Subject: RFA PA-90-30.082490 NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 23 Aug 90 08:27 EST

Hi Again,
  Another to be posted to the NIH Listserver.  Please post as:
     RFAPA90-30.082490
Thanks.
       Dottie
 ---------------------------- Text of forwarded message -----------------------
 
                                                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.