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: 
http://grants.nih.gov/grants/funding/phs398/phs398.html

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://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 
http://grants.nih.gov/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 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
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 http://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 
http://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: 
http://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: 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    
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 
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 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 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 
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/ 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 
http://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.

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