[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR67.15]

[Page 395-397]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 67--AGENCY FOR HEALTH CARE POLICY AND RESEARCH GRANTS AND CONTRACTS--Table of Contents
 
  Subpart A--Research Grants for Health Services Research, Evaluation, 
                Demonstration, and Dissemination Projects
 
Sec. 67.15  Peer review of applications.

    (a) General procedures for peer review. (1) All applications for 
support under this subpart will be submitted by the Administrator for 
review to a peer review group, in accordance with section 922(a) of the 
PHS Act, except that applications eligible for review under section 
922(d)(2) of the PHS Act (``small grants'') may be reviewed under 
adjusted procedures in accordance with paragraph (b) of this section.
    (2) Members of the peer review group will be selected based upon 
their training and experience in relevant scientific and technical 
fields, taking into account, among other factors:
    (i) The level of formal education (e.g., M.A., Ph.D., M.D., D.N.Sc.) 
completed by the individual and/or the individual's pertinent experience 
and expertise;
    (ii) The extent to which the individual has engaged in relevant 
research, the capacities (e.g., principal investigator, assistant) in 
which the individual has done so, and the quality of such research;
    (iii) The extent of the professional recognition received by the 
individual as reflected by awards and other honors received from 
scientific and professional organizations outside the Department of 
Health and Human Services;
    (iv) The need of the peer review group to include within its 
membership experts representing various areas of specialization within 
relevant scientific and technical fields, or specific health care 
issues; and
    (v) Appropriate representation based on gender, racial/ethnic 
origin, and geography.
    (3) Review by the peer review group under paragraph (a) of this 
section is conducted by using the criteria set out in paragraph (c) of 
this section.
    (4) The peer review group to which an application has been submitted 
under paragraph (a) of this section shall make a written report to the 
Administrator on each application, which shall contain the following 
parts:
    (i) The first part of the report shall consist of a factual summary 
of the proposed project, including a description of its purpose, 
scientific approach, location, and total budget.
    (ii) The second part of the report shall address the scientific and 
technical merit of the proposed project with a critique of the proposed 
project with regard to the factors described in paragraphs (c)(1)(i) 
through (c)(1)(x) or (c)(2)(i) through (c)(2)(vii) of this section as 
applicable. This portion of the report shall include a set of 
recommendations to the Administrator with respect to the disposition of 
the application based upon its scientific and technical merit. The peer 
review panel may recommend to the Administrator that an application:
    (A) Be given consideration for funding,
    (B) Be deferred for a later decision, pending receipt of additional 
information, or
    (C) Not be given further consideration.
    (iii) For each application recommended for further consideration by 
the Administrator, the report shall also provide a priority score based 
on the scientific and technical merit of the proposed project, and make 
recommendations on the appropriate project period and level of support. 
The report may also address, as applicable, the degree to which the 
proposed project relates to AHCPR-announced priorities.
    (b) Procedural adjustments for small grants. (1) The Administrator 
may make adjustments in the peer review procedures established in 
accordance with paragraph (a) of this section for grant applications 
with total direct costs that do not exceed the amount specified in 
section 922(d)(2) of the PHS Act, hereafter referred to as ``small 
grants.''

[[Page 396]]

    (2) Non-Federal and Federal experts will be selected by the 
Administrator for the review of small grant applications on the basis of 
their training and experience in particular scientific and technical 
fields, their knowledge of health services research and the application 
of research findings, and their special knowledge of the issue(s) being 
addressed or methods and technology being used in the specific proposal.
    (3) Review of applications for small grants may be by a review group 
established in accordance with paragraph (a) of this section, or by 
individual field readers, or by an ad hoc group of reviewers.
    (4) The review criteria set forth in paragraph (c) of this section 
shall be used for the review of small grant applications.
    (5) Each reviewer or group of reviewers to whom an application has 
been submitted under paragraph (b) of this section shall make a written 
report to the Administrator on each application. Each report shall 
summarize the findings of the review and provide a recommendation to the 
Administrator on whether the application should be given further 
consideration. For applications recommended for further consideration, 
the report may also address, as applicable, the degree to which the 
proposed project relates to AHCPR-announced priorities.
    (c) Review criteria. The review criteria set out in this paragraph 
apply to both applications reviewed by peer review panels in accordance 
with paragraph (a) of this section, and applications for small grants 
reviewed in accordance with paragraph (b) of this section.
    (1) General review criteria. In carrying out a review under this 
section for grants (other than conference grants), the following review 
criteria will be taken into account, where appropriate:
    (i) The significance and originality from a scientific or technical 
standpoint of the goals of the project;
    (ii) The adequacy of the methodology proposed to carry out the 
project;
    (iii) The availability of data or the adequacy of the proposed plan 
to collect data required in the analyses;
    (iv) The adequacy and appropriateness of the plan for organizing and 
carrying out the project;
    (v) The qualifications and experience of the principal investigator 
and proposed staff;
    (vi) The reasonableness of the budget and the time frame for the 
project, in relation to the work proposed;
    (vii) The adequacy of the facilities and resources available to the 
grantee;
    (viii) The extent to which women and minorities are adequately 
represented in study populations;
    (ix) Where an application involves activities which could have an 
adverse effect upon humans, animals, or the environment, the adequacy of 
the proposed means for protecting against or minimizing such effects; 
and
    (x) Any additional criteria that may be announced by the 
Administrator from time to time for specific categories of grant 
applications (e.g., proposed projects for support of research centers) 
eligible for support under this subpart.
    (xi) In addition to the scientific and technical criteria above, 
peer reviewers may be asked to consider the degree to which a proposed 
project addresses any special AHCPR priorities that have been announced 
by the Administrator, as applicable.
    (2) Review criteria for conference grants. In carrying out reviews 
of conference grants under paragraphs (a) and (b) of this section, the 
following review criteria will be taken into account, as appropriate:
    (i) The significance of the proposed conference, specifically the 
importance of the issue or problem being addressed, including 
methodological or technical issues for dealing with the development, 
conduct, or use of health services research;
    (ii) The qualifications of the staff involved in planning and 
managing the conference;
    (iii) The adequacy of the facilities and other resources available 
for the conference;
    (iv) the appropriateness of the proposed budget, including other 
sources of funding;
    (v) The extent to which the health concerns of women and minorities 
will be addressed in the conference topic(s), as appropriate;

[[Page 397]]

    (vi) The plan for evaluating and disseminating the results of the 
conference; and
    (vii) Any additional criteria that may be announced by the 
Administrator.
    (viii) In addition to the scientific and technical criteria above, 
peer reviewers may be asked to consider the degree to which a proposed 
project addresses any special AHCPR priorities that have been announced 
by the Administrator, as appropriate.
    (d) Conflict of interest. (1) Members of peer review groups will be 
screened for potential conflicts of interest prior to appointment and 
will be required to follow Department policies and procedures consistent 
with the Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635), Executive Order 12674 (as modified by 
Executive Order 12731).
    (2) In addition to any restrictions referenced under paragraph 
(d)(1) of this section:
    (i) No member of a peer review group (or individual reviewer) may 
participate in or be present during any review by such group of a grant 
application in which, to the member's knowledge, any of the following 
has a financial interest:
    (A) The member or his or her spouse, minor child, or partner;
    (B) Any organization in which the member is serving as an officer, 
director, trustee, general partner, or employee; or
    (C) Any organization with which the member is negotiating or has any 
arrangement concerning prospective employment or other similar 
association, and further;
    (ii) In the event that 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, that member of the group, or the group, may be 
disqualified from the review and the review conducted by another group 
with the expertise to do so. An ad hoc group selected in accordance with 
Sec. 67.15(a), or Sec. 67.15(b) as applicable, may also be used for the 
review. Any individual reviewer to whom the conditions of this paragraph 
apply would also be disqualified as a reviewer.
    (iii) No member of a peer review group or individual may participate 
in any review under this subpart of a specific grant application 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.
    (3) Where permissible under the standards and order(s) cited in 
paragraph (d)(1) of this section, the Administrator may waive the 
requirements in paragraph (d)(2) of this section if it is determined 
that there is no other practical means for securing appropriate expert 
advice on a particular grant application.

[62 FR 12909, Mar. 18, 1997, as amended at 62 FR 37124, July 10, 1997]