kristoff@GENBANK.BIO.NET (Dave Kristofferson) (08/23/90)
ANIMAL RESOURCES PROGRAM
INFORMATION FOR APPLICANTS
RFA: RR-90-03
ANIMAL FACILITY IMPROVEMENTS FOR SMALL RESEARCH PROGRAMS
P.T. 34; K.W. 1002002
An Administrative Document Issued By:
Animal Resources Program
National Center for Research Resources
National Institutes of Health
Department of Health and Human Services
August 1990
INTRODUCTION
The Animal Resources Program (ARP) of the National Center for
Research Resources (NCRR), National Institutes of Health (NIH),
assists institutions in developing and improving animal
resources for biomedical research and research training through
the award of research and resource grants. For the purpose of
this program, animal resources are defined as all animals,
their associated facilities, and staff which support biomedical
research activities. The ARP supports various activities which
assist in meeting the animal resource needs of investigators
and the public demand and legal requirements for proper care of
laboratory animals. This document relates to institutional
animal resource improvement projects which will be supported
with funds anticipated to be made available to the Department
of Health and Human Services (DHHS) in Fiscal Year 1991 for
this activity.
PROGRAM GOALS AND SCOPE
Animal resource improvement grants are awarded to assist
biomedical research and educational institutions in upgrading
their animal facilities and in developing centralized programs
of animal care. Another major objective is to enable
institutions to comply with the USDA Animal Welfare Act and
DHHS policies related to the care and use of laboratory
animals. Allowable requests include alterations and
renovations (A&R) to improve existing laboratory animal
facilities; major resource equipment related to the
improvement, such as animal cage systems and cage washers; and
large items of basic equipment for centralized surgeries or
diagnostic laboratories. This improvement grant is not
intended to provide operational support for the resource (e.g.,
funding for personnel, consumable supplies for routine animal
care, or small equipment items costing less than $1,000 per
manufacturer's unit). Equipment to monitor/provide animal
facility security is also not provided under this grant. To
gain approval and support, both the need for resource
improvements and a sound plan to bring the entire animal
resource to required standards (or to maintain the entire
animal resource at required standards) must be well-described
in the context of the biomedical research programs of the
institution.
It is expected that the institution will assume complete
financial responsibility for its basic animal resources after
its facility improvement program is completed.
ELIGIBILITY AND SUPPORT
Any domestic public or private institution, organization, or
association with one or more research projects supported by an
agency of the Public Health Service (PHS) and which involve the
use of laboratory animals is eligible to apply. However, the
total amount of PHS support during the institution's current
fiscal year for research projects using animals must be less
than $500,000 (direct costs). An institution that applies to
this program may not, within the same Federal fiscal year of
PHS funding, also apply for support under the previously issued
Request for Applications, RFA-RR-90-02, entitled "Developing
and Improving Institutional Animal Resources." The applicant
institution is strongly encouraged to develop a single proposal
for a campus-wide program with a single, centralized animal
care program whenever possible.
The total cost of the proposed project may be any amount.
However, for the purposes of this application, the request to
PHS is limited to $150,000 for equipment and $100,000 for A&R.
Matching funds are not required. Support for new construction,
including completion of shell space, is not authorized.
Following the actual award, funds for A&R will not be released
until final architectural drawings, specifications, and updated
cost estimates are received and approved by NCRR. Awards will
be made for a period of one year and are not renewable.
However, this does not preclude the submission of applications
for additional improvements or support for other types of
animal resource activities in subsequent fiscal years if an RFA
is issued for these activities.
The NCRR anticipates that approximately $1.5 million may be
available to support these animal resource improvement grants
in Fiscal Year 1991. It is anticipated that approximately 15
awards may be made. The number and specific amounts of these
awards will depend on the merit and scope of the applications
received and the availability of funds. All policies and
requirements which govern PHS grant programs will apply. If
this program is successful, it may be expanded further in
future years.
REVIEW PROCEDURES AND CRITERIA
Applications will be received by the Division of Research
Grants (DRG). Applicants must use Form PHS 398 (Rev. 10/88),
"Application for Public Health Service Grant." There will be a
single receipt date of December 3, 1990. Applications received
after this date will be returned without further processing.
All applications will be reviewed by a Special Review
Committee(s) managed by NCRR for scientific merit and by the
National Advisory Research Resources Council for program
considerations.
Review of animal resource improvement projects will be based on
the request itself as well as on the entire animal resource
program to which the specific improvement request relates.
Factors entering into the appraisal of an animal resource
improvement project include:
A. The Improvement Request
1 Need - The extent to which the project will fill a need of
the research and educational community to be served by the
resource will be an important part of the evaluation. Evidence
of the necessity of resource grant support for improvements
which will enable the institution to meet the standards of the
Animal Welfare Act and DHHS policies on the care and use of
animals should be demonstrated. The amount(s) and source(s) of
funding for animal-related biomedical research utilizing the
resource will also be evaluated.
2 Procedural Plans - Evidence of campus-wide planning to
assure a comprehensive and acceptable research animal program
will be evaluated. The specific methods proposed will be
judged for scientific and technical soundness and their ability
to meet the applicable standards.
3 Budget - The budget will be evaluated in relation to the
program scope, institutional commitment, and justification
provided for the requested items.
4 Animal Welfare - The extent to which the project will
enhance the welfare of animals maintained in the facility to be
served by the resource will be an important part of the
evaluation. An assessment of the benefit of the improvements
to the welfare of animals in the facility, including advances
in the humane treatment of the animals due to husbandry changes
allowed by the improvements, should be described. Increases
above the minimum space recommendations for laboratory animals,
as set forth in the "Guide for the Care and Use of Laboratory
Animals" (Guide), HHS, NIH Publication No. 86-23, Revised 1985
edition or succeeding revised editions may be requested by the
applicant from the ARP, NCRR office noted later in this
document. The overall application will be evaluated for its
scientific merit, technical soundness, and cost effectiveness.
B. The Animal Resources Program
The scope of coverage of the animal resources program to be
enhanced by this facility improvement request should be
carefully defined. Normally, it should cover the entire
applicant institution.
1 Animal Care - The quality of the proposed animal husbandry
program will be considered, including training of the animal
technical staff, housing, caging, feeding, record keeping,
sanitation, and other animal care practices. Consideration of
the animal health program will include clinical services,
laboratory support, preventive medicine programs, and any
relevant specialized procedures.
2 Personnel - The adequacy of the staff will be evaluated.
There should be a sufficient number of professional staff with
appropriate qualifications to operate the animal resource in a
competent manner. Provisions should be made for an adequate
number of appropriately trained non-professional staff and
supporting services. An appropriate preventive health program
should be in place.
3 Administrative Arrangements - An evaluation will be made of
the administrative arrangements for planning and day-by-day
management of the animal resource. There should be a sound
plan for financial support of the resource, e.g., through a
recharge system. Previous expenditures by the institution for
capital improvements of the animal resource program should be
described.
4 Resources and Environment - The suitability of the
institutional setting for achieving the goals of the program
will be considered. This will include an appraisal of the
academic environment and the support for the animal resource by
the administration and faculty. The adequacy of the physical
environment, buildings, and equipment for the animal resource
will be evaluated.
APPLICATION PROCEDURES
There will be a single receipt date of December 3, 1990.
Applications received after this date will be returned to the
applicant. Applications must be submitted on Form PHS 398
(Rev. 10/88), the application form used for research grants.
Application kits can be obtained from most institutional
business offices, or from the Division of Research Grants, NIH,
(see address at end of this document). The RFA label included
in Application Form PHS 398 must be affixed to the bottom of
the face page. Failure to use this label could result in
delayed processing of the application such that it may not
reach the review committee in time for review. The format and
details applicable to regular research grant applications
should be followed, except for the following:
SECTION 1
A. Face Page of the Application - Item 2 - Check the box
marked "Yes" and type in the number and title of this RFA (RFA
#RR-90-03, "Animal Facility Improvements for Small Research
Programs").
Item 5 - Check the box marked "No" at Item 5a. Item 5b - Not
applicable.
B. Key Personnel - Application Page 2 - All key personnel
should be listed here with the percent effort to be devoted to
the animal resource even though salary support is not
requested. This must include the chief or consulting
veterinarian. It may also include the principal investigator,
director of the animal facility, or chief animal technician, as
appropriate. Biographical sketches must be provided for all
personnel listed.
C. Table of Contents - Indicate page numbers for all major
headings outlined under Section 1 and Section 2, Research Plan.
This is very helpful to the reviewers of the application.
D. Detailed Budget - Application Page 4 - The total request
for PHS support may not exceed $250,000. Of this total, the
A&R request may not exceed $100,000 and the Equipment request
may not exceed $150,000. No matching funds are required.
Personnel Category - List only those individuals who will
devote time/effort to the execution of the facility improvement
project and the time/effort required. Salary support should
not be requested.
The requested budget should be limited to items of major
equipment for animal care or other aspects of the facility's
functions, and A&R. Equipment should be classified as movable
or fixed, using the institution's own classification guidelines
as provided by its Business Office. Fixed equipment is
considered as part of the A&R request. Small equipment items
costing less that $1,000 per manufacturer's unit should not be
requested. This includes multiple polycarbonate rodent cages
for replacement or change-out purposes. However, as an
exception to this, microisolator cages are acceptable if an
appropriate change station is also purchased or is already
available. To avoid deletion, requests for items that may
require the purchase of small component parts, i.e., a rack and
cages, should be priced as a single item, but a description of
the individual components must be provided (see below).
Large items of basic surgical equipment, such as tables,
lights, and gas anesthesia machines may be requested if the
operating room is an integral part of the animal facility and
is available to all investigators. Such a request must be
justified by listing the number of investigators, case load,
and types of surgeries involved. Similarly, basic diagnostic
equipment to be used in support of the animal facility, but not
for research, will be allowed if adequate justification is
given. Office equipment (including data processing items) and
research equipment should not be requested. Physical facility
security systems are not allowable, but systems for
environmental monitoring are acceptable.
Each major equipment item must be fully described. The
manufacturer, model number, size, capacity, design criteria,
total unit cost, and facility where it will be used should be
included. This information should be provided on a separate
page immediately following the budget section and should not be
in an appendix.
On the budget page, the total cost of the equipment and A&R
needed for the project described should be entered in the
rectangular space under the appropriate headings on the left.
The right hand column should reflect only the amount being
requested from the PHS. The Total Direct Costs (bottom right
hand column total) should be the total application request to
the PHS, not including funds from other sources. These data
should be summarized in tabular form. (Contact the Animal
Resources Program at address below for suggested format.)
E. Budget for Entire Proposed Project Period - Application,
Page 5 - Not applicable.
F. Justification - Application, Page 5 - Justification should
be provided for all equipment items requested in terms of the
proposed improvement program. Failure to adequately justify
each requested item will likely result in its deletion from the
recommended budget. In this section, justification may be
relatively brief, e.g., "The cage washer is needed to wash
cages in the Life Sciences Center because the current unit
frequently breaks down and replacement parts are no longer
available." More extensive justification may be provided in
the body of the narrative (SECTION 2, D.2.f.). As part of the
justification, additional information, such as, the species,
number of animals, cages, tests, or surgeries involved, should
be provided as appropriate. The location and use of each item
of equipment should be clearly described. The lack of adequate
justification for requested items has been a major weakness of
applications in the past.
G. Summary Sheets - These sheets have been developed to assist
applicants in preparing the application as well as to assist the
reviewers in reviewing the application. The summary sheets
should be filled out as appropriate and placed between the
Budget Justification and the Biographical Sketches section of
the application. (Contact the Animal Resources Program at the
address below for samples of these sheets.)
SECTION 2 - Research Plan
The points identified under REVIEW PROCEDURES AND CRITERIA, should be
carefully considered when this section is prepared. Please
note the instructions on Page 20 of Form PHS 398 concerning the
limitation of 20 pages for Sections A-D of the Research Plan.
A. Specific Aims - (Limit to 1 page)
Clearly present the aims of the animal resource improvement
project and relate them to the short- and long-term goals of
the institution's animal resource program.
B. Background and Significance - (Limit to 2-3 pages)
This section should demonstrate the institution's overall
involvement in animal related research. In addition, the
following information for the last fiscal year should be
provided as shown on the sample Data Sheet (contact the Animal
Resources Program at address below for sample data sheet): 1)
the institution's total annual research budget that involves
the use of animals (institution's current fiscal year should be
used); 2) the annual dollar level from PHS vs. non-PHS sources
that make up this budget; and 3) the institution's total number
of projects using laboratory animals. Failure to provide this
data will weaken the application.
This section should also be used to relate the significance of
the proposed resource improvement project to the institution's
overall biomedical research programs, as well as to the
specific research projects that will be affected. If the
resource will be used by a relatively small number of research
projects, a brief description of those projects, including the
source and amount of funding on an annual basis (institution's
current fiscal year) for each, must be indicated. At least one
currently active, PHS-supported research project that involves
the use of animals in the facility to be supported, must be
identified in order to be eligible for consideration.
C. Progress Report/Preliminary Studies - Not applicable.
D. Experimental Design and Methods - This section should
provide a clear and concise overall description of the
institution's animal care and use program. It should also
demonstrate how the facility improvement program will enhance
the resource and how it fits into the institution's overall
plan to meet or maintain PHS standards for animal care and use.
The equipment items requested should be justified as part of
this narrative. The A&R request should be described/justified
as indicated in Paragraph 2.g. below.
1 Introduction - Provide relevant background information and a
description of the current status of the institution's animal
resource facilities and program as they relate to biomedical
research and research training. Include relevant information
regarding deficiencies in the animal care program which has
been cited by the American Association for Accreditation of
Laboratory Animal Care (AAALAC), the Institutional Animal Care
and Use Committee (IACUC) facility review reports, and the
institution's PHS Animal Welfare Assurance Statement. Any
problems in meeting the provisions of the Animal Welfare Act
should also be addressed. This information is an important
method of documenting the need for facility improvement
support.
2 Project Plan - This section should describe how the
requested improvements will accomplish the Specific Aims
presented in Item A. It is important to show how the requested
improvements will correct the deficiencies and problems
documented above. This part should also include a description
of the following aspects of the animal resource and an
explanation of how they will be affected by the project plan:
a. Administrative arrangements and structure of the animal
resource. The lines of authority and responsibility for
administering the institution's program for the care and use of
animals should be clearly presented. The role and composition
of the IACUC and how compliance with relevant laws, policies,
and guidelines is achieved should be included. The campus-
wide planning process, which resulted in this proposal, should be
described.
b. Animal care procedures and the animal health program. This
section should include information on veterinary oversight,
vendor surveillance, conditioning programs, colony and
environmental monitoring, and diagnostic capabilities in
anatomic pathology, clinical chemistry, hematology, and
microbiology. The general description of the animal care
program should be supported by data which characterizes various
activities, such as numbers of laboratory procedures for
monitoring and disease diagnosis, veterinary inspections for
animal health, etc. If specialized equipment, such as
microisolators, is requested, it should be part of an overall
system, and the husbandry program to utilize this equipment
should be carefully outlined. Failure to carefully describe
the basic program of animal care, including veterinary care,
has been a major weakness of many applications.
c. Outline the total staff and functional organization of the
animal resource, both current and planned following the
requested improvements. Outline the qualifications of the
animal care staff and the training opportunities available to
them.
d. List all current financial support for the animal resource,
including sources and amounts (e.g., recharge, core funding
from the institution, etc.) and the operating budget (listed by
major categories). Provide a copy of per diem and service
charge schedules and indicate their method of determination.
The latter information may be included in an Appendix.
e. Expenditures for capital improvements (facilities and
equipment) during the past five years and future plans for such
needs should be described. Any previous support for
improvement of the institution's animal facilities from the
Animal Resources Program, NCRR, NIH, should be noted. How this
support was utilized and its effect on the animal care program
should be briefly described.
f. Provide a brief description of all on- and off-campus
animal facilities, including sites where experimental surgery
is performed. Indicate who is responsible for the direction
and day-to-day management of each animal facility. This
section should justify the need for specific items of
equipment, in relationship to the various facilities where they
will be located (See D.2.g. below for A&R). The reason for the
need, the facility that will be affected, and the ultimate
improvement of the overall animal care program should be
clearly described. As shown on the sample Data Sheet (contact
the Animal Resources Program at address below for sample data
sheet), indicate the number of animals (by species) used or
produced per year, and the average daily census for each major
component of the animal resource. If equipment is requested
for surgical or diagnostic facilities, the case load, species,
and types and numbers of surgeries or diagnostic tests must be
documented on the Data Sheet. These data are critical to the
evaluation of the application, as well as for the justification
of need.
g. For any proposed A&R, a narrative summary (as outlined
below), line drawings, and cost estimates must be supplied.
(See sample formats for cost estimates.) The total PHS support
for the A&R category is limited to $100,000. If the total cost
exceeds this amount, the source(s) of additional funds must be
provided. If multiple sites are involved, the A&R, including
the cost estimate proposed for each site, should be described
separately. The following narrative format should be followed:
Narrative Summary
(1) Relate the proposed renovations to projected animal
populations by species and research projects that will utilize
the facility. Daily and annual census data (by species) must
be provided. The animal care and use program for the animal
facility which is to be renovated must be well described in
D.2.b., Animal care procedures and the animal health plan,
above.
(2) List the functional components, with the size (dimensions)
and square footage of each component (room, alcove, cubicle,
etc.) that will be directly affected by the renovation project.
(3) List engineering criteria applicable to each component
(mechanical, electrical, and utilities). Include information
such as the number of air changes per hour, electrical power,
light levels, hot and cold water, steam, etc.
(4) List appropriate architectural criteria, such as width of
corridors and doors, surface finishes, etc.
(5) List all fixed equipment requested for the renovated area.
(6) List all movable equipment requested for the renovated
area.
Line Drawings (On 8-1/2" x 11" paper only, DO NOT SUBMIT
BLUEPRINTS) - These drawings will not be counted within the 20
page limit for Section 2.
All floor plans must be legible, with the scale clearly
indicated.
(1) The plot plan should indicate the location of the proposed
renovation area in the building.
(2) Include the as-built drawings of the proposed renovation
area and indicate any demolition.
(3) Provide the architectural plan(s) of the proposed
renovation at a scale adequate to explain the project. The
plans should indicate size (dimensions), function, and net and
gross square feet of space for each room. The total net and
gross square feet of space to be renovated should also be
given.
(4) Changes or additions to existing mechanical and electrical
systems should be clearly explained in notes made directly on
the plan or attached to the plan.
(5) A Finish Schedule, indicating the type(s) of new finishes
to be applied to room surfaces, should be included in the plan.
SECTION 3 Appendix Material
All information critical for the review must be included in
Sections 1 and 2 of the application. Be very selective and
include only relevant supplementary information in the
appendix. Do not include standard references or other
generally available information. Six collated sets of the
appendix material should be included in the application
package. All appendix material must be identified with the
name of the Principal Investigator and the institution. Do not
mail this appendix material separately, but include it with the
original grant application.
APPLICATION PROCEDURE
1 The completed original application and four copies should
be mailed or delivered to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, Maryland 20892**
2 An additional two copies of the application should be mailed
to:
Executive Secretary
Animal Resources Review Committee
National Center for Research Resources
Westwood Building, Room 10A16
National Institutes of Health
5333 Westbard Avenue
Bethesda, Maryland 20892
To ensure their timely review, applications must be received by
the close of business December 3, 1990. Applications received
after this date will be returned without further processing.
This one-time request for applications is based on the Fiscal
Year 1991 President's budget.
INQUIRIES ABOUT APPLICATION AND OTHER ASPECTS OF THE PROGRAM
SHOULD BE DIRECTED TO:
Animal Resources Program
National Center for Research Resources
Westwood Building, Room 857
National Institutes of Health
5333 Westbard Avenue
Bethesda, Maryland 20892
Telephone: (301) 496-5175
APPLICATION FORMS (PHS 398) MAY BE OBTAINED FROM:
Office of Grants Inquiries
National Institutes of Health
Westwood Building, Room 449
5333 Westbard Avenue
Bethesda, Maryland 20892
Telephone: (301) 496-7441
SUPPLEMENTARY INSTRUCTIONS
SMALL GRANTS FOR INNOVATIVE TECHNOLOGY
PA: PA-90-28
P.T. 34; K.W. 0706000, 0790000
National Center for Research Resources
Applications must be submitted on the standard PHS research
grant application form (PHS-398, Rev.10/88), following the
instructions supplied with those forms EXCEPT for the
following:
1 Face page of application
Item 2: Response to specific Program Announcement: Yes.
Write in: Small Grants for Innovative Technology,
PA-90-28
Item 8: Not applicable; mark NA.
2 Application page 4: Detailed Budget for the 12-Month budget
period. Funds should be limited to the following categories:
personnel (including technicians), consultants, rental or
service fees, supplies, travel, and small equipment items. All
requests must be strongly and SPECIFICALLY justified. The
total request may not exceed $35,000 direct costs. (Use
application page 5 for justification of the need for proposed
expenditures.)
3 Application page 5: Budget Estimates for All Years. Not
applicable; do not complete. (This page may be used instead to
justify budget requests for the one-year project period.)
4 Biographic sketch: Not to exceed one page per individual.
Include this information for all professional personnel
associated with this project as collaborators, consultants,
etc. Include an appropriate letter from each collaborator or
consultant confirming his/her role in the project.
5 Other Support: Follow instructions for PHS-398 (Rev.
10/88).
6 Resources and Environment: Follow instructions for PHS-398
(Rev. 10/88).
7 Introduction: Not to exceed one-half page (including a
brief statement on preliminary work, if any).
8 Research Plan: Specific aims, background and significance,
and experimental design and methods; not to exceed four pages.
These sections of the research plan are described in the PHS-
398 grant application kit instructions, and should be followed
while keeping within the four-page limitation. Citations in
this section are limited to one additional page entitled:
Literature Cited.
Applications must be readily legible. In an effort to include
as much information as possible within the page limitations,
some applicants have compressed the spaces between letters and
words and reduced the type size to such a degree that the
application is not readily legible. Such applications will
also be returned without review. The type must not exceed 15
characters per inch. If the type used varies in the
characters per inch (i.e., a different spacing for each
letter), the range of characters per inch should not exceed 15.
In addition, the type should not be reduced in height, but
should be the standard size, which is in the 10 to 12 point
range (approximately 1/8 inch for capital letters).
9 Human Subjects; Follow instructions for PHS 398 (Rev.
10/88). No page limitation.
10 Vertebrate Animals: Follow instructions for PHS 398 (Rev.
10/88). No page limitation.
11 Checklist: Follow instructions for PHS 398 (Rev. 10/88).
Calculations for indirect costs must be shown.
12 Appendix: Not applicable. Do not submit.
13 Submission of the completed application forms:
Copies of applications should be sent to:
A. Division of Research Grants:
Mail or deliver the complete and signed typewritten
original application and four copies, to the Division
of Research Grants, as specified in the general
instructions.
B. Biomedical Research Technology Program:
enable us to carry out expedited review of
Please mail 2 additional stapled copies
of the application to:
Biomedical Research Technology Program
(SMALL GRANTS)
National Center for Research Resources, NIH
5333 Westbard Ave., Room 8A11
Bethesda, Maryland 20892
Applications not following the above instructions will be
returned to the applicant.
If you have questions, please call: (301) 496-5411.
14 Review Procedures:
Applications will be submitted for initial review to the
Biomedical Research Technology Review Committee. This is a
chartered committee of the National Center for Research
Resources. The second level of review will be conducted by the
National Advisory Research Resources Council.
July 1990
GUIDELINES
FOR
THE GENERAL CLINICAL RESEARCH CENTERS PROGRAM
OF
NATIONAL CENTER FOR RESEARCH RESOURCES
NATIONAL INSTITUTE OF HEALTH
SUPPLEMENT II
Instructions for Preparing a Clinical Associate Physician
(CAP) Supplemental Application
PA: PA-90-30
P.T. 04; K.W. 0785035
GENERAL INFORMATION
PURPOSE: To provide up to three years of support to either a
young physician or dentist to become an independent clinical
investigator.
ELIGIBILITY: Applicant physician or dentist with at least two
years of subspecialty (fellowship) training. Applicant must be a
U.S. citizen or hold a permanent immigration visa. Applicants
may not hold independent peer-reviewed grant support, as the
principal investigator, prior to or concurrently with funding of
this application. Applications are to be submitted as a
supplement to a funded GCRC. One CAP application may be
submitted from a Center per review cycle.
METHOD OF APPLYING: The initial application for CAP support must
be submitted as a competing supplemental application to a funded
GCRC, using Form PHS 398 (Rev. 10/88). Three
deadlines exist for filing this application with the General
Clinical Research Centers Program and Division of Research Grants:
October 1, February 1, and June 1, respectively. Applications
filed by those dates have the corresponding earliest beginning
dates of July 1, December 1, and April 1. Send two copies of the
application to the General Clinical Research Centers Program. In
addition, the original plus four copies must be sent to the
Division of Research Grants (see instructions for Form PHS 398
(Rev. 10/88)).
ELIGIBLE COSTS: Maximum salary of $42,500 plus fringe benefits for
at least 80% of time and effort for the 01 year of the award and
salary incremental increases of $1,000 for each of the 02 and 03
years of the award (maximum $44,500). The salary request must be
commensurate with institutional salary policies for individuals
with comparable experience. Funds for small scientific equipment,
supplies, and domestic travel to scientific meetings may be
requested up to a maximum of $5,000 per year (domestic travel
portion not to exceed $1,000).
REVIEW CRITERIA: Based on the scientific merit of research
proposal, qualifications of the applicant, expertise to be gained
by the CAP applicant, suitability of the CAP sponsor and the
likelihood that the applicant will become an independent
investigator capable of successfully competing for independent
peer-reviewed grant support.
FORMAT FOR APPLICATIONS: Applicants should follow Form PHS 398
(Rev. 10/88) instructions except for the following which are in
lieu of Form PHS 398 (Rev. 10/88) instructions. Applicants are
encouraged to pay particular attention to the instructions
regarding supplemental application project period dates which
appear on page 14 of the Form PHS 398 (Rev. 10/88) kit. The
project period begin dates for a CAP application must be July 1,
December 1, or April 1. The project period end date must be
within the project period of the currently funded GCRC grant. The
supplemental application should clearly delineate the entire
budget period to be requested and the research plan should also
reflect that anticipated budget period. If insufficient time
exists within the currently funded GCRC grant budget period to
complete the three year CAP funding request, the competitive
renewal application (Type 2) of the Center must include that
additional portion of the projected budget period for the CAP
applicant along with a research protocol and other supporting
materials. The CAP applicant need not present at the Center's
site visit if the application has been reviewed previously by the
GCRC Committee (study section) and approved by the National
Advisory Research Resources Council. Three letters of support are
to be included with the application. To protect confidentiality
of reference letters, applicants are asked not to open the sealed
envelopes. The sealed letters are to be attached to the original
application. Otherwise, the application will be returned to the
applicant by the Division of Research Grants and it would not
become eligible for submission until next submission date.
These instructions supplement those for Form PHS 398 (Rev. 10/88).
SPECIFIC INSTRUCTIONS
Form PHS 398 (Rev. 10/88)
SECTION 1
PAGE 1:
ITEM 1. TITLE OF PROJECT: The CAP applicant's name is to be
inserted in the title. For example, "GCRC - CAP-Kelly Smith,
M.D." Do not include the title of the applicant's research
proposal here.
ITEM 2. Check the box marked "YES" and enter the program
announcement title, "CAP Supplements to GCRC Grants, PA-90-30."
ITEM 3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR: Name of
Principal Investigator of the GCRC grant. Do not indicate Program
Director's name here.
ITEM 4. See instructions for Form PHS 398 (Rev. 10/88). For item
4a, indicate "Yes." For "IRB Approval Date," indicate the date on
which IRB approval was completed for the application. (If IRB
approval of the application is not completed by the time of
submission of the application, enter "Pending." A follow-up
certification of IRB approval of the application must be submitted
to the Executive Secretary, GCRC Committee, and received within 60
days of the application submission.)
Occasionally PHS initial review may be scheduled to occur before
the end of the 60-day grace period. In these special cases of
accelerated review, the follow-up certification will be requested
earlier. Otherwise, it is the responsibility of the applicant
organization to submit the follow-up certification. The PHS does
not guarantee that it will remind the applicant organization or
the Principal Investigator/Program Director to provide this
missing information. If certification of IRB approval is not
received prior to the scheduled PHS initial review date, the
application will be considered incomplete and deferred to the next
review cycle.
If a follow-up certification of IRB approval has to be sent to the
Executive Secretary of the GCRC Committee, an appropriately
completed and signed Form HHS 596 (available on request from DRG)
continues to meet the requirements for certification. In lieu of
this preferred form, a letter prepared on organizational
letterhead stationery or a revised Face Page (Form PHS 398) is
acceptable provided that all of the following required information
is included: title of project, application number, name of
investigator and institution, Multiple Project Assurance number,
date of IRB approval, and appropriate signatures. The Form HHS
596, the organizational letter, or the revised Face Page with an
attachment must contain any changes or modifications required by
the IRB, and if none, provide a statement to that effect.
ITEM 5. If protocols include use of vertebrate animals, section F
of the application must be completed. Information in Items 5a and
5b and the signatures on the Face Page fulfill the requirement for
verification of IACUC approval. To insure against delays in the
review of the application, IACUC review is best completed prior to
submission of the application. However, if the IACUC review is
unavoidably delayed beyond the submission of the application,
enter "pending" at Item 5a. A follow-up verification of IACUC
approval from an official signing for the applicant organization
must then be sent to and received by the Executive Secretary of
the GCRC Committee within 60 days after the receipt date for which
the application is submitted. Any modifications in the Research
Plan section of the application required by the IACUC must be
submitted with the follow-up verification. Occasionally PHS
initial review may be scheduled to occur before the end of the 60-
day grace period. In these special cases of accelerated review,
the follow-up verification will be requested earlier. Otherwise,
it is the responsibility of the applicant organization to submit
the follow-up verification. The PHS does not guarantee that it
will remind the applicant organization or the Principal
Investigator/Program Director to provide this missing information.
If verification of IACUC approval is not received prior to the
scheduled PHS initial review date, the application will be
considered incomplete and deferred to the next review cycle.
If a follow-up verification of IACUC approval has to be sent to
the Executive Secretary of the GCRC Committee, an appropriately
completed and signed letter, prepared according to the example
found on page 16 of the PHS Policy on Humane Care and Use of
Laboratory Animals (revised as of September 1986), continues to
meet the requirements for verification. In lieu of this preferred
method, a revised Face Page is acceptable, provided that all of
the following information is included: application number, title
of project, name of investigator and institution, Animal Welfare
Assurance number, date of IACUC approval, and appropriate
signatures. An attached page should contain any changes or
modifications required by the IACUC, and if none, a statement to
that effect.
ITEM 6. DATES OF ENTIRE PROPOSED PROJECT PERIOD: Up to a period
of three years may be requested.
ITEM 7. COSTS REQUESTED: If the requested start date is the same
as that of the parent grant (i.e., December 1), insert the
requested budget here, and on page 4 of the application. The
amount should reflect a full 12 months. If the requested start
date is different from that of the parent grant, insert the
requested budget here, and on page 4 of the application, prorated
to reflect the period from the requested CAP start date to the end
of the parent grant budget period (i.e., to November 30). Funds
may be used only for the specified applicant and for no other
purpose. If a funded Clinical Associate Physician terminates
earlier than expected, the GCRC Program office is to be notified
in writing. Funds not used will revert to the GCRC Program if the
CAP does not complete the funded term.
PAGE 2:
Describe the research project to be performed.
KEY PERSONNEL ENGAGED ON PROJECT: List the Principal Investigator
of the grant, the Program Director, the CAP applicant, and the CAP
applicant's Sponsor(s). The Sponsor is a senior investigator with
whom the CAP will be associated. The Sponsor should be an
established investigator with independent grant support.
PAGE 4:
DETAILED BUDGET: The budget should be completed. The only items
should be the CAP's salary and fringe benefits, and the items
described above under ELIGIBLE COSTS.
BIOGRAPHICAL SKETCHES: Include a current biographic sketch for
both the CAP candidate and his/her Sponsor, both sketches to
contain current, as well as pending, grant support.
SECTION 2
Provide a narrative description of the following:
A. Describe the proposed duties of the CAP with reference to
his/her interaction with the Program Director, Sponsor(s), other
investigators, and laboratory personnel. In addition, summarize
the CAP's patient care responsibilities and other duties. The CAP
should not have any administrative responsibilities that relate
to GCRC function. The application should contain an estimate of
the percentage of time spent for each function. At least 80% of
the CAP's time and effort must be devoted to the clinical research
proposal. Allocation of the CAP's time between clinical and
laboratory activities will vary according to the nature of the
project and the background of the applicant, but all those
activities should center around clinical research. Applicants
should note that NIH urges the inclusion of minorities and women
in study populations. If minorities and women are not included in
a protocol, a clear rationale for their exclusion should be
provided.
B. Describe the research to be performed. This portion of the
proposal is to be prepared by the CAP applicant. It should be
arranged as follows: Hypothesis, Significance, and Background
(collectively limited to about three pages), along with Materials,
Methods, and References (generally not to exceed ten pages). A
description of relevant available resources of the GCRC and of the
senior investigators with whom the CAP will be associated should
be provided.
C. Detail how the CAP's laboratory research activities relate to
the clinical research project. Summarize the candidate's past
research accomplishments, fellowship experience, and relevant work
experience. Specify the research skills to be acquired and used
by the candidate. Include a letter of endorsement from the
applicant's Sponsor and three letters of reference in sealed
envelopes.
Examine the checklist below to be sure your application is
complete.
CHECKLIST
(Use Form PHS 398 (Rev. 10/88) for application.)
1. The original and four copies should be mailed to the Division
of Research Grants at the address noted in the PHS 398 kit; two
copies should be submitted to the General Clinical Research
Centers Program, Room 10A03 Westwood Building, 5333 Westbard
Avenue, Bethesda, Maryland 20892.
2. Documentation of review and endorsement of the CAP, and
his/her research plans by the GCRC Advisory Committee, the
Principal Investigator, and the Program Director.
3. Statement of mechanism of candidate selection.
4. Biographical sketches including current and pending grant
support for both the applicant and the Sponsor.
5. Description of any Institutional commitment to the applicant
for an academic appointment or any other commitment(s).
6. Letter of endorsement from Sponsor and three letters of
reference in sealed envelopes.
7. Narrative:
A. Duties of the CAP on the GCRC and elsewhere and distribution
of time and effort in those activities.
B. Description of research proposed.
C. Relevance of CAP's laboratory activities to the clinical
research project and skills to be acquired.
July 1990
GUIDELINES
FOR
THE GENERAL CLINICAL RESEARCH CENTERS PROGRAM
OF
NATIONAL CENTER FOR RESEARCH RESOURCES
NATIONAL INSTITUTE OF HEALTH
SUPPLEMENT II-A
Instructions for Preparing a Minority Clinical Associate Physician
(MCAP) Supplemental Application
PA: PA-90-29
P.T. 04, FF; K.W. 0785035
GENERAL INFORMATION
PURPOSE: To provide up to three years of support to an
underrepresented minority physician or dentist to become an
independent clinical investigator.
ELIGIBILITY: M.D. or D.D.S. degree or equivalent, and completion
of residency; completion of subspecialty (fellowship) training
for two years is preferred but not required. Applicant must be a
U.S. citizen or hold a permanent immigration visa. Applicants
may not hold independent peer-reviewed grant support, as the
principal investigator, prior to or concurrently with funding of
this application. Applications are to be submitted as a
Supplement to a funded General Clinical Research Center (GCRC).
Applicant would generally be expected to not be as far along in
his/her career progression as applicants for the Clinical
Associate Physician (CAP) program. One Minority Clinical
Associate Physician application may be submitted from a Center
per review cycle. Each review cycle, each Center may submit one
MCAP application and one CAP application (for two different
individuals). The existence of the MCAP program is not meant to
discourage underrepresented minority participation in the CAP
program.
"Underrepresented minority" is defined as belonging to a
particular ethnic or racial group which has been determined by
the grantee institution to be underrepresented in biomedical or
behavioral research. In making awards, NIH will give priority
to applicants who are Black, Hispanic, Native Americans,
Pacific Islanders, or other ethnic or racial group members who
have been found to be underrepresented in biomedical or
behavioral research nationally.
It would be desirable, but not mandatory, that the applicant
move from one institution to another upon beginning in the
program.
METHOD OF APPLYING: The initial application for MCAP support
must be submitted as a competing supplemental application to a
funded GCRC, using Form PHS 398 (Rev. 10/88).
Three deadlines exist for filing this application: October 1,
February 1, and June 1. Applications filed by those dates have
the corresponding earliest beginning dates of July 1, December
1, and April 1. Send two copies of the application to the
General Clinical Research Centers Program. In addition, the
original plus four copies must be sent to the Division of
Research Grants (see instructions for Form PHS 398 (Rev.
10/88)).
ELIGIBLE COSTS: For applicants who have completed subspecialty
(fellowship) training, maximum salary of $42,500 plus fringe
benefits for at least 80% of time and effort for the first year
of the award. For those with no subspecialty training, maximum
$40,000. Salary incremental increases of $1,000 for each of the
second and third years of the award (maximum $44,500). The
salary request must be commensurate with institutional salary
policies for individuals with comparable experience. Funds for
small scientific equipment, supplies, and domestic travel to
scientific meetings may be requested up to a maximum of $5,000
per year (domestic travel portion not to exceed $1,000).
REVIEW CRITERIA: Based on the scientific merit of the
proposal, qualifications of the applicant, expertise to be
gained by the applicant, suitability of the preceptor, and the
likelihood that the applicant will become an independent
investigator capable of successfully competing for independent
peer-reviewed grant support. In cases when the MCAP applicant
has no research experience, the scientific proposal part of the
application (twenty-page maximum) would be expected to be the
preceptor's idea and to be written in conjunction with the
preceptor, not totally by the applicant as in a CAP proposal.
In cases where the MCAP applicant has sufficient research
experience, he/she could write the scientific proposal part of
the application, and should so indicate.
FORMAT FOR APPLICATIONS: Applicants should follow Form PHS 398
(Rev. 10/88) instructions except for the following which are in
lieu of Form PHS 398 (Rev. 10/88) instructions. Applicants are
encouraged to pay particular attention to the instructions
regarding supplemental application project period dates which
appear on page 14 of the Form PHS 398 (Rev. 10/88) kit. The
project period begin dates for a MCAP application must be July
1, December 1, or April 1. The project period end date must be
within the project period of the currently funded GCRC grant.
The supplemental application should clearly delineate the
entire budget period to be requested and the research plan
should also reflect that anticipated budget period. If
insufficient time exists within the currently funded GCRC grant
budget period to complete the three-year MCAP funding request,
the competitive renewal application (Type 2) of the Center must
include that additional portion of the projected budget period
for the MCAP applicant. Three letters of support are to be
included with the application. To protect confidentiality of
reference letters, applicants are asked not to open the sealed
envelopes. The sealed letters are to be attached to the
original application. Otherwise, the application will be
returned to the applicant by the Division of Research Grants
and it would not become eligible for submission until the next
submission date.
These instructions supplement those for Form PHS 398 (Rev.
10/88).
SPECIFIC INSTRUCTIONS
Form PHS 398 (Rev. 10/88)
SECTION 1
PAGE 1:
ITEM 1. TITLE OF PROJECT: The MCAP applicant's name is to be
inserted in the title. For example, "GCRC - MCAP - John
Williams, M.D." Do not include the title of the applicant's
research proposal here.
ITEM 2. RESPONSE TO SPECIFIC PROGRAM ANNOUNCEMENT: Check the
box marked "YES" and insert the program announcement title,
"MCAP Supplements to GCRC Grants, PA-90-29."
ITEM 3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR: Name of
Principal Investigator of the GCRC grant. Do not indicate
Program Director's name here.
ITEM 4. See instructions for Form PHS 398 (Rev. 10/88). For
item 4a, indicate "Yes." For "IRB Approval Date," indicate the
date on which IRB approval was completed for the application.
(If IRB approval of the application is not completed by the
time of submission of the application, enter "Pending." A
follow-up certification of IRB approval of the application must
be submitted to the Executive Secretary, GCRC Committee, and
received within 60 days of the application submission.)
Occasionally PHS initial review may be scheduled to occur
before the end of the 60-day grace period. In these special
cases of accelerated review, the follow-up certification will
be requested earlier. Otherwise, it is the responsibility of
the applicant organization to submit the follow-up
certification. The PHS does not guarantee that it will remind
the applicant organization or the Principal
Investigator/Program Director to provide this missing
information. If certification of IRB approval is not received
prior to the scheduled PHS initial review date, the application
will be considered incomplete and deferred to the next review
cycle.
If a follow-up certification of IRB approval has to be sent to
the Executive Secretary of the GCRC Committee, an appropriately
completed and signed Form HHS 596 (available on request from
DRG) continues to meet the requirements for certification. In
lieu of this preferred form, a letter prepared on
organizational letterhead stationery or a revised Face Page
(Form PHS 398) is acceptable provided that all of the following
required information is included: title of project,
application number, name of principal investigator and
institution, Multiple Project Assurance number, date of IRB
approval, and appropriate signatures. An attached page should
contain any changes or modifications required by the IRB, or if
none, a statement to that effect.
ITEM 5. If the proposal includes the use of vertebrate
animals, section F of the application must be completed.
Information in Items 5a and 5b and the signatures on the Face
Page fulfill the requirement for verification of IACUC
approval. To insure against delays in the review of the
application, IACUC review is best completed prior to submission
of the application. However, if the IACUC review is
unavoidably delayed beyond the submission of the application,
enter "pending" at Item 5a. A follow-up verification of IACUC
approval from an official signing for the applicant
organization must then be sent to and received by the Executive
Secretary of the GCRC Committee within 60 days after the
receipt date for which the application was submitted. Any
modifications in the application required by the IACUC must be
submitted with the follow-up verification. Occasionally PHS
initial review may be scheduled to occur before the end of the
60-day grace period. In these special cases of accelerated
review, the follow-up verification will be requested earlier.
Otherwise, it is the responsibility of the applicant
organization to submit the follow-up verification. The PHS
does not guarantee that it will remind the applicant
organization or the Principal Investigator/Program Director to
provide this missing information. If verification of IACUC
approval is not received prior to the scheduled PHS initial
review date, the application will be considered incomplete and
deferred to the next review cycle.
If a follow-up verification of IACUC approval has to be sent to
the Executive Secretary of the GCRC Committee, an appropriately
completed and signed letter, prepared according to the example
found on page 16 of the PHS Policy on Humane Care and Use of
Laboratory Animals (revised as of September 1986), continues to
meet the requirements for verification. In lieu of this
preferred method, a revised Face Page is acceptable, provided
that all of the following information is included: application
number, title of project, name of principal investigator and
institution, Animal Welfare Assurance number, date of IACUC
approval, and appropriate signatures. An attached page should
contain any changes or modifications required by the IACUC, or
if none, a statement to that effect.
ITEM 6. DATES OF ENTIRE PROPOSED PROJECT PERIOD: Up to a
period of three years may be requested.
ITEM 7. COSTS REQUESTED: If the requested start date is the
same as that of the parent grant (i.e., December 1), insert the
requested budget here, and on page 4 of the application. The
amount should reflect a full 12 months. If the requested start
date is different from that of the parent grant, insert the
requested budget here, and on page 4 of the application,
prorated to reflect the period from the requested MCAP start
date to the end of the parent grant budget period (i.e., to
November 30). Funds may be used only for the specified
applicant and for no other purpose. If a funded MCAP position
is terminated earlier than expected, the GCRC Program office is
to be notified in writing, and these funds are to remain
unexpended.
PAGE 2:
Describe the research project to be performed.
KEY PERSONNEL ENGAGED ON PROJECT: List the Principal
Investigator of the grant, the Program Director, the MCAP
applicant, and the MCAP applicant's preceptor. The preceptor
is to be a senior investigator with whom the MCAP applicant
will be associated. In general, the preceptor should hold
independent peer-reviewed support.
PAGE 4:
DETAILED BUDGET: The budget should be completed. The only
items should be the MCAP applicant's salary and fringe
benefits, and the items described above under ELIGIBLE COSTS.
BIOGRAPHICAL SKETCHES: Include a current biographic sketch for
both the MCAP applicant and his/her preceptor, both sketches to
contain current, as well as pending, grant support.
SECTION 2
Provide a narrative description of the following:
A. Describe the proposed duties of the MCAP applicant with
reference to his/her interaction with the GCRC Program
Director, preceptor, other investigators, and laboratory
personnel. In addition, summarize the MCAP applicant's patient
care responsibilities and other duties. The MCAP applicant
should not have any administrative responsibilities which
relate to GCRC function. The application should contain an
estimate of the percentage of time spent for each function.
At least 80% of the MCAP applicant's time and effort must be
devoted to clinical research. Allocation of the MCAP
applicant's time between clinical and laboratory activities
will vary according to the nature of the project and the
background of the applicant, but all those activities should
center around clinical research. Applicants should note that
NIH urges the inclusion of minorities and women in study
populations. If minorities and women are not included in a
protocol, a clear rationale for their exclusion should be
provided.
B. Describe the research to be performed and the techniques
the MCAP applicant will be learning. It should be arranged as
follows: Hypothesis, Significance, and Background
(collectively limited to about three pages), along with
Materials, Methods, and References (generally not to exceed ten
pages). A description of relevant available resources of the
GCRC and of the senior investigators with whom the MCAP
applicant will be associated should be provided.
C. Detail how the MCAP applicant's laboratory research
activities relate to the clinical research project. Summarize
the candidate's past research accomplishments, experience, and
relevant work experience. Specify the research skills to be
acquired and used by the applicant.
Include a letter of endorsement from the applicant's preceptor
and three letters of reference in sealed envelopes.
Examine the checklist below to be sure the application is
complete.
CHECKLIST
(Use Form PHS 398 (Rev. 10/88) for application.)
1. The original and four copies should be mailed to the
Division of Research Grants at the address noted in the PHS 398
kit; two copies should be submitted to the General Clinical
Research Centers Program, Room 10A03 Westwood Building, 5333
Westbard Avenue, Bethesda, Md. 20892.
2. Documentation of review and endorsement of the MCAP
applicant, and his/her research plans by the GCRC Advisory
Committee, the Principal Investigator, and the Program
Director.
3. Statement of mechanism of candidate selection.
4. Biographical sketches including current and pending grant
support for both the applicant and the preceptor.
5. Description of any Institutional commitment to the
applicant for an academic appointment or any other
commitment(s).
6. Letter of endorsement from preceptor and three letters of
reference in sealed envelopes.
7. Narrative:
A. Duties of the MCAP applicant on the GCRC and elsewhere and
distribution of time and effort in those activities.
B. Description of research proposed.
C. Relevance of MCAP applicant's laboratory activities to the
clinical research project and skills to be acquired.