the causes, diagnosis,
treatment, control, and prevention of physical and mental diseases. In
its research arrangement with ACC, NIEHS cited sections of the act as
the authority it relied on to enter into the arrangement. These
sections enumerate the general powers and duties of the Secretary of
Health and Human Services and the directors of the institutes and
centers in broad terms, including the authority to encourage and
support studies through grants, contracts, and cooperative agreements.
Similarly, ORD relied on broad authorities granted to EPA under
sections of the Clean Air Act, as amended; the Clean Water Act, as
amended; and the Solid Waste Disposal Act, as amended, to enter into
its research arrangement with ACC (sections 103, 104, and 8001,
respectively). These sections authorize EPA to promote the coordination
and acceleration of research relating to the causes, effects, extent,
prevention, reduction, and elimination of pollution in the air and
water, and from solid waste. These sections authorize the EPA
Administrator and other EPA officials to cooperate with appropriate
public and private agencies, institutions, organizations, and industry
to conduct research and studies.
NIEHS and ORD Did Not Formally Evaluate, but Took Steps to Manage, the
Potential for Conflicts of Interest in Their Arrangements with ACC:
NIEHS and ORD did not formally evaluate the possibility that
organizational conflicts of interest could result from their research
arrangements with ACC because neither agency had policies requiring
such evaluations. However, officials at both agencies took steps to
manage potential conflicts that might arise during implementation of
the arrangements.
NIEHS and ORD Did Not Formally Evaluate Potential Conflicts of Interest
that Could Result from Research Arrangements with ACC:
In 2001 and 2003, when they entered into arrangements with ACC, neither
NIH nor EPA had specific policies requiring officials to formally
evaluate potential conflicts of interest that could result from
entering into such collaborative arrangements. As a result, neither
NIEHS nor ORD conducted such evaluations. During negotiations with ACC
on their research arrangements, NIEHS and ORD officials recognized the
potential for organizational conflicts of interest, or at least the
appearance of such conflicts. However, in light of the lack of policies
on this issue, neither agency formally evaluated the potential for
conflicts before finalizing their arrangements with ACC. Instead,
officials told us, they informally evaluated the potential for
conflicts of interest and intended to manage potential conflicts that
might arise during implementation. To date, neither agency has
developed any such policy guidance.
NIEHS and ORD Relied on Existing Research Management Processes to Help
Mitigate Potential Conflicts of Interest:
In implementing their arrangements with ACC, NIEHS and ORD used their
general research management processes to help manage potential
conflicts of interest. These processes are designed to help ensure the
integrity of scientific research undertaken by these agencies.
According to agency officials, these processes helped guard against
undue influence of ACC by limiting ACC's participation in the
selection, review, and oversight of agency-funded research conducted
under the arrangements. For example:
* Developing research topics. Research priorities at both NIEHS and ORD
were identified through routine agency planning processes that involved
significant input from a range of stakeholders before the arrangements
with ACC were finalized. In addition, NIEHS included research topics
suggested by the National Research Council, a congressionally chartered
scientific advisory body. Both NIEHS and ORD then worked with ACC to
select the specific scientific topics that would become the focus of
the research conducted under the arrangements. According to NIEHS and
ORD officials, their arrangements with ACC did not change or influence
the agencies' research priorities. Because the research conducted under
these arrangements supported the agencies' existing research agendas,
officials believe that the ACC arrangements helped them effectively
leverage federal research dollars.
* Advisory council consultation. Both agencies have advisory panels
that they routinely consult on matters related to the conduct and
support of research, among other things.[Footnote 9] These
consultations include public sessions that allow interested
individuals, in addition to the panel members, to provide comments on
the topics discussed. NIEHS obtained approval from its National
Advisory Environmental Health Sciences Council before entering into the
arrangement with ACC. ORD did not specifically consult its Board of
Scientific Counselors regarding the agency's arrangement with ACC, but
did seek input from the Board regarding the research priorities covered
by the arrangement. Both advisory bodies were established under the
Federal Advisory Committee Act and must comply with the requirements of
the act as well as related regulations.
* Publicly announcing the availability of funds. Both NIEHS and ORD, in
2001 and 2003, respectively, announced the opportunity to apply for
grant funds available under the arrangements with ACC throughout the
scientific community. Both agencies announced the availability of
funding on their Web sites and included detailed information on the
research programs and how to apply for funds. Both agencies also posted
announcements in publications that are commonly used to advertise the
availability of federal funding. Specifically, NIEHS published an
announcement in the NIH Guide to Grants and Contracts, and ORD
published its announcement in the Catalog of Federal Domestic
Assistance. In addition, both agencies sent announcements to relevant
scientific and professional organizations and to interested scientists
who had signed up for electronic notice of funding opportunities. ORD
also published a notice in the Federal Register. By widely announcing
the availability of funds, the agencies hoped to ensure the
participation of many qualified researchers and to avoid the appearance
of preferential treatment for specific researchers. Moreover, widely
publicizing the availability of funds would help ensure the openness of
the agencies' research processes. However, the agencies differed in the
clarity of their instructions regarding how information would be shared
with ACC. For example, in the portion of the announcement labeled
"special requirements," NIEHS's announcement stated that applicants
"should," among other things, submit a letter allowing NIEHS to share
their proposals with ACC. According to NIEHS this wording was not
intended to be interpreted as a requirement but instead was intended to
be a request. We believe that the language could have confused
potential applicants about whether sharing information with ACC was
required and could have dissuaded some qualified applicants from
submitting proposals. In contrast, under the ORD-ACC arrangement,
researchers were clearly advised that they could elect to have their
proposals considered for funding by either ORD or ACC or solely by ORD.
Applicants who did not want to share their proposals with ACC could
elect to have their applications reviewed and considered solely by ORD.
* Determining completeness and responsiveness. Initially, NIEHS and ORD
reviewed all submitted research proposals for compliance with
administrative requirements. ACC did not participate in these reviews.
At both agencies, research proposals judged incomplete were to receive
no further consideration. NIEHS and ORD also had similar approaches for
determining the responsiveness of the applications to the goals of the
research program. At ORD, responsiveness was determined as part of the
agency's completeness review and did not involve ACC. Similarly, at
NIEHS, responsiveness was determined solely by agency officials.
Although NIEHS's announcement stated that ACC would participate in the
responsiveness review, NIEHS and ACC officials told us that ACC did not
take part in this review.
* Peer review of research proposals. At both NIEHS and ORD, complete
and responsive research proposals were independently peer reviewed for
technical and scientific merit. According to officials, each agency
followed its standard procedures for selecting experts to serve as peer
reviewers and excluded representatives of ACC from serving as
reviewers. At both agencies, only meritorious research proposals
qualified for funding decisions. Both agencies also subjected these
proposals to additional independent review. NIEHS's National Advisory
Environmental Health Sciences Council reviewed qualified proposals, and
ORD required other EPA staff to review research proposals that were
judged "excellent" or "very good" to help ensure a balanced research
portfolio responsive to the agency's existing research agenda.[Footnote
10] ACC convened its own technical panels to review qualified research
proposals to ensure the relevancy of the proposals to the industry's
research needs and to ensure that the proposals balanced its research
portfolio.
* Making results available to the public. NIEHS and ORD required--
without input from ACC--the results of the research funded under the
arrangements to be made public. For example, according to agency
officials, NIEHS and ORD required researchers to discuss their
preliminary findings in periodic public meetings, and, once their
projects were completed, both agencies required researchers to submit
their results for publication in peer-reviewed scientific
journals.[Footnote 11] In addition, NIEHS strongly encouraged
researchers to present their results at professional conferences and
workshops. Officials from both agencies agreed that publicizing the
results of research conducted under the arrangements helped ensure that
agency-sponsored research adhered to accepted analytic standards and
was unbiased.
ORD Took Additional Steps that Officials Believe Helped Manage
Potential Conflicts of Interest:
In addition to the routine research management processes, discussed in
the previous section, officials at ORD took further steps that they
believe helped them manage the potential for conflicts of interest in
their collaboration with ACC. Specifically:
* Research arrangement developed with public input. ORD publicly
announced that it might collaborate with ACC and invited public comment
on the terms and conditions of the proposed partnership. In addition,
ORD invited public comment on the draft announcement of the opportunity
to apply for funding. ORD officials told us that they believed an open
and public process to define the terms of ORD's collaboration with ACC
could help guard against real or perceived conflicts of interest.
* Membership of review panels. In addition to prohibiting ACC
representatives from serving as expert reviewers, ORD did not allow
employees of ACC member companies to serve on the peer review panels
that evaluated research proposals for technical and scientific merit.
ORD officials said this step helped minimize the perception that ACC or
its members could play a role in evaluating the scientific merit of
research proposals.
NIEHS Generally Complied with NIH's Gift Acceptance Policy, but the
Policy Cannot Provide Assurance that Conflicts of Interest Are
Evaluated and Managed:
When accepting funds from ACC under the research arrangement, NIEHS
officials complied with those sections of NIH's policy that guide the
acknowledgement and administration of gifts. However, the policy's
guidance on evaluating and managing potential conflicts is extremely
broad, lacking clarity and consistency. Consequently, officials have
wide discretion in deciding how to fulfill their responsibilities under
the gift acceptance policy. Further, the policy does not require
officials to document the basis of their decisions. As a result, the
gift policy does not provide the public sufficient assurance that
potential conflicts of interest between NIH and donor organizations
will be appropriately considered.
Specifically, NIH's gift acceptance policy outlines several steps that
officials must take to acknowledge and administer gifts. NIEHS
officials generally complied with these policy sections when accepting
the gift from ACC. For example, NIEHS officials acknowledged the
acceptance of ACC's gift in a timely manner, deposited the funds in
government accounts, and used the gift only for the purposes stipulated
by ACC. As the policy also requires, NIEHS obtained ACC's written
agreement that any remaining funds could be used to further NIH's goals
without additional stipulation.
However, other policy sections are inconsistent or unclear about what
actions officials must take to evaluate conflicts of interest when
accepting gifts--thereby affording officials wide discretion in
carrying out their responsibilities. For example, one part of the
policy in effect at that time and in subsequent revisions requires the
approving official to use two assessment tools to evaluate conflicts of
interest before accepting a gift, but another part of the policy states
that the use of these tools is recommended rather than required. The
Director of NIEHS, who had authority to accept the gift, said he was
acutely aware that accepting the ACC money could pose the potential for
real or apparent conflicts of interest. In light of his concerns, he
spoke informally with the Acting NIH Director, senior NIEHS officials,
NIH legal advisers, and senior officials from two external groups.
Through these discussions and using his professional judgment, the
NIEHS Director determined that accepting the ACC funds would not
present a conflict of interest for NIEHS. When he decided to accept the
ACC gift, the Director said that he was unaware of the assessment tools
recommended by NIH's policy. However, he believes the steps he and
other NIEHS officials took in accepting ACC's gift satisfied the gift
acceptance policy regarding conflicts of interest. Given the lack of
consistency in the policy sections that relate to conflicts of interest
and the use of the assessment tools, it is difficult for us to
determine whether the actions the director took complied with the NIH
policy. Moreover, without documentation of his actions, we could not
determine whether the steps he took were adequate to evaluate the
potential for conflicts of interest.
Furthermore, the policy in effect at that time and in subsequent
revisions does not provide clear guidance on what type of coordination
should occur between NIH offices in evaluating the potential for
conflicts of interest when accepting a gift. For example, several NIEHS
staff were concerned that the proposed ACC gift could result in an
apparent conflict of interest and, consistent with NIH's gift policy,
forwarded the written agreement to the NIH Legal Advisor's Office for
review. However, the gift policy does not require staff to identify
their concerns when seeking legal advice. According to these officials,
in referring the agreement to NIH attorneys for review, they did not
specifically request a determination of whether the gift would
constitute a conflict of interest. As a result, the NIH attorneys
conducted a general legal review of the gift and the proposed research
arrangement, focusing primarily on the agency's legal authority to
enter into the arrangement. NIH legal staff told us that they could
have provided assistance on conflict-of-interest issues had they been
notified that the program staff had such concerns, or if in their view,
the gift or written agreement had contained clauses that were obviously
illegal or contrary to NIH policy. If the policy had been clearer about
how conflict of interest concerns are to be communicated to NIH
attorneys, we believe the legal staff would have conducted a conflict-
of-interest review.
Finally, NIH's policy does not require officials to document how they
have addressed conflict-of-interest concerns. Neither the NIEHS
Director nor other senior NIH officials documented their consideration
of potential conflicts of interest when accepting the ACC gift. The
lack of documentation, coupled with the broad discretion resulting from
the inconsistency and lack of clarity in the policy, allows officials
to satisfy requirements with a wide array of actions, ranging from a
formal evaluation to a highly informal one.
Research Arrangements Such as Those with the American Chemistry Council
Are Not Widely Used:
At NIH, we identified nine arrangements that were somewhat comparable
to the ACC research arrangements, but we did not identify any similar
arrangements at ORD, other EPA program offices, FDA, or FAA.[Footnote
12] None of the nonprofit partners in the nine research arrangements we
found at NIH represents industry in the same direct manner that ACC
represents the chemical industry. However, some of the nonprofit
partners have either general corporate sponsorship or corporate
sponsorship for specific events. For example, sponsors of the
Parkinson's Unity Walk in 2004 included pharmaceutical companies. The
sponsors helped defray operating expenses to ensure that all proceeds
from the walk supported Parkinson's research. Likewise, the Juvenile
Diabetes Research Foundation received corporate sponsorship from an
airline company, manufacturers of soft drinks and household products,
and others, none of whom had any material connection to the outcome of
the research. One nonprofit partner is a corporation's philanthropic
foundation.
At NIH, we found a total of 11 institutes and centers--either singly or
with other institutes and centers--that had entered into research
arrangements with one or more nonprofit partners. Under the terms of
four of the arrangements, NIH accepted gift funds from nonprofit
partners to support the research described in the arrangements. In four
other arrangements, when NIH institutes or centers lacked sufficient
money to fund all the research proposals rated highly by peer review
panels, they forwarded the research proposals to their nonprofit
partner(s) for possible funding. (See table 1 for details on the NIH
arrangements.)
Table 1: NIH Arrangements with Nonprofit Partners for Cosponsoring
Research, 1999-2004:
Purpose of arrangement: "Progress for Patients" project on early phase
clinical interventions in breast cancer;
NIH partner: National Cancer Institute;
Nonprofit partner: Avon Products Foundation;
Nonprofit partner's corporate or industry connection: Philanthropic arm
of Avon Corporation;
Plan for funding research: NIH accepted gift funds.
Purpose of arrangement: Research on the neurobiology of diabetic
complications;
NIH partner: National Institute of Neurological Disorders and Stroke,
National Institute of Diabetes and Digestive and Kidney Diseases;
Nonprofit partner: Juvenile Diabetes Research Foundation International;
Nonprofit partner's corporate or industry connection: Sponsorship by
Proctor & Gamble, Coca Cola, Delta Airlines, and others;
Plan for funding research: NIH accepted gift funds.
Purpose of arrangement: Support for infrastructure and research at
Islet Cell Resource Centers;
NIH partner: National Center for Research Resources;
Nonprofit partner: Juvenile Diabetes Research Foundation International;
Nonprofit partner's corporate or industry connection: Sponsorship by
Proctor & Gamble, Coca Cola, Delta Airlines, and others;
Plan for funding research: NIH accepted gift funds.
Purpose of arrangement: Research relevant to the cure, prevention, and
treatment of Parkinson's disease and its complications;
NIH partner: National Institute of Neurological Disorders and Stroke,
National Institute of Deafness and Other Communication Disorders,
NIEHS, National Institute of Mental Health;
Nonprofit partner: Parkinson's Unity Walk;
Nonprofit partner's corporate or industry connection: 2004 sponsors
include Boehringer Ingelheim, MirapexPramipexoe Dihydrochloride
Tablets, Pfizer, and others. Sponsors fund operating expenses for the
walk;
Plan for funding research: NIH accepted gift funds.
Purpose of arrangement: Research relevant to the cure, prevention, and
treatment of Parkinson's disease and its complications;
NIH partner: National Institute of Neurological Disorders and Stroke,
National Institute of Deafness and Other Communication Disorders,
NIEHS, National Institute of Mental Health;
Nonprofit partner: National Parkinson Foundation;
Nonprofit partner's corporate or industry connection: Some corporate
funding but no information available on who those corporate sponsors
are.
Purpose of arrangement: Research relevant to the cure, prevention, and
treatment of Parkinson's disease and its complications;
NIH partner: National Institute of Neurological Disorders and Stroke,
National Institute of Deafness and Other Communication Disorders,
NIEHS, National Institute of Mental Health;
Nonprofit partner: Parkinson Alliance;
Nonprofit partner's corporate or industry connection: Corporate
sponsorship varies with different fundraising events, includes
sometimes Pfizer, Boehringer Ingelheim, Medtronic.
Purpose of arrangement: Research relevant to the cure, prevention, and
treatment of Parkinson's disease and its complications;
NIH partner: National Institute of Neurological Disorders and Stroke,
National Institute of Deafness and Other Communication Disorders,
NIEHS, National Institute of Mental Health;
Nonprofit partner: Michael J. Fox Foundation for Parkinson's Research.
Purpose of arrangement: Research relevant to the cure, prevention, and
treatment of Parkinson's disease and its complications;
NIH partner: National Institute of Neurological Disorders and Stroke,
National Institute of Deafness and Other Communication Disorders,
NIEHS, National Institute of Mental Health;
Nonprofit partner: Parkinson's Disease Foundation.
Purpose of arrangement: Support Muscular Dystrophy Cooperative Research
Centers;
NIH partner: National Institute of Neurological Disorders and Stroke,
National Institute of Arthritis and Musculoskeletal and Skin Diseases,
National Institute of Child Health and Human Development;
Nonprofit partner: Muscular Dystrophy Association;
Nonprofit partner's corporate or industry connection: Extensive
corporate sponsorship, including Albertsons, CITCO, Harley Davidson
Motor Co., AmEx, Acosta Sales and Marketing;
Plan for funding research: Partner provides separate funding directly
to research centers.
Purpose of arrangement: Research on the effects of candidate drugs for
neurodegeneration;
NIH partner: National Institute of Neurological Disorders and Stroke;
Nonprofit partner: Families of Spinal Muscular Atrophy
Plan for funding research: Agency shares unfunded qualified research
proposals with partner.
Purpose of arrangement: Research on the neurological aspects of
lysosomal storage disorders;
NIH partner: National Institute of Neurological Disorders and Stroke;
Nonprofit partner: The Lysosomal Storage Disease Research Consortium
Plan for funding research: Agency shares unfunded qualified research
proposals with partner.
Purpose of arrangement: Research on treatment of hemophilia, von
Willebrand disease, and other hereditary bleeding disorders;
NIH partner: National Heart Lung and Blood Institute;
Nonprofit partner: National Hemophilia Foundation;
Nonprofit partner's corporate or industry connection: Sponsorship from
Wyeth, AHF, Baxter Healthcare, Bayer, Aventis Behring Company, and Novo
Nordisk for its "it's time for a cure" campaign and "project red flag";
Plan for funding research: Agency shares unfunded qualified research
proposals with partner.
Purpose of arrangement: Research to better understand the role of
religiousness and spirituality in the prevention, treatment, and
recovery from alcoholism and alcohol-related diseases;
NIH partner: National Institute on Alcohol Abuse and Alcoholism;
Nonprofit partner: Fetzer Institute
Plan for funding research: Agency shares unfunded qualified research
proposals with partner.
Source: GAO analysis of NIH data.
[End of table]
At EPA, none of the 16 program and regional offices we contacted
identified any arrangements similar to the research arrangement between
ORD and ACC. In addition, we did not identify any partnerships similar
to the ACC research arrangement at FDA or at FAA. FDA officials we
contacted said the agency had no research arrangements similar to the
ACC arrangement with organizations that represent industry. Finally,
FAA officials said that the agency had not entered into any research
arrangements like the arrangements with ACC and generally did not use
this type of collaborative arrangement to conduct extramural research.
Conclusions:
Federally funded research advances scientific understanding and helps
improve regulatory approaches to protecting human health and the
environment. For both regulatory and nonregulatory agencies
collaboration with external organizations is one mechanism to maximize
the financial and intellectual resources available to federal agencies.
However, collaboration, particularly with organizations that directly
represent regulated industries, can raise concerns about conflicts of
interest that could call into question the quality and independence of
federally funded research. As a result, it is imperative that federal
agencies ensure, before they enter into collaborative research
arrangements with nonfederal partners, that they fully consider the
potential for conflicts of interest.
NIEHS and ORD relied on their general research management processes to
minimize any potential conflicts of interest that might arise during
implementation of their respective ACC arrangements. While these
processes were appropriate for managing the arrangements, they were not
specifically designed to address conflict-of-interest concerns and
therefore cannot be considered adequate substitutes for formal conflict-
of-interest evaluations. Consequently, without policies requiring
officials at NIH and EPA to formally evaluate and manage potential
conflicts of interest when they enter into collaborative arrangements
such as those with ACC, neither agency can ensure that similar
arrangements in the future will be systematically evaluated and managed
for potential conflicts of interest.
When accepting the gift from ACC, NIEHS officials believed their
actions satisfied the conditions of the NIH gift acceptance policy for
conflict of interest. However, NIH's policy--both the wide discretion
allowed in deciding on whether and how officials should evaluate
conflicts of interest and the lack of required documentation--provides
little assurance of systematic evaluation of gifts that may present
potential conflicts of interest for the agency. To allay concerns about
the potential for conflicts of interest that may result from accepting
gifts, officials should clearly document both their evaluation of the
potential for conflicts of interest and the basis for their decisions
to accept or reject a gift.
Recommendations for Executive Action:
The Director of NIH and the Administrator of EPA should develop formal
policies for evaluating and managing potential conflicts of interest
when entering into research arrangements with nongovernmental
organizations, particularly those that represent regulated industry.
The Director of NIH should further revise the NIH gift acceptance
policy to require NIH officials to evaluate gifts, particularly from
organizations that represent regulated industry, for potential
conflicts of interest and to document the basis for their decisions,
including what, if any, steps are needed to manage potential conflicts.
Agency Comments and Our Evaluation:
We provided EPA and NIH with a draft of this report for their review
and comment. EPA neither agreed nor disagreed with our recommendation,
but provided technical comments that we have incorporated as
appropriate. (See app. II.) NIH concurred with our recommendations and
stated it would take steps to implement them. In addition, NIH
emphasized that is it not a regulatory agency and suggested changes to
the report to clarify its role. We have added language to clarify NIH's
relationship with the regulated industry. NIH also provided technical
comments that we have incorporated as appropriate. NIH's comments and
our response are included in appendix III.
Signed by:
Anu K. Mittal, Director:
Natural Resources and Environment:
[End of section]
Appendixes:
Appendix I: Objectives, Scope, and Methodology:
As requested by the Ranking Member of the Subcommittee on Environment,
Technology and Standards, House Committee on Science, and the Ranking
Member of the Subcommittee on Research, House Committee on Science, we
determined the (1) legal authority the National Institutes of Health's
(NIH) National Institute of Environmental Health Sciences (NIEHS) and
the Environmental Protection Agency's (EPA) Office of Research and
Development (ORD) used to enter into arrangements with the American
Chemistry Council (ACC); (2) extent to which NIEHS and ORD evaluated
and managed the possibility that conflicts of interest could result
from their arrangements; (3) extent to which NIEHS complied with NIH's
gift acceptance policy when accepting ACC's funds; and (4) extent to
which similar research arrangements exist within other offices and
programs within NIH and EPA, as well as other regulatory agencies.
To determine the legal authorities NIEHS and ORD relied on to enter the
research arrangements with ACC to solicit and fund extramural research,
we reviewed the statutes cited in agency documentation related to the
arrangements. For NIH, these authorities included sections 301 and 405
of the Public Health Service (PHS) Act, as amended (42 U.S.C. §§ 241
and 284); and gift acceptance statutes contained in sections 231 and
405(b)(1)(H) of the PHS Act as amended (42 U.S.C. §§ 238,
284(b)(1)(H)). For ORD these authorities included section 103 of the
Clean Air Act, as amended (42 U.S.C. § 7403), section 104 of the Clean
Water Act, as amended (33 U.S.C. §1254), and section 8001 of the Solid
Waste Disposal Act, as amended (42 U.S.C. § 6981). We also reviewed the
following related documentation on delegations of authority:
* Memorandum from the Assistant Secretary for Health to Public Health
Service Agency Heads for "Delegation of Authority To Accept Gifts Under
Title XXI of the PHS, Miscellaneous" (July 10, 1995), and:
* NIH Manual Chapter 1130, Delegations of Authority, Program: General
#5 Accept Gifts Under Section 231 of the PHS Act, Program: General #10
National Library of Medicine.
We also reviewed relevant legislative histories and Comptroller General
decisions and interviewed attorneys at NIEHS and ORD about their
reviews of the arrangements. Furthermore, we compared each agency's
policies and both formal arrangements with the authorities cited above.
To determine what measures NIEHS and ORD took to evaluate and manage
the potential that conflicts of interest could result from their
arrangements with ACC, we interviewed program officials on their
perceptions of conflict of interest when the ACC arrangement was being
considered, as well as on the actions they took to develop and
implement the arrangements. We also interviewed budget and legal
officials, as appropriate, at each agency on their involvement in
reviewing and completing the arrangements. We reviewed the research
arrangements with ACC, as well as other documentation related to the
arrangements, including correspondence between agency officials and
ACC, interagency memorandums, and documentation of agency legal and
other reviews. We considered statutes on conflict of interest and
ethics guidelines that might address the need for agencies to consider
and manage real or apparent conflicts of interest (18 U.S.C. § 209, and
the Ethics in Government Act of 1978, 5 U.S.C. app. 4). Finally, we
interviewed ACC officials to obtain their views on conflicts of
interest and on the role of ACC representatives in developing the
announcement of funding availability, reviewing and funding research
proposals, and administering the grants. We did not test the NIEHS or
ORD internal controls governing the administration of grants awarded
under the arrangements.
To determine whether NIEHS's acceptance of ACC funds as a gift complied
with NIH policy for accepting gifts, we collected and analyzed NIH's
policy for gift acceptance and we interviewed legal staff at NIEHS
concerning their review of potential gifts and their assistance to
program officials. We obtained and reviewed the research arrangement
and related documentation on transferring and administering the gift
funds. We interviewed program officials on their actions in accepting
the funds and compared activities and documentation pertaining to
NIEHS's acceptance of ACC's gift with the requirements and
recommendations outlined in NIH's policy.
To determine the extent of similar research arrangements at other
federal agencies, we identified officials responsible for 96 percent or
more of the extramural research budgets at NIH, EPA, and two additional
agencies. We then used a structured guide to determine what, if any,
research arrangements the agencies had with external partners. In
addition to NIEHS and ORD, we selected a nonprobability sample of two
additional agencies on the basis of the magnitude of the research
component of their mission and congressional interest.[Footnote 13] The
two agencies selected were the Food and Drug Administration (FDA) and
the Federal Aviation Administration (FAA) because each agency had a
research component to its mission, a corresponding research budget, and
a regulatory role. We determined that the selection was appropriate for
our design and objectives and that the selection would generate valid
and reliable evidence to support our work.
To determine the extent to which arrangements exist within these four
agencies, we obtained the most current available data on extramural
research budgets from institutes and centers in NIH, program and
regional offices in EPA, and the programs and centers at FAA and FDA.
To assess the reliability of these data, we used a structured guide to
interview officials at each agency responsible for maintaining the
databases containing the data provided. Specifically, we obtained
descriptions of the databases, how data are entered into the databases,
quality control checks on the data, testing conducted on the data, and
officials' views on the accuracy and completeness of the data. We asked
follow-up questions whenever necessary. FDA officials noted one
limitation on the data that were provided. Specifically, when compiling
data on research budgets, officials must sometimes subjectively
interpret the term "research." The impact of such interpretation may
cause the extramural research figures for FDA to be slightly
overstated. After taking these steps, we determined that the data were
sufficiently reliable for the purposes of this report.
We used these data to rank order the programs and centers and identify
officials in each agency responsible for administering 96 percent or
more of each agency's extramural research budget. In our interviews
with these officials, we focused on arrangements established since
January 1999--specifically, arrangements with characteristics similar
to the ACC arrangements. We looked for and considered arrangements with
nongovernmental, nonacademic partners to sponsor research extramural to
both organizations. We did not collect information or report on the use
of other types of agency research cooperation with external partners
such as cooperative research and development agreements or informal
consultations between agency and external scientists.
At NIH, we used a structured guide to interview officials at the
following institutes or centers, listed in order of greatest to least
extramural research grant-dollar totals, in fiscal year 2002: National
Cancer Institute; National Heart, Lung, and Blood Institute; National
Institute of Allergy and Infectious Diseases; National Institute of
General Medical Sciences; National Institute of Diabetes and Digestive
and Kidney Diseases; National Institute of Neurological Disorders and
Stroke; National Institute of Mental Health; National Center for
Research Resources; National Institute of Child Health and Human
Development; National Institute on Drug Abuse; National Institute on
Aging; National Eye Institute; NIEHS; National Institute of Arthritis
and Musculoskeletal and Skin Diseases; National Human Genome Research
Institute; National Institute on Alcohol Abuse and Alcoholism; National
Institute on Deafness and Other Communication Disorders; National
Institute of Dental and Craniofacial Research; National Institute of
Nursing Research; and National Institute of Biomedical Imaging and
Bioengineering. Together, these institutes and centers accounted for 99
percent of NIH's total extramural research funds for fiscal year 2002.
At EPA, we used a structured guide to interview program officials from
the following offices and regions (shown in order of greatest to least
funding available for extramural research fiscal year 2003): [Footnote
14] ORD; Office of Water; Region 6; Region 9; Office of International
Affairs; Region 3; Office of Solid Waste and Emergency Response; Region
4; Region 5; Region 1; Region 2; Region 7; Region 10; Region 8; Office
of Prevention, Pesticides and Toxic Substances; and Office of Air and
Radiation. Together, these offices accounted for 99 percent of the
EPA's extramural research funds for fiscal year 2003.
At FDA, we interviewed the agency official responsible for getting
approval for Memorandums of Agreement from the General Counsel's Office
and Office of Grants Management and for ensuring that each agreement is
published in the Federal Register. FDA does not accept funds from
external partners under these agreements.
Finally, at FAA, we interviewed officials from the research and
development offices at headquarters as well as the division manager of
the Acquisition, Materiel, and Grants Division of the William J. Hughes
Technical Center. Together, these offices accounted for 96 percent of
the agency's fiscal year 2003 funds for extramural research.
To independently corroborate the information obtained from agency
officials, to the extent possible, we collected documents on the
agreements we identified at these agencies and reviewed agency Web
sites maintained by the relevant centers and offices, as well as Web
sites maintained by external sources, such as advocacy or trade groups.
We conducted our review from February 2004 through February 2005 in
accordance with generally accepted government auditing standards.
[End of section]
Appendix II: Comments from the Environmental Protection Agency:
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY:
OFFICE OF RESEARCH AND DEVELOPMENT:
WASHINGTON, D.C. 20460:
JAN 26 2005:
Ms. Anu K. Mittal:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
Washington, DC 20548:
Dear Ms. Mittal:
Thank you for the opportunity to comment on the Government
Accountability Office (GAO) draft report entitled, Federal Research.
NIH and EPA Need to Improve Conflict of Interest Reviews for Research
Agreements with Private Sector Entities (GAO-05-191). We are especially
pleased that GAO found that: (1) "...the actions the agencies took to
manage potential conflicts of interest were appropriate;" and (2) "ORD
officials took appropriate steps to minimize potential conflicts of
interest as their research agreements with ACC [American Chemistry
Council] were implemented." In light of these findings, we believe that
GAO needs to substantially revise the title of the report to more
accurately portray the results of its review.
We, therefore, suggest a more accurate title to consider could be:
"Federal Research: Agencies Took Reasonable Steps to Manage Potential
Conflicts of Interest but Policies and Procedures Can be Improved."
This revision would be consistent with the findings of the draft
report.
Extramural Research Agreements:
As discussed below, GAO's use of the term "research agreement" to
describe EPA's legal relationship with organizations that EPA
cooperates with to coordinate environmental research is not accurate.
In addition, we have enclosed detailed comments on specific portions of
the text of the draft report.
Extramural research agreements may take the form of contracts, grants,
cooperative agreements, or Memoranda of Understanding (MOU), depending
upon the nature of the transaction. Contracts allow federal agencies to
purchase services and products for their direct use or benefit,
including research that agencies use directly in the development of
regulations. Agencies use grants and cooperative agreements to support
research that has broader application in the scientific community as a
whole. Once the scope of work for a grant is negotiated, federal
involvement in grant-funded research is generally limited to that
necessary to effectively oversee the use of federal funds. On the other
hand, federal agencies are substantially involved in research carried
out under cooperative agreements through ongoing collaboration on
scientific matters, and data sharing and other joint activities, with
more intense monitoring of the substantive aspects of the research. MOU
specify the terms under which federal agencies will cooperate with non-
federal organizations, but do not involve transfers of funds between
the parties to the MOU, unless the federal agency has gift acceptance
authority. The term, MOU, is accurate and avoids confusion with
"research agreements," which are used for grants or cooperative
agreements.
The MOU that the Office of Research and Development (ORD) entered into
with ACC is not unique. Since 1975, ORD has entered into MOUs under its
broad authority to cooperate with federal and non-federal parties to
encourage, coordinate, and accelerate environmental research.
We appreciate the opportunity to respond to this draft report. Should
you have any questions or need additional information, I can be reached
at 202-564-6620.
Sincerely,
Signed by:
Lek G. Kadeli:
Acting Deputy Assistant Administrator for Management:
Enclosure:
[End of section]
Appendix III: Comments from the National Institutes of Health:
DEPARTMENT OF HEALTH & HUMAN SERVICES:
Public Health Service:
National Institutes of Health:
Bethesda, Maryland 20892:
http://www.nih.gov:
JAN 31 2005:
Ms. Anu K. Mittal:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street, N.W.:
Washington, D.C. 20548:
Dear Ms. Mittal:
We appreciate the opportunity to review and comment on the draft report
entitled Federal Research: NIH and EPA Need to Improve Conflict of
Interest Reviews For Research Agreements With Private Sector Entities
(GAO-05-191). Enclosed are the comments of the National Institutes of
Health. Since the report involves both the NIH and the Environmental
Protection Agency, a regulatory agency, we feel it is important to
emphasize that NIH is not a regulatory agency. A reader could infer,
from the recommendations that contain references to "regulated
industry," that there are industries regulated by NIH. We believe that
the report should clearly indicate that NIH is not a regulatory agency
and therefore could not enter into research agreements with or accept
gifts from industries that it regulates.
Should you or your staff have any questions, please call Patricia Quast
at 301-402-8264.
Sincerely,
Signed by:
Elias A. Zerhouni, M.D.
Director:
-Enclosures:
Comments of the National Institutes of Health (NIH) On the U. S.
Government Accountability Office (GAO) Revised Draft Report "Federal
Research: NIH and EPA Need to Improve Conflict of Interest Reviews for
Research Agreements With Private Sector Entities" GAO-05-191:
We appreciate the opportunity to review and comment on this revised
draft report. The report acknowledges that NIH used the tools, then
extant, to assess and manage potential conflicts of interest. It is
important to note that the GAO evaluation team did not identify or
conclude that conflicts of interest existed in the collaborative
research effort described in the report. Nonetheless, we know that
improvements can be made to our policies and procedures for evaluating
the potential for conflicts of interest. Therefore, we concur with the
two recommendations and plan to take actions to implement them.
Despite our concurrence with the recommendations, we believe that the
report contains erroneous comparisons and unsupported statements that
could lead the reader to make incorrect conclusions about the public
health role and mission of the NIH. For example:
* The body of the report, and both recommendations, discuss relations
between governmental agencies and "regulated industry." The way this is
written, a reader of this report could infer that there are industries
regulated by the NIH. We believe that it is important to clarify--
throughout the report--that NIH, unlike the Environmental Protection
Agency (and the other Federal agencies used in the report for
comparison purposes), is not a regulatory agency. By definition,
therefore, NIH could not enter into research agreements or accept gifts
from industries it regulates.
* The revised version of this draft report added a sentence on page 13
that states, in part, that "...certain aspects of NIEHS' announcement
could [emphasis added] have deterred some qualified researchers from
applying..." If there is evidence that this occurred, it should be
included in the report. Otherwise, this is a speculative statement that
is inappropriate to include in the report.
* The report does not put into perspective the relationship of the
collaborative effort to the entire extramural research effort. The
monies provided by the collaborative partner represent about 6/100,000
of 1 percent (0.000057%) of NIH's extramural research budget for fiscal
year 2002.
We also offer a number of technical comments that we believe improve
the clarity and accuracy of the final report.
GAO Recommendation:
The Director of NIH and the Administrator of EPA should develop formal
policies for evaluating and managing potential conflicts of interest
when entering into research agreements with nongovernmental
organizations, particularly those that represent regulated industry.
NIH Response:
We concur with this recommendation. As noted in the report, NIH has
policies and processes to ensure the integrity of scientific review and
that grant funds are awarded and administered appropriately. However,
we agree that a formal policy should be developed for evaluating and
managing potential conflicts of interest when entering into agreements
to fund extramural research with industry or organizations that
represent industry. Because this is an issue that is important to NIH,
we plan to establish a high-level working group to develop such a
policy.
GAO Recommendation:
The Director of NIH should further revise the NIH gift acceptance
policy to require NIH officials to evaluate gifts, particularly from
organizations that represent regulated industry, for potential
conflicts of interest and to document the basis for their decisions,
including what, if any, steps are needed to manage potential conflicts.
NIH Response:
We concur with this recommendation. NIH will clarify and make
consistent the actions officials must take to evaluate conflicts of
interest when accepting gifts and include these updated procedures in a
revision to NIH Policy Manual 1135, Gifts Administration. The revisions
will include:
1. Making mandatory, consistently throughout the policy manual, the
requirement for approving officials to use the "Gift Acceptance
Validity Survey" and the "NIH Gift Pre-Acceptance Checklist" assessment
tools to evaluate conflicts of interest before accepting a gift; and:
2. Requiring reviewing officials to formally document their decisions
and any plans to manage potential conflict.
[End of section]
Appendix IV: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Anu Mittal, (202) 512-3841;
Cheryl Williams, (404) 679-1991:
Staff Acknowledgments:
In addition to the individuals listed above, key contributions to this
report were made by Amy Dingler, Karen Keegan, Judy Pagano, Carol
Herrnstadt Shulman, Barbara Timmerman, Mindi Weisenbloom, and Eugene
Wisnoski. Also contributing to this report were Anne Dievler and Jim
Lager.
(360433):
FOOTNOTES
[1] Federal Funds for Research and Development: Fiscal Years 2000,
2001, and 2002. Because it is being used for background purposes only,
we did not assess the reliability of the National Science Foundation
data in this report.
[2] Congress has provided some agencies, such as NIH, with the
authority to accept gifts--including money--while other agencies, such
as EPA, do not have this authority.
[3] Although NIH is not a regulatory agency the scientific knowledge
that results from NIH-sponsored research may be used by regulatory
agencies, such as EPA, when making decisions about potential risks
chemicals pose to public health and the environment. It is in this
context that the ACC-NIEHS arrangement has raised concerns.
[4] NIEHS used its gift acceptance statute, 42 U.S.C. § 238(a), to
accept the ACC funds as a conditional gift. In a separate effort, our
Office of General Counsel is preparing a legal opinion to address
whether the gift acceptance statute authorizes NIEHS to accept
donations with the specific conditions attached by the agreement
between NIEHS and ACC.
[5] For purposes of this report we will refer to the memorandums of
understanding that NIEHS and ORD signed with ACC as well as documents
to implement the memorandums, such as the announcement of funding
availability, as research arrangements.
[6] EPA consists of nine programmatic offices and 10 regional offices
that collectively develop and implement the agency's programs.
[7] Researchers who wanted their proposals considered for funding
solely from ACC were advised to send their proposals directly to ACC
for review and evaluation. ORD did not review or evaluate any such
proposals.
[8] ACC was formerly known as the Chemical Manufacturers Association.
[9] These advisory panels are comprised of experts in scientific
disciplines and other relevant fields.
[10] Under the agreement, researchers could request that their
proposals be considered for funding solely by ORD or by either ORD or
ACC. Applicants who wanted their proposals considered for funding
solely from ACC were advised to send their proposals directly to ACC
for review and evaluation. ORD did not review or evaluate any such
proposals.
[11] In addition, ORD obtained agreement from ACC that results of ACC-
funded research would also be discussed in periodic public meetings and
published in peer-reviewed journals.
[12] We also identified one agreement that is under negotiation at NIH,
which if signed would share some characteristics of the ACC research
agreement. Specific details on the terms and conditions of the
agreement will not be available until it is signed.
[13] Results from nonprobability samples cannot be used to make
inferences about a population because, in a nonprobability sample, some
elements of the population being studied have no chance or an unknown
chance of being selected as part of the sample.
[14] EPA has 10 regional offices, each of which is responsible within
its states and territories for the execution of the agency's programs.
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