[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR52h.5]



[Page 221-222]

 

                         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



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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 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.



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