Subject: NIH GUIDE - RFA CA-91-32 - V20(34) 09/13/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 13 Sep 91 08:01 EST

Hi Paul,
   Next to be posted to the NIH Listserver.  Please post as:
      RFACA-91-32.910913
  Thanks.   Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA CA9132 CA-91-32 P1O1 *****************************************
 
REQUEST FOR APPLICATION
 
RFA:  CA-91-32
 
CLINICAL ONCOLOGY RESEARCH CAREER DEVELOPMENT PROGRAM
 
P.T. 34; K.W. 0785140, 0785035
 
National Cancer Institute
 
Letter of Intent Receipt Date:  October 25, 1991
Application Receipt Date:  December 31, 1991
 
I. INTRODUCTION
 
The National Cancer Institute (NCI), through its Cancer Training Branch,
invites grant applications for Institutional Physician Scientist program
grants that will prepare medical doctors for clinical research careers
in medical oncology, surgical oncology, radiation oncology and other
clinical specialties with a focus on cancer.  The high level of support
and intense activity in basic cancer research over the past decades have
resulted in the rapid growth and constantly increasing body of knowledge
about the molecular biology, immunology, genetics, and cell biology of
cancer.  However, the clinical application of this knowledge to improve
procedures that benefit cancer patients has not kept pace with the
accumulation of research results.  This RFA is intended to stimulate the
recruitment and research career development of clinicians who will be
oriented and skilled in the translation of accumulated research results
into new clinical procedures and approaches which are of direct benefit
to cancer patients.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000", a
PHS-led national activity for setting priority areas.  This RFA,
Clinical Oncology Research Career Development Program, is related to the
priority area of Cancer.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Statement No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, D. C. 20402-9325
(telephone 202-783-3238).
 
II.  BACKGROUND INFORMATION
 
A workshop on "Training in Clinical Research in Oncology" was held on
September 12, 1990 to identify the concerns and problems facing the
clinical oncology community and to examine the adequacy of NCI training
and career grant mechanisms and institutional research environments for
attracting and retaining physicians in clinical oncology research.  A
summary of the workshop was published in Cancer Research 51:  753-756,
1991.  Participants included 20 clinicians representing a wide
geographic distribution of oncology programs and cancer centers as well
as NCI staff.  There was unanimous agreement on the decline in the
number of clinical oncologists pursuing careers in innovative clinical
research, resulting in a shortage of properly trained research
clinicians to translate salient basic research findings to patient
populations.  Conversely, interesting clinical observations and problems
also need to be communicated to the basic research laboratory.  In order
to address this deficit in clinical oncology research, NCI is initiating
a new 'program' career grant (K12) mechanism to be awarded to excellent
clinical departments and/or cancer centers which would then have greater
flexibility in selecting and sustaining young physicians for the
critical three to five year period during which these physician
scientists will learn the skills needed for the successful transition to
their own independent grant support.
 
III.  RESEARCH GOALS AND SCOPE
 
The objectives of this RFA are to increase the number of clinical
oncologists who are motivated and properly prepared to:  (1) interact
and coordinate clinical research activities with basic research
scientists in order to expedite the translation of basic information
into patient-oriented research; (2) perform independent clinical
research that develops and tests rational, scientific hypotheses based
on fundamental and clinical research findings for improving the medical
care of cancer patients; and (3) design and test innovative clinical
protocols and manage all phases of clinical trials research.
 
These clinical oncology research career development programs must
involve staff and clinical candidates representing a spectrum of
clinical oncology disciplines such as medical, surgical and radiation
oncology.  Programs limited to one clinical oncology discipline are not
responsive to the objective of this initiative.  Interaction during
these early years of career training might serve to enhance the kinds of
coordination and team approach necessary for optimum cancer patient
care.
 
Applicants must propose a program that is designed to provide clinician
candidates with the research skills that deal directly with aspects of
cancer detection, diagnosis, prognosis, or treatment of cancer patients.
It is expected that these clinical oncology career development programs
will include both a didactic component (e.g., formal courses, lecture
series, seminars, and journal clubs) and a research component that
focuses on the skills necessary for translating basic cancer research
results into clinical experiments, procedures, and trials directly
involving cancer patients in a clinical environment.  For example, it
will not be sufficient within the scope of this initiative to use human
cells and other clinical materials in an isolated basic laboratory
setting as the total research development program.  Basic laboratory
research experience is essential, but it must be properly integrated
with clinical research.
 
The proposed program must have the flexibility to accommodate clinical
candidates with different levels of research competence.  Although the
end goal of this program is specifically to prepare physicians for
dedicated careers in clinical oncology research, not basic research,
candidates must be or become competent in the fundamentals of the
scientific method, particularly hypothesis development, experimental
design, and biostatistical methods that are usually gained through a
significant hands-on basic research experience.  The research
environment will be a critical factor.  It should be one in which there
are active basic/clinical research collaborations that exemplify a
dynamic two-way exchange of information and ideas between laboratory and
clinical scientists.  It should also promote rapid translation of basic
research into clinical testing as well as stimulate new ideas and
laboratory experiments, based on clinical observations and testing
results.  In most cases, candidates would acquire both basic and
clinical research skills that will prepare them to become dedicated
clinical researchers able to interact and communicate effectively with
basic research scientists in the design and implementation of
collaborative research involving patients. In this context, it might
also be appropriate for the basic scientists to be involved in the
clinical seminars, protocol planning sessions, and grand rounds.
However, applicants may address these issues in other creative ways.
 
Applicants must clearly address the following issues:  (l) A detailed
outline of the content and scope of the program for the career
development of clinicians in innovative clinical oncology research and
how it will provide the skills and experience necessary for the
development and testing of new clinical procedures  that will be of
direct benefit to cancer patients; (2) A research environment that
promotes the interactions and collaborations of clinical researchers and
basic researchers which are necessary for the translation of basic
research results into the clinical arena; (3) the qualifications of the
faculty mentors, highlighting their clinical and basic research projects
and how this research will promote the integration of basic and clinical
research experiences to achieve the overall objectives of this RFA; each
candidate must have a specific mentor who would have responsibility for
his/her research program and day-to-day progress; (4) the procedures to
be used to announce the program and to select appropriate candidates,
mentors, and research projects; (5) the efforts that will be made to
evaluate each candidate's level of research experience and needs and to
report on the progress of each candidate in the program; and (6) the
establishment of an advisory committee (see Section V) to provide an
oversight function and annual evaluation of the clinical research
development program as a whole.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of the disease, disorder or
condition under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders and
conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.
 
The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with a rationale for
its choice.  In addition, gender and racial/ethnic issues should be
addressed in developing a research design and sample size appropriate
for the scientific objectives of the study.  This information should be
included in the form PHS 398 in Section 2, A-D of the Research Plan AND
summarized in Section 2, E, Human Subjects.  Applicants are urged to
assess carefully the feasibility of including the broadest possible
representation of minority groups.  However, NIH recognizes that it may
not be feasible or appropriate in all research projects to include
representation of the full array of United States racial/ethnic minority
populations (i.e., Native Americans (including American Indians or
Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics).  The
rationale for studies on single minority population groups should be
provided.  This policy applies to clinical trials as well as clinical
research involving human biomedical and behavioral studies of etiology,
epidemiology, prevention (and preventive strategies), diagnosis, or
treatment of diseases, disorders or conditions.
 
The usual NIH policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be
identified or linked to individuals are excluded.  However, every effort
should be made to include human tissues from women and racial/ethnic
minorities when it is important to apply the results of the study
broadly, and this aspect should be addressed by applicants.
 
If the required information is not contained within the application, the
application will be returned.
 
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies. If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in the
assignment of the priority score to the application.
 
All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants or
cooperative agreements that do not comply with these policies.
 
IV.  MECHANISM OF SUPPORT AND ALLOWABLE COSTS
 
Support of this program will be through the National Institutes of
Health's (NIH) grant-in-aid, the Institutional Physician Scientist Award
(K12).  Applicants will be responsible for the planning, direction, and
execution of the proposed project.  Except as otherwise stated in this
RFA, awards will be administered under PHS grants policy as stated in
the Public Health Service Grants Policy Statement, DHHS Publication No.
(OASH) 90-50,000, revised October 1, 1990.  If there is a current
institutional (T32) National Research Service Award (NRSA) supporting a
clinical or surgical oncology training program within the same milieu of
this proposed institutional clinical oncology research development
program (K12), the relationship between the existing and proposed
program must be addressed (see SPECIAL REQUIREMENTS, Section V.)
 
This RFA is a one-time solicitation.  Future competitive continuation
applications will compete with all investigator-initiated applications.
If the NCI determines that there is a sufficient continuing program
need, a request for competitive continuation and/or new applications
will be announced.
 
Total costs of $2.7 million for the first year, $3.6 million the second
year, and $4.5 million per year for the third, fourth, and fifth years
will be committed to fund applications submitted in response to this
RFA. It is anticipated that approximately ten awards will be made.  This
funding level is dependent upon the receipt of a sufficient number of
applications of high scientific merit. The total project period for
applications submitted in response to the present RFA may not exceed
five years. The earliest feasible start date for the initial awards will
be July 1, 1992.  Although this program is provided for in the financial
plans of the National Cancer Institute (NCI), the award of grants
pursuant to this RFA is also contingent upon the availability of funds
for this purpose.
 
In order to fund enough programs to generate sufficient diversity and
distribution of programs, direct costs for the 01 year must not exceed
$300,000, and any increases in future year positions must be incremented
gradually over the five-year program.  Peer review will assess the
quality of resources available to support the type of program proposed
and the number of positions requested within the above limitations.
 
Clinical research candidates will be provided salary support of up to
$50,000 each year, plus fringe benefits commensurate with the applicant
institution's salary structure for persons of equivalent qualifications,
experience, and rank.  Each candidate will also be provided up to
$20,000 annually to partially support supplies, equipment, travel,
tuition, and other costs that are essential for the individual's
clinical research development program.  Indirect costs will be provided
at a rate not exceeding eight percent of the total direct costs of each
award, exclusive of tuition, fees, and expenditures for equipment.
 
V. SPECIAL REQUIREMENTS
 
The Principal Investigator must establish an advisory committee for this
program.  Clinical and basic science departments participating in this
program should be represented on the committee by clinical investigators
from the various oncology disciplines such as medical oncology, surgical
oncology, radiation oncology, and other oncology specialties, as well as
by basic research investigators.  The committee's responsibilities might
include:  selecting physician candidates, assigning preceptors,
approving each candidate's clinical research development plan,
evaluating each candidate's progress, and monitoring the overall
effectiveness of the program.  A detailed description must be provided
of the committee's composition, function, and frequency of meetings.
 
Each clinical research candidate must have one or more
preceptor/mentor(s) who are accomplished investigators in their field.
The advisor(s) must assume responsibility for devising a career
development and research plan with the candidate, obtaining the
concurrence of the program advisory committee, and providing day-to-day
advice.
 
Plans for an annual evaluation of the program must be described.  The
Annual Progress Report for the grant must provide a summary of this
evaluation and include a description of the research and career progress
of each candidate, describing how laboratory and clinical research and
practice are being integrated.  These Annual Reports will be closely
monitored by NCI staff to ensure that the grant is achieving the goals
of this Clinical Oncology Research Career Development Program.
 
If there already exists an active institutional (T32) National Research
Service Award (NRSA) supporting a surgical or other clinical oncology
research training program, the applicant must address the relationship
between the existing T32 and proposed K12 programs.  If there is
significant overlap in the programs, the T32 award can be merged into
the K12 program or modified to remove areas of overlap.
 
VI.  ELIGIBILITY REQUIREMENTS
 
A. INSTITUTION
 
Only domestic, non-profit, universities, schools, and institutions are
eligible to apply for this program. Applicant organizations must have
well-established research programs with adequate peer-reviewed grant
support and highly qualified faculty in clinical and basic science
departments.
 
B. CLINICAL CANDIDATES
 
All candidates must be U.S. citizens, nationals, or lawfully admitted
permanent residents of the U.S.  All candidates must be physicians
holding the M.D. or D.O. degree.
 
A minimum 75 percent effort must be devoted to the basic/clinical
research program.  The remaining 25 percent may be divided among other
clinical and teaching activities only if they are consonant with the
program goals, i.e., the candidate's development into an independent
clinical investigator.
 
C. PROGRAMS
 
Proposed programs must demonstrate the potential to provide research
career development opportunities in a range of clinical oncology
research disciplines (e.g., medical oncology, surgical oncology,
radiation oncology) and not be limited to a single discipline.
 
VII.  REVIEW PROCEDURES AND CRITERIA
 
A. REVIEW PROCEDURE
 
Upon receipt, applications initially will be reviewed by the Division of
Research Grants (DRG) for completeness. Incomplete applications will be
returned to the applicant without further consideration.  Evaluation for
responsiveness to the RFA is an NCI program staff function.
Applications will be judged to determine how well they meet the goals
and objectives of the program as described in the RFA.  Applications
judged non-responsive will be returned. Questions concerning the
relevance of proposed programs to the RFA are to be directed to program
staff as described in the INQUIRIES section.
 
In cases where the number of applications is large compared to the
number of awards to be made, the NCI may conduct a preliminary
scientific peer review to eliminate those applications that are clearly
not competitive.  The NCI will withdraw from further competition those
applications judged to be non-competitive and notify the applicant and
institutional business official.
Those applications judged to be both competitive and responsive will be
further evaluated according to the review criteria stated below for
scientific and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities (DEA), NCI.  The
second level of review by the National Cancer Advisory Board will
consider the special needs of the Institute and the priorities of the
National Cancer Program.
 
B. REVIEW CRITERIA
 
The review criteria set forth below are neither exhaustive nor
prescriptive.  Applicants are asked at a minimum, to address each
criterion.  Members of the peer review group convened by the DEA will be
requested to use their best professional judgment in evaluating the
educational and scientific merit of applications under review.  The
review criteria, therefore, are more than a guide but less than an
absolute requirement.
 
o Appropriateness of detailed plans for a comprehensive program to
provide physicians with the proper integration of basic and clinical
research skills and experiences necessary for careers in clinical
oncology research.
 
o Adequacy of procedures for announcing the program and criteria for
selecting candidates and mentors.
 
o Adequacy of procedures for assessing each candidate's level of
scientific research experience, ability, and needs in order to optimize
his/her research career development and as a prerequisite for clinical
research.
 
o Appropriateness of a research environment that provides collaborations
among clinical and basic research scientists or of plans to establish
and promote such collaborations.
 
o Scientific and administrative leadership qualifications and experience
of the Principal Investigator.
 
o Qualifications of faculty mentors:  adequacy of peer-reviewed clinical
and basic cancer research projects, publications and training experience
in the context of achieving the objectives of this RFA.
 
o Availability of sufficient cancer patient populations and clinical
materials to support appropriate clinical research experiences.
 
o Adequacy of the membership and functions of the program advisory
committee.
 
o Effective plans for program oversight and evaluation to be reported in
the Annual Progress Report.
 
o Adequacy of facilities and other resources.
 
C. BUDGET
 
o The review group will critically examine the proposed budget and
recommend an appropriate budget for each approved application within the
guidelines stated above (SECTION IV).
 
VIII.  METHOD OF APPLYING
 
The most recent revision of the research grant application form PHS 398
(revised 10/88) must be used in applying for these grants.  These forms
are available at most institutional business offices and from:
 
Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
Westwood Building, Room 449
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7441
 
and from the NCI Program Director named below.
 
The RFA label available in the 10/88 revision of 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.  In addition, the
RFA number and title must be typed on line 2 of the face page of the
application form.
 
Submit a signed, typewritten original of the application, including the
Checklist, and four signed, exact photocopies, in one package to the
address below.  The photocopies must be clear and single sided.
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
At time of submission, send two additional copies of the application to:

REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD  20892
 
Applications must be received by December 31, 1991.  If an application
is received after that date, it will be returned.  If the application
submitted in response to this RFA is substantially similar to a grant
application already submitted to the NIH for review but has not yet been
reviewed, the applicant will be asked to withdraw either the pending
application or the new one.  Simultaneous submission of identical
applications will not be allowed, nor will essentially identical
applications be reviewed by different review committees.  An
application, therefore, cannot be submitted in response to this RFA
which is essentially identical to one that has already been reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
IX.  LETTER OF INTENT
 
Prospective applicants are asked to submit by October 25, 1991, a letter
of intent that includes a descriptive title of the proposed program, the
name and address of the Principal Investigator, the names of other key
personnel, the participating institutions and the number and title of
the RFA in response to which the application is being submitted.
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, it is requested in
order to provide an indication of the number and scope of applications
to be reviewed.
 
The letter of intent is to be sent to:
 
Dr. Vincent J. Cairoli
Cancer Training Branch
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Room 232
Bethesda, MD  20892
Telephone:  (301) 496-8580
FAX:  (301) 402-0181
 
X. INQUIRIES
 
Written and telephone inquiries concerning the objectives and scope of
this RFA and inquiries about whether or not specific proposed career
research development and educational activities would be responsive to
this RFA are encouraged and are to be directed to Dr. Vincent Cairoli at
the above address.  The Program Director welcomes the opportunity to
clarify any issues or questions from potential applicants.
 
For information regarding grants management issues (e.g., individual
budget items, administrative concerns, legal questions) related to this
RFA, contact:
 
Mr. Robert Hawkins
Team Leader, GAB
National Cancer Institute
National Institutes of Health
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800 ext 13
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
Number 93.398, Cancer Research Manpower.  Awards are made under the
authorization of the Public Health Service Act, Title IV, Part A, Public
Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285 and
administered under PHS grants policies and Federal Regulations 42 CFR
Part 52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.