Subject: (Copy) NIH GUIDE - Vol. 20, No. 15, April 12, 1991, Part 2 of
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 10 Apr 91 14:24 EST

Hi Paul,
  Please post to the NIH Listserver as:
     NIHGUIDE2.910412
                     Thanks,   Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID NIHGUIDE 19910412 V20N15 P2O2 ************************************
community data and epidemiological studies, applicants should consult
BSR staff for advice.
 
V. INCLUSION OF MINORITIES AND WOMEN
 
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/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 or 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
review will be deferred until the information is provided.
 
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
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.
 
VI.  ELIGIBILITY
 
Applications for research grants may be made by public or private,
for-profit or non-profit organizations, such as universities, colleges,
hospitals, or laboratories.  Women and minority investigators, in
particular, are encouraged to apply.
 
VII.  MECHANISMS OF SUPPORT
 
The primary mechanisms for support of this initiative are the research
project grant (R01), program project (P01), FIRST award (R29),
institutional training grant (T32), individual fellowships (F32, F33),
and research career development awards (K04).
 
VIII.  REVIEW CRITERIA AND APPLICATION PROCEDURES
 
R01, R29, F32, F33 and K04 applications will be reviewed for scientific
and technical merit by an appropriate Initial Review Group of the
Division of Research Grants.  All other applications will be reviewed by
an appropriate Institute review group.  Secondary review will be by the
corresponding National Advisory Council.  Applications compete on the
basis of scientific merit.
 
Although it is not required, potential applicants are encouraged to
contact NIA staff in advance of formal submission.  This may be
accomplished by calling the program office listed below.  Requests for
additional information should be addressed to:
 
Richard Suzman, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
Building 31, Room 5C32
Bethesda, MD  20892
Telephone:  (301) 496-3136
 
For fiscal and administrative matters, contact:
 
Joe Ellis
Grants and Contracts Management Office
National Institute on Aging
Building 31, Room 5C07
Bethesda, MD  20892
Telephone:  (301) 496-1472
 
Applicants must use the research project application form (PHS 398,
revised 10/88, reprinted 9/89) that is available at the applicant's
institutional research office and from the Office of Grants Inquiries,
Division of Research Grants, NIH (301-496-7441).  Individual fellowship
applicants must use PHS 416-1 (revised 7/88).  In order to expedite the
application's routing, please check the box on the application face
sheet indicating that your proposal is in response to this announcement
and type (next to the box) "Economics of Aging, Health and Retirement,
PA-91-41."
 
The application (with six copies) must be mailed to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
If applying for an F32, the application and only two copies need to be
sent to the above address.
 
Receipt dates for Research Project Grant, Career Development Award, and
FIRST Award applications are February 1, June 1, and October 1 of each
year.  Those for the individual fellowships (F32, F33) and institutional
training grants (T32) applications are January 10, May 10, and September
10.
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.866.  Agency Research Awards will be made under the authority of
the Public Health Service Act, Title III, Section 301 (Public Law
78-410, as amended; 42 USC 241 and 41 USC 289) and be subject to PHS
Grant Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part
74.  This program is not subject to Health Systems Agency review.
 
$$P2 END ***************************************************************
 
$$P3 BEGIN *************************************************************
 
CLINICAL CANCER THERAPY RESEARCH
 
PA:  PA-91-42
 
P.T. 34; K.W. 0715035, 0740020, 0745005, 0755025, 0785140
 
National Cancer Institute
 
Application Receipt Dates:  June 1, October 1, February 1
 
I.  PURPOSE
 
The National Cancer Institute (NCI) seeks grant applications
to conduct clinical therapeutic studies of neoplastic diseases in
human subjects.  Clinical research, by definition, involves a
clinician/patient-subject interaction with a therapeutic intent.
This Program Announcement (PA) encompasses a full range of
therapeutic studies and clinical trials employing drugs,
biologics, radiation, or surgery.  The intent of the announcement
is to encourage clinical researchers to translate insights in
cancer biology and the development of new agents into innovative
cancer therapeutic studies.
 
This type of grant solicitation (Program Announcement) is
utilized when it is desired to encourage investigator-initiated
research projects in areas of special importance to the National
Cancer Institute.  Applicants who will be funded under this PA
will be supported through the customary National Institutes of Health
(NIH) grant-in-aid (R01, R29).
 
The 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 PA, Clinical Cancer Therapy Research, 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 "Healthy People 2000"
(Summary Report:  Stock 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
 
In the past several years, the research effort into understanding
the basic biology of the cancer cell has been highly productive.
Recent discoveries concerning the role of growth factors, genes
that promote and suppress neoplasia, mechanisms of treatment
sensitivity and resistance, and the biology of the immune systems
have provided the basis for the development of novel and improved
cancer treatments.  The rate of progress in the treatment of
cancer will depend upon the translation of these basic and
preclinical discoveries into clinical cancer therapies.
The NCI supports an extensive network of clinical and laboratory
research studies related to cancer therapy through contracts,
grants, and cooperative agreements.  At present, the traditional
research grant mechanism (R01, R29) is underutilized by clinical
investigators for the support of clinical research.  The Cancer
Therapy Evaluation Program (CTEP), Division of Cancer Treatment,
NCI, the program primarily responsible for the promotion and
translation of new basic and preclinical research into
therapeutic advances, receives relatively few research grant
applications.  Whereas a Request for Applications (RFA)
represents a single solicitation, a
PA provides the opportunity for the receipt of
new applications on an indefinite basis.  NCI encourages clinical
investigators to submit clinical therapeutic studies and is
committed to moving advances in basic biology and drug
development into the clinical setting.
 
III.  RESEARCH GOALS AND SCOPE
 
The Division of Cancer Treatment (DCT) is requesting qualified
investigators to develop research grant applications (R01,
R29) involving clinical therapeutic studies of neoplastic
diseases.  Clinical studies must involve human subjects and be
designed to ultimately improve cancer treatment.  The
applications may include single or multi-institutional (e.g.,
consortia, cooperative groups) research studies with appropriate
biological correlates linked to these studies.  New clinical
therapeutic studies may employ drugs, biologics, radiation, or
surgery used as single agents/modalities or in combination.
Biological correlative studies that have clinical relevance to
cancer therapies and are aimed at improving cancer treatment are
also appropriate.
 
Some examples of clinical therapeutic studies include:
1) therapies based on novel mechanisms of action; 2) mechanism of
action and metabolic studies of antitumor agents; 3) studies of
mechanisms of hormone-, drug- or radiation-resistance and
reversal; 4) mechanism of action of biological response modifiers
in the treatment of cancer, e.g., cancer immunotherapy
(monoclonal antibodies, cytokines, antisense, and vaccines) alone or
in combination with chemotherapeutic agents; 5) mechanism of
action of new growth factor targeted therapies; 6) new radiation
therapies or radiation modifiers to enhance cell kill or protect
normal tissue; 7) surgical therapies in combination with
therapeutic agents.
 
Some examples of biological correlative studies include:
1) phenotypic or genotypic alterations that appear to correlate
with the development of drug-, hormone-, or radiation-resistance;
2) oncogenes, growth factors, and specific antigen expression on
tumor cells; 3) pharmacokinetic and pharmacodynamic measurements;
4) biochemical pharmacologic parameters; 5) imaging studies to
assess efficacy of treatment.
 
Investigators are not limited to the above areas of potential
studies.  Clinical research, by definition, must involve a
clinician/patient-subject interaction with a therapeutic intent.
 
Applicants from institutions that have a General Clinical
Research Center (GCRC) funded by the NIH National Center for
Research Resources are requested to identify the GCRC as a resource
for conducting the proposed research.
 
IV. MECHANISM OF SUPPORT
 
Support of this program will be through the research project (R01
and R29) NIH grant-in-aid.  Applicants will be responsible for
the planning, direction, and execution of the proposed project.
All PHS and NIH grants policies will apply to applications
received in response to this announcement.  Domestic applicants
may request no more than five years of support, and foreign
applicants may request no more than three years.  Applications
submitted in response to this PA will compete for funds with all
other investigator-initiated applications.  The award of grants
in response to this PA is also contingent upon the availability
of funds.
 
V. ELIGIBILITY REQUIREMENTS
 
Non-profit organizations and institutions, governments and their
agencies, and occasionally individuals are eligible to apply.
For-profit organizations are also eligible unless specifically
excluded by legislation.  Both domestic and foreign applicants
may apply.  Applications may be submitted from a single
institution or may include arrangements with multiple
institutions (e.g., consortia, clinical cooperative group) if
appropriate.  Applications from minority individuals and women
are encouraged.
 
VI. REVIEW PROCEDURES AND CRITERIA
 
A. REVIEW PROCEDURE
 
Upon receipt, applications will be reviewed initially by the
Division of Research Grants (DRG) for completeness.  Incomplete
applications will be returned to the applicant without further
consideration.  Applications will be assigned on the basis of
established Public Health Service referral guidelines.
Applications will be reviewed for scientific and technical merit
by appropriate peer review groups.
Following peer review, the applications
will receive a second-level review by the appropriate national
advisory council/board.
 
B. 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.
 
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 not but 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 review will be deferred until the information is
provided.
 
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 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.
 
VII.  METHOD OF APPLYING
 
The research grant
application form PHS 398 (revised 10/88) must be used in applying
for these grants and will be accepted at the regular application
deadlines.  These forms are available at most institutional
business offices; from the Office of Grants Inquiries, Division
of Research Grants, National Institutes of Health, Room 449,
Westwood Building, Bethesda, MD 20892; or from the NCI Program
Director named below.  The title and number of this announcement
must be typed in line 2 on the face page of the application.
 
The original application and six (6) signed exact photocopies
must be submitted or delivered to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
IX. INQUIRIES
 
Written or telephone inquiries concerning the objectives and
scope of this PA and inquiries about whether or not specified
proposed research would be responsive are encouraged and should
be directed to the Program Directors, Ms. Diane Bronzert and Dr.
Roy Wu, at the address below.  The Program Directors welcome the
opportunity to clarify any issues or questions from potential
applicants.
 
For Technical Information:              For Business Information:
 
Ms. Diane A. Bronzert or                Ms. Donna Shields
Dr. Roy S. Wu                           Grants Management Specialist
Program Directors                       National Cancer Institute
Cancer Therapy Evaluation Program       EPS, Room 242
Division of Cancer Treatment            Bethesda, MD  20892
National Cancer Institute               Telephone:  (301) 496-7800
EPN, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX #:  (301) 480-4663
 
This program is described in the Catalog of Federal Domestic
Assistance No 93.395, Cancer Treatment Research.  Awards are made
under the authorization of the Public Health Service Act,
Sections 301, 410, and 411 (Public Law 78-410, 42 USC 241 as
amended, Public Law 99-158, 42 USC 285a) and administered under
PHS grant policies and Federal Regulations at 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.
 
$$P3 END ***************************************************************
 
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS
THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.
APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO
FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS.  THE
ADDRESS FOR THE WESTWOOD BUILDING IS:
 
5333 Westbard Avenue
Bethesda, Maryland 20816

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