[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR52h.5]

[Page 222-223]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 52h_SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND 
RESEARCH AND DEVELOPMENT CONTRACT PROJECTS--Table of Contents
 
Sec. 52h.5  Conflict of interest.

    (a) This section applies only to conflicts of interest involving 
members of peer review groups. This section does not cover individuals 
serving on National Advisory Councils or Boards, Boards of Scientific 
Counselors, or Program Advisory Committees who, if not already officers 
or employees of the United States, are special Government employees and 
covered by title 18 of the United States Code, the Office of Government 
Ethics Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635), and Executive Order 11222, as amended. For 
those federal employees serving on peer review groups, in accordance 
with Sec. 52h.4, the requirements of title 18 of the United States 
Code, 5 CFR part 2635 and Executive Order 12674, as modified by 
Executive Order 12731, apply.
    (b) A reviewer with a real conflict of interest must recuse him/
herself from the review of the application or proposal, except as 
otherwise provided in this section.
    (1) A reviewer who is a salaried employee, whether full-time or 
part-time, of the applicant institution, offeror, or principal 
investigator, or is negotiating for employment, shall be considered to 
have a real conflict of interest with regard to an application/proposal 
from that organization or principal investigator, except that the 
Director may determine there is no real conflict of interest or an 
appearance of a conflict of interest where the components of a large or 
multicomponent organization are sufficiently independent to constitute, 
in effect, separate organizations, provided that the reviewer has no 
responsibilities at the institution that would significantly affect the 
other component.
    (2) Where a reviewer's real conflict of interest is based upon the 
financial or other interest of a close relative or professional 
associate of the reviewer, that reviewer must recuse him/herself, unless 
the Director provides a waiver in accordance with paragraph (b)(4) of 
this section.
    (3) For contract proposal reviews, an individual with a real 
conflict of interest in a particular proposal(s) is generally not 
permitted to participate in the review of any proposals responding to 
the same request for proposals. However, if there is no other qualified 
reviewer available having that individual's expertise and that expertise 
is essential to ensure a competent and fair review, a waiver may be 
granted by the Director to permit that individual to serve as a reviewer 
of those proposals with which the reviewer has no conflict, while 
recusing him/herself from the review of any particular proposal(s) in 
which there is a conflict of interest.
    (4) The Director may waive any of the requirements in paragraph (b) 
of this section relating to a real conflict of interest if the Director 
determines that there are no other practical means for securing 
appropriate expert advice on a particular grant or cooperative agreement 
application, contract project, or contract proposal, and that the real 
conflict of interest is not so substantial as to be likely to affect the 
integrity of the advice to be provided by the reviewer.
    (c) Any appearance of a conflict of interest will result in recusal 
of the reviewer, unless the Director provides a waiver, determining that 
it would be difficult or impractical to carry out the review otherwise, 
and the integrity of the review process would not be impaired by the 
reviewer's participation.
    (d) When a peer review group meets regularly it is assumed that a 
relationship among individual reviewers in the group exists and that the 
group as a whole may not be objective about evaluating the work of one 
of its members. In such a case, a member's application or proposal shall 
be reviewed by another qualified review group to ensure that a competent 
and objective review is obtained.
    (e) When a member of a peer review group participates in or is 
present during the concept review of a contract proposal that occurs 
after release of the solicitation, as described under Sec. 52h.10(b), 
but before receipt of proposals, the member is not considered to

[[Page 223]]

have a real conflict of interest as described in paragraph (b) of this 
section, but is subject to paragraph (c) of this section concerning 
appearance of conflict of interest if the member is planning to respond 
to the solicitation. When the concept review occurs after receipt of 
proposals, paragraph (b) applies.
    (f) No member of a peer review group may participate in any review 
of a specific grant application or contract project for which the member 
has had or is expected to have any other responsibility or involvement 
(whether pre-award or post-award) as an officer or employee of the 
United States.
    (g) The Director may periodically issue guidance to the government 
officials responsible for managing reviews and reviewers on what 
interests would constitute a real conflict of interest or an appearance 
of a conflict of interest.