Subject: RFACA-91-04 2/8/91 NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 07 Feb 91 08:36 EST

Hello,
   Five of six.  Please post to the listserver as:
RFACA-91-04.910208
    Thanks.  dottie
 ---------------------------- Text of forwarded message -----------------------
 
REQUEST FOR APPLICATIONS
 
RFA:  CA-91-04
 
SMALL GRANTS TO STIMULATE CORRELATIVE 	 LABORATORY STUDIES AND
CLINICAL TRIALS IN RADIATION THERAPY
 
P.T. 34; K.W. 0745062, 0715035, 0755015
 
National Cancer Institute
 
Letter of Intent Receipt Date:  March 4, 1991
Application Receipt Date:  May 22, 1991
 
I.  INTRODUCTION
 
The Division of Cancer Treatment (DCT) of the National Cancer
Institute (NCI) invites grant applications from interested
investigators for tightly focused basic science laboratory
studies that interface with radiation therapy clinical trials
or for radiation therapy clinical trials that attempt to
correlate new and/or unique developments in the laboratory.
 
Grants are awarded to non-profit and for-profit organizations
and institutions, governments and their agencies, and
occasionally to individuals.  This type of grant solicitation,
the Request for Applications (RFA), is utilized when it is
desired to encourage investigator-initiated research projects
in areas of special importance to the National Cancer Program.
Applicants funded under the RFA are supported through the
customary National Institutes of Health (NIH) grant-in-aid, in
accordance with Public Health Service (PHS) policies
applicable to research project grants.
 
This RFA represents a single solicitation with a specific
deadline for receipt of applications.  All applications received
in response to the RFA will be reviewed by the same NCI initial
review group and NCI program staff.  Applications should be
prepared and submitted in accordance with the aims and
requirements described in the following sections:
 
II.	BACKGROUND INFORMATION
III.	RESEARCH GOALS AND SCOPE
IV.	MECHANISM OF SUPPORT
V.	ELIGIBILITY REQUIREMENT
VI.	REVIEW PROCEDURES AND CRITERIA
VII.	METHOD OF APPLYING
VIII.	INQUIRIES
 
II.  BACKGROUND INFORMATION
 
The NCI supports an extensive network of clinical and
laboratory research studies related to cancer therapy through
contracts, grants, and cooperative agreements.  At present,
there is no mechanism targeted to stimulate the
communication of promising and potentially relevant new
developments between the basic science laboratory and the
clinical setting.  It has been difficult for investigators to
obtain complementary funding through either the traditional
basic research grant (R01) mechanism or through the
cooperative agreement (U10) mechanism for either:  (1) pilot
clinical trials that take advantage of new developments in the
laboratory or (2) correlative laboratory studies relevant to
existing clinical trials.
 
The small grants (R03) mechanism provides research support
specifically limited in time and amount for studies in
categorical program areas.  Small grants provide flexibility
for initiating studies that are generally for preliminary
short-term projects.  These small grants are non-renewable.
Furthermore, the time interval from application to funding is
shortened under the R03 mechanism, thus allowing new ideas
to be investigated and pursued in a more expeditious manner.
The Radiation Research Program, DCT, NCI, has targeted the
use of the small grants mechanism to support single or
multiple institutions (individual institutions, consortia, or
cancer centers) to perform correlative studies utilizing
pilot clinical trials to test and verify basic laboratory
findings.  Some examples of categorical areas for R03 studies
include, but are not limited to:  (1) growth factors and
radiation response; (2) radiosensitivity and cell kinetics
studies; (3) predictive assays of tumor radiocurability; (4)
physiological determinants of hyperthermia response; (5) low
dose rate effects and radioimmunotherapy; (6) biochemical and
molecular studies of radioresistance; and (7) interaction
between radiation and drugs, or radiation and radiosensitizers,
or radiation and hyperthermia.
 
III.  RESEARCH GOALS AND SCOPE
 
The aims of this initiative are two-fold:  (1) to provide a
mechanism for accelerated funding of correlative studies
relevant to radiation therapy clinical trials and (2) to
stimulate pilot clinical studies with or without relevant
laboratory correlations so as to foster the development of
interactions between basic science laboratories and clinicians
performing radiotherapy clinical trials.  Laboratory correlates
should be designed to ultimately lead to improved radiation
therapy.
 
Studies should be proposed for a tightly focused, integrated,
research program at the interface of laboratory
experimentation and concurrent radiation therapy clinical
trials.  The laboratory studies must have been demonstrated to
be applicable to tissue samples and/or body fluids from
patients entered into clinical trials.  Evidence of statistical
support should be included to ensure proper correlation of
assay parameters with clinical outcome.  Some examples of
support that would qualify under this RFA would be:  (1) salary
for an additional technician; (2) funds for additional supplies
or small equipment required for the project; (3) salary support
for data management, data entry, and coordination of sample
procurement; (4) funds for the collection and shipment of
specimens.
 
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 and 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/offerors are urged to assess carefully the
feasibility of including the broadest possible representation of
minority groups.  However, NIH recognize 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.
 
For the purpose of this policy, clinical research includes
human biomedical and behavioral studies of etiology,
epidemiology, prevention (and preventive strategies),
diagnosis, or treatment of diseases, disorders or conditions,
including but not limited to clinical trials.
 
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 should be addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies
fully;  since the definition of minority differs in other
countries, the applicant must discuss the relevance of
research involving foreign population groups to the United
States' populations, including minorities.
 
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 and 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
assigning 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
 
This RFA will use the NIH small grant mechanism (RO3).
Responsibility for the planning, direction, and execution of the
proposed research will be solely that of the applicant.  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.  Small grants are designated as R03
grants.
 
This RFA is a non-renewable, one-time solicitation.  Future
unsolicited competing applications derived from preliminary
projects supported by the R03 mechanism will compete as
Type 1 R01's with all investigator-initiated grant applications
and will be reviewed by the appropriate study section of the
Division of Research Grants (DRG).
 
Approximately $375,000 in first year total costs will be
committed to specifically fund applications that are
submitted in response to this RFA.  This funding level is
dependent on the receipt of a sufficient number of applications
of high scientific merit.  NCI plans to make multiple awards
for project periods up to two years.  All awards will be
limited to a $50,000 direct-cost ceiling for a period of up to
two (2) years.  The total project period for applications
submitted in response to the present RFA should not exceed
two (2) years.  The earliest feasible start date for the initial
awards will be December 2, 1991.  Although this program is
provided for in the financial plans of the
NCI, the award of grants pursuant to this RFA is
also contingent upon the continuing availability of funds for
this purpose.
 
V.  ELIGIBILITY REQUIREMENT
 
Only domestic non-profit and for-profit organizations,
institutions, governments and their agencies are eligible to
apply.  Although NCI-funded Cooperative Groups are ineligible
to apply, individual institutions or consortia of the
Cooperative Groups may apply through their own institutions.
Awards will be made only to institutions with either a funded
clinical or laboratory component of the proposed study.  These
awards are to complement a previously existing source of
support.  These pre-existing resources need not be at a single
institution but may exist within a consortium.  The sources of
funding must be documented in the application.  Applications
submitted without this documentation will be returned to the
applicants without further review.  We encourage new as well as
experienced investigators.  Minority investigators are also
strongly encouraged to apply.
 
VI.  REVIEW PROCEDURES AND CRITERIA
 
REVIEW PROCEDURE
 
Upon receipt, applications will be reviewed by
DRG for completeness.  Incomplete
applications will be returned to the applicant without further
consideration.  Applications will be evaluated by NCI program
staff to determine whether they are responsive to the program
requirements and criteria stated in this RFA.  Applications
that are judged non-responsive will be returned by the NCI
but may be resubmitted as investigator-initiated regular
research grants at the next receipt date.  Questions concerning
the responsiveness of proposed research to the RFA should be
directed to program staff as described in Section VIII.
 
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 clearly fail to meet minimum mandatory
requirements and are, therefore, judged to be non-competitive.
The applicant and institutional business official of
applications judged to be non-competitive will be so notified.
 
Those applications judged to be both competitive and
responsive will be further evaluated using the review criteria
stated below for scientific and technical merit, by an
appropriate peer review group convened by the Division of
Extramural Activities, NCI.  The second level of review by the
NCI program staff considers the application in light of the
special needs of the Institute and the priorities of the National
Cancer Program.
 
REVIEW CRITERIA
 
Minimal Mandatory Requirements will include:
 
1  Documentation that the applicant has a funded (i.e., by
government, medical society, industry) clinical or
laboratory component of the proposed study.
 
2  Submission of the clinical protocol (as an appendix).
 
3  Animal assurance approval number, if applicable.
 
4  Letters of commitment from key participating individuals
outside the jurisdiction of the applicant (Principal
Investigator).  These letters should clearly state the
availability and time commitment of the participating
individual.
 
5  Evidence of statistical input and continuing support for the
proposed study.
 
6  A listing of sources of existing financial support.
 
The factors considered in evaluating the scientific merit of
each response to this RFA include:
 
1  The importance of the proposed clinical trial in developing
new radiation treatment regimens or in addressing issues of
therapy in highly prevalent or scientifically exploitable
diseases.
 
2  The relevance of the proposed laboratory studies to the
radiation therapy clinical trials.
 
3  Originality of the research from a scientific and technical
viewpoint.
 
4  Feasibility of research and adequacy of study design.
 
5  Quality of the assay methodology and laboratory research
and experience of the laboratory with the assay methodology
proposed.
 
6  Experience, training, time commitment, and clinical and
research competence of the investigators involved.
 
7  Adequacy of plans for effective communication between
laboratory, clinical, and statistical investigators.
 
8  Adequacy of available facilities, statistical collaboration,
and patient population.
 
9  Provision for the adequate protection of human subjects and
the humane treatment of animals.
 
10  Adequacy of women and minority representation in the
study population.  Applicants must include a description of the
anticipated race/ethnic/gender composition of the study
population and a rationale for its choice.
 
The review group will critically examine the submitted budget
and will recommend an appropriate budget for each approved
application.
 
VII.  METHOD OF APPLYING
 
The USPHS 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 the
Office of Grants Inquiries, Division of Research Grants, National
Institutes of Health, Room 449, Westwood Building, 5333 Westbard
Avenue, Bethesda, MD 20892.  They are also available from the NCI
Program Director named below.
 
The RFA label available in the 10/88 revision of
PHS 398 must be affixed to the bottom of the face page.
Failure to use this label could result in delayed processing of
your application such that it may not reach the review
committee in time for review.  In addition, the RFA number and
title should 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 (4) signed, exact, clear and
single-sided photocopies,
in one package to the
address given below.
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Also, send two (2) additional copies of the application directly
to:
 
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD  20892
 
The applicant should provide with the application certification
of institutional review board (IRB) approval if humans are
involved and verification of the institutional animal care and
use committee (IACUC) approval if animals are involved.
These reviews and approvals should occur PRIOR TO
SUBMISSION of the applications, and the certifications and
verifications should be SUBMITTED WITH the applications.
Failure to provide required certifications and verifications
with applications may result in deferral or rejection.  If
animals or humans will be subjects of the research at
PERFORMANCE SITES OTHER THAN THE APPLICANT
ORGANIZATION, the applicants must identify, with the
application, the assurance status of each participant.  Failure
to provide this information with applications may result in
deferral or rejection.
 
Applications must be received by May 22, 1991.  If an
application is received after the indicated date, it will be
returned.  If the application submitted in response to this RFA
is substantially similar to a research 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.  Therefore, an application cannot be
submitted in response to this RFA if it 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.
 
VIII.  LETTER OF INTENT
 
Prospective applicants are asked to submit, by March 4, 1991, a
letter of intent that includes a descriptive title of the
proposed research, 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 the subsequent
application, it is requested in order to provide an indication
of the number and scope of applications to be reviewed.
 
The letter of intent should be sent to:
 
Thomas A. Strike, Ph.D.
Radiation Research Program
Division of Cancer Treatment
National Cancer Institute
6130 Executive Boulevard, Suite 800
Rockville, MD  20852
Telephone:  (301) 496-9360
 
IX.  INQUIRIES
 
Written or telephone inquiries concerning the objectives and
scope of this RFA or inquiries about whether or not specific
proposed research would be responsive are encouraged and
should be directed to Dr. Thomas A. Strike at the above
address.  The program director welcomes the opportunity to
clarify any issues or questions from potential applicants.
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.395, (Clinical Treatment Research).  Awards
are under 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 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.