NIH Conflict of Interest
Recusal Policies for Senior Employees Need Clarification Gao ID: GAO-07-319 April 30, 2007To safeguard the integrity of National Institutes of Health (NIH) research, government employees who have significant decision-making responsibilities and peer reviewers who evaluate the scientific and technical merit of research funding requests should be free from conflicts of interest. One method to resolve a conflict of interest is recusal, which is accomplished by not participating in work that will affect a personal interest or involves a personal relationship. GAO reported on (1) how NIH informs senior employees about recusal and what the requirements are for them to notify supervisors, and (2) how NIH informs peer reviewers about recusal and how NIH monitors their compliance with recusals. GAO reviewed relevant NIH policy manual chapters and NIH guidance and interviewed NIH officials. GAO selected NIH's National Cancer Institute and National Institute of Allergy and Infectious Diseases for the review because they have the largest budgets at NIH.
NIH has provided several methods to inform senior employees about recusal as a remedy to conflicts of interest, such as annual ethics training. However, NIH has not established clear recusal policies for senior employees, as the NIH policy manual is contradictory on whether senior employees must recuse in writing and notify their supervisors of their recusals. For example, the policy manual contains contradictory directions on how employees seeking nongovernment employment are to recuse. One section states that the employee "must" put the recusal in writing and that his or her supervisor "should" be notified, while another section states that the recusal "may" be done in writing and that the supervisor "must" be notified if the recusal is not written. Moreover, the two definitions of recusal in the policy manual imply that the employee must put a recusal into writing but do not explicitly require such action, and neither definition requires that the employee's supervisor be notified of the recusal. Senior employees who consult the policy manual may or may not put their recusals in writing and may or may not notify their supervisors, depending on what section of the policy manual they consult. NIH provides written and oral methods for informing peer reviewers about recusal and for monitoring compliance with recusals. In the NIH policy manual and guidance, NIH states that peer reviewers must be informed about NIH conflict of interest regulations and policies, which include information pertaining to recusal. The policy manual refers to a form that describes situations that may constitute conflicts of interest and the need to recuse in those situations. The Scientific Review Administrators (SRAs)-- NIH employees who manage the scientific review group (SRG), or peer review meeting--are also instructed to give oral guidance on the NIH conflict of interest policy to peer reviewers, according to NIH guidance. The NIH policy manual states that the SRA is responsible for overseeing the SRG meeting to ensure fair and unbiased evaluations of research funding requests, and that peer reviewers must certify in writing after the meeting that they have executed their recusals. GAO concludes that, although the NIH policy manual and guidance describe how peer reviewers are to be informed about and comply with recusals, the lack of clear recusal policies for senior employees results in a vulnerability in the management of one part of NIH's conflict of interest policies.
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-07-319, NIH Conflict of Interest: Recusal Policies for Senior Employees Need Clarification
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
April 2007:
NIH Conflict of Interest:
Recusal Policies for Senior Employees Need Clarification:
GAO-07-319:
GAO Highlights:
Highlights of GAO-07-319, a report to congressional requesters
Why GAO Did This Study:
To safeguard the integrity of National Institutes of Health (NIH)
research, government employees who have significant decision-making
responsibilities and peer reviewers who evaluate the scientific and
technical merit of research funding requests should be free from
conflicts of interest. One method to resolve a conflict of interest is
recusal, which is accomplished by not participating in work that will
affect a personal interest or involves a personal relationship. GAO
reported on (1) how NIH informs senior employees about recusal and what
the requirements are for them to notify supervisors, and (2) how NIH
informs peer reviewers about recusal and how NIH monitors their
compliance with recusals. GAO reviewed relevant NIH policy manual
chapters and NIH guidance and interviewed NIH officials. GAO selected
NIH‘s National Cancer Institute and National Institute of Allergy and
Infectious Diseases for the review because they have the largest
budgets at NIH.
What GAO Found:
NIH has provided several methods to inform senior employees about
recusal as a remedy to conflicts of interest, such as annual ethics
training. However, NIH has not established clear recusal policies for
senior employees, as the NIH policy manual is contradictory on whether
senior employees must recuse in writing and notify their supervisors of
their recusals. For example, the policy manual contains contradictory
directions on how employees seeking nongovernment employment are to
recuse. One section states that the employee ’must“ put the recusal in
writing and that his or her supervisor ’should“ be notified, while
another section states that the recusal ’may“ be done in writing and
that the supervisor ’must“ be notified if the recusal is not written.
Moreover, the two definitions of recusal in the policy manual imply
that the employee must put a recusal into writing but do not explicitly
require such action, and neither definition requires that the
employee‘s supervisor be notified of the recusal. Senior employees who
consult the policy manual may or may not put their recusals in writing
and may or may not notify their supervisors, depending on what section
of the policy manual they consult.
NIH provides written and oral methods for informing peer reviewers
about recusal and for monitoring compliance with recusals. In the NIH
policy manual and guidance, NIH states that peer reviewers must be
informed about NIH conflict of interest regulations and policies, which
include information pertaining to recusal. The policy manual refers to
a form that describes situations that may constitute conflicts of
interest and the need to recuse in those situations. The Scientific
Review Administrators (SRAs)” NIH employees who manage the scientific
review group (SRG), or peer review meeting”are also instructed to give
oral guidance on the NIH conflict of interest policy to peer reviewers,
according to NIH guidance. The NIH policy manual states that the SRA is
responsible for overseeing the SRG meeting to ensure fair and unbiased
evaluations of research funding requests, and that peer reviewers must
certify in writing after the meeting that they have executed their
recusals.
GAO concludes that, although the NIH policy manual and guidance
describe how peer reviewers are to be informed about and comply with
recusals, the lack of clear recusal policies for senior employees
results in a vulnerability in the management of one part of NIH‘s
conflict of interest policies.
What GAO Recommends:
GAO recommends that NIH expeditiously clarify its policies with regard
to written recusals and supervisor notification related to senior
employees‘ use of recusal to resolve conflicts of interest. HHS, on
behalf of NIH, concurred with GAO‘s recommendation and plans to revise
and reissue relevant portions of its policy manual within 6 months.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-319].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Cynthia A. Bascetta at
(202) 512-7101 or bascettac@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
NIH Informs Senior Employees about Recusal through Several Methods;
However, Its Policy Requirements for Notification of Supervisors Are
Unclear:
NIH Provides Written and Oral Methods for Informing Peer Reviewers
about Recusal and for Monitoring Compliance with Recusals:
Conclusions:
Recommendation:
Agency Comments:
Appendix I: Comments from the Department of Health and Human Services:
Appendix II: GAO Contact and Staff Acknowledgments:
Abbreviations:
DAEO: Designated Agency Ethics Official:
DEC: Deputy Ethics Counselor:
FACA: Federal Advisory Committee Act:
HHS: Department of Health and Human Services:
NCI: National Cancer Institute:
NEO: National Institutes of Health Ethics Office:
NIAID: National Institute of Allergy and Infectious Diseases:
NIH: National Institutes of Health:
OER: Office of Extramural Research:
OGE: Office of Government Ethics:
R&D: research and development:
SGE: special government employee:
SRA: Scientific Review Administrator:
SRG: Scientific Review Group:
United States Government Accountability Office:
Washington, DC 20548:
April 30, 2007:
The Honorable Joe Barton:
Ranking Member:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Ed Whitfield:
Ranking Member:
Subcommittee on Oversight and Investigations:
Committee on Energy and Commerce:
House of Representatives:
The National Institutes of Health (NIH), a part of the Department of
Health and Human Services (HHS), is the primary federal agency for
supporting medical research. In fiscal year 2005, NIH awarded
approximately 85 percent of its $28 billion budget through awards of
grants and research and development (R&D) contracts to researchers at
universities, medical schools, and other research institutions. NIH
senior employees, such as the NIH director and the directors of NIH's
27 institutes and centers, provide leadership for NIH scientific
research priorities and programs and have significant decision-making
responsibilities. Peer reviewers, who are generally outside scientific
experts from academia, also play significant roles in advising NIH
research and programs through the scientific and technical review of
requests for research funding. There is a potential for conflicts of
interest to occur when senior employees or peer reviewers have personal
or financial interests that could impair their judgment in carrying out
their NIH responsibilities. Identifying and addressing conflicts of
interest among senior employees and peer reviewers helps to safeguard
public funds and the integrity of NIH-funded research.
Under federal ethics laws and regulations, employees and peer reviewers
are responsible for identifying and appropriately resolving their
conflicts of interest. Federal criminal law on conflict of interest
prohibits government employees from participating personally and
substantially in a particular matter in which they have a financial
interest, if the matter will have a direct and predictable effect on
that interest.[Footnote 1] Federal regulations also provide that an
employee should not participate in a matter when there is an appearance
of a conflict of interest such that a reasonable person with knowledge
of the relevant facts would question the employee's impartiality in the
matter.[Footnote 2] HHS regulations prohibit peer reviewers from
reviewing requests for research funding with which they have conflicts
of interest or which present an appearance of a conflict.[Footnote 3]
One method an employee or peer reviewer may use to resolve a conflict
of interest or the appearance of a conflict is recusal.[Footnote 4]
According to federal regulations, recusal is the responsibility of the
employee or peer reviewer and is accomplished by the employee or peer
reviewer not participating in the matter affected by the conflict of
interest.[Footnote 5] Additionally, an employee may also notify his or
her supervisor about the recusal to help ensure that the matter
affected by the conflict of interest is not presented to the recused
employee.
In response to concerns about ethics at NIH raised by congressional
committees and in the media, the agency created the NIH Blue Ribbon
Panel on Conflict of Interest Policies to assess the status of conflict
of interest policies and procedures.[Footnote 6] The panel issued a
report in 2004 with 18 recommendations for improving NIH conflict of
interest policies and procedures for employees, including one
recommendation that employees be required to submit recusals in writing
to their supervisors.[Footnote 7] Also in response to congressional
concerns, the NIH Director stated, in a May 2004 prepared statement for
a subcommittee of the House Committee on Energy and Commerce, that NIH
would require a uniform policy for employees to notify relevant
personnel of recusals and would establish a new process for monitoring
employees' recusals.[Footnote 8]
In light of these congressional concerns, you asked us to examine
issues related to conflicts of interest at NIH. We report on (1) how
NIH informs senior employees about recusal and what the requirements
are for them to notify supervisors, and (2) how NIH informs peer
reviewers about recusal and how NIH monitors their compliance with
recusals.
Our work is based on our review of written materials and interviews in
NIH's Office of the Director--the agency's central office--and in 2 of
NIH's 27 institutes and centers.[Footnote 9] We selected the National
Cancer Institute (NCI) and the National Institute of Allergy and
Infectious Diseases (NIAID) for our review because they have the
largest budgets among all NIH institutes.[Footnote 10]
To report on how NIH informs senior employees about recusal and what
the requirements are for them to notify supervisors, we reviewed
relevant chapters of the NIH policy manual. We also reviewed NIH ethics
training materials for 2005 and 2006 and NIH guidance on identifying
conflicts of interest. We used the definition of "senior employee" that
is found in the HHS supplemental ethics regulations.[Footnote 11] Under
this definition, NIH senior employees are the Director and Deputy
Director; members of the senior staff within the Office of the Director
who report directly to the Director; the institutes' Directors, Deputy
Directors, Scientific Directors, and Clinical Directors; Extramural
Program Officials who report directly to an institute Director; and any
employee of equivalent levels of decision-making responsibility who is
designated as a senior employee by either the HHS Designated Agency
Ethics Official (DAEO)[Footnote 12] or the NIH Director in consultation
with the HHS DAEO.[Footnote 13] We did not include two senior
employees--the NIH Director and the NCI Director--in our review. The
individuals who hold these positions are appointed by the President,
and the HHS DAEO, rather than an NIH ethics official, serves as their
ethics officer. We interviewed ethics officials who provide advice and
counseling to senior employees, including the Director, NIH Ethics
Office; the HHS DAEO; the HHS DAEO's representative on the NIH campus;
the NIH Deputy Ethics Counselor (DEC); and the NCI and NIAID DECs.
To report on how NIH informs peer reviewers about recusal and how NIH
monitors their compliance with recusals, we reviewed relevant NIH
policy manual chapters and guidance for peer reviewers. We interviewed
officials in the NIH Office of Extramural Research, which is
responsible for developing NIH peer review policies. We also
interviewed officials at NCI and NIAID who are responsible for the peer
review process at those institutes.
Our review focused on recusal; we did not review the other remedies to
a conflict of interest, which are waivers, authorizations, and
divestiture. Our scope of review included recusals that senior
employees or peer reviewers communicate to NIH officials; it was not
possible to identify recusals by senior employees or peer reviewers who
did not disclose their recusals to NIH officials. We also examined only
the recusal processes in place for senior employees' and peer
reviewers' recusals; we did not examine whether these processes were
followed or specific instances of recusal for individual senior
employees or peer reviewers. Furthermore, for peer reviewers we
reviewed recusals related to the scientific peer review process for
grant applications and R&D contract proposals, which is carried out by
scientific review groups (SRGs) composed of peer reviewers who are
primarily nonfederal scientists selected for membership based on their
current research areas and depth of scientific expertise.[Footnote 14]
Finally, our findings from interviews with NCI and NIAID officials
cannot be generalized to other institutes at NIH. We conducted our work
from March 2006 through April 2007 in accordance with generally
accepted government auditing standards.
Results in Brief:
NIH has provided several methods to inform senior employees about
recusal as a remedy to conflicts of interest, such as annual ethics
training. However, NIH has not established clear recusal policies for
senior employees, as the NIH policy manual is contradictory on whether
senior employees must recuse in writing and notify their supervisors of
their recusals. For example, the policy manual contains contradictory
directions on how employees seeking nongovernment employment are to
recuse. One section states that the employee "must" put the recusal in
writing and that his or her supervisor "should" be notified, while
another section states that the recusal "may" be done in writing and
that the supervisor "must" be notified if the recusal is not written.
Moreover, the two definitions of recusal in the policy manual imply
that the employee must put a recusal into writing but do not explicitly
require such action, and neither definition requires that the
employee's supervisor be notified of the recusal. These inconsistencies
raise questions as to which sections of the manual are to be followed.
Senior employees who consult the policy manual may or may not put their
recusals in writing and may or may not notify their supervisors,
depending on what chapter and section of the policy manual they
consult.
NIH provides written and oral methods for informing peer reviewers
about recusal and for monitoring compliance with recusals. In the NIH
policy manual and guidance, NIH states that peer reviewers must be
informed about NIH conflict of interest regulations and policies, which
include information pertaining to recusal. The policy manual refers to
a form that describes situations that may constitute conflicts of
interest and the need to recuse in those situations. NCI and NIAID
officials told us that peer reviewers are provided with this form
before the SRG meets. In addition, the Scientific Review Administrators
(SRAs)--NIH employees who manage the SRGs--are instructed to give oral
guidance on the NIH conflict of interest policy to peer reviewers prior
to the first meeting of the SRG, according to NIH's SRA handbook. The
NIH policy manual states that the SRA is responsible for overseeing the
SRG meeting to ensure fair and unbiased evaluations of applications and
proposals. Peer reviewers must certify in writing after the meeting
that they have executed their recusals, according to NIH policy.
To address the inconsistencies in the policy manual related to senior
employees' notification of recusals and ensure that NIH helps its
senior employees fulfill their responsibilities related to recusal, we
recommend that the Director of NIH expeditiously clarify NIH policies
with regard to written recusals and supervisor notification related to
senior employees' use of recusal to resolve conflicts of interest. In
commenting on a draft of this report on behalf of NIH, HHS concurred
with our recommendation and said it plans to revise and reissue
relevant portions of its policy manual within 6 months. NIH also
provided technical comments that we incorporated as appropriate.
Background:
One of the ways that NIH assists its employees, including senior
employees, in avoiding and preventing conflicts of interest is through
its ethics program. NIH ethics officials assist senior employees in
examining potential conflicts of interest between senior employees'
myriad and changing job responsibilities and their professional and
financial outside activities and interests. Peer reviewers at NIH are
subject to HHS regulations governing conflict of interest and recusal.
To manage conflicts of interest that may arise in the course of the
peer review process, NIH officials provide ethics guidance and advice
to peer reviewers.
The NIH Ethics Program and the Office of Extramural Research:
All executive branch agencies, including HHS, are required to have an
ethics program and a DAEO who is tasked with coordinating and managing
the agency's ethics program.[Footnote 15] HHS has established a
decentralized ethics program, allowing all agencies within HHS to
administer their own distinct programs. The NIH Ethics Office (NEO)
administers the NIH ethics program and provides leadership, guidance,
and advice to the NIH community. The NEO is headed by the NIH DEC and
is located in the Office of the Director. In addition, the NEO also
serves as the ethics office for all senior employees and for employees
in the Office of the Director. In addition to the NEO, each institute
has its own ethics office. Each institute's ethics office is headed by
an institute DEC who can provide ethics advice and counseling to
institute employees. The HHS DAEO has delegated most of his
responsibility for ethics matters at NIH to the NIH DEC and to the
institute DECs.[Footnote 16] There is also a representative of the HHS
DAEO located on the NIH campus. The HHS DAEO serves as the agency's
primary liaison to the Office of Government Ethics (OGE), an
independent executive branch agency that oversees ethics programs at
all executive branch agencies and advises agencies on many ethics
issues.
While the NEO administers the ethics program for senior employees, the
NIH Office of Extramural Research (OER) develops NIH peer review
policy, including policy regarding conflicts of interest. The OER is
located within the Office of the Director. NIAID and NCI each have a
Division of Extramural Activities that implements, and provides
information about, peer review in the institute.
NIH Senior Employees and Conflict of Interest Regulations:
OGE promulgates regulations relating to conflicts of interest and
remedies for conflicts of interest for all employees in executive
branch agencies. In addition to OGE regulations, HHS has issued
supplemental conflict of interest regulations specific to its
agencies.[Footnote 17] According to OGE and HHS supplemental
regulations, as described below, conflicts of interest may generally
arise because of an NIH employee's (1) financial holdings, (2) outside
activities, (3) pursuit or negotiation of nonfederal employment, or (4)
receipt of awards and honorary degrees.[Footnote 18]
* Financial holdings: Generally, under federal law and OGE regulations,
an employee may not participate personally and substantially in a
particular matter in which the employee has a financial interest if
participation in the matter will have a direct and predictable effect
on that interest.[Footnote 19] Although this standard calls for a case-
by-case analysis of an employee's interests, OGE regulations also allow
agencies to prohibit ownership of certain kinds of financial holdings
by regulation.[Footnote 20] HHS supplemental regulations state that NIH
senior employees generally may not have holdings in a substantially
affected organization. However, holdings of $15,000 or less are
generally permitted.[Footnote 21] Substantially affected organizations
generally include organizations such as biotechnology or pharmaceutical
companies and medical device manufacturers, and organizations
significantly involved in those industries through research,
development, or manufacturing.[Footnote 22] The HHS supplemental
regulations state that when a senior employee is permitted to retain a
financial interest, that employee is generally obligated to recuse from
any particular matter that would affect that interest.[Footnote 23]
* Outside activities: OGE and HHS supplemental regulations generally
prohibit employees from engaging in outside employment or other outside
activities that conflict with their official duties.[Footnote 24] The
OGE regulations contain many exceptions, particularly in the areas of
speaking, teaching, and writing. OGE also allows agencies to prohibit
participation in or require prior approval of outside
activities.[Footnote 25] HHS supplemental regulations prohibit NIH
employees from participating in certain outside activities (such as
teaching, speaking, writing, or editing for compensation) with any
substantially affected organization, a supported research institution,
or a health care provider or insurer.[Footnote 26] In addition, the HHS
regulations require NIH employees to apply for advance approval of
certain outside activities, such as editing a journal or book that
relates to the employee's official duties.[Footnote 27] According to
the OGE regulations, even when an outside activity is permitted,
participation in that activity may require an employee to recuse from
matters involving or affecting the employee's interest in the outside
entity or employer to avoid conflicts of interest.[Footnote 28]
* Pursuit or negotiation of nonfederal employment: According to OGE
regulations, a conflict may arise when an employee seeks or negotiates
for nonfederal employment with an organization whose financial
interests would be affected by the employee's actions as a government
employee.[Footnote 29] Generally, OGE regulations require an employee
to recuse from particular matters that would have a direct and
predictable effect on a prospective employer.[Footnote 30] However, an
employee may receive a waiver or authorization to participate in the
matter.[Footnote 31] In addition, an agency may determine that an
employee must recuse for a certain period of time after negotiations
that did not result in employment have concluded.[Footnote 32] Finally,
according to the Procurement Integrity Act, if an employee who is
participating in an agency procurement initiates contact with or is
contacted by the contractor regarding employment with the contractor,
then the employee must report the contact in writing to his or her
supervisor and to the DAEO or the DAEO's designee. The employee must
then either reject the employment or recuse from further participation
in the procurement.[Footnote 33]
* Receipt of awards and honorary degrees: OGE regulations permit
federal employees to accept awards with a value of less than $200 if
the donor does not have interests that may be substantially affected by
the employee's duties.[Footnote 34] Awards from such donors with values
greater than $200 may be accepted only with the approval of an agency
ethics official.[Footnote 35] An employee may also accept an honorary
degree with written permission from an agency ethics official.[Footnote
36] The HHS supplemental regulations require NIH employees to obtain
advance approval for any award, regardless of value.[Footnote 37]
Further, the HHS regulations generally prohibit employees from
accepting an award with a value greater than $200 if the employee has
official responsibility over matters affecting the donor of the
award.[Footnote 38] However, an exception can be made for an award that
would further an agency interest because it confers an exceptionally
high honor in the fields of medicine or scientific research.[Footnote
39] According to the HHS supplemental regulations, when any award is
approved, the employee must recuse from any particular matter in which
the donor is a party for 1 year following receipt of the
award.[Footnote 40]
Peer Reviewers at NIH and Conflict of Interest Regulations:
NIH uses a peer review process to evaluate the scientific and technical
merit of grant applications and R&D contract proposals.[Footnote 41]
These evaluations are conducted by peer reviewers in SRGs, which can
include standing committees and special emphasis panels.[Footnote 42]
Standing committees generally meet three times per year and have as
many as 16 to 20 members, who usually serve for a term of 4 years.
Special emphasis panels are not standing but instead are convened on an
as-needed basis. NIAID convenes about 120 special emphasis panels per
year, and NCI convenes about 50 to 75 special emphasis panels per year.
In the SRG meeting, applications with the highest merit, and all
proposals, are discussed and scored by the peer reviewers. Consistent
with the Federal Advisory Committee Act (FACA), NIH policy designates a
Scientific Review Administrator (SRA) to manage the SRG
meeting.[Footnote 43] A non-NIH scientist also chairs each SRG meeting.
HHS regulations govern the procedures for selecting peer reviewers and
contain a section on conflict of interest.[Footnote 44] According to
the regulations, conflicts of interest may arise because of peer
reviewers' financial interests, employment, or professional
relationships. Conflicts occur when a peer reviewer or his or her close
relative or professional associate[Footnote 45]
* has or could receive a direct financial benefit of any amount
deriving from an application or proposal;
* has or could receive a financial benefit over $10,000 from an
institution, offeror, or principal investigator named in an application
or proposal;[Footnote 46] or:
* is currently employed or negotiating for employment with an
institution, offeror, or principal investigator named in the
application or proposal.[Footnote 47]
The HHS regulations provide two possible remedies for conflicts of
interest--recusals and waivers. If a recusal is used, then the peer
reviewer for an NIH SRG does not evaluate the application or
applications with which there is a conflict. If a waiver is used, then
the peer reviewer may participate in the review of the application
despite the conflict.[Footnote 48] Waivers of conflicts are allowed
when the NIH Director or his designee determines that there are no
other practical means of securing appropriate expert advice and that
the conflict is not so substantial as to be likely to affect the
integrity of the advice of the reviewer.[Footnote 49]
NIH Informs Senior Employees about Recusal through Several Methods;
However, Its Policy Requirements for Notification of Supervisors Are
Unclear:
NIH has provided several methods to inform senior employees about
recusal as a remedy to conflicts of interest, such as annual ethics
training. However, NIH has not established clear recusal policies for
senior employees, as the NIH policy manual is contradictory on whether
senior employees must recuse in writing and notify their supervisors of
their recusals. For example, the policy manual contains contradictory
directions on how employees seeking nongovernment employment are to
recuse. One section states that the employee "must" put the recusal in
writing and that his or her supervisor "should" be notified, while
another section states that a recusal "may" be done in writing and that
the supervisor "must" be notified if the recusal is not written. The
two definitions of recusal in the policy manual imply that the employee
must put the recusal into writing but do not explicitly require such
action, and neither definition requires that the employee's supervisor
be notified of the recusal.
NIH Informs Senior Employees about Recusal through Several Methods:
NIH informs senior employees about recusal through several methods,
including annual ethics training, preemployment financial disclosure
review, and information on various ethics forms that are completed for
certain new financial interests and outside activities as they arise.
NIH is required by regulation to conduct annual ethics training that
includes certain topics, such as the Standards of Ethical Conduct for
Employees of the Executive Branch.[Footnote 50] The agency may
supplement the training to cover additional topics as needed each year.
For example, the 2005 training not only provided a high-level summary
of the Standards of Ethical Conduct for Employees of the Executive
Branch and ethics principles, but also described what constitutes a
conflict of interest related to outside activities, awards, and
prohibited financial interests. These additional topics were the focus
of the HHS supplemental ethics regulations revised in August 2005. The
2005 training also noted that recusal may be used in cases of conflicts
arising from the acceptance of an award or from financial interests and
that recusal involves nonparticipation in official duties related to
the particular matter. However, it did not discuss the use of recusal
as a remedy for conflicts arising from outside activities. The 2006
training noted that recusal may be used to remedy conflicts arising
from seeking employment, after receiving an award from an outside
organization, and in any situation where an employee's impartiality
would be questioned. In addition to the annual ethics training for all
employees, staff with supervisory responsibilities, which includes most
senior employees, completed an ethics training module for supervisors
in 2005, according to a NEO official. This training module described
how to screen employees' financial disclosures related to substantially
affected organizations for potential conflicts of interest and how to
evaluate whether recusals are an appropriate remedy to resolve the
conflicts.[Footnote 51]
The preemployment financial disclosure review is another method of
informing senior employees about recusal. In the review, required by
HHS since October 2004, HHS guidance states that NIH ethics officials
inform prospective NIH senior employees about the ethics laws and
regulations they will be subject to as federal employees and discuss
the remedies for conflicts of interest, including recusal. NIH ethics
officials are to review the prospective senior employees' outside
activities and financial holdings before the prospective senior
employees make final decisions about employment. If an actual or
apparent conflict of interest is identified through this process, the
prospective senior employee is required to agree to resolve the
conflict, which may include using recusal. NIH provides a standard
ethics agreement form on which the prospective senior employee
describes specific actions to be taken to execute the recusal and
indicates the duration of the recusal in the recusal section of the
form.
NIH also informs senior employees about recusal through information
presented on several other ethics forms that senior employees complete
for certain new financial interests and outside activities as they
arise. Certain ethics forms--specifically the "Confidential Report of
Financial Interests in Substantially Affected Organizations for
Employees of the National Institutes of Health" (HHS Form 717-
1),[Footnote 52] the "Request for Approval of Outside Activity" (HHS
Form 520),[Footnote 53] and the "Annual Report of Outside Activity"
(HHS Form 521)[Footnote 54]--provide detailed summaries of conflict of
interest regulations and recusal.[Footnote 55] For example, all of
these forms notify employees that they must refrain entirely and
absolutely from participating personally and substantially in a
government matter that affects their own financial interest or that of
an outside employer, and HHS Form 520 lists examples of official duties
from which an employee might be required to recuse. These forms also
state that employees must refrain from participating in all parts of
their official duties that are in conflict with any financial interests
or outside activities. In addition, HHS Form 717-1 includes a space for
the employee to describe a recusal, including naming another employee
to whom the official duties are transferred. By signing the forms,
employees certify that they have read and understand the summaries
provided on the forms and that any statements they have made on the
forms, such as recusal statements, are correct. Finally, senior
employees may also seek individual advice and counseling from the DECs
and supervisors about recusal as a resolution to an identified conflict
of interest, according to NIH ethics officials.[Footnote 56]
NIH Policy Manual Is Contradictory on Whether Written Recusals and
Notification of Supervisors Are Required:
The NIH policy manual is contradictory on whether senior employees must
recuse in writing and notify their supervisors of their recusals. For
example, with respect to employees seeking nongovernment
employment,[Footnote 57] one section of the manual chapter "Avoiding
Conflicts of Interest" states that an employee must submit a recusal
statement to the person responsible for the employee's assignment.
However, the same section also states that recusal is "accomplished by
not participating in the particular matter,"[Footnote 58] which could
lead the reader to assume that there are no other requirements.
Further, a section in the manual chapter "Outside Work and Related
Activities with Outside Organizations" on employees seeking
nongovernment employment states that the notice of recusal "must be in
writing" and that the employee's supervisor "should" be notified of the
recusal.[Footnote 59] In contrast, another section of the same chapter
states that a recusal "may be done either in writing or simply by the
employee withdrawing from participation" in the particular matter but
that employees who do not recuse in writing "must" notify their
supervisors of their recusal.[Footnote 60] These inconsistencies raise
questions as to which sections of the manual are to be followed.
Moreover, neither definition of recusal in the policy manual provides
clear guidance. Both imply that the employee must put a recusal into
writing but do not explicitly require that action, and neither
definition requires that the employee's supervisor be notified of the
recusal.[Footnote 61] The definition of recusal in the chapter
"Avoiding Conflicts of Interest" states that the recused employee
"signs a written statement" reflecting the scope of the recusal and the
nature of the conflicting interest or activity,[Footnote 62] and the
definition of recusal in the chapter "Outside Work and Related
Activities with Outside Organizations" states that recusal is a
"written statement used to resolve an apparent or actual conflict of
interest."[Footnote 63]
NIH ethics officials, who may be contacted by senior employees for
guidance, provided varying responses on whether recusals must be put in
writing and whether supervisors must be notified. The DECs we
interviewed generally stated that in practice senior employees either
put recusals in writing, or were advised to do so, and notified their
supervisors of their recusals. However, other ethics officials at NIH
and HHS each correctly stated that OGE's regulations do not require
written recusal, and the HHS ethics official stated that employees meet
the legal obligation for recusal by not participating in the particular
matter.[Footnote 64] As a result, a senior employee seeking clarity
from an NIH ethics official could receive varying directions about how
to recuse.
NIH officials provided us with a draft paragraph in October 2006 that
would require employees to put recusals in writing and notify their
supervisors. The officials expect the paragraph will be included in the
forthcoming revision to the policy manual. However, as of February 2007
this revision to the policy manual had not been issued and NIH
officials reported that they did not know when it would be issued.
Furthermore, it is not clear to what extent this revision will address
the inconsistencies we identified in different chapters of the manual.
NIH ethics officials said that although they may be notified of a
recusal they were not involved in monitoring compliance with it. A NEO
official told us that monitoring compliance with recusals was a
management responsibility, because recusals relate to official duties
of the recused employee and it is the supervisor, rather than the
ethics officials, who has access to information about official duties.
The NEO official told us that she did not know whether supervisors are
trained or instructed on monitoring compliance with their employees'
recusals. Our review of the 2005 and 2006 annual ethics training
materials found that neither set of materials contained instructions
for supervisors to monitor compliance with recusals.
NIH Provides Written and Oral Methods for Informing Peer Reviewers
about Recusal and for Monitoring Compliance with Recusals:
In the NIH policy manual and guidance, NIH states that peer reviewers
must be informed about recusal and describes how compliance with such
recusals is to be monitored. According to NCI and NIAID officials,
prior to the SRG meeting peer reviewers are given a form, referred to
in the policy manual, that describes situations that may constitute
conflicts of interest and the need to recuse in those situations. In
addition, peer reviewers are to receive oral instruction on the NIH
conflict of interest policy from SRAs at the beginning of each SRG
meeting, according to NIH's SRA handbook. The NIH policy manual states
that SRAs are required to oversee the SRG meeting to ensure fair and
unbiased evaluations of grant applications and R&D contract proposals.
The NIH policy manual also requires peer reviewers to certify in
writing after the SRG meeting that they have recused.
NIH Provides Written and Oral Methods for Informing Peer Reviewers
about Recusal:
The NIH policy manual and guidance provide written and oral methods for
informing peer reviewers about recusal, including guidance on a form.
The NIH policy manual states that peer reviewers must be informed about
NIH conflict of interest regulations and policies, which include
information pertaining to recusal. The policy manual refers to the
form, "NIH Conflict of Interest, Confidentiality and Non-Disclosure
Rules: Information for Reviewers of Grant Applications and R&D Contract
Proposals," that describes situations that may constitute conflicts of
interest and the need to recuse in these situations, and states that it
is the responsibility of the peer reviewer to notify the SRA of any
potential conflict of interest. This form is provided to all peer
reviewers prior to each SRG meeting, according to NCI and NIAID
officials. A NIAID official told us that after a notification of a
potential conflict of interest, the SRA follows up with the peer
reviewer to discuss whether a conflict exists.[Footnote 65] In
addition, peer reviewers are to receive oral instruction on the NIH
conflict of interest policy from SRAs at the beginning of each SRG
meeting, according to NIH's SRA handbook. NCI and NIAID also send
written review guides to peer reviewers prior to each SRG meeting,
according to NCI and NIAID officials. These guides include sections
describing circumstances in which peer reviewers may encounter
conflicts of interest and describe the NIH policy that requires peer
reviewers to leave the room in order to execute recusals during the SRG
meeting.
NIH Policy and Guidance Provide for Monitoring Compliance with Recusals
through Required Certification Forms and Oversight at SRG Meetings:
The NIH policy manual requires peer reviewers to sign an "NIH Pre-
Review Certification Form" before each SRG meeting. This form instructs
peer reviewers to list the grant applications or R&D contract proposals
with which they have a conflict and to certify that they will not
review these applications or proposals.[Footnote 66] NIH policy also
requires peer reviewers to sign an "NIH Post-Review Certification Form"
to certify that they recused from discussion of any application or
proposal with which they had a conflict. NIH policy requires the SRA
and his or her staff to compile an SRG file that contains the pre-and
postreview certification forms. NCI and NIAID officials told us that
their institutes maintain these SRG files.
The NIH policy manual states that SRAs are required to oversee the SRG
meeting to ensure fair and unbiased evaluations of grant applications
and R&D contract proposals. According to NCI and NIAID officials, the
SRA is responsible for ensuring that the peer reviewer leaves the room
to execute his or her recusal. The SRA handbook states that the SRA or
the chair of the SRG should ask peer reviewers to leave the room during
discussion of the application or proposal with which they have a
conflict. The SRA's assistant is to tell the peer reviewers when to
return to the meeting, according to the SRA handbook.
Conclusions:
The NIH policy manual and guidance describe how peer reviewers are to
be informed about and comply with recusal, but NIH has not established
clear recusal policies for senior employees. The statements in the NIH
policy manual regarding whether employees' recusals must be put in
writing and whether supervisors must be notified are unclear, and,
regarding recusals associated with seeking nongovernment employment,
contradictory. Senior employees who consult the policy manual may or
may not put their recusals in writing and may or may not notify their
supervisors, depending on what chapter and section of the policy manual
they consult. Therefore, it is unclear what actions NIH wants senior
employees to take regarding notifications of recusals.
Although recusal is only one resolution to conflicts of interest, it
constitutes an important component of NIH's overall framework for
managing conflicts of interest and ensuring the integrity of NIH-funded
research. Clear policies and guidance for senior employees' recusals
are particularly important because senior employees serve in positions
of leadership. NIH has undertaken a number of activities to improve its
policies and processes related to conflicts of interest, such as
requiring a preemployment financial disclosure review for prospective
senior employees and implementing the revised HHS supplemental
regulations through the annual ethics training and ethics forms.
Nevertheless, the lack of clear recusal policies for senior employees
results in a vulnerability in the management of one part of NIH's
conflict of interest policies.
Recommendation:
To address the inconsistencies in the policy manual related to senior
employees' notification of recusals and ensure that NIH helps its
senior employees fulfill their responsibilities related to recusal, we
recommend that the Director of NIH expeditiously clarify NIH policies
with regard to written recusals and supervisor notification related to
senior employees' use of recusal to resolve conflicts of interest.
Agency Comments:
On behalf of NIH, HHS provided us with comments on a draft of this
report, which we have reprinted in appendix I. In its comments, HHS
agreed with our recommendation and said it plans to revise and reissue
relevant portions of its policy manual within 6 months. NIH also
provided technical comments, which we have incorporated as appropriate.
As arranged with your offices, unless you publicly announce its
contents earlier, we plan no further distribution of this report until
30 days after its issue date. At that time, we will send copies of this
report to the Director of the National Institutes of Health and other
interested parties. We will also provide copies to others on request.
In addition, the report will be available at no charge on the GAO Web
site at http://www.gao.gov.
If you or your staffs have any questions about this report, please
contact me at (202) 512-7101 or bascettac@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. GAO staff who made major contributions
to this report are listed in appendix II.
Signed by:
Cynthia A. Bascetta:
Director, Health Care:
[End of section]
Appendix I: Comments from the Department of Health and Human Services:
Office Of The Assistant Secretary For Legislation:
Department Of Health & Human Services:
Washington, D.C. 20201:
Apr 11 2007:
Ms. Cynthia A. Bascetta:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Ms. Bascetta:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO) draft report entitled, "NIH Conflict of
Interest: Recusal Policies for Senior Employees Need Clarification"
(GAO-07-319), before its publication.
The report notes that the current NIH manual chapter contains
inconsistencies regarding the procedures senior employees should follow
to document their need to recuse from a matter and recommends that we
expeditiously clarify our policies on written recusals and supervisor
notification. We concur and will work quickly to clarify our policies
by revising and reissuing the relevant portions of the manual chapter.
We expect to complete this task as soon as possible and certainly
within six months.
We are committed to providing consistent and clear guidance to our
employees on the situations that require them to recuse from official
duty matters because of a conflict of interest and on the procedures
they should follow.
The Department has provided several technical comments directly to your
staff.
The Department appreciates the opportunity to review and comment on
this draft.
Sincerely,
Signed by:
Vincent J. Ventimiglia:
Assistant Secretary for Legislation:
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Cynthia A. Bascetta, (202) 512-7101:
Acknowledgments:
In addition to the contact named above, Linda Kohn, Assistant Director;
Lori Fritz; Adrienne Griffin; Roseanne Price; and Ann Tynan made key
contributions to this report.
FOOTNOTES
[1] See 18 U.S.C. § 208(a). Participation is also prohibited when the
financial interest is held by a person or organization that is closely
related to the employee, namely, (1) the employee's spouse; (2) the
employee's minor child; (3) the employee's general partner; (4) an
organization in which the employee serves as officer, director,
trustee, partner, or employee; or (5) a person or organization with
which the employee is negotiating for prospective employment or has an
arrangement for prospective employment. These interests are often
referred to as "imputed interests."
[2] See 5 C.F.R. § 2635.502(a) (2006).
[3] See 42 C.F.R. § 52h.5 (2006). These regulations define a conflict
of interest as a situation in which a reviewer or a close relative or
professional associate of the reviewer has a financial or other
interest in an application or proposal that is known to the reviewer
and is likely to bias the reviewer's evaluation of that application or
proposal. An appearance of a conflict occurs when the financial
interest of the reviewer or a close relative or professional associate
of the reviewer would cause a reasonable person to question the
reviewer's impartiality if he or she were to participate in the review.
See 42 C.F.R. § 52h.2 (2006).
[4] Recusal is called disqualification in the ethics regulations that
apply to the executive branch. The other three methods for resolving a
conflict of interest are waivers, authorizations, and divestiture.
Waivers permit employees or peer reviewers to participate in the matter
in spite of a conflict. Authorizations permit employees to participate
in the matter in spite of a conflict. Divestiture, which is not used by
peer reviewers, typically involves selling the financial holdings that
pose the conflict.
[5] See, for example, 5 C.F.R. § 2635.402(c) (2006) and 42 C.F.R. §
52h.5 (2006).
[6] Also in response to media reports and congressional hearings, in
August 2005 HHS issued revised regulations that focus on outside
activities, awards, prohibited financial interests, and financial
reporting requirements. See 5 C.F.R. Parts 5501 and 5502 (2006).
[7] National Institutes of Health, Working Group of the Advisory
Committee to the Director, Report of the National Institutes of Health
Blue Ribbon Panel on Conflict of Interest Policies (June 22, 2004).
Accessed on February 6, 2007, at Hyperlink,
http://www.nih.gov/about/ethics_COI_panelreport.htm.
[8] See NIH Ethics Concerns: Consulting Arrangements and Outside
Awards: Hearings Before the Subcomm. on Oversight and Investigations of
the House Comm. on Energy and Commerce, 108th Cong. (2004) 24
(statement of Elias A. Zerhouni, Director, National Institutes of
Health).
[9] Throughout the report, we use the term institute to refer to an
institute or center.
[10] NCI and NIAID also have the largest budgets among all institutes
for awards of grants and R&D contracts.
[11] See 5 C.F.R. § 5501.110(b)(1) (2006). This section prohibits
senior employees at NIH from having certain financial interests.
[12] The DAEO is the individual selected by the Secretary of HHS to
coordinate its ethics program.
[13] There are 9 senior employees at NIAID, 14 senior employees at NCI,
and 16 senior employees in the Office of the Director.
[14] Unlike many other federal agencies, NIH does not appoint the
members of these SRGs as Special Government Employees (SGEs). HHS
regulations state that no more than one-quarter of the members of an
SRG may be full-time federal employees. See 42 C.F.R. § 52h.4(c)
(2006). However, according to NIH, membership on SRGs has been only
about 1 percent full-time federal employees since the inception of
NIH's peer review process approximately 50 years ago. NIH also conducts
a subsequent review of grant applications that is carried out by
different advisory committees that comprise both scientific and lay
members chosen for their expertise, interest, or activity in matters
related to health and disease. Most of these committee members are
appointed as SGEs, who are subject to less restrictive conflict of
interest prohibitions than regular federal employees and to different
rules than those applicable to NIH peer reviewers.
[15] See 5 C.F.R. Part 2638, Subpart B (2006).
[16] The DAEO has retained his responsibility for the ethics actions
involving the NIH Director, who is a presidential appointee confirmed
by the Senate. The DAEO also has responsibility for the ethics actions
involving the NCI Director, who is a presidential appointee.
[17] See 5 C.F.R. Parts 5501 and 5502 (2006).
[18] In addition to those situations in which an actual conflict of
interest may arise, OGE regulations state that executive branch
employees must take appropriate steps to avoid the appearance of a loss
of impartiality in the performance of their official duties. See 5
C.F.R. § 2635.501 (2006). For example, such appearance problems may
arise when the employee knows that a particular matter is likely to
have a direct and predictable effect on the financial interest of a
member of the employee's household. See 5 C.F.R. § 2635.502(a) (2006).
[19] This prohibition also applies to instances in which the financial
interest is held by a person whose interests are imputed to the
employee. See 18 U.S.C. § 208(a) (2006); 5 C.F.R. § 2635.402(a) (2006).
[20] See 5 C.F.R. § 2635.403 (2006). These regulations must be based on
the agency's determination that the holdings would cause a reasonable
person to question the impartiality and objectivity with which agency
programs are administered.
[21] This rule also applies to the spouses and minor children of the
senior employees. See 5 C.F.R. § 5501.110 (2006). The regulation
provides for other exceptions to this rule, including for interests
held in pension plans or other employee benefits and publicly available
mutual funds.
[22] See 5 C.F.R. § 5501.109(b)(10) (2006).
[23] See 5 C.F.R. § 5501.110(d) (2006). Recusal is not required when
the value of the interest is less than the thresholds for regulatory
exemptions established by OGE in its executive branch regulations at 5
C.F.R. § 2640.202 (2006).
[24] See 5 C.F.R. Part 2635, Subpart H (2006).
[25] See 5 C.F.R. §§ 2635.802(a); 2635.803 (2006).
[26] See 5 C.F.R. § 5501.109(c) (2006). There are several exceptions to
the general prohibition, including one for the authorship of writings
subjected to scientific peer review or a substantially equivalent
editorial review process.
[27] See 5 C.F.R. § 5501.106(d) (2006). The regulation states that
approval may only be given if the activity is not expected to involve
conduct prohibited by statute or federal regulation, including the OGE
regulations.
[28] See 5 C.F.R. § 2635.802 (2006).
[29] There are no HHS supplemental regulations on seeking or
negotiating outside employment.
[30] See 5 C.F.R. § 2635.602 (2006).
[31] Whether a waiver or an authorization must be sought depends on
whether the employee is merely seeking employment or has begun to
negotiate for employment. See 5 C.F.R. §§ 2635.605 and 2635.606 (2006).
[32] This decision to require the recusal for a certain period of time
after negotiations have ended is made based on an assessment of whether
the employee's participation in the matter would create an appearance
of a conflict. See 5 C.F.R. § 2635.606(b) (2006).
[33] See 41 U.S.C. § 423(c).
[34] See 5 C.F.R. § 2635.204(d)(1) (2006). The award must be given for
meritorious public service or achievement. The rule governing the
acceptance of awards is an exception to the general gifts rule. For the
purposes of this report, we use the term award to refer specifically to
gifts given as awards or given incident to awards.
[35] All awards consisting of cash or investment interests, regardless
of value, must be approved by an agency ethics official prior to
acceptance by the employee.
[36] See 5 C.F.R. § 2635.204(d)(2) (2006).
[37] See 5 C.F.R. § 5501.111(c)(2) (2006). The HHS supplemental
regulations do not address honorary degrees.
[38] See 5 C.F.R. § 5501.111(c)(1) (2006). Awards of cash or investment
interests are prohibited under these circumstances regardless of value.
[39] See 5 C.F.R. § 5501.111(d). In addition, it must be determined
that the award would be otherwise permissible under the OGE regulations
and that the application of the prohibition is not necessary to ensure
public confidence in the impartiality or objectivity with which NIH
programs are administered or to avoid a violation of the OGE
regulations.
[40] See 5 C.F.R. § 5501.112 (2006). An authorization to participate
may be granted under 5 C.F.R. § 2635.502(d) (2006).
[41] Peer review of grant applications and R&D contract proposals is
required by statute. See 42 U.S.C. § 289a. Grants are awarded to
institutions on behalf of a principal investigator to facilitate the
pursuit of a scientific objective when the idea for the research is
initiated by the investigator and the institute anticipates no
substantial involvement. R&D contracts are awarded to procure specific
activities for scientific inquiries in particular areas of R&D needed
by NIH.
[42] SRGs for solicited grant applications and R&D contract proposals
are conducted in the institutes. Specifically, the majority of
scientist-initiated grant applications are reviewed by NIH's Center for
Scientific Review, whereas applications that are submitted in response
to an institute-initiated request for applications are generally
reviewed by that institute. R&D contract proposals are reviewed by the
institute that requested the proposals for that individual contract.
[43] FACA requires agencies to designate a federal officer or employee
to chair or attend every meeting of each advisory committee it
convenes. Committee meetings may not be held without the advance
approval of the designated official. See 5 U.S.C. app., § 10(e),(f).
[44] See 42 C.F.R. Part 52h (2006).
[45] Close relative means the peer reviewer's parent, spouse, child, or
domestic partner. Professional associate means a colleague, scientific
mentor, or student with whom the peer reviewer is currently conducting
research or other significant professional activities or with whom the
peer reviewer has conducted such activities within 3 years of the date
of the SRG meeting. 42 C.F.R. §§ 52h.2(e) and (m) (2006).
[46] A principal investigator oversees the scientific and technical
aspects of the grant and manages the day-to-day research funded by the
grant. An offeror is the organization submitting a proposal for an R&D
contract.
[47] The regulation allows for a determination that there is no
conflict of interest in situations where the components of a large or
multicomponent organization are sufficiently independent so as to be
considered separate organizations. In these situations, the reviewer
would be allowed to consider an application or proposal from a separate
component, provided that he or she has no responsibilities at the
institution that would significantly affect that component. 42 C.F.R. §
52h.5(b)(1) (2006).
[48] The rules of recusal for grant applications differ from the rules
of recusal for R&D contract proposals. For grant applications, peer
reviewers who have a conflict with an application must recuse from, or
obtain a waiver for, the application with which they have a conflict of
interest. See 42 C.F.R. § 52h.5(b) (2006). Therefore, a reviewer who
has recused from one application is allowed to review and score the
other applications in the group. For R&D contract proposals, a peer
reviewer who has a conflict with one proposal must recuse from the
review of all proposals for the same contract, unless the NIH Director
grants a waiver to allow the peer reviewer to recuse from the proposal
with which he has a conflict and to review the other proposals in the
group. The waiver is based on a determination that there is no other
qualified reviewer available with the reviewer's expertise and that
expertise is essential to ensure a competent and fair review. See 42
C.F.R. § 52h.5(b)(3) (2006) .
[49] 42 C.F.R. § 52h.5(b)(4) (2006). In comparison, waivers are
permitted for an appearance of a conflict when the NIH Director or his
designee determines that it would be difficult or impractical to carry
out the review otherwise and that the integrity of the review process
would not be impaired by the peer reviewer's participation. 42 C.F.R. §
52h.5(c) (2006).
[50] See 5 C.F.R. Part 2638, Subpart G (2006), for the requirements
related to agency ethics training programs. According to the
regulations, certain federal employees, such as those who are required
to file public or confidential financial disclosure reports, are
required to receive annual ethics training. Since 2004, NIH has
required that all NIH employees receive annual ethics training,
according to NIH ethics officials.
[51] NIH also requires all new employees to receive initial ethics
training, according to NIH ethics officials. The training we reviewed
consists of an overview of the Standards of Ethical Conduct for
Employees of the Executive Branch and an ethics orientation module.
Both the overview and the ethics orientation module state that recusal
may be used in cases of conflicts arising from financial interests,
seeking employment, and outside activities, and that recusal involves
nonparticipation in official duties related to the particular matter.
[52] This form is used to fulfill the requirement in the HHS
supplemental regulations that certain NIH employees, including all
senior employees, file supplemental disclosures of their financial
interests in substantially affected organizations. 5 C.F.R. §
5502.107(c) (2006). Employees must disclose these interests upon
beginning employment with NIH, and within 30 days of acquiring any
additional interests during their employment.
[53] Employees use this form to comply with the HHS supplemental
regulation requiring approval of certain outside activities, 5 C.F.R. §
5501.106(d) (2006).
[54] Employees use this form to comply with the HHS supplemental
regulation requiring an annual supplemental report on any activities
for which prior approval has been obtained or is required. 5 C.F.R. §
5502.102 (2006). This form must be reviewed by the employee's
supervisor, in consultation with a DEC or other ethics official, to
make sure the employee has complied with applicable ethics laws and
regulations and to determine whether approval of the activities listed
should be continued or canceled.
[55] In addition, two other forms--the "Public Financial Disclosure
Report" (Form 278) and the "Confidential Financial Disclosure Report"
(OGE 450)--do not specifically include information about conflicts of
interest and recusals but when completed may disclose information about
financial interests that allows for identification of potential
conflicts of interest. These forms were developed by OGE based on their
regulations implementing provisions of the Ethics in Government Act,
which required a public annual financial reporting system for certain
high-level federal employees and authorized a confidential annual
financial reporting system for other employees, as OGE deems
appropriate. See 5 U.S.C. app. §§ 101; 107 and 5 C.F.R. Part 2634
(2006).
[56] A NEO official told us that the NIH DEC is the official ethics
officer of record for all NIH senior employees and signs senior
employees' ethics forms, except for those of the NIH Director and the
NCI Director, who are presidential appointees. The HHS DAEO serves as
the ethics officer for these appointees.
[57] This includes but is not limited to services as an officer,
director, employee, agent, attorney, consultant, contractor, general
partner, or trustee. See 5 C.F.R. § 2635.603(a) (2006).
[58] See National Institutes of Health Policy Manual, Chapter 2300-735-
1--Avoiding Conflicts of Interest (June 19, 1998), p. 12.
[59] National Institutes of Health Policy Manual, Chapter 2300-735-4--
Outside Work and Related Activities with Outside Organizations,
February 17, 1998, Appendix 4, p. 3.
[60] Ibid., pp. 1-2.
[61] NIH also makes available on its Web site two templates that senior
employees may use to write a recusal memorandum. One recusal memorandum
template is for institute directors, and the other template is for all
other NIH employees. Although these templates allow for notification of
supervisors, employees are not required to use these templates.
[62] National Institutes of Health Policy Manual, Chapter 2300-735-1--
Avoiding Conflicts of Interest, p. 7.
[63] National Institutes of Health Policy Manual, Chapter 2300-735-4--
Outside Work and Related Activities with Outside Organizations, p. 4.
[64] OGE regulations state that recusal is accomplished by not
participating in the particular matter. See, for example, 5 C.F.R. §
2635.402(c) (2006). Written recusal is not required by the regulation,
with some exceptions that apply to the NIH Director, who is nominated
by the President and confirmed by the Senate and is under an ethics
agreement. The regulations further state that the employee "should
notify the person responsible for his assignment" about a recusal and
that the employee "may" make "appropriate oral or written notification"
to coworkers. Several other federal agencies, such as the Department of
Defense and the Department of Energy, have promulgated supplemental
regulations approved by OGE that require employees to provide written
notice of recusals in certain situations. Additionally, the Procurement
Integrity Act requires written recusals resulting from a government
employee's contacts regarding employment with a bidder or offeror in a
contract exceeding the simplified acquisition threshold (most contracts
greater than $100,000). See 41 U.S.C. § 423(c).
[65] HHS regulations allow the SRA to determine whether a peer reviewer
has a conflict of interest with an application or proposal. See 42
C.F.R. § 52h.2(q) (2006).
[66] Reviewers with no stated conflicts must also certify to that fact
on the form. NCI and NIAID officials told us that peer reviewers with
conflicts of interest generally do not receive documents related to
applications with which they have a conflict, or if they have received
them are instructed to destroy those documents.
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