SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS
RELEASE DATE: January 30, 2003
RFA: DK-03-013
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
LETTER OF INTENT RECEIPT DATE: June 11, 2003
APPLICATION RECEIPT DATE: July 11, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE OF THIS RFA
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for Silvio O. Conte Digestive Diseases
Core Center grants. Three competing Digestive Diseases Core Center
Grants (P30) will be awarded in fiscal year 2004.
The Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs)
are part of an integrated program of digestive diseases-related
research support provided by the NIDDK. The Centers currently funded
in this program have provided a focus for increasing collaboration and
improving the cost-effectiveness of supported research among groups of
successful investigators at institutions with an established,
comprehensive digestive diseases research base.
RESEARCH OBJECTIVES
The objective of the Core Centers is to bring together investigators
from relevant disciplines to enhance and extend the effectiveness of
research related to digestive diseases and their complications. A Core
Center must be an identifiable unit within a single university medical
center or a consortium of cooperating institutions, including an
affiliated university. The overall goal of the Core Center is to bring
together clinical and basic science investigators in a manner that will
enrich the effectiveness of digestive diseases research. An existing
program of excellence in biomedical research in the area of digestive
diseases and disorders is required. This research must be in the form
of NIH funded research projects, program projects, or other peer-
reviewed research that is already funded at the time of submission of a
Center grant application. Close cooperation, communication, and
collaboration among all involved personnel of all professional
disciplines are the ultimate objectives.
The Core Center must have a central focus of research investigation.
The central focus must be a digestive disease, group of diseases or
functional studies relating to digestive diseases; at least half of the
research must relate to this central focus. Examples of a
gastrointestinal disease-related central focus of research
investigation include (but are not restricted to) inflammatory bowel
disease, functional bowel disorders, pancreatic disease, liver disease,
pediatric gastrointestinal disease, and AIDS in gastrointestinal
disease. Examples of functional studies as the central focus include
(but are not restricted to) gastrointestinal motility, gastrointestinal
hormones, or gene therapy for digestive diseases. Applicants should
consult with NIDDK staff concerning plans for the development of the
Center and the organization of the application.
Silvio O. Conte Digestive Diseases Research Core Centers are based on
the core concept. Three to six cores are usually included in a Center.
Cores are defined as shared resources that enhance productivity or in
other ways benefit a group of investigators working in a center to
accomplish the stated goals of the Center. Examples of such resources
include imaging resources, transgenic animal, and membrane preparation
facilities.
Centers are encouraged to include a clinical component. This clinical
component can exist as a stand-alone component or as a part of another
core such as the Administrative core. Besides leading to a better
understanding of disease etiology and natural history of disease,
clinical components might provide biostatistics support; enhance
clinical study design; foster collaboration among researchers; aid in
recruitment of subjects for clinical studies; support epidemiological
studies in areas of digestive diseases; or provide modest funding for
tissue, DNA, or serum storage. In addition, a clinical component may
more effectively address NIH policies concerning issues of women,
children, and ethnic minority population participation in clinical
studies.
Two other types of activities may also be supported with Center
funding: a Pilot and Feasibility (P/F) program and an Enrichment
program. The P/F program provides modest support for new initiatives
or feasibility research studies. This program is directed at new
investigators, at investigators established in other research
disciplines with expertise that may be applied to digestive disease
research, and, occasionally, at investigators already working in
digestive diseases who wish to make a substantial change in the
direction of their research. In addition, temporary salary support for
one Named New Investigator in a specified area of research with a
defined P/F study may be requested for up to 24 months. Subsequent
individuals for this position will be named by the Center Director and
approved by the Center's External Advisory Board and the NIDDK.
The Core Center grant may include limited funds for program enrichment
such as seminars, visiting scientists, consultants, and workshops.
MECHANISM OF SUPPORT
This RFA will use the NIH Core Center grant (P30) award mechanism. As
an applicant you will be solely responsible for planning, directing,
and executing the proposed project. This RFA is a one-time
solicitation. The anticipated award date is June 1, 2004 for one
center and September 1, 2004 for two centers.
This RFA uses just-in-time concepts as well as the non-modular
budgeting format.
The receipt of three competing continuation applications is
anticipated. These will compete with all other applications received
in response to this RFA.
FUNDS AVAILABLE
The NIDDK intends to commit approximately $3.5 in FY 2004 to fund 3 new
and/or competing continuation grants in response to this RFA. An
applicant may request a project period of up to 5 years and a budget
for direct costs of up to $750,000 per year. Although the financial
plans of the IC(s) provide support for this program, awards pursuant to
this RFA are contingent upon the availability of funds and the receipt
of a sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic
Foreign institutions are not eligible to apply.
For the purpose of this RFA, the NIDDK will not support more than one
DDRCC center grant (P30) in an applicant institution. More details on
the DDRCC program are available in the SILVIO O. CONTE DIGESTIVE
DISEASES RESEARCH CORE CENTER GUIDELINES available on the Internet at
http://www.niddk.nih.gov/fund/other/centers.htm#digestive or from the
program director listed under INQUIRIES, below.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
o The DDRCC Director, who is the Principal Investigator on the P30
application and Director of the Administrative Core, should be a
scientist who can provide effective administrative and scientific
leadership. The Director will be responsible for the organization and
operation of the DDRCC and for communication with the NIDDK on
scientific and operational matters. Center Directors are required, and
their administrators strongly encouraged, to attend an annual meeting to
be held at a location to be determined by the NIDDK. Funds for travel
to this meeting should be included in the budget for the Administrative
Core of the Center.
o Applications for DDRCC grants must propose a theme for the Center
that is relevant to digestive diseases research and supported by the
research projects comprising the research base for the DDRCC. The
research base grants must be summarized in accordance with the DDRCC
guidelines found at
http://www.niddk.nih.gov/fund/other/centers.htm#digestive
o At least 50 percent of the already funded research base in a new
application must be supported by the NIDDK. In competing continuation
applications the percent may be less than 50 percent due to, for
example, a growing research base of investigators entering digestive
diseases from other fields. The initial review group will determine
the significance of the research base.
o Scientific personnel and institutional resources capable of supporting
the research base must be available. In addition, the institution and
pertinent departments must show a strong commitment to the Center's
support. Such commitment may be provided as dedicated space, staff
recruitment, salary support for investigators, dedicated equipment, or
other financial support for the proposed Center.
o Each core unit proposed for funding under the DDRCC must be
utilized by a minimum of three federally funded research projects.
A detailed description of each core unit proposed as part of the Center
must be provided, with detailed budget and budget justification. A core
director must be named for each core proposed. The description of each
core unit proposed should include a rationale, indicating how it will
support the research effort in a cost-effective manner. Facilities must
be available for the primary needs of the DDRCC Program because funds
for new construction are not available.
o Promoting interdisciplinary collaboration among scientists working
within a Center is a major goal of the DDRCC Program. Each Center
application should describe how continuing and new interactions will be
fostered and encouraged by the DDRCC.
o Another goal of the DDRCC is to attract scientists to the field
of digestive diseases research. Therefore, both a Pilot and
Feasibility (PF) program as well as an Enrichment Program are available
within the DDRCC program.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Judith Podskalny, Ph.D.
Program Director
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 667
Bethesda, MD 20892-5450
Telephone: (301) 594-8876
Fax: (301) 480-3500
Email: jp53s@nih.gov
o Direct your questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
Fax: (301) 480-3505
Email: fc15y@nih.gov
o Direct your questions about financial or grants management matters
to:
Teresa Farris Marquette
Senior Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 728
Bethesda, MD 20892-5456
Telephone: (301) 594-7682
Fax: (301) 480-3504
Email: tm275a@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed center
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel (Associate Directors, Core Directors)
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows NIDDK staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Francisco O. Calvo, Ph.D.
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 752
Bethesda, MD 20892-5452
(Courier use Zip 20817)
Telephone: (301) 594-8897
Fax: (301) 480-3505
Email: fc15y@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS: The 'Silvio O. Conte Digestive Diseases
Research Core Center' guidelines provide more detailed information on
the Centers and on preparing the application. The guidelines are
accessible at
http://www.niddk.nih.gov/fund/other/centers.htm#digestive
or from the program director listed under INQUIRIES.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. 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. The RFA
label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three 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)
At the time of submission, two additional copies of the application and
all appendices must be sent to:
Francisco O. Calvo, Ph.D.
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 752
Bethesda, MD 20892-5452
(Courier use Zip 20817)
Telephone: (301) 594-8897
APPLICATION PROCESSING: Applications must be received by the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
The Center for Scientific Review (CSR) 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 CSR will not accept any application that is
essentially the same as one already 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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and for responsiveness to the RFA by the NIDDK. Incomplete and/or non-
responsive applications will be returned to the applicant without
further consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDDK in accordance with the review
criteria stated below. No site visits are planned in the review of
these applications; all information required for evaluation must be
contained in the application. As part of the initial merit review, all
applications will:
o Receive a written critique
o Undergo a process in which all applications will be discussed and
assigned a priority score
o Receive a second level review by the NIDDK National Advisory Council
or Board.
REVIEW CRITERIA
All applications responding to this RFA will be evaluated according to
the review criteria as outlined in the SILVIO O. CONTE DIGESTIVE
DISEASES RESEARCH CORE CENTER GUIDELINES available on the Internet at
http://www.niddk.nih.gov/fund/other/centers.htm#digestive or from the
program director listed under INQUIRIES, above.
As part of the initial scientific review, which will result in an
overall priority score for the P30 application, reviewers will rate each
individual research core and, if requested, the clinical component. as
well as the P/F program. The evaluation of the Enrichment program will
be reflected in the score for the Administrative Core. The scores for
each of these will appear in the summary statement. The review group
will assign a descriptor, rather than a score, for the research base,
the P/F program, and the Center Director.
Review Criteria
The most important component of a DDRCC is an ongoing, strong base of
digestive disease-related research.
Specific review criteria for Digestive Diseases Research Core Centers
are:
o the scientific excellence of the Center's research base (its
strengths, its breadth and depth) as well as the relevance and
interrelation of these separately funded research projects to the
central theme(s) or focus of the Center and the likelihood for
meaningful collaborations among Center investigators. The existence of
a base of established, independently supported biomedical research of
high quality is a prerequisite for the establishment of a Digestive
Diseases Research Core Center and is the most important component of
the review. The results of previous peer reviews of its content will
weigh heavily in the assessment of the application's overall strength.
o the qualifications, experience, and commitment of the Center
investigators responsible for the individual research projects, and
their willingness to interrelate with each other and contribute to the
overall objectives of the Digestive Diseases Core Center.
o the appropriateness and relevance of the proposed Cores and their
modes of operation (such as how usage will be prioritized), facilities,
and potential for contribution to ongoing research. Competing
continuation applications must document the use, utility, quality
control, and cost effectiveness of each Core requested to continue as
part of the Center. Progress will be judged in part by the list of
publications arising from the cores. At least two users are required
to establish a core. However, a greater number of users will be
considered to be more cost effective.
o for all applications, four P/F studies should be submitted for
evaluation as part of the review of the P/F program. In general for
new applications, the proposed P/F projects will be examined to assess
the eligibility of the P/F applicant and the adequacy of the selection
process by which the individual studies were selected. Applicants
should refer to the Administrative Guidelines for DDRCCs for specific
details regarding the P/F program and its review by the IRG.
o the Named New Investigator, if requested, will be considered
separately.
o the scientific and administrative leadership abilities of the
proposed Center Director and Associate Director and their commitment
and ability to devote adequate time to the effective management of the
program.
o the administrative organization proposed for the following:
(a) Coordination of ongoing research between the separately funded
projects and the Center, including mechanisms for internal monitoring;
(b) Establishment and maintenance of internal communication and
cooperation among the Center investigators;
(c) Mechanism for selecting and replacing professional or technical
personnel within the Core Center;
(d) Mechanism for reviewing the use of and administering funds for the
P/F program;
(e) Management capabilities that include fiscal administration,
procurement, property and personnel management, planning, budgeting,
and other appropriate
capabilities;
o The institutional commitment to the program, including lines of
accountability regarding management of the Center grant and the
institution's contribution to the management capabilities of the
Center;
o The academic environment and resources in which the activities will
be conducted, including the availability of space, equipment,
facilities, and the potential for interaction with scientists from
other departments and institutions;
o Efficient and effective use and/or planned use of the limited
enrichment funds, including the contribution of these activities in
enhancing the objectives of the Center;
o The appropriateness of the budgets for the proposed and approved
work to be done in Core facilities, for P/F studies (these are
restricted funds and are capped at $150,000), and for enrichment in
relation to the total Center program.
Total requested Direct Costs are limited to $750,000 (including the P/F
program). For competing continuation applications, total requested
Direct Costs should not exceed the $750,000 cap.
In addition to the criteria stated above, in accordance with NIH policy,
all applications will be reviewed with respect to the following:
o The adequacy of plans to include children, both genders, minorities,
and their subgroups, 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 size and duration in
relation to the proposed DDRCC.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 11, 2003
Application Receipt Date: July 11, 2003
Peer Review Date: November 2004
Council Review: January 2004
Earliest Anticipated Start Date: June 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o relevance to research areas of high programmatic interest to the
Division of Digestive Diseases, NIDDK and research areas targeted by
Congress;
o availability of funds
o geographic distribution
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research
components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures. In
addition, it is NIH policy that all clinical trials require data and
safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-sponsored clinical research
projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_
2001.htm. The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance
with the new OMB standards; clarification of language governing NIH-
defined Phase III clinical trials consistent with the new PHS Form 398;
and updated roles and responsibilities of NIH staff and the extramural
community. The policy continues to require for all NIH-defined Phase
III clinical trials that: a) all applications or proposals and/or
protocols must 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) investigators must
report annual accrual and progress in conducting analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy 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 is available at
https://grants.nih.gov/grants/funding/children/children.htm.
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. You will find this policy announcement in the
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the Human
Embryonic Stem Cell Registry will be eligible for federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s) for the hESC line(s) to be used
in the proposed research. Applications that do not provide this
information will be returned without review.
Because P30 funds do not directly support research projects, the issues
of minority/gender representation, inclusion of children as participants
in research involving human subjects, required education on the
protection of human subject participants, and the use of human embryonic
stem cells will have been addressed at the individual project level
(i.e., R01 level). However, the application must specifically address
these issues for any P/F projects or cores as appropriate.
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
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA 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.
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. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
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 RFA 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.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.848, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. 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 described
at https://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the 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.