Full Text DK-93-01

DIABETES ENDOCRINOLOGY RESEARCH CENTERS

NIH GUIDE, Volume 21, Number 35, October 2, 1992

RFA:  DK-93-01

P.T. 04

Keywords: 
  Diabetes 
  Endocrinology 
  Metabolism 
  Biomedical Research, Multidiscipl 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  December 14, 1992
Application Receipt Date:  January 14, 1993

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for funding of one Diabetes Endocrinology
Research Center (DERC) grant to be competitively awarded in Fiscal Year
1994.

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 RFA,
Diabetes Endocrinology Research Centers, is related to the priority
area of diabetes mellitus.  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 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.  Foreign
institutions are not eligible to apply.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of
Health (NIH) grant-in-aid core center (P30) award.  Responsibility for
the planning, direction, and execution of the proposed project will be
solely that of the applicant.  In addition to the requirements stated
in this announcement, awards will be administered under PHS grants
policy as stated in the PHS Grants Policy Statement.

FUNDS AVAILABLE

The NIDDK anticipates awarding one DERC Grant in Fiscal Year 1994 on a
competitive basis.  The receipt of one competing continuation
application is anticipated, which will be in competition together with
the other applications received in response to this announcement.  The
anticipated award will be for five years and will be contingent upon
the availability of appropriated funds.  Requests for support must be
limited to no more than $750,000 in direct costs per year.  Any
application exceeding this amount will be returned to the applicant.

RESEARCH OBJECTIVES

The NIDDK-supported DERCs are part of an integrated program of
diabetes-related research support provided by the NIDDK.  These Centers
have provided a focus for increasing collaboration and cost
effectiveness among groups of successful investigators at institutions
with established comprehensive diabetes research bases.

The objectives of the DERCs are to bring together investigators from
relevant disciplines in a manner that will enhance and extend the
effectiveness of research related to diabetes and its complications.
A Diabetes 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 DERC is to
bring together, on a cooperative basis, clinical and basic science
investigators in a manner that will enrich the effectiveness of
diabetes research.  An existing program of excellence in biomedical
research in the area of diabetes and related metabolic and endocrine
disorders is required.  This research should be in the form of
NIH-funded research projects, program projects, or other peer-reviewed
research that is in existence at the time of submission of a Center
application.  Close cooperation, communication, and collaboration among
all involved personnel of all professional disciplines are ultimate
objectives.  Applicants should consult with NIDDK staff concerning
plans for the development of the Center.

The DERCs are based on the core concept.  Cores are defined as shared
resources that enhance productivity or in other ways benefit a group of
investigators working in diabetes or diabetes-related areas to
accomplish the stated goals of the Center.  Two other types of
activities may also be supported with Center funding---a pilot and
feasibility program and an enrichment program.  The pilot and
feasibility program provides modest support for new initiatives or
feasibility research studies.  This program is directed at new
investigators or investigators established in other research
disciplines, whose expertise may be applied to diabetes research.  The
center grant may also include limited funds for program enrichment such
as seminars, visiting scientists, consultants, and workshops.

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.  In such a case, a letter of agreement from either the GCRC
program director or Principal Investigator should be included with the
application.

STUDY POPULATIONS

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

NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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.  This policy is applicable for
every individual study or project proposed in the application.

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
Sections 1-4 of the Research Plan AND summarized in Section 5, Human
Subjects.  Applicants are urged to assess carefully the feasibility of
including the broadest possible representation of minority groups.
However, the 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, 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.

LETTER OF INTENT

Potential applicants are strongly encouraged to submit a letter of
intent no later than December 14, 1992.  The letter of intent need only
include the names of the Principal Investigator/program director and
principal collaborators, descriptive title of the potential
application, identification of the organization(s) involved, and
reference to the RFA number DK-93-01.  The letter of intent is to be
sent to the Chief, Review Branch, NIDDK at the address noted below.

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 the review of applications.  It
allows NIDDK staff to estimate the potential review workload and to
avoid conflict of interest in the review.

APPLICATION PROCEDURES

Applicants are strongly encouraged to request a copy of "Guidelines for
Diabetes Endocrinology Research Centers."  These guidelines contain
important additional information on the format, content, and review of
applications and review criteria.  Prospective applicants may obtain
guidelines from and may address inquiries to:

Dr. Sanford A. Garfield
Diabetes Centers Program Director
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 626
Bethesda, MD  20892
Telephone:  (301) 496-7418
FAX:  (301) 480-0383

Applications are to be submitted on the form PHS 398 (rev. 9/91)
available at most institutional business offices 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.  On item 2a of the face page of the application,
applicants must enter the RFA title and number.  The RFA label
available in the application form PHS 398 must be affixed to the bottom
of the face page.  Failure to use this label could result in delayed
processing of the application to the extent that it may not reach the
review committee in time for review.

Applications must be received by January 14, 1993.  The original and
three copies of the application must be sent or delivered to:

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

Two additional copies of the application must be sent under separate
cover to:

Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 603
Bethesda, MD  20892

REVIEW CONSIDERATIONS

Upon receipt, applications will be initially reviewed by the Division
of Research Grants (DRG) for completeness.  Incomplete applications
will be returned to the applicant without further consideration.
Evaluation of responsiveness to the program requirements and criteria
stated in this RFA is an NIDDK staff function.

Those applications that are complete and responsive will be evaluated
in competition in accordance with the criteria stated below and in the
DERC Guidelines for scientific/technical merit by an appropriate peer
review group convened by the NIDDK.  It is essential that the written
application be in a form to be reviewed on its own merit, since no
site-visit is anticipated.  Following this review, the applications
will be given a second level review by the National Diabetes and
Digestive and Kidney Diseases Advisory Council.

The initial review group will review each application using the
criteria stated below:

o  Scientific excellence of the Center's research base that must have
a broad and central focus in diabetes and may extend to related
metabolism and endocrinology.  The relevance of the separately funded
research to the DERC and the likelihood for meaningful collaboration
among Center investigators must be demonstrated.

o  Appropriateness and relevance of the cores and their modes of
operation, facilities, and potential for contribution to ongoing
research.  Renewal applications must include the use, utility, quality
control, cost effectiveness, and demonstrated progress of any
developmental research in the shared resources.

o  For new applications, the pilot and feasibility program is judged on
the basis of:  (1) scientific merit of the studies as submitted and (2)
the merit of the administrative process for selecting subsequent
studies.  In competitive renewal applications, emphasis is accorded to
the program as a whole, including past track record and management of
the program.

o  Efficiency and effectiveness of use and/or planned use of enrichment
funds.

o  The scientific and administrative leadership abilities of the DERC
Director and Associate Director and their commitment and ability to
devote adequate time to the effective management of the DERC program.

o  The appropriateness of the DERC budgets for the proposed and
approved work to be done in core facilities, for pilot and feasibility
studies, and for enrichment in relation to the total Center program.

o  Institutional commitment to the program, including lines of
accountability regarding management of the DERC grant and a commitment
to establish new positions as necessary.

o  Enriched academic environment with resources to enable the
activities to be conducted.

o  The institutional commitment to establishing new positions should be
presented.

o  Appropriateness, suitability and integration of research training
and other training programs into the overall Center.

AWARD CRITERIA

Applications will compete for available funds with all other
applications submitted in response to this RFA and recommended by peer
review.  The following will be considered in making funding decisions:

o  Quality of the proposed Center as determined by peer review

o  Availability of funds

o  Overall balance in the DERC program

Schedule

Letter of Intent Receipt Date:   December 14, 1992
Application Receipt Date:        January 14, 1993
Initial Review Dates:            Jun/Jul 1993
Second Level Review Dates:       Sep/Oct 1993
Anticipated Award Date:          December 1, 1993

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues and requests to:

Dr. Sanford A. Garfield
Diabetes Centers Program Director
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 626
Bethesda, MD  20892
Telephone:  (301) 496-7418
FAX:  (301) 480-038

Direct inquiries regarding fiscal matters to:

Ms. Linda Stecklein
Team Leader and Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.847.  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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