This Program Announcement expires October 1, 2004 unless reissued.
INNOVATIVE AND EXPLORATORY RESEARCH IN DIGESTIVE DISEASES AND NUTRITION
Release Date: August 20, 2001
PA NUMBER: PA-01-129
National Institute of Diabetes and Digestive and Kidney Diseases
(http://www.niddk.nih.gov)
PURPOSE
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398
(REVISION 5/2001) AVAILABLE AT
http://grants.nih.gov/grants/funding/phs398/phs398.html.
PURPOSE
The Division of Digestive Diseases and Nutrition at the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications
through the exploratory/developmental (R21) grant mechanism from
investigators with research interests in gastroenterology, hepatology,
obesity and nutrition and that serve the mission of NIDDK. The aim of this
program announcement is to stimulate the application of highly novel
approaches to important areas of digestive disease and nutrition research.
This mechanism is primarily aimed at attracting and supporting new
investigators in these research fields. Clinical or epidemiological research
will not be supported through this Program announcement and should be
submitted according to PAR-01-056
(http://grants.nih.gov/grants/guide/pa-files/PAR-01-056.html).
Applications will be accepted only from (1) newly
independent investigators or (2) established investigators developing a
completely new line of research. Results obtained from the R21 grant should
allow subsequent submission of R01 applications focusing on research problems
relevant to the study of digestive diseases and nutrition. These grants are
not intended to support or supplement ongoing funded research of an
established investigator, or to serve as an alternative mechanism of support
for projects not receiving funding as competitive continuation applications.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a PHS
led national activity for setting priority areas. This Program Announcement
(PA), Title of PA, is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
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. Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as principal investigators.
Furthermore, this mechanism is for the support of either new investigators
[defined as independent investigators who have NOT yet held R01, R29, or
subprojects of program project (P01) or center grants (P50) or equivalent],
or established investigators entering a new research field or developing a
completely new line of research. NIDDK K08 and K23 recipients, who are
eligible for R03 grants
(http://grants.nih.gov/grants/guide/pa-files/PAR-01-066.html)
are encouraged to utilize that mechanism of support. Receipt of a
K-associated R03 does not preclude the subsequent submission of an
application for this R21 program.
MECHANISM OF SUPPORT
This program will be supported through the exploratory/developmental grant
(R21) mechanism. This provides short-duration support for preliminary
studies of a highly speculative or innovative nature which are expected to
yield, within the 2 year time frame, sufficient information upon which to
base a well-planned and rigorously defined series of further investigations.
Projects will be limited to $100,000 direct costs per year and are limited to
two years duration. These grants will not be renewable, competing
continuation applications will not be accepted. Continuation of projects
developed under this program will be through the regular research grant
mechanism (for example, R01).
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant. The NIH Grants policy
statement applies to these awards. Submission of an application under this PA
precludes concurrent submission of any other Public Health Service
application containing substantially the same research proposal. In
addition, these R21 awards may not be used to supplement research projects
currently supported by Federal or non-Federal funds, or to provide interim
support of projects under review by the Public Health Service.
RESEARCH OBJECTIVES
Areas of special interest in this PA include but are not limited to:
o Identification of novel signaling molecules and pathways involved in
cellular and tissue development, differentiation, gene transcription, and
function of the gastrointestinal tract, exocrine pancreas, liver and
adipocytes.
o Identification and characterization, isolation of gastrointestinal,
pancreatic and hepatic stem cells. Identification and characterization the
differentiation factors and processes determining gastrointestinal,
pancreatic and adipose stem cells development into mature tissues and its
potential uses as therapeutic alternatives.
o Characterization of gastrointestinal neuroendocrine cell and enteric
nervous system and their role in gastrointestinal motility and nutrient
absorption. Nutrient-gene interaction and gene expression regulation.
o Gastrointestinal, hepatic, and pancreatic cell regeneration and adaptive
responses to to aging and injury mechanisms. The role of telomers and
telomerase activity in tissue regeneration, dysplasia and aging in the
setting of chronic injury and carcinogenesis.
o Development, characterization and utilization of novel cellular and animal
models of gastrointestinal, pancreatic and hepatic diseases.
o Development of biological markers for staging and prognosis in diseases
such us celiac disease, pancreatitis, colitis, immune and viral hepatitis,
obesity and nonalcoholic steatohepatitis (NASH).
o Development of novel vectors and delivery systems for use in gene therapy
of gastrointestinal, pancreatic, hepatobiliary and nutritional diseases.
o Development of new methods for temporal and spatial control of transgene
expression in gastrointestinal, pancreatic, hepatic and adipose
tissues/cells. High output characterization of gene expression and function
from parenchymal and epithelial cells under physiological and pathological
conditions, using microarrays, proteomics, RNA interference, differential
display reverse transcriptase-polymerase chain reaction.
o Identification of genes involved in susceptibility, phenotypic variation
or response to therapy of gastrointestinal, hepatobiliary and pancreatic
diseases or animal models of these diseases.
o Development of animal and in vitro cellular models and test systems to
investigate the mechanisms of drug-induced liver disease and explore
innovative preventive and therapeutic interventions (replenishment of GSH or
chaperon molecules) during acute episodes, or as preventive measures in
situation of high hepatotoxic potential (chemotherapies)or prior to liver
collection of transplant.
o Development of novel non invasive imaging methods to study function of the
gastrointestinal tract, liver, pancreas and adipose tissue and pathogenic
processes such as fibrosis, inflammation, hyperplasia, fat body accumulation.
o Elucidation of the pathogenesis of digestive and nutritional diseases of
unknown or poorly defined cause, such as celiac disease, ulcerative colitis,
Crohn’s disease, childhood motility disorders, functional bowel disease,
chronic idiopathic pancreatitis, primary biliary cirrhosis, sclerosing
cholangitis, autoimmune hepatitis, biliary atresia and childhood cholestatic
liver diseases.
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 sub-populations 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 indicating 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
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable, and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is found in the NIH Guide for Grants and
Contracts Announcement dated June 5, 2000, at the following website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev. 5/2001)
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in
applying for these grants and will be accepted at the standard application
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the
application kit. This version of the PHS 398 is available in an interactive,
searchable PDF format. Although applicants are encouraged to begin using the
5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to
accept applications prepared using the 4/1998 revision until January 9, 2002.
Beginning January 10, 2002, however, the NIH will return applications that
are not submitted on the 5/2001 version. For further assistance contact
GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov.
All application instructions outlined in the PHS 398 application kit are to
be followed, with the following modifications:
1. Applicants MUST cite the Program Announcement number on line 2 of the
application. Applicants are strongly urged to contact the Program Directors
listed in the INQUIRIES section prior to submission of a application, for
advice about eligibility and responsiveness.
2. R21 applications will use the MODULAR GRANT and JUST-IN-TIME
concepts, with direct costs requested in $25,000 modules, up to the total
direct costs limit of $100,000 per year.
3. Although preliminary data are not required for an R21 application, they
may be included.
4. Sections a-d of the Research Plan may not exceed 15 pages, including
tables and figures.
5. Appendix materials should be limited, as is consistent with the
exploratory nature of the R21 mechanism, and should not be used to circumvent
the page limit for the research plan. Copies of appendix material will only
be provided to the primary reviewers of the application and will not be
reproduced for wider distribution. The following materials may be included
in the appendix:
o Up to five publications, including manuscripts (submitted or accepted for
publication), abstracts, patents, or other printed materials directly
relevant to the project. These may be stapled as sets.
o Surveys, questionnaires, data collection instruments, and clinical
protocols. These may be stapled as sets.
o Original glossy photographs or color images of gels, micrographs, etc.,
provided that a photocopy (may be reduced in size) is also included within
the 15 page limit of items a-d of the research plan.
Include five collated sets of all appendix material, in the same package with
the application, following all copies of the application. Identify each item
with the name of the principal investigator.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award. It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers
and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in
applying for these grants, with modular budget instructions provided in
Section C of the application instructions. Applicants are permitted,
however, to use the 4/1998 revision of the PHS 398 for scheduled application
receipt dates until January 9, 2002. If you are preparing an application
using the 4/1998 version, please refer to the step-by-step instructions for
Modular Grants available at
http://grants.nih.gov/grants/funding/modular/modular.htm. Additional
information about Modular Grants is also available on this site.
The title and number of the program announcement 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 five signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
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 PHS referral
guidelines. Applications will be evaluated for scientific and technical
merit by an appropriate scientific review group convened in accordance with
the standard NIH peer review procedures. As part of the initial merit
review, all applications will receive a written critique and undergo a
process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under review, will
be discussed, assigned a priority score, and receive a second level review by
the appropriate national advisory council or board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Frank Hamilton, M.D., M.P.H.
Branch Chief
Gastrointestinal Motility Program Director,
Gastrointestinal Mucosa and Immunology Program Director,
AIDS Program Director
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 627
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Telephone: (301) 594-8877
Fax: (301) 480-8300
Email: fh14e@nih.gov
Michael Ken May, Ph.D.
Gastrointestinal Neuroendocrinology Program Director,
Gastrointestinal Transport and Absorption Program Director
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 627
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Telephone: (301) 594-8884
Fax: (301) 480-8300
Email: mm102i@nih.gov
Jose Serrano M.D., Ph.D.
Director Liver and Pancreas Programs
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 627
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Telephone: (301) 594-8871
Fax: (301) 480-8300
Email: js362q@nih.gov
Susan Yanovski M.D.
Obesity and Eating Disorders Program,
National Task Force on the Prevention and Treatment of Obesity
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 627
6707 Democracy Boulevard
Bethesda, MD 20892-5458
Telephone: (301) 594-8882
Fax: (301) 480-8300
Email: sy29f@nih.gov
Direct inquiries regarding fiscal and administrative matters to:
Donna A. Huggins
Division of Extramural Activities
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza Room 711
6707 Democracy Blvd
Bethesda, MD 20892-5458
Telephone: (301) 594-8848
FAX: (301) 480-3504
Email: dh48v@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.849. Awards are made under authorization of sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and administered
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. 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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