Full Text PA-97-049
 
EXPLORATORY STUDIES FOR HIGH RISK/HIGH IMPACT RESEARCH
 
NIH Guide, Volume 26, Number 10, March 28, 1997
 
PA NUMBER:  PA-97-049 (see PA-03-100)
 
P.T. 34

Keywords: 
  Biomedical Research, Multidiscipl 
  Biology, Cellular 
  Biotechnology 
  Biochemistry 
  Instrumentation, Scientific 

 
National Institute of General Medical Sciences
 
PURPOSE
 
The purpose of this initiative is to broaden the base of inquiry in
fundamental biomedical research by encouraging applications for
research projects that involve an especially high degree of
innovation and novelty and, therefore, require a preliminary test of
feasibility.  The research projects proposed under this program
announcement may involve substantial experimental risks such that
their potential for highly significant outcomes may be difficult to
judge by the standard criteria used in evaluating R01 proposals.  The
amount awarded for each of these pilot projects will be lower than
that awarded for the average research project (R01) grant.  New
applications will be accepted under this program announcement on the
regular application receipt deadlines:  February 1, June 1 and
October 1.
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign, domestic, for-profit and
non-profit organizations, both public and private, such as
universities, colleges, hospitals, laboratories, units of state and
local governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
 
MECHANISM OF SUPPORT
 
Research projects will be supported with the
exploratory/developmental research grant mechanism (R21).  Applicants
may request up to two years of support and up to $70,000 per annum in
direct costs.  The award is non-renewable.  If desired,  the specific
aims of the R21 project may be incorporated into a research project
grant application (R01) submitted prior to the termination of the R21
award.
 
RESEARCH OBJECTIVES
 
The National Institute of General Medical Sciences (NIGMS) seeks to
encourage fundamental research projects that fall into the following
classes: projects to test novel and significant hypotheses for which
there is scant precedent or preliminary data and which, if confirmed,
would have a substantial impact on current thinking; projects to
explore a new experimental organism or system in order to address
particularly difficult basic biomedical questions for which the new
system would be particularly advantageous; and projects to develop
innovative techniques or methodologies with wide applicability to the
study of basic biomedical problems.
 
The projects must support the NIGMS mission as detailed in the
publication, "Divisions and Grant Award Mechanisms," available from
the NIGMS Public Information Office (301/496-7301); additional
information can be found on the NIGMS World Wide Web home page at
http://www.nih.gov/nigms/.  In brief, NIGMS supports research in (a)
cell biology and molecular biophysics, including basic studies of the
structure and function of cells, cellular components, and the
biological macromolecules that make up these components;  (b)
fundamental mechanisms of inheritance and development that typically
utilize non-human model systems; (c) basic studies in pharmacology,
physiology,  biochemistry, biorelated chemistry and anesthesiology;
(d) basic studies in biotechnology, including biocatalysis and
metabolic engineering; (e) bioengineering, including instrumentation
development and refinement and development of bioanalytical methods
and biomaterials; and (f) trauma and burn injury.
 
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 is 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, Volume 23, Number 11,
March 18, 1994.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95).  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.
 
The title and number of this program announcement must be typed in
Section 2 on the face page of the application.
 
The completed original application and five legible copies must be
sent or delivered to:
 
OFFICE OF GRANTS INFORMATION
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)
 
REVIEW CONSIDERATIONS:
 
Applications will be assigned on the basis of established Public
Health Service referral guidelines.  Applications will be reviewed
for scientific and technical merit by an appropriate Initial Review
Group of the Division of Research Grants.  Following the initial
scientific-technical review, the applications will receive a
second-level review by the appropriate National Advisory Council.
 
REVIEW CRITERIA
 
o  scientific, technical, or medical significance and originality of
proposed research
 
o  prospects for the demonstration of feasibility, given a modest
budget and term of award;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  adequacy of plans to include both genders and minorities and their
subgroups for the scientific goals of the research;
 
o  availability of the resources necessary to perform the research.
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
 
The initial review group also will examine the provisions for the
protection of human and animal subjects, the safety of the research
environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions:
 
o  the quality of the proposed project as determined by peer review;
o  the availability of funds;
o  other research funding available to the applicant;
 
The following additional factor will be considered for applications
assigned to the NIGMS:
 
o  potential for ground-breaking, precedent setting significance of
the proposed research, with particular emphasis on novel and
innovative approaches that clearly require additional preliminary
data for their value to be established.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Dr. James C. Cassatt
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone: (301) 594 0828
FAX: (301) 480-2004
email:  czj@cu.nih.gov
 
Dr. Judith Greenberg
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594 0943
FAX:  (301) 480-2228
email:  greenbej@gm1.nigms.nih.gov
 
Dr. Michael E. Rogers
Division of Pharmacology, Physiology and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594 3827
FAX: (301) 480-2802
email:  rogersm@gm1.nigms.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Ms. Carol Tippery
Grants Management Office
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5135
FAX:  (301) 480-1969
email:  tipperyc@gm1.nigms.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Numbers 93.821, 93.859, and 93.862.  Awards are made under
authorization of the Public Health Service Act, as amended  and
administered under PHS grants 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.
 
The PHS 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, and
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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