Full Text DK-93-13

DIGESTIVE DISEASES CORE CENTERS

NIH GUIDE, Volume 22, Number 2, January 15, 1993

RFA:  DK-93-13

P.T. 04

Keywords: 
  Digestive Diseases & Disorders 
  Clinical Medicine, General 
  Epidemiology 
  Etiology 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  June 15, 1993
Application Receipt Date:  July 13, 1993

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for Digestive Diseases Core Center
grants.  The NIDDK anticipates the award of three competitive
Digestive Diseases Core Center Grants (P30s) in Fiscal Year 1994.

The Digestive Diseases Core Centers 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.

HEALTHY PEOPLE 2000

The Public Health Service (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 Request
for Applications (RFA), Digestive Diseases Core Centers, is related
to the priority area of diabetes and chronic disabling conditions.
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, DC 20402-9325
(telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic (not foreign) 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.
Minority individuals and women are encouraged to submit as Principal
Investigators.

Applicant institutions must have an adequate base of established
programs of high quality in laboratory and/or clinical digestive
diseases related research.  The quality of the programs must be
evident from the fact that they have been awarded support through
peer reviewed competition, such as NIDDK research project grants
(R01), program project grants (P01), FIRST (R29) awards, cooperative
agreements, and contracts or peer reviewed and funded through other
Federal Agencies or non-federal groups.

MECHANISM OF SUPPORT

Support of this program will be through the NIH core center (P30)
award.  Responsibility for the planning, direction, and execution of
the proposed center will be solely that of the applicant.  Awards
will be administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement.

This RFA is a one-time solicitation.  The receipt of three competing
continuation applications is anticipated.  These applications will
compete for the awards along with other applications received in
response to this RFA.  The total project period for applications
submitted in response to the present RFA may not exceed five years.
The earliest possible award dates will be June 1994 for one center
grant and September 1994 for the other two grants.  Applicants must
limit their requests to not more than $700,000 direct costs for the
initial budget period.  Included in this $700,000 are funds with a
limit of $100,000 for the pilot and feasibility program.  Future
budget period escalations should not exceed a four percent increase
over the previous budget period.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or a Principal Investigator must be included
with the application.

FUNDS AVAILABLE

For FY 1994, up to $2,307,000 in total costs will be committed to
fund applications submitted in response to this RFA.  It is
anticipated that three awards will be made with an average size of
approximately $750,000 per year, total costs; however, this funding
level is dependent upon the receipt of a sufficient number of
applications of high scientific merit.  Although this program is
provided for in the financial plans of the NIDDK, the award of grants
pursuant to this RFA is also contingent upon the availability of
funds for this purpose.

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 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 ultimate objectives.

The Core Centers 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, peptic ulcer disease, pancreatic disease, liver disease, or
pediatric 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.

Digestive Diseases Core Centers are based on the core concept.  Five
or 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 digestive diseases centers to
accomplish the stated goals of the Center.  Examples of such
resources include electron microscope, tissue culture, and
radioimmunoassay facilities.

Centers are encouraged to include a clinical component or core that
deals with patients.  This clinical component can exist as a stand
alone core or part of another core such as the administrative core.
Besides leading to a better understanding of disease etiology and
natural history of disease, such cores might provide biostatistical
support, enhance clinical study design, enhance collaboration among
researchers and recruitment of subjects for clinical studies, provide
for epidemiological studies in areas of digestive diseases or provide
modest funding for tissue, DNA, or serum storage.  In addition, a
clinical or epidemiology core may more effectively address NIH
policies concerning issues of women and ethnic minority 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 but 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, with
subsequent individuals to 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.

SPECIAL REQUIREMENTS

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 significance of the
research base will be determined by the initial review group.

STUDY POPULATIONS

It is NIH policy that women and minorities must be included in
clinical study populations unless there is a good reason to exclude
them.  The study design must seek to identify any pertinent gender or
minority population differences.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are 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 must 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 must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) in Item 4 (Research Design and Methods) of the Research
Plan AND summarized in Item 5, 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 is defined as human
biomedical and behavioral studies of etiology, epidemiology,
pathophysiology, 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.

If the required information is not contained within the application,
the application will be returned without review.

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 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 15, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIDDK staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney Diseases
Westwood Building, Room 605
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7083
FAX:  (301) 402-1277

APPLICATION PROCEDURES

Applications are to be submitted using form PHS 398 (rev. 9/91),
available in the business or grants offices of most academic or
research institutions and from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301)
496-7441.

Administrative Guidelines for Digestive Diseases Research Core
Centers should be requested from the NIDDK program staff listed under
INQUIRIES below.

The RFA label available in the application form must be affixed to
the bottom of the face page.  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 2a of the face page of the
application form and check the YES box.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies, in one package
to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by July 13, 1993.  If an application is
received after that date, it will be returned to the applicant.  The
Division of Research Grants (DRG) will not accept any application in
response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  The DRG 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 previously
reviewed.  Such applications must not only include an introduction
addressing the previous critique but also be responsive to this RFA.

REVIEW CONSIDERATIONS

Upon receipt, applications will be initially reviewed by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NIDDK staff function.  If the application is not responsive
to the RFA, NIDDK staff will contact the applicant to determine
whether it should be returned to the applicant.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.  If
the number of applications is large compared to the number of awards
to be made, a preliminary scientific peer review may be conducted and
applications withdrawn from further competition when they are not
competitive for the award.  The NIDDK will notify the applicant and
institutional official of this action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group specifically convened
for this RFA.  Applications are unlikely to be reviewed by a site
visit team; therefore, the written application must be complete to
facilitate review without a site visit.  Following this review, the
applications will be given a second level review by the National
Diabetes and Digestive and Kidney Diseases Advisory Council unless
not recommended for further consideration by the initial review
group.

Review criteria for RFAs generally include those for unsolicited
research grant applications:

o  scientific, technical, or medical significance and originality of
proposed research;

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  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  if an application involves activities that could have an adverse
effect upon humans, animals, or the environment, the adequacy of the
proposed means for protecting against or minimizing such effects.

Specific review criteria for Digestive Diseases Core Centers include:

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 collaboration 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 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 application's overall strength as a
potential recipient of an award.)

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 on
the list of publications arising from the cores.  At least two users
are required to establish a core.  However, a greater number of users
generally can be evaluated as more cost effective.

o  For new and competing continuation applications, four or five P/F
studies may be submitted for evaluation as part of the review of the
P/F program.

o  In general for new applications, the proposed Pilot and
Feasibility (P/F) projects will be examined to assess:  the
eligibility of the P/F applicant, i.e., whether they fit the three
eligibility categories (1) new investigator, (2) an investigator
bringing a different expertise into digestive diseases, or (3) an
established investigator making a substantial change in direction in
digestive diseases; the reasonableness of the hypothesis; and
scientific and technical feasibility of projects for which funds are
requested.  The P/F program also will be judged as a whole.

o  In addition, in the case of new applications, the P/F studies
should be presented as the Centers' best selection.  The internal
selection process should be described.  In competitive continuation
applications, the P/F studies should have been selected by using the
existing internal evaluation mechanisms.

o  For competing continuation applications, the P/F program also will
be assessed as a whole, including past accomplishments indicated by
publications arising from P/F studies, peer reviewed funded grants
arising from P/F studies, and investigators remaining in academic
research even if they have moved to another research or academic
environment; management of the program; and the general scientific
merit of past, ongoing, and proposed P/F studies as a group.  The
quality of these P/F studies is an indication of how well the
internal selection mechanism has been working.

o  In each case (new and competing continuation), the effectiveness
of the proposed P/F program will be evaluated.  However, in the case
of the competing continuation, the progress of the established
program will also serve as a basis for recommendations concerning the
level at which P/F studies will be supported throughout the grant
award period.

o  The Named New Investigator, when identified in the application,
must be reviewed separately.  The associated pilot study must be
evaluated in a manner similar to the P/F studies in general.  In a
competing continuation application only, the progress of previous
Named New Investigators should also be evaluated:  whether their P/F
projects led to publications, grant awards, and whether the
investigator has remained in digestive diseases related research in
that research environment or elsewhere.

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 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.  The general quality of P/F studies selected for the
application.  These funds are restricted and thus can only be used
for this 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  The institutional commitment to new individuals responsible for
conducting essential Center functions.

o  The institutional commitment to establishing new positions
specifically designed to enhance the operation 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 $100,000), and for enrichment in
relation to the total Center program.  Total Direct Costs are limited
to $700,000 (including the P/F program).  Sometimes the cap may
exceed this amount due to requested indirect costs which are incurred
by contracts.  In the competing continuation applications,
consideration must be taken for reductions instituted in FY 1987 in
accordance with NIDDK administrative policy.  Ongoing Center grants
incurred negotiated budget reductions averaging approximately 20 to
25 percent per year in addition to the Initial Review Group
recommended reductions indicated in the summary statements.

AWARD CRITERIA

The anticipated date of award is June 1994 for one center grant and
September 1994 for the other two center grants.

Applications recommended for approval by the National Diabetes and
Digestive and Kidney Diseases Advisory Council will be considered for
funding on the basis of overall scientific and technical merit of the
research as determined by peer review, program needs and balance, and
availability of funds.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
It is strongly suggested that the pamphlet "Administrative Guidelines
for Digestive Diseases Core Centers" be obtained before an
application is prepared.  Inquiries regarding programmatic issues and
requests for the Administrative Guidelines may be directed to:

Ms. Tommie Sue Tralka
Director, Digestive Diseases Centers Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A15
Bethesda, MD  20892
Telephone:  (301) 496-9717

Inquiries regarding fiscal matters may be directed to:

Ms. Nancy Dixon
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 637A
Bethesda, MD  20892
Telephone:  (301) 496-7467

Schedule

Letter of Intent Receipt Date:  June 15, 1993
Application Receipt Date:       July 13, 1993
Initial Review:                 November 1993
Second Level Review:            February 1994
Anticipated Date of Awards:     June 1994 and September 1994

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.848.  Awards are made 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 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.

.

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