Full Text CA-97-009
 
AIDS-ONCOLOGY CLINICAL SCIENTIST DEVELOPMENT PROGRAM
 
NIH GUIDE, Volume 26, Number 9, March 21, 1997
 
RFA:  CA-97-009
 
P.T. 34

Keywords: 
  AIDS 
  Cancer/Carcinogenesis 
  Oncology 

 
National Cancer Institute
 
Letter of Intent Receipt Date:  April 25, 1997
Application Receipt Date:  July 16, 1997
 
PURPOSE
 
The National Cancer Institute (NCI) invites applications for Clinical
Scientist Development Program Awards to support institutional,
multidisciplinary, training programs focused on the HIV/AIDS Oncology
field.  The goal of the program is to train a cadre of clinicians
with the highly specialized skills necessary to address the clinical
and research problems associated with AIDS-related malignancies.
There is an important need for trained AIDS-Oncology specialists to
exploit research opportunities, conduct patient-oriented research,
and provide the clinical management skills necessary for advancement
in this field.
 
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 Request
for Application (RFA), AIDS-Oncology Clinical Scientist Development
Program, is related to the priority area of human resource
development in cancer research.  Potential applicants may obtain a
copy of "Healthy People 2000" (Full Report:  Stock No. 017-001-0047-0
or Summary Report:  Stock No. 017-001-00473-1) from the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Institution:  Applications may be submitted by domestic, for-profit
and non-profit organizations, public and private, such as
universities, colleges, hospitals, laboratories, units of State and
local governments, and eligible agencies of the Federal government.
Applicant organizations should have well-established research
programs with adequate peer-reviewed grant support and highly
qualified faculty in clinical and basic science departments.
Minorities and women are encouraged to apply as principal
investigators.
 
Clinical Candidates:  All candidates for support under this program
award must currently be physicians holding the M.D. or D.O. degrees.
In addition, they should have completed a minimum of one year of sub-
specialty training, for example in Hematology, Gynecology, or
Oncology disciplines prior to joining this training program.
Appointments of clinical candidates to the program must be for a
minimum of two years.  The candidate must be willing to devote a
minimum of 75 percent of full-time professional effort to the
basic/clinical research program.  The remaining 25 percent can 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.
 
Candidates appointed under this program award must be U.S. citizens
or noncitizen nationals, or have been lawfully admitted for permanent
residence and possess an Alien Registration Card (I-151 or I-551) or
some other verification of legal admission as a permanent resident.
Noncitizen nationals, although not U.S. citizens, owe permanent
allegiance to the U.S. They are usually born in lands that are not
states, but are under U.S. sovereignty, jurisdiction, or
administration.  Individuals on temporary or student visas are not
eligible.
 
Candidates who are or have been former principal investigators on NIH
research projects (R01), FIRST Awards (R29), sub-projects of program
project grants (P01) or the equivalent, are not eligible for
appointment under this program.
 
MECHANISM OF SUPPORT
 
Support for this program will be through the National Institutes of
Health's (NIH) grant-in-aid, the Institutional Clinical Scientist
Development 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.
 
This RFA is a one-time solicitation.  Generally, future competitive
continuation applications will compete with all investigator-
initiated applications.  Should the NCI determine that there is a
sufficient continuing program need, a request for competitive
continuation and/or new applications will be announced.
 
FUNDS AVAILABLE
 
Total costs of $1,500,000 for the first year, $3,000,000 for years
two and three, and $1,500,000 for the fourth and final year will be
committed to fund applications which are submitted in response to
this RFA.  It is anticipated that approximately five 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 should not exceed four years.  The earliest feasible
start date for the initial awards will be December 31, 1997. 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.
 
RESEARCH OBJECTIVES
 
Background:  Malignancies have been associated with HIV/AIDS since
the beginning of the epidemic in the early 1980s.  As the AIDS
epidemic continues, additional AIDS-defining malignancies have been
identified; larger numbers of HIV-infected individuals have been
diagnosed with malignancies as improved anti-retroviral and
opportunistic infection management has allowed them to live longer.
The AIDS Malignancy Working Group, which includes NCI staff and
extramural scientists, identified the need for interdisciplinary
training programs to provide the spectrum of clinical and research
skills necessary for conducting patient-oriented research in
conjunction with appropriate management of patients with HIV/AIDS
malignancies.
 
At the present time, there is no specific subspecialty of Medicine in
the area of HIV/AIDS, nor are there any formal, nationally recognized
training programs integrating the specialized skills in Hematology,
Oncology disciplines, and Infectious Diseases needed to address AIDS-
related malignancies.  The expanding population of patients with
HIV/AIDS and malignancies have complex multi-system illnesses,
requiring the expertise of physicians with considerable
multidisciplinary knowledge.  Most investigators pursuing research in
the HIV/AIDS field have had sub-specialty training in Infectious
Diseases and most Oncology programs have no formal training in AIDS
Oncology.
 
It is clear that advances in the field of HIV/AIDS Oncology will
require highly specialized expertise and "cross-training" of
clinicians.  Interdisciplinary training is essential to developing a
cadre of experts in clinical and translational research to move the
field forward and to contribute to the competent management of HIV-
infected individuals with malignancies.
 
Environment:  Institutions should have well-established basic and
clinical research programs in the areas of oncology, hematology, and
infectious diseases. Departmental/Divisional collaborations should be
arranged in order to achieve the required multidisciplinary training.
The program must include clinical researchers with expertise in AIDS-
related malignancies and experience in postdoctoral research
training.  There should also be sufficient numbers of patients with
AIDS and AIDS-related malignancies available to sustain a credible
training program.
 
Program:  Applicants should provide details of the content and scope
for a TWO YEAR interdisciplinary training program for each candidate.
The proposed training program must provide didactic, research, and
clinical components that will integrate knowledge and skills across
disciplines relevant for clinical research and care for AIDS patients
with malignancies, for example, Oncology disciplines, Hematology and
Infectious Diseases The program should prepare clinicians to handle
the clinical complexities of patients with HIV/AIDS and malignancies.
Additionally, the program should provide laboratory/translational
research training in areas directly involved in AIDS research or in
related fields of immunology, virology, or molecular biology.  The
research component should focus on the skills necessary for
translating research results into clinical experiments, procedures,
and trials directly involving patients with AIDS/HIV malignancies.
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 experience.
 
Applicants should clearly address the following issues:  1)
arrangements for organizational interactions and collaborations
necessary to achieve the objectives of this RFA; 2) the
qualifications of the faculty mentors, highlighting their clinical
and basic research projects and prior training experience; 3) the
availability of appropriate mentors who would have responsibility for
the candidate's clinical/research program and day-to-day progress; 4)
the availability of sufficient numbers of patients with AIDS and
AIDS-related malignancies; 5) procedures to be used to announce the
program and to select appropriate candidates, mentors, and projects;
and 6) the establishment of an Advisory Committee (see Special
Requirement) to provide an oversight function and annual evaluation
of the AIDS-Oncology Clinical Scientist Development Program as a
whole.
 
Special Requirements:  The Principal Investigator must establish an
Advisory Committee for this program.  The various
departments/divisions participating in this program should be
represented on the committee.  Examples of 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.
 
Each candidate should have one or more preceptor(s) who are
accomplished investigator/clinicians in their field.  The advisor(s)
should assume responsibility for devising a career development and
clinical research plan with the candidate, obtaining the concurrence
of the Advisory Committee, and providing day-to-day advice.
 
Plans for an annual evaluation of the program by the Advisory
Committee should be described.  The Annual Progress Report for the
grant should provide a summary of this evaluation and include a
description of the clinical 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 the RFA and for a final evaluation to determine the success
and need for a continuation of the program beyond the initial four
year period.
 
ALLOWABLE COSTS
 
In order to provide sufficient diversity and distribution of
programs, direct costs for the (01) year should not exceed $300,000,
and any increases in future year positions should be incremented
gradually with appropriate justification. The budget should take into
consideration that each candidate should receive a minimum of two
years of training. Peer review will assess the quality of resources
available to support the type of program proposed and the number of
training positions requested within the above limitations.
 
Salary:  Clinical research candidates will be provided salary support
of up to $50,000 each year, plus applicable fringe benefits
commensurate with the applicant institution's salary structure for
persons of equivalent qualifications, experience, and rank.  The
institution may supplement the NCI contribution; however,
supplementation may not be from Federal funds unless specifically
authorized by the Federal program from which such funds are derived.
In no case may PHS funds be used for salary supplementation.
Institutional supplementation of salary may not require extra duties
or responsibilities that would interfere with the purpose of this
award.  Under expanded authorities, however, institutions may
rebudget funds within the total costs awarded to cover salaries
consistent with the institution salary scale.  The total salary
requested must be based on a full-time 12 month staff appointment.
 
Other Expenses:  $20,000 per candidate will be provided annually to
partially support supplies, equipment, travel, tuition, and other
costs which are essential for the individual's clinical research
development program.
 
Ancillary Personnel Support:  Salary for mentors, secretarial and
administrative assistance , etc.  is not allowed.
 
Indirect Costs:  Indirect costs will be provided at a rate not
exceeding eight percent of total direct costs of each award,
exclusive of tuition, fees, and expenditures for equipment.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification are
provided that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research.  This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal register of March 28, 1994 (FR 59 14508-14513) and in the NIH
Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by April 25, 1997, a
letter of intent that includes a descriptive title of the proposed
program, the name, address, telephone and FAX numbers, and E-mail
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, the information
that it contains allows NCI staff to estimate the potential review
workload and avoid conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Dr. Vincent J. Cairoli
Division of Cancer Treatment, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Room 520
Bethesda, MD  20892-7390
Telephone:  (301) 496-8580
FAX:  (301) 402-4472
Email:  VC14Z@NIH.GOV
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, email:
ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed
under INQUIRIES.
 
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
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 title and number must be typed on
line 2 of the face page of the application form and the YES box must
be marked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD 20892-7405
Rockville, MD 20852 (express/courier service)
 
Applications must be received by July 16, 1997.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NCI.  Incomplete or unresponsive
applications will be returned without further consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit in accordance with the
review criteria stated below by an appropriate peer review group
convened by the NCI.  As part of the initial merit review, all
applications will receive a written critique and may undergo a
process in which only those applications deemed to have the highest
scientific merit will be discussed and assigned a priority score.
All applications will receive a second level of review by the
National Cancer Advisory Board.
 
REVIEW CRITERIA
 
Review criteria will include:
 
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 Recruitment and selection plans for appointees and the availability
of high quality candidates.
 
o Appropriateness of detailed plans for a comprehensive program to
provide physician appointees with the proper integration of knowledge
and skills in oncology and infectious diseases necessary for clinical
research and care of patients with AIDS-related malignancies.
 
o Appropriateness of an environment to promote collaborations among
clinicians and research scientists as well as departmental/division
programs.
 
o Adequacy of facilities and other resources.
 
o Availability of sufficient AIDS and AIDS-related malignancy 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 the proposed means for protecting human subjects and
vertebrate animals against hazardous or unethical research procedures
and for protecting the privacy of human subjects.
 
Budget
 
The review group will critically examine the proposed budget and
recommend an appropriate budget for each approved application within
the guidelines stated above.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other scored
applications submitted in response to this RFA.  The following will
be considered in making decisions:  quality of the proposed project
as determined by peer review, availability of funds and program
priority.  The NCI will notify the applicant of the National Cancer
Advisory Board's (NCAB) action.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding Career/Training issues to:
 
Dr. Vincent J. Cairoli
Division of Cancer Treatment, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Room 520
Bethesda, MD  20892-7390
Telephone:  (301) 496-8580
FAX:  (301) 402-4472
Email:  VC14Z@NIH.GOV
 
Direct inquiries regarding Clinical issues to:
 
Ellen Feigal, M.D.
Division of Cancer Treatment, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Room 741
Bethesda, MD 20892
Telephone:  (301) 496-2522
FAX:  (301) 402-0557
Email:  FEIGALE@CTEP.NCI.NIH.GOV
 
Direct inquiries regarding Fiscal/Administrative matters to:
 
Ms. Kelli Oster
Office of Administrative Management
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext 261
FAX:  (301) 496-8601
Email:  OSTERK@GAB.NCI.NIH.GOV
 
AUTHORITY AND REGULATION
 
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 grant 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.
 
The Public Health Service strongly encourages all grant and contract
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  In addition, Public Law 103-227, the Pro-
Children Act of 1994, prohibits smoking in certain facilities (or, in
some cases, any portion of a facility) in which regular or routine
education, library, day care, health care or early childhood
development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental
health of the American people.
 
.

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