Subject: NIH GUIDE - RFA DK-91-11 - V20(22) 06/07/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 07 Jun 91 10:01 EST

Hi Paul,
    # 4 of 4.  Please post to the NIH Listserver as:
    RFADK-91-11.910607
Please call me at 966-5625 as soon as all are posted.  Thanks.
        Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA DK9111 DK-91-11 P1O1 *****************************************
 
DIABETES AND ENDOCRINOLOGY RESEARCH CENTERS
 
RFA:  DK-91-11
 
P.T. 04; K.W. 0715075, 0785050, 0710030
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  January 10, 1992
Application Receipt Date:  February 11, 1992
 
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for Diabetes and Endocrinology Research
Center grants.
 
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), Diabetes and 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, D.C. 20402-9325 (telephone 202-783-3238).
 
BACKGROUND
 
The NIDDK-supported Diabetes and Endocrinology Research Centers (DERCs)
are part of an integrated program of diabetes-related research support
provided by 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.
 
OBJECTIVES AND SCOPE
 
The objective of the DERCs is 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 established investigators in other research disciplines
where their 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 must be included with the
application.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be 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 should 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 should 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 should be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information should be included in the form PHS 398 in Section 2,
A-D of the Research Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors 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 includes 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 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.
 
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 will be 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.
 
MECHANISM OF SUPPORT
 
NIDDK expects to award up to three DERC grants in Fiscal Year 1993 on a
competitive basis.  The receipt of three competing continuation
applications is anticipated that will be in competition with other
applications received in response to this announcement.  Foreign
institutions are not eligible to apply.  Awards will be for five years
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.
 
REVIEW PROCEDURES
 
Applications for a DERC grant will be evaluated by the NIH grant peer
review process.  Applications will be reviewed initially by an ad hoc
review group convened by the NIDDK and subsequently by the National
Diabetes and Digestive and Kidney Diseases Advisory Council.
 
METHOD OF APPLYING
 
Applicants should request a copy of "Guidelines for Diabetes
Endocrinology Research Centers (DERCs)".  These guidelines contain
important additional information on the format, content, and review of
applications and review criteria.
 
Letter of Intent:
 
Potential applicants are strongly encouraged to submit a letter of
intent by January 10, 1992.  The letter of intent may only include names
of the Principal Investigator/program director and principal
collaborators, descriptive title of the potential application, and
identification of the organization(s) involved.  The letter of intent is
to be sent to the Chief, Review Branch, NIDDK at the address noted
below.
 
Format for Application:
 
Applications must be submitted on the form PHS 398 (rev. 10/88)
available at most institutional business offices and from the Division
of Research Grants, NIH, (301) 496-7441.  On item 2 of the face page of
the application, applicants must enter:  Diabetes Centers, RFA number
DK-91-11.  The RFA label available in the current revision of
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.
 
Application Procedures:
 
Applications must be received by February 11, 1992.  The original and
four copies of the application must be sent or delivered to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892
 
Two additional copies of the application under separate cover must be
sent to:
 
Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 406
Bethesda, MD  20892
 
Receipt, Review, and Start Dates:
 
Letter of Intent Receipt Date:  January 10, 1992
Application Receipt Date:  February 11, 1992
Initial Review:  June - July 1992
Council Review:  September - October 1992
Earliest Start Date:  December 1, 1992
 
INQUIRIES
 
Inquiries and requests for guidelines should be directed 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
 
For fiscal and administrative matters, contact:
 
Linda Stecklin
Supervisory Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 639
Bethesda, MD  20892
Telephone:  (301) 496-7467
 
These programs are described in the Catalog of Federal Domestic
Assistance No. 93.847 - Diabetes, Endocrinology and Metabolic Diseases
Research.  Awards will be made under the authority of the Public Health
Service Act, Title III, Section 301 (Public Law 78-4110, as amended:  42
USC 241) and administered under PHS Grants Policies and Federal
Regulations 42 CFR Part 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.