Subject: RFA PA90-29.082490 NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 23 Aug 90 08:35 EST

Hi Again,
  Still one or two more to be forwarded this morning.  Please post this
one to the NIH Listserver as:
      RFAPA-90-29.082490
   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-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.