[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR52h.5]

[Page 224-225]
 
                         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) Members of peer review groups covered by this part are subject 
to relevant provisions in title 18 of the United States Code, relating 
to criminal activity, the Department of Health and Human Services 
Standards of Conduct (45 CFR part 73), and Executive Order 11222, as 
amended.
    (b) In addition to any restrictions imposed under paragraph (a) of 
this section:
    (1) No member of a peer review group may participate in or be 
present during any review by said group of a grant application, contract 
project, or contract proposal in which, to the member's knowledge, any 
of the following has a financial interest: (i) The member or his or her 
spouse, parent, child, or partner, (ii) any organization in which the 
member or his or her spouse, parent, child, or partner is serving as an 
officer, director, trustee, partner, or employee, or is otherwise 
similarly associated, or (iii) any organization with which the member or 
his or her spouse, parent, child, or partner is negotiating or has any 
arrangement concerning prospective employment or other similar 
association.
    (2) In the event any member of a peer review group or his or her 
spouse, parent, child, or partner is currently or expected to be the 
principal investigator or member of the staff responsible for carrying 
out any research or development activities contemplated as part of a 
grant application, contract

[[Page 225]]

project, or contract proposal, that group is disqualified and the review 
will be conducted by another group with the expertise to do so. If there 
is no other group with the requisite expertise, the review will be 
conducted by an ad hoc group no more than 50 percent of whose members 
may be from the disqualified group. The composition of any such ad hoc 
group will be determined in accordance with Sec. 52h.4(b) and 
Sec. 52h.4(c) of this part and, to the extent feasible, Sec. 52h.4(a) of 
this part.
    (3) Where a member of a peer review group participates in or is 
present during:
    (i) Development or review of a project approach or request for 
proposals by said group or
    (ii) Review by said group under Sec. 52h.10(b) or Sec. 52h.10(c), 
i.e. after the issuance of a request for proposals, no contract may 
thereafter be awarded as the result of such development or review to 
said member, his or her spouse, parent, child, or partner or any 
organization in which the member, his or her spouse, parent, child, or 
partner was serving as officer, director, trustee, partner, or employee 
at the time of such development or review or with which the member, his 
or her spouse, parent, child, or partner was negotiating or had any 
arrangement concerning prospective employment at said time.
    (4) No member of a peer review group may participate in any review 
under this part 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 preaward or postaward) as an officer or employee 
of the United States.
    (c) Where permissible under the statutes, standards, and order cited 
in paragraph (a) of this section, the Director of the National 
Institutes of Health, the Administrator of the Alcohol, Drug Abuse, and 
Mental Health Administration, the Administrator of the Health Resources 
and Services Administration, or their designees may waive the 
requirements in paragraph (b) of this section if he or she determines 
that there is no other practical means for securing appropriate expert 
advice on a particular grant application, contract project, or contract 
proposal.

(Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 
360, 89 Stat. 315, 92 Stat. 3436 (42 U.S.C. 289l-4))

[43 FR 7862, Feb. 24, 1978, as amended at 45 FR 35328, May 27, 1980; 49 
FR 38111, Sept. 27, 1984]