NIH Conflict of Interest: Recusal Policies for Senior Employees  
Need Clarification (30-APR-07, GAO-07-319).			 
                                                                 
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. 					 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-319 					        
    ACCNO:   A68945						        
  TITLE:     NIH Conflict of Interest: Recusal Policies for Senior    
Employees Need Clarification					 
     DATE:   04/30/2007 
  SUBJECT:   Conflict of interests				 
	     Employee training					 
	     Ethical conduct					 
	     Federal regulations				 
	     Medical research					 
	     Policy evaluation					 
	     Reporting requirements				 
	     Requirements definition				 
	     Written communication				 
	     Peer review					 
	     Policies and procedures				 

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GAO-07-319

   

     * [1]Results in Brief
     * [2]Background

          * [3]The NIH Ethics Program and the Office of Extramural Research
          * [4]NIH Senior Employees and Conflict of Interest Regulations
          * [5]Peer Reviewers at NIH and Conflict of Interest Regulations

     * [6]NIH Informs Senior Employees about Recusal through Several M

          * [7]NIH Informs Senior Employees about Recusal through Several M
          * [8]NIH Policy Manual Is Contradictory on Whether Written Recusa

     * [9]NIH Provides Written and Oral Methods for Informing Peer Rev

          * [10]NIH Provides Written and Oral Methods for Informing Peer Rev
          * [11]NIH Policy and Guidance Provide for Monitoring Compliance wi

     * [12]Conclusions
     * [13]Recommendation
     * [14]Agency Comments
     * [15]Appendix I: Comments from the Department of Health and Human
     * [16]Appendix II: GAO Contact and Staff Acknowledgments

          * [17]GAO Contact
          * [18]Acknowledgments

               * [19]Order by Mail or Phone

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

Contents

Letter 1

Results in Brief 5
Background 6
NIH Informs Senior Employees about Recusal through Several Methods;
However, Its Policy Requirements for Notification of Supervisors Are
Unclear 13
NIH Provides Written and Oral Methods for Informing Peer Reviewers about
Recusal and for Monitoring Compliance with Recusals 19
Conclusions 20
Recommendation 21
Agency Comments 21
Appendix I Comments from the Department of Health and Human Services 23
Appendix II GAO Contact and Staff Acknowledgments 24

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

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separately.

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. 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 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.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.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.3 One method an employee or peer
reviewer may use to resolve a conflict of interest or the appearance of a
conflict is recusal.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.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.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.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.8

1See 18 U.S.C. S 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."

2See 5 C.F.R. S 2635.502(a) (2006).

3See 42 C.F.R. S 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. S 52h.2 (2006).

4Recusal 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.

5See, for example, 5 C.F.R. S 2635.402(c) (2006) and 42 C.F.R. S 52h.5
(2006).

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.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.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.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)12 or the NIH
Director in consultation with the HHS DAEO.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.

6Also 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).

7National 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
http://www.nih.gov/about/ethics_COI_panelreport.htm .

8See 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).

9Throughout the report, we use the term institute to refer to an institute
or center.

10NCI and NIAID also have the largest budgets among all institutes for
awards of grants and R&D contracts.

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.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.

11See 5 C.F.R. S 5501.110(b)(1) (2006). This section prohibits senior
employees at NIH from having certain financial interests.

12The DAEO is the individual selected by the Secretary of HHS to
coordinate its ethics program.

13There are 9 senior employees at NIAID, 14 senior employees at NCI, and
16 senior employees in the Office of the Director.

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.

14Unlike 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. S 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.

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.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.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.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.18

15See 5 C.F.R. Part 2638, Subpart B (2006).

16The 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.

17See 5 C.F.R. Parts 5501 and 5502 (2006).

           o 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.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.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.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.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.23 
           o 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.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.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.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.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.28
		   
18In 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. S 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. S
2635.502(a) (2006).

19This 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. S 208(a) (2006); 5 C.F.R. S 2635.402(a) (2006).

20See 5 C.F.R. S 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.

21This rule also applies to the spouses and minor children of the senior
employees. See 5 C.F.R. S 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.

22See 5 C.F.R. S 5501.109(b)(10) (2006).

23See 5 C.F.R. S 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. S 2640.202 (2006).

24See 5 C.F.R. Part 2635, Subpart H (2006).

25See 5 C.F.R. SS 2635.802(a); 2635.803 (2006).

26See 5 C.F.R. S 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.

27See 5 C.F.R. S 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.

28See 5 C.F.R. S 2635.802 (2006).		   

           o 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.29 Generally, OGE regulations require an
           employee to recuse from particular matters that would have a
           direct and predictable effect on a prospective employer.30
           However, an employee may receive a waiver or authorization to
           participate in the matter.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.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.33
		   
29There are no HHS supplemental regulations on seeking or negotiating
outside employment.

30See 5 C.F.R. S 2635.602 (2006).

31Whether 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. SS 2635.605 and 2635.606 (2006).

32This 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. S 2635.606(b) (2006).

33See 41 U.S.C. S 423(c).		   

           o 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.34 Awards from such donors with
           values greater than $200 may be accepted only with the approval of
           an agency ethics official.35 An employee may also accept an
           honorary degree with written permission from an agency ethics
           official.36 The HHS supplemental regulations require NIH employees
           to obtain advance approval for any award, regardless of value.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.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.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.40
		   


34See 5 C.F.R. S 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.

35All awards consisting of cash or investment interests, regardless of
value, must be approved by an agency ethics official prior to acceptance
by the employee.

36See 5 C.F.R. S 2635.204(d)(2) (2006).

37See 5 C.F.R. S 5501.111(c)(2) (2006). The HHS supplemental regulations
do not address honorary degrees.

38See 5 C.F.R. S 5501.111(c)(1) (2006). Awards of cash or investment
interests are prohibited under these circumstances regardless of value.

39See 5 C.F.R. S 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.

40See 5 C.F.R. S 5501.112 (2006). An authorization to participate may be
granted under 5 C.F.R. S 2635.502(d) (2006).

           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.41 These evaluations are conducted by peer reviewers in
           SRGs, which can include standing committees and special emphasis
           panels.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.43 A non-NIH
           scientist also chairs each SRG meeting.
		   
41Peer review of grant applications and R&D contract proposals is required
by statute. See 42 U.S.C. S 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.

42SRGs 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.

43FACA 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., S 10(e),(f).		   

           HHS regulations govern the procedures for selecting peer reviewers
           and contain a section on conflict of interest.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 associate45

           o has or could receive a direct financial benefit of any amount
           deriving from an application or proposal;

           o has or could receive a financial benefit over $10,000 from an
           institution, offeror, or principal investigator named in an
           application or proposal;46 or

           o is currently employed or negotiating for employment with an
           institution, offeror, or principal investigator named in the
           application or proposal.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.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.49
		   
44See 42 C.F.R. Part 52h (2006).

45Close 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. SS 52h.2(e) and (m) (2006).

46A 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.

47The 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. S 52h.5(b)(1) (2006).

48The 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. S 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. S 52h.5(b)(3) (2006) .

4942 C.F.R. S 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. S 52h.5(c)
(2006).		   

           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.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.51
		   
50See 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.

51NIH 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.

           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),52 the "Request for Approval of Outside
           Activity" (HHS Form 520),53 and the "Annual Report of Outside
           Activity" (HHS Form 521)54--provide detailed summaries of conflict
           of interest regulations and recusal.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.56
		   
52This 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. S 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.

53Employees use this form to comply with the HHS supplemental regulation
requiring approval of certain outside activities, 5 C.F.R. S 5501.106(d)
(2006).

54Employees 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. S 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.	

           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,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,"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.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.60 These inconsistencies raise questions as to which
           sections of the manual are to be followed.
		   

55In 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. SS 101;
107 and 5 C.F.R. Part 2634 (2006).

56A 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.

57This 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. S 2635.603(a) (2006).

58See National Institutes of Health Policy Manual, Chapter
2300-735-1--Avoiding Conflicts of Interest (June 19, 1998), p. 12.

59National Institutes of Health Policy Manual, Chapter 2300-735-4--Outside
Work and Related Activities with Outside Organizations, February 17, 1998,
Appendix 4, p. 3.

60Ibid., pp. 1-2.

           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.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,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."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.64 As a
           result, a senior employee seeking clarity from an NIH ethics
           official could receive varying directions about how to recuse.
		   
61NIH 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.		   

62National Institutes of Health Policy Manual, Chapter
2300-735-1--Avoiding Conflicts of Interest, p. 7.

63National Institutes of Health Policy Manual, Chapter 2300-735-4--Outside
Work and Related Activities with Outside Organizations, p. 4.

           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.
		   
64OGE regulations state that recusal is accomplished by not participating
in the particular matter. See, for example, 5 C.F.R. S 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. S 423(c).	

           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.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.
		   
65HHS 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. S
52h.2(q) (2006).

           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.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.
		   
		   Conclusions

           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.
           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.
		   
66Reviewers 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.

           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 [email protected] . 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.

           Cynthia A. Bascetta
		   Director, Health Care
		   
		   Appendix I: Comments from the Department of Health and Human
		   Services
		   
		   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.
		   
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Highlights of [30]GAO-07-319 , a report to congressional requesters

April 2007

NIH CONFLICT OF INTEREST

Recusal Policies for Senior Employees Need Clarification

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.

[31]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.

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.

References

Visible links

  30. http://www.gao.gov/cgi-bin/getrpt?GAO-07-319
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