INNOVATIVE PARTNERSHIPS IN TYPE 1 DIABETES RESEARCH
RELEASE DATE: June 26, 2003
RFA: DK-03-015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/)
National Eye Institute (NEI)
(http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov/)
Office of Dietary Supplements (ODS)
(http://dietary-supplements.info.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.847, 93.855, 93.867,
93.837, 93.853 and 93.361.
LETTER OF INTENT RECEIPT DATE: October 16, 2003
APPLICATION RECEIPT DATE: November 13, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
National Institute of Allergy and Infectious Diseases (NIAID), National Eye
Institute (NEI), National Heart, Lung, and Blood Institute (NHLBI), National
Institute of Neurological Disorders and Stroke (NINDS), National Institute of
Nursing Research (NINR), and the Office of Dietary Supplements (ODS) invite
applications to support collaborations between investigators who focus their
research efforts on type 1 diabetes or its complications and researchers from
other research areas with expertise relevant to type 1 diabetes research. The
purpose of this Request for Applications (RFA) is to attract new research
talent to type 1 diabetes research, strengthen the ongoing efforts of type 1
diabetes researchers by providing access to specialized expertise or
technologies relevant to their research, and facilitate the formation of
interdisciplinary research partnerships to investigate significant biological
and medical problems associated with type 1 diabetes. Applications should
propose collaborative research partnerships between independent principal
investigators, at least one currently pursuing research relevant to type 1
diabetes and one (or more) with expertise relevant to some aspect of type 1
diabetes that is not currently being applied by the investigator to research
on this disease. This RFA encourages type 1 diabetes researchers to act as
"talent scouts" by identifying and recruiting leading scientists with
relevant scientific expertise to the field of type 1 diabetes research. A
similar RFA (DK-02-023) was issued in 2002. We anticipate that a future
solicitation will provide an opportunity for expanded support for successful
collaborations funded through the current RFA.
RESEARCH OBJECTIVES
Background
Type 1 diabetes is an autoimmune disease characterized by the destruction of
the insulin-secreting beta cells of the pancreas mediated by lymphocytes of
the immune system. The incidence of type 1 diabetes appears to be increasing
worldwide. Although the disease may occur at any age, the onset of type 1
diabetes peaks prior to twenty years of age. In some populations, about one
percent will develop type 1 diabetes during their lifetime. Those affected
with type 1 diabetes suffer from devastating complications including
accelerated onset of cardiovascular and peripheral vascular diseases,
neuropathy, nephropathy, retinopathy and premature mortality.
Objectives and Scope
The objectives of this RFA are to attract new research talent to type 1
diabetes research, strengthen the ongoing efforts of type 1 diabetes
researchers by providing access to specialized expertise or technologies
relevant to their research, and facilitate the formation of interdisciplinary
research partnerships to investigate significant biological and medical
problems associated with type 1 diabetes.
Generally, pilot and feasibility applications (such as the "seed"
collaborative R01 applications solicited through this RFA) are expected to
have little preliminary data and are reviewed based on the development of
unique hypotheses and supporting literature. While no preliminary data from
the collaboration between the two investigators mentioned above are required,
applicants should include some preliminary data relevant to the proposed
project from the partner currently working in the area of type 1 diabetes.
Some information documenting the ability of the collaborator regarding the
technology or expertise s/he will be providing to the partnership should also
be provided.
Applications should propose collaborative research partnerships. The
recruited research partner may have worked on a project relevant to diabetes
and its complications, but this should not have been a significant focus of
his/her research effort. Review criteria (see below) will include
consideration of whether one partner is new to diabetes research and is
likely to make substantial contributions to the diabetes research effort.
The application will be judged in the context of the objectives of the RFA
(see above); a major objective is attracting new talent to diabetes research.
Each of the research partners should be a successful independent investigator
with a track record of successful research accomplishments.
The collaborating investigators need not be at the same institution. If at
separate institutions, the application should document how the collaboration
will be achieved. One potential mechanism for collaboration between two
independent laboratories might be a shared postdoctoral fellow or other
research staff position. Funds for travel between the collaborating
laboratories may be included in the budget proposal, and each research
partner should request funds to attend one meeting in Bethesda, MD.
Each of the research partners will serve as a principal investigator on an
R01 grant application within a collaborative R01 project. The level of
effort proposed by the collaborating independent investigators should be
appropriate for the scope of the project.
R01 applications submitted in response to this RFA may address any topic
relevant to type 1 diabetes and its complications ranging from fundamental
research on etiology and pathogenesis to applied research focused on the
development of methods for prevention, improved treatment, or cure. R01
applications may involve collaborations between diabetes researchers and
investigators in diverse fields including, but not limited to, cardiovascular
disease, nephrology, ophthalmology, neuroscience, molecular virology,
immunology, infectious disease, genetics, epidemiology, behavioral and/or
psychosocial research, biophysics, materials science, bioengineering,
bioimaging, developmental biology, cell biology, cell signaling, structural
biology, genomics, proteomics, or bioinformatics.
Examples of types of research projects that are responsive to this RFA
include but are not limited to:
o Development and/or testing of strategies to prevent or reverse type 1
diabetes and its macro- and microvascular complications
o Research to discover the biochemical mechanisms by which diabetes genes
function to create susceptibility to diabetes and its complications
o Identification of viral or environmental triggers of type 1 diabetes and
mechanisms by which such triggers initiate an autoimmune response
o Development and/or testing of measures to identify and quantify the risk of
developing type 1 diabetes or to assess response to therapy to prevent or
reverse the autoimmune process and beta cell loss (i.e. pathogenic T-cell
assays, imaging of beta cell mass or inflammation, etc.)
o Development and/or testing of devices to measure glucose in blood, saliva
or other body fluids and/or deliver insulin which offer advantages over
current devices, and the development of closed loop systems for glucose
sensing and insulin delivery
o Research to prevent or reduce hypoglycemia in type 1 diabetes
o Research to identify islet stem cells, understand their differentiation,
growth and development, and develop improved methods for isolation,
maintenance, growth and propagation, or differentiation of beta cells/islets
o Research on signaling pathways involved in the regulation of normal
pancreatic beta cell function
o Research on strategies to develop new or improved sources of beta
cells/islets or to enhance the regeneration or viability of beta cells/islets
o Development and/or testing of improved methods of immunoalteration of beta
cells/islets or of the immune response in an attempt to prevent autoimmune
and host-versus-graft destruction of beta cells/islets
o Development of immunobarrier technology to protect transplanted islets or
engineered insulin-producing cells from autoimmune destruction or rejection
o Definition of the genetic, molecular or cellular processes and the sequence
of events in the pathogenesis of hyperglycemia-induced injury so that
potential sites for intervention can be identified
o Development or testing of innovative pharmacological agents and
interventions to prevent or halt the progression of type 1 diabetes or its
long-term complications
o Development of animal models of type 1 diabetes and its complications
which closely parallel the human disease useful for exploring the
pathogenesis and therapy of type 1 diabetes or its complications
o Development of strategies and tools to improve diabetes management and
outcomes
o Development of tests that will facilitate clinical trials such as measures
of risk for diabetes and/or complications or measures of response to therapy
o Development of proteomic approaches to the study of type 1 diabetes and its
complications (e.g. study of insulitis and autoimmunity recurrence;
identification of beta cell-specific proteins in plasma; identification of
markers for monitoring pancreatic beta cell differentiation, development,
function, and mass)
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) research project
grant (R01) award mechanism to support collaborative research projects. For
collaborative R01 projects, a group of investigators must submit
simultaneously at least two, but typically not more than three, R01 grant
applications with a collaborative research project. R01 grant applications
may be from a single institution or several institutions, and may include
shared resources. Collaborative R01 research projects must demonstrate the
interdependence of the individual components. For this RFA, the R01 grant
mechanism is being used to "seed" collaborative research partnerships. As an
applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications based on this project will
compete with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated award date
is July 1, 2004. Projects that are not funded in the competition described in
this RFA may be re-structured and designed as traditional R01s, and submitted
as NEW applications using the standard receipt dates for NEW applications
described in the instructions to the PHS 398 application at:
https://grants.nih.gov/grants/funding/phs398/phs398.html
This RFA uses just-in-time concepts. It also uses the modular budgeting
format. (see https://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format. This program does not
require cost sharing as defined in the current NIH Grants Policy Statement at
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The participating ICs intend to commit approximately $4 million in FY 2004 to
fund 12 to 15 new projects in response to this RFA. These awards are intended
to provide seed funding to initiate research collaborations. Applicants for
collaborative R01 grants may request a project period of up to 2 years. The
combined budgets for all of the R01 applications within a collaborative group
may not exceed $300,000 in direct costs per year. We anticipate that a
future solicitation will provide an opportunity for expanded support for
successful collaborations funded through the current RFA. Because the nature
and scope of the proposed research will vary from project to project, it is
anticipated that the size of each award will also vary. Although the
financial plans of the ICs 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
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Applicants from institutions that have a Diabetes Endocrinology Research
Center (DERC), a Diabetes Research and Training Center (DRTC), or a General
Clinical Research Center (GCRC) funded by the NIH National Center for
Research Resources may wish to identify the Center(s) as a resource for
conducting the proposed research. In such a case, a letter of agreement
from either the principal investigator or the GCRC program director should be
included with the application.
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:
James F. Hyde, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 603
Bethesda, MD 20892-5460
Telephone: (301) 594-7692
FAX: (301) 435-6047
E-mail: jh486z@nih.gov
John Paul Ridge, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 5259
Bethesda, MD 20892-7640
Telephone: (301) 496-7104
FAX: (301) 402-2571
E-mail: jr34g@nih.gov
Peter A. Dudley, Ph.D.
Division of Extramural Research
National Eye Institute
Executive Plaza South, Suite 350
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: pad@nei.nih.gov
Cristina Rabadan-Diehl, Ph.D.
Vascular Biology Research Program
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10186
6701 Rockledge Drive
Bethesda, MD 20892-7956
Phone: 301-435-0545
FAX: 301-480-2858
E-mail: cr225k@nih.gov
Paul L. Nichols, Ph.D.
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2108
6001 Executive Blvd.
Bethesda, MD 20892
Phone: 301-496-9964
FAX: 301-401-2060
E-mail: pn13w@nih.gov
Nell Armstrong, PhD, RN
Program Director
National Institute of Nursing Research
6701 Democracy Blvd, Rm. 710
Bethesda MD 20892-4870
Phone: 301-594-5973
FAX: 301-480-8260
E-mail: armstrongn@nih.gov
Rebecca B. Costello, Ph.D., F.A.C.N.
Deputy Director
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., Room 3B01
Bethesda, Maryland 20892-7517
Phone: (301) 435-2920
FAX: (301) 480-1845
E-mail: CostellB@od.nih.gov
o Direct your questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: CalvoF@extra.niddk.nih.gov
o Direct your questions about financial or grants management matters to:
Kathleen J. Shino, M.B.A.
Supervisory Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 708
Bethesda, MD 20892-5456
Telephone: (301) 594-8869
FAX: (301) 480-3504
E-mail: ShinoK@extra.niddk.nih.gov
Pamela G. Fleming
Grants Management Officer
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
6700-B Rockledge Drive, Room 2119
Bethesda, MD 20892-7614 (Regular Mail)
Bethesda, MD 20817 (Express Mail)
Phone: (301) 402-6580
FAX: (301) 493-0597
E-mail: pf49e@nih.gov
Chris Davis
Grants Management Specialist
National Eye Institute
6120 Executive Blvd, Suite 350
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 496-99977
E-mail: cad@nei.nih.gov
Susan Lowenthal
Grants Management Specialist
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7155
Bethesda, MD 20892-7926
Telephone: 301-435-0159
FAX: 301-480-3310
E-mail: sl262k@nih.gov
Karen Shields
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3290
6001 Executive Blvd.
Bethesda, MD 20892
Phone: 301-496-9231
FAX: 301-402-0129
E-mail: ks26n@nih.gov
Diane E. Drew
Grants Management Specialist
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870
(Courier Delivery: Bethesda, MD 20817)
Phone: 301-594-2807
FAX: 301-451-5651 or 301-402-4502
E-mail: diane_drew@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel, including PIs of Collaborative R01s
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
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8885
FAX: (301) 480-3505
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR R01 APPLICATIONS: All application instructions
outlined in the PHS 398 application kit are to be followed, with the
following requirements for R01 applications:
1. For these collaborative R01 projects, the individual components must be
submitted as one packet accompanied by a cover letter that lists the
principal investigators, their institution(s), and their identical project
titles. To facilitate proper processing and review, include this letter with
each of the individual R01s, and, in each R01 grant application, list the
collaborating projects and principal investigators on page 2, under
"Performance Sites." In addition, the DESCRIPTION (page 2) for each R01
grant application within a collaborative R01 project should be the same and
the applicants should define in the DESCRIPTION how and why the individual
participants propose to collaborate.
2. The RESEARCH PLAN section should be included in ONLY one of the R01 grant
applications. All of the remaining R01 grant applications within the
collaborative R01 project should refer to the RESEARCH PLAN from the
designated R01 application, rather than duplicate the RESEARCH PLAN.
Applicants should elaborate on the significance and nature of the
collaboration in an Introduction section of the "Research Plan" of each
component R01.
3. Those collaborative R01 applications that do not include, but only refer
to, the RESEARCH PLAN must include the following information in their
application: face page, DESCRIPTION, Performance Sites, and Key Personnel,
Research Grant Table of Contents, modular budget, budget justification,
biographical sketches of PI and other key personnel, resources and
environment, and checklist. Sections for Human Subjects Research and/or
Vertebrate Animals must also be completed, if appropriate.
4. Collaborative R01 applications will use the "MODULAR GRANT" and "JUST-IN-
TIME" concepts, with direct costs requested in $25,000 modules. The combined
budgets for all of the research projects in a collaborative R01 application
may not exceed $300,000 in direct costs per year. For these collaborative
R01 projects, each R01 grant application must include its own budget. The
total direct costs for a collaborative R01 project are limited to $300,000 in
direct costs per year, and these funds should be distributed, as appropriate,
among the PIs within the collaborative project. In addition, each research
partner should request funds to attend one meeting in Bethesda, MD.
5. Although preliminary data are not required for these seed R01
applications, they may be included.
6. Sections a-d of the Research Plan of the R01 application may not exceed
15 pages, including tables and figures.
7. R01 appendix materials should be limited, and should not be used to
circumvent the page limit for the research plan. Copies of appendix
material will only be provided to the primary reviewers of the application
and will not be reproduced for wider distribution. The following materials
may be included in the appendix:
o Up to five publications, including publications, abstracts, patents, or
other printed materials directly relevant to the project. These may be
stapled as sets.
o Surveys, questionnaires, data collection instruments, and clinical
protocols. These may be stapled as sets.
o Original glossy photographs or color images of gels, micrographs, etc.,
provided that a photocopy (may be reduced in size) is also included within
the 15 page limit of items a-d of the research plan.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Collaborative R01
applications requesting up to $250,000 per year in direct costs must be
submitted in a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Section C of the research grant application instructions for the PHS 398
(rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants. Additional
information on modular grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
appendices must be sent to:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
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. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDDK. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIDDK in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
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 second level review by an appropriate national advisory council
or board.
Collaborative R01 grant applications will NOT be reviewed individually, but
as components of a single research project, and, as such, the individual R01
applications within a collaborative R01 project will be assigned the same
priority score and receive the same reviewers' comments within the individual
summary statements.
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 discuss the following
aspects of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning the application's overall score, weighting them as appropriate
for each application. 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
carry out important work that by its nature is not innovative but is
essential to move a field forward.
SIGNIFICANCE: Does this study address an important problem in type 1 diabetes
research? 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?
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? Preliminary data are not required for these seed R01
applications.
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?
INVESTIGATORS: Are the investigators 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? Is the research
partnership innovative? Does the partnership include an independent
investigator new to type 1 diabetes research with appropriate expertise to
contribute significantly to diabetes research? Is the research partnership
interdisciplinary and does it merge scientific expertise based upon strong
experimental rationale and sound project goals?
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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered for each R01 application within a collaborative R01
project in the determination of scientific merit and the priority score:
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.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 16, 2003
Application Receipt Date: November 13, 2003
Peer Review Date: February/March 2004
Council Review: May, 2004
Earliest Anticipated Start Date: July 1, 2004
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
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
MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://stemcells.nih.gov/index.asp and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the 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 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
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA 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). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
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
https://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/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. 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. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
https://grants.nih.gov/grants/policy/policy.htm
The Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and
established within the Office of the Director, National Institutes of Health
(NIH). The Dietary Supplement Health and Education Act (DSHEA) [Public Law
103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act "to
establish standards with respect to dietary supplements." This law authorized
the establishment of the ODS.
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.