and Human Services (HHS)
EXPIRED
BETA CELL BIOLOGY CONSORTIUM (U01)
RELEASE DATE: June 21, 2004
RFA Number: RFA-DK-04-018 (Reissued as RFA-DK-09-011)
(see addendum NOT-DK-04-016)
EXPIRATION DATE: November 20, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.847
LETTER OF INTENT RECEIPT DATE: October 19, 2004
APPLICATION RECEIPT DATE: November 19, 2004
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 Supplementary Instructions
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 invite
new U01 applications to participate in a consortium of investigators and
institutions, the Beta Cell Biology Consortium
(BCBC); http://www.betacell.org. The BCBC will work collaboratively to
generate resources that will facilitate research to 1) understand how
endogenous beta cells are made by studying pancreatic development, with the
hope of making pancreatic islets in culture 2) explore the potential of
animal and/or human stem cells (embryonic or adult; if human embryonic, only
NIH approved hES cell lines may be used) as a source for making pancreatic
islets, and 3) determine the basic mechanisms underlying beta cell
regeneration in the adult as a basis for producing new cellular therapies for
diabetes. The BCBC will be responsible for collaboratively generating
necessary reagents, mouse strains, antibodies, assays, protocols, and
technologies that are beyond the scope of any single research effort.
RESEARCH OBJECTIVES
Background
Type 1 and type 2 diabetes result from the anatomical or functional loss of
insulin-producing beta cells of the pancreas. Replacement of these cells
through transplantation could offer lifelong treatment for diabetes. A major
obstacle in implementing treatment is the lack of sufficient islet cell
tissue for transplantation. The generation of an alternative source of
pancreatic islet cells derived from human stem/progenitor cells (adult or
embryonic) could provide a limitless source of islet cells for
transplantation therapies.
The Beta Cell Biology Consortium (BCBC), is a basic science consortium of
cooperative agreements that originated in 2001 through an RFA DK-01-014
http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-014.html
In addition to investigator initiated research projects, consisting of 5 U19s
and 1 U01, the BCBC supports an administrative infrastructure located at
Vanderbilt University that oversees collaborative research cores designed to
coordinate efforts in creating key research tools that will support studies
in pancreatic development and function (http://www.betacell.org). These resources
were created to substantially accelerate efforts to efficiently differentiate
animal and human embryonic and adult stem cells into pancreatic
progenitor/islet tissue appropriate for transplantation.
The BCBC was created in 2001 by RFA DK-01-014 as a direct response to
recommendations of the Congressionally-established Diabetes Research Working
Group http://www.niddk.nih.gov/federal/dwg/dwgsummary.htm that developed a
strategic plan for research in diabetes. Two of the extraordinary research
opportunities recommended by the plan were to increase basic research
opportunities on the control and regulation of islet cell differentiation,
growth and development and to create interdisciplinary centers for Beta
Cell Biology to expand current efforts and bring new investigators into the
field .
At a May 2002 NIH advisory committee meeting on the Use of Special
Congressional Funds for Type 1 Diabetes Research, the advisory panel
emphasized continued investment in cellular therapy as a high priority
http://www.niddk.nih.gov/federal/planning/type1_specialfund/
A companion RFA, RFA-DK-04-017, will request new and competing U19 grants.
The BCBC will be comprised of awardees from RFA-DK-04-017 and RFA-DK-04-018, as
well as the existing BCBC Coordinating Center located at Vanderbilt
University and an existing U01 at the University of Pennsylvania (U01
DK056947). A U01 is a single project similar to an R01, and can have
multiple collaborators. A U19 is composed of at least 3 subprojects and 1 or
more cores similar to a P01.
Research objectives
This RFA is intended to provide support for new U01 projects for the BCBC,
focusing on research to understand the control and regulation of pancreatic
development, as well as islet cell growth and regeneration through the
generation of necessary resources and approaches. Major scientific advances
and technological breakthroughs in basic disciplines such as developmental
biology, stem cell biology, mouse genetics, and bioinformatics demand that a
multifaceted, interdisciplinary, coordinated and collaborative approach on
several fronts be utilized to generate key reagents, assays and new
strategies for the development of novel cellular therapies in diabetes.
Therefore, at least 50% of the application should be directly related to the
generation of these novel resources and approaches, which could include
development of new assays or protocols, development of new animal models,
and/or application of a new technology. Research objectives should be focused
on at least one of the three targeted scientific goals described below: Beta
Cell Development, Beta Cell Regeneration, and/or Stem Cell Biology.
Beta Cell Development
A goal of this RFA and the BCBC is to understand the developmental pathways
required to produce a fully functioning pancreatic islet.
Areas of emphasis may include but are not restricted to:
o Characterizing sets of specific mouse strains for genes that would mark
specific cell lineages in the pancreas and/or regulate fate decisions within
the organ. New mouse strains should be created through coordination with the
BCBC Mouse ES and Transgenic Core (http://www.betacell.org/php/cc.php);
o Characterizing poly- and monoclonal antibodies to cell surface antigens to
define critical stages of pancreas development, including cell-specific
antibodies that would delineate stem/progenitor cells of the pancreas and be
useful for purification of these cells. New antibodies should be developed
through coordination with the BCBC Antibody Core
(http://www.betacell.org/php/cc.php);
o Discovering mechanisms that control pancreatic cell fate decisions using
classical vertebrate embryology;
o Identifying mesenchymal signals that promote pancreatic growth;
o Identifying the signals that regulate the temporal differentiation of islet
cells during normal endocrine development;
o Identifying the signals that support islet cell morphogenesis, growth,
function and survival;
o Combining molecular and computational approaches to identify the
transcriptional networks that regulate pancreatic development.
Beta Cell Regeneration
A goal of this RFA and the BCBC is to understand the mechanisms of beta cell
regeneration in the adult animal and human islet.
Areas of emphasis may include but are not restricted to:
o Determining the factors important for beta cell regeneration and designing
strategies to foster regeneration;
o Developing new animal models, such as non-human primates transplanted with
human islets that can be used to identify exogenous or endogenous factors
that might promote beta cell regeneration or neogenesis;
o Characterizing the lineage of cells that may contribute or participate in
beta cell regeneration by genetic marking;
o Developing assays to screen chemical libraries for modifiers of beta cell
regeneration, differentiation, and/or expansion.
Stem Cell Biology
A goal of this RFA and the BCBC is to understand the nature of
stem/progenitor cells during normal pancreatic development and in the adult
pancreatic islet.
Areas of emphasis may include but are not restricted to:
o Characterizing pancreatic stem/progenitor cells during normal development;
o Providing genetic evidence for stem/progenitor cells in the adult pancreas;
o If pancreatic stem cells exist in the adult, designing strategies to foster
development into new endocrine cells in vivo;
o Comparing different sources of human pancreatic progenitor cells at the
molecular level;
o Using existing NIH-approved human ES cell lines or mouse embryonic cells to
efficiently generate endoderm, pancreatic progenitor cells, or differentiated
beta cells in culture;
o Developing clonogenic assays for quantitatively assessing the efficacy of
new cellular replacement therapies.
MECHANISM OF SUPPORT
This RFA will use the NIH U01 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
July 31, 2005.
Follow the instructions for non-modular budget research grant applications.
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
The NIH U01 is a cooperative agreement award mechanism. In the cooperative
agreement mechanism, the Principal Investigator retains the primary
responsibility and dominant role for planning, directing, and executing the
proposed project, with NIH staff being substantially involved as a partner
with the Principal Investigator, as described under the section "Cooperative
Agreement Terms and Conditions of Award". Continuation of the cooperative
agreement project beyond the initially award period of performance will
require an RFA or other announcement.
FUNDS AVAILABLE
The NIDDK intends to commit approximately $2.5 million in FY 2005 to fund 3-5
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 $500,000 per year.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the NIDDK 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(s) 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 or foreign institutions/organizations
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.
A Principal Investigator may apply for either a U01 or a U19 (RFA-DK-04-017),
but not both.
SPECIAL REQUIREMENTS
To promote the development of a collaborative program among the award
recipients, the Principal Investigator is expected to attend BCBC Steering
Committee meetings twice a year. A major goal of these meetings is to
facilitate progress by providing a forum that will lead to sharing skills,
ideas, technology, data, and biological reagents. At the meetings,
participants will discuss quality assurance, bioinformatics, coordination,
sharing, and a means of informing the community about progress made by the
Consortium. Funds should be requested to attend Steering Committee meetings
as well as other collaborative meetings of the BCBC.
During the course of the funding period, technologies will improve and the
rate of progress and scope of the research may change. It is expected that
the Principal Investigators, in consultation with NIDDK program staff, will
make necessary adjustments to accommodate the changing research environment,
to remain focused on appropriate goals, to maintain excellent coordination
with the other projects funded under this RFA and the RFA-01-017, and to
incorporate new technological advances.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
Data and Reagent Sharing:
All applications submitted through this announcement and the companion
RFA (RFA-DK-04-017) must include technology transfer and sharing plans for both
data and unique research resources that are generated by the projects in
concordance with the BCBC policies
http://www.betacell.org/php/about.php#policies. It is expected that
resources developed by the BCBC will be made available to the broader
scientific community, after a propriety period agreed upon by the Steering
Committee, at no charge other than the cost of reproduction and distribution.
Applicants must indicate their willingness to distribute research tools to
the wider community including antibodies, transgenic mouse strains, mouse ES
cell lines, and other reagents. A distribution plan should be included.
Likewise the applicants must describe their willingness to submit microarray
data generated through this project, if applicable, to EPConDB
http://www.betacell.org/php/epcondb.php and other pertinent information about
research resources generated through this U01 to the BCBC Coordinating Center
(http://www.betacell.org).
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF THE AWARD
A. Applicability
These special Terms of Award are in addition to and not in lieu of otherwise
applicable OMB administrative guidelines, HHS Grant Administration
Regulations at 45 CFR Parts 74 and 92, and other HHS and NIH Grant
Administration policy statements.
The administrative and funding instrument used for this program is a
cooperative agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during performance
of the activity.
Under the cooperative agreement, the NIH purpose is to support and/or
stimulate the recipient's activity by involvement in and otherwise working
jointly with the award recipient in a partner role, but it is not to assume
direction, prime responsibility, or a dominant role in the activity.
Consistent with this concept, the dominant role and prime responsibility for
the activity resides with the awardee for the project as a whole, although
specific tasks and activities in carrying out the studies will be shared
among the awardees and the NIDDK Project Scientist or designee.
Under the cooperative agreement, a relationship will exist between the
recipient of these awards and the NIDDK, in which the performers of the
activities are responsible for the requirements and conditions described
below, and agree to accept program technical assistance, advice and/or other
coordination above and beyond normal program stewardship from a named NIDDK
Project Scientist in achieving the project objectives.
Failure of an awardee to meet the performance requirements, including these
special terms and conditions of award, or significant changes in the level of
performance, may result in a reduction of budget, withholding of support,
suspension and/or termination of the award.
B. Awardee Rights and Responsibilities
The Awardee is a member of the Beta Cell Biology Consortium (BCBC) and is
responsible for:
o Defining objectives and approaches, and planning, conducting, analyzing,
and publishing results, interpretations, and conclusions of studies conducted
under the terms and conditions of the cooperative agreement award;
o Conducting the research supported by the project in accordance with the
terms and conditions of the award;
o Participating as a permanent, voting member(s) of the Steering Committee as
described below;
o Contributing to and implementing the goals, priorities, procedures, and
policies agreed upon by the Steering Committee;
o Coordinating and cooperating with the other components of the BCBC and with
the NIDDK staff;
o Contributing to BCBC Core resources and serving on BCBC subcommittees as
needed;
o Sharing both data and unique research resources that are generated by the
projects in concordance with the BCBC policies;
o Awardees will retain custody of, and have primary rights to, the data
developed under these awards, subject to Government rights of access
consistent with current HHS and NIH policies.
C. NIDDK Staff Responsibilities
An NIDDK Program Director identified in the Notice of Grant Award will be
responsible for the normal stewardship and monitoring of the award and will
serve as the NIDDK Project Scientist.
The NIDDK Project Scientist will have substantial scientific-programmatic
involvement during conduct of this activity, through technical assistance,
advice and coordination. The dominant role and primary responsibility for
the activity resides with the awardees for the project as a whole, although
specific tasks and activities in carrying out the studies will be shared
among the awardees and the NIDDK Project Scientist.
An NIDDK Project Scientist will have substantial involvement in the project
above and beyond normal stewardship and monitoring of the award, as described
below:
o Being a voting member of the Steering Committee and, as determined by that
committee, its subcommittees;
o Being the contact point for all facets of the scientific interaction with
awardee(s). As required for the coordination of activities and to expedite
progress, NIDDK may designate additional NIDDK staff to provide advice to the
awardee on specific scientific issues;
o Serving as a resource with respect to other ongoing NIDDK activities that
may be relevant to the research of the BCBC in order to facilitate
compatibility and avoid unnecessary duplication of effort.
Responsibilities as NIDDK Program Director:
o Retaining overall programmatic responsibility for the award, and will
clearly specify to the awardee the name(s) and role(s) of any additional
individuals with substantial involvement in the project and the lines of
reporting authority;
o Interacting with the Principal Investigator (s) on a regular basis to
monitor research progress. Monitoring may include: regular communications
with the Principal Investigator and staff, periodic conference calls for
discussions with awardee research teams, quality control, fiscal review, and
other relevant matters; as well as attendance at Steering Committee meetings,
External Advisory Board Meetings, and related meetings. The NIDDK retains,
as an option, periodic external review of progress;
o Reviewing and approving applications of the Pilot and Feasibility Program
to insure that they are within the scope of peer review and NIH guidelines;
o Making recommendations for continued funding based on: a) overall research
progress, b) cooperation in carrying out the research (e.g. attendance at
Steering Committee meetings, implementation of group decisions, compliance
with the terms of award, and c) maintenance of a high quality of research,
which will allow pooling of data and comparisons across multiple cooperative
agreement awards for common data elements.
D. Joint Responsibilities
BCBC Steering Committee
o The Steering Committee will be composed of the Principal Investigator from
each U01 project, 2 members from each U19 project (the Principal Investigator
and co-Investigator), and the NIDDK Project Scientist. Each member of the
Steering Committee will have one Steering Committee vote. The chairperson
will be someone other that the NIDDK Project Scientist, and will be selected
by NIDDK.
o The Steering Committee has primary responsibility to establish priorities,
develop common protocols, and review progress. The Steering Committee will
refine the BCBC scientific objectives consistent with progress in the BCBC
components and other laboratories. Major scientific decisions regarding BCBC
core data and resources, as well as setting scientific priorities for special
programs such as the Pilot and Feasibility Program
(http://www.betacell.org/php/cc.php) will be determined by the Steering
Committee. The Steering Committee will document progress in written reports
to the NIDDK Program Director, and will provide supplementary reports upon
request.
o There will be two Steering Committee meetings annually, one in the Spring
and the other in the Fall.
o The Steering Committee may, when necessary, invite additional, non-voting
scientific advisors to the meetings at which research priorities and
opportunities are discussed. The NIDDK reserves the right to augment the
scientific expertise of the BCBC when necessary.
o At the Fall meeting each year, the Steering Committee will formulate plans
for the Fall Investigator’s retreat or any symposia to be held
(http://www.betacell.org/php/cc.php).
o The BCBC members will serve on subcommittees, scientifically review
applications for special programs such as the Pilot and Feasibility Program,
as it is deemed appropriate; the NIDDK Project Officer will serve on
subcommittees as appropriate. NIDDK staff with special expertise may serve
on subcommittees at the request of the Steering Committee. Subcommittee
chairs will be selected from the Steering Committee and will report progress
at Steering Committee Meetings and lead discussions at the Annual
Investigator’s Retreat.
External Advisory Board
An independent External Advisory Board has been established by the NIDDK.
The External Advisory Board will review periodically interim progress of the
U01s, U19s, and BCBC Coordinating Center and report to NIDDK. The External
Advisory Board will continue to meet annually. An NIDDK staff person other
than the NIDDK Project Scientist/Program Director will serve on the External
Advisory Board and organize these meetings.
E. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within
the scope of a U01 or U19 award) may be brought to arbitration. An
arbitration panel will be composed of three members--one selected by the
awardee (or Steering Committee, with the NIDDK Project Scientist not voting),
a second member selected by the NIDDK; and, the third member selected by the
two prior selected members. This special arbitration procedure in no way
affects the awardee's right to appeal an adverse action that is otherwise
appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart
D and HHS regulation at 45 CFR Part 16.
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:
Sheryl Sato, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 6105
Bethesda, MD 20892-5460
Telephone: (301) 594-8811
FAX: (301) 480-3503
Email: [email protected]
o Direct your questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Mary K. Rosenberg
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 708
Bethesda, MD 20892-5452
Telephone: (301) 594-8891
FAX: (301) 594-9532
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
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 IC 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:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a DUN and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTARY INSTRUCTIONS
Applicants must budget for travel and per diem that will allow the Principal
Investigator of the U01 to participate in 2 steering committee meeting, as
well as Subcommittee meetings throughout the year. In addition, applicants
should plan for at least 3 investigators per U01 grant to attend the Annual
Investigator’s Retreat and Subcommittee meetings, when needed. There will be
at least one interim review meeting conducted by the External Scientific
Board and NIDDK in which the Principal Investigator and collaborating
investigators are required to attend, and applicants will be expected to
include funds for all required meetings in their travel budget.
Additional materials
The Research Plan should have a section entitled Collaboration within the
BCBC. In this section:
o The applicant should describe how they believe their unique expertise can
contribute to the collective efforts of the BCBC.
o The applicant should provide evidence of their intention to work together
with other members of the BCBC to share ideas, and develop common tools and
reagents.
o In generating unique research tools, applicants should describe their
willingness to cooperate and coordinate with the research activities and
priorities of the BCBC Antibody Core/Database
http://www.betacell.org/php/cc.php, the BCBC Mouse/ES Core
http://www.betacell.org/php/cc.php and the Endocrine Pancreas Consortium
Database (http://www.cbil.upenn.edu/EPConDB). All protocols, antibodies,
vectors, cells, animals and data generated through the BCBC will be made
freely available to the general scientific community. In working with the
BCBC Coordinating Center at Vanderbilt University, and Steering Committee,
applicants must agree to distribute unique resources developed through the
BCBC.
o The application must reflect adequate time commitment of personnel. Levels
of effort that are awarded will vary depending on the requirements of the
research to be performed and the anticipated contributions to the BCBC.
o The BCBC is a collaborative effort that requires frequent interactions of
awardees among themselves and with the NIH. Applicants must explicitly
indicate their willingness to: participate in Steering Committee Meetings (2
times per year), regular telephone conference calls; cooperate with other
awardees in the development and design of research priorities, especially
regarding resources, and accept the Cooperative Agreement Terms and
Conditions of Award given above.
o Budget Information: The actual award will vary yearly, depending upon the
work scope of the BCBC scientific cores, and other special BCBC programs.
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:
http://grants.nih.gov/grants/funding/phs398/labels.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
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
APPLICATION PROCESSING: Applications must be received on or before 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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
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.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is, the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes from the
previous unfunded version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR.
NIDDK will conduct the review. The Chief of the Review Branch, assigned SRA,
and NIDDK Program Staff will conduct an administrative review to determine if
the application is responsive to the RFA, or missing any information.
Incomplete applications will not be reviewed and will returned to the
applicant. 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. As part of the initial merit review, all applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Diabetes and Digestive and
Kidney Diseases Advisory Council.
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 evaluate the application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review group
will address and consider each of the following criteria in assigning the
application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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 generate important
reagents or tools that by its nature are not innovative but are essential to
move the field forward. The BCBC will focus on generating important reagents
and tools and conducting challenging research in a cooperative spirit that
might be considered too descriptive, ambitious, risky, or less likely to
succeed as an individual R01 research project.
SIGNIFICANCE: Does this study address an important problem in beta cell
biology? 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? Will the resources or technology
to be developed be useful to investigators working in pancreatic development
and stem cell biology and furthermore, benefit the larger beta cell
biology/diabetes community?
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?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
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)?
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?
COLLABORATION: Does the applicant provide evidence of sharing and developing
reagents? Does the applicant state their intention to cooperate with other
BCBC members?
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations,
below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
The reviewers will also consider the willingness of the applicant to work
with other members of the Consortium to provide research resources.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 19, 2004
Application Receipt Date: November 19, 2004
Peer Review Date: March-April 2005
Council Review: May 2005 Council
Earliest Anticipated Start Date: July 31, 2005
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.
REQUIRED FEDERAL CITATIONS
ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities
involving live, vertebrate animals must comply with PHS Policy on Humane Care
and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as
mandated by the Health Research Extension Act of 1985
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA
Animal Welfare Regulations
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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-supported 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 "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
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
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.
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
http://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
http://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 http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH 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, in the project
description and elsewhere in the application as appropriate, 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.
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 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the Standards for Privacy of Individually Identifiable Health Information ,
the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on Am I a covered
entity? Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ in the following
citations: No. 93.847, Diabetes Research, No. 93.855. Awards are made under
the authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under 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 123472 or Health Systems Agency
review. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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