[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: 42CFR67.15]



[Page 402-404]

 

                         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 403]]



    (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 404]]



    (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]