PLANNING GRANTS FOR TRANSLATIONAL RESEARCH FOR THE PREVENTION AND CONTROL OF 
DIABETES 

RELEASE DATE:  January 22, 2003

PA NUMBER:  PAR-03-060

EXPIRATION DATE:  February 2, 2006, unless reissued.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)
Centers for Disease Control and Prevention – Division of Diabetes Translation
(CDC-DDT)  
 (http://www.cdc.gov)

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 
the National Eye Institute (NEI), and the Centers for Disease Control and 
Prevention -- Division of Diabetes Translation (CDC-DDT) seek to foster the 
development of innovative programs to translate recent advances in the 
prevention and treatment of diabetes and its complications into clinical 
practice for individuals and communities at risk. An ongoing program 
announcement, PA 02-153 (http://grants.nih.gov/grants/guide/pa-files/
PA-02-153.html), established a diabetes prevention and control program, and
seeks applications for public health, clinical or behavioral studies to develop
and test 1) improved methods of health care delivery to patients with or at risk 
of diabetes, 2) improved methods of diabetes self management, and 3) cost 
effective community-based strategies to promote healthy lifestyles that will 
reduce the risk of diabetes and obesity. This PAR establishes a small grant 
program to fund pilot studies that would lead to full-scale trials under the 
parent program announcement. Studies submitted to this program should focus 
on developing preliminary data of feasibility of a proposed approach, or 
other information needed  for the development and assessment of an 
application for a full-scale trial. The trials should test strategies for 
achieving objectives that have already been proven beneficial, such as 1) 
control of glycemia and other risk factors for diabetic complications, 
including hypertension and dyslipidemia and 2) altering life style to prevent 
or delay the onset of type 2 diabetes in at risk populations, including 
children and adolescents.  Of particular interest are interventions that 
focus on translating new advances into practice in underserved and minority 
populations. 

RESEARCH OBJECTIVES

Background

Several large, controlled clinical trials have established "gold standard" 
approaches for treating type 1 and type 2 diabetes, and for preventing type 2 
diabetes in individuals at high risk for developing the disorder.  Programs 
are needed to translate the results of these trials into widespread practice. 
Translational research related to prevention and therapy of obesity, a major 
risk factor for type 2 diabetes, is also needed. In particular, fostering 
wider use or more cost effective methods of delivery of established 
approaches for treating childhood obesity, as well as programs for preventing 
regain of weight after weight loss treatment, are appropriate targets for 
translational research. 

The Diabetes Control and Complications Trial (DCCT), for type 1 diabetes, and 
the United Kingdom Prospective Diabetes Study (UKDPS), for type 2 diabetes, 
established the importance of intensive glycemic control in dramatically 
reducing the devastating complications that result from poorly controlled 
diabetes.  Both the DCCT and the UKPDS demonstrated the efficacy of intensive 
glucose control in reducing the risk for the microvascular complications of 
diabetes, such as retinopathy, neuropathy, and nephropathy. In addition, 
results from the UKPDS and other trials demonstrate that cardiovascular 
events are reduced in patients with type 2 diabetes through rigorous control 
of blood pressure and LDL-cholesterol.

Unfortunately, the therapies proven to delay or prevent complications in 
these studies have not been widely incorporated into general health care 
practice. Prevention and treatment of long-term micro- and macrovascular 
complications remain a critical problem in the management of type 1 and type 
2 diabetes mellitus. In the United States, diabetes is the leading cause of 
new blindness in working-age adults, of new cases of end stage renal disease 
and of non-traumatic lower leg amputations. In addition, cardiovascular 
complications are now the leading cause of diabetes-related morbidity and 
mortality, particularly among women and the elderly.  In adults with 
diabetes, the risk of cardiovascular disease (CVD) is two to four fold 
greater than in nondiabetics. Comorbid conditions (hypertension, dyslipidemia 
and smoking) combine with hyperglycemia to contribute to accelerated 
atherosclerosis. Hypertension also contributes substantially to development 
of microvascular complications, and clinical trial data has established 
unequivocal benefit of rigorous control of blood pressure in preventing both 
micro- and macrovascular complications of diabetes. Smoking cessation, 
aspirin therapy and lipid control have also been shown to prevent morbidity.  
Despite clear-cut evidence of benefit, recently available data demonstrate 
that patients with diabetes are not achieving the recommended levels of 
comprehensive risk factor management.

Underutilization of current knowledge was highlighted in recent studies of 
diabetic individuals that demonstrated a low frequency of achievement of 
targets for management of glycemia, blood pressure, and lipids, aspirin use, 
self-monitoring of blood glucose, regular foot care, and ophthalmic 
examinations, all of which markedly reduce the incidence and progression of 
diabetic complications. Alarmingly, less than 2% of adults with diabetes 
receive the level of care that has been recommended by the American Diabetes 
Association (ADA), with self-monitoring of blood glucose following the ADA 
guidelines performed by only one in five adults with diabetes. Thus, it is 
clear that effective mechanisms for diabetes treatment, shown by the DCCT, 
the UKPDS and other clinical trials to reduce the burden of diabetes, are not 
being implemented.  

The difficulties inherent in achieving good glucose control and preventing 
diabetes complications make prevention a compelling strategy. This is 
particularly true for type 2 diabetes, which is clearly linked to modifiable 
risk factors – e.g., overweight or obesity and a sedentary lifestyle. The 
Diabetes Prevention Program (DPP) tested strategies to prevent or delay the 
development of  type 2 diabetes in individuals at high risk for its 
development by virtue of their having impaired glucose tolerance (IGT).  The 
DPP demonstrated that intensified lifestyle or drug intervention in 
individuals with IGT, prevented or delayed the onset of type 2 diabetes.  The 
results were striking.  Lifestyle intervention reduced diabetes incidence by 
58% and the drug metformin by 31% compared with placebo.  The effects were 
similar for men and women and for all racial and ethnic groups.  Similar 
effects of lifestyle intervention were seen in another recent study conducted 
in Finland. Cost-effective strategies for promoting lifestyle modification in 
these high-risk individuals, outside the setting of a controlled, clinical 
trial, need to be established. Population-based, as well as generalizable, 
clinic-based, strategies are needed to establish cost-effective programs to 
1) identify individuals at high risk who could benefit from prevention 
programs, and/or 2) successfully promote lifestyle change. 

Childhood obesity, the prevalence of which has more than doubled in the past 
two decades, is a major risk factor for type 2 diabetes. Indeed, the increase 
in childhood obesity has been linked to an alarming rise in type 2 diabetes 
in the pediatric population. Family-based behavioral interventions have been 
shown to have a long-term impact on degree of overweight. However, cost-
effective interventions in primary care and community-based settings are 
needed. 

In addition, while behavioral treatment of obesity in adults leads to 
clinically significant weight loss, prevention of weight regain remains an 
elusive goal for many. Continuing care models show promise in promoting long-
term weight maintenance and cost-effective means of providing such care need 
to be developed.

Finally, the results of ongoing clinical trials that also address the 
prevention and/or treatment of type 1 or type 2 diabetes and/or obesity 
(e.g., Look-AHEAD, ACCORD, TrialNet) are likely to become available in the 
future. In the event of positive outcomes in any of these studies, it will be 
even more crucial that effective translation strategies be developed and 
adopted to improve adherence to accepted standards of diabetes care, and to 
overcome barriers to the translation of scientific advances into clinical 
practice. 

Objectives and Scope

The NIDDK, the NEI, and the CDC-DDT seek to enhance diabetes prevention and 
control research. The overall objective of this program announcement is to 
support research to develop and test intervention strategies that will 
enhance health promotion in those with or at risk of diabetes, diabetes self 
management and reduction in risk at the community, health care system, 
provider, and/or patient level. This PAR establishes a small grant program to 
fund pilot studies to develop innovative research  protocols to translate 
recent advances in the prevention and treatment of diabetes and its 
complications into clinical practice for individuals and communities at risk. 
It is anticipated that studies funded under this program will form the basis 
for applications for full-scale trials that would be submitted as research 
demonstration and dissemination projects (R18) under PA 02-153 
(http://grants.nih.gov/grants/guide/pa-files/PA-02-153.html). 

Studies proposed under this program should test 1) improved methods of health 
care delivery to patients with or at risk of diabetes, 2) improved methods of 
diabetes self management, and 3) cost effective community-based strategies to 
promote healthy lifestyles that will reduce the risk of diabetes and obesity. 
Generally, these studies will take interventions that have been demonstrated 
to be beneficial by controlled clinical investigations (e.g., intensive 
glycemic, blood pressure or lipid control in individuals with diabetes, or 
increased physical activity in individuals at risk for diabetes), and extend 
or adapt these interventions to larger populations or other settings or more 
cost effective methods of delivery. 

The translation of new science to patient care would occur more rapidly if it 
were not for the existence of certain barriers, which impede the adoption and 
implementation of current knowledge.  Such barriers include but are not 
limited to:
o health care provider knowledge,
o communication between patient and health care provider, 
o attitudes and beliefs of the patient, community/culture, health care 
provider and health care system
o racial and ethnic disparities,
o variations in settings, including the health care system,
o clinical traditions,
o socioeconomic status,
o cost. 

Proposed research studies should be designed to overcome these barriers. 
Topics of interest include, but are not limited to:

o strategies to enhance glycemic, blood pressure, and lipid control or reduce 
risk factors for the development of the complications of type 1 or type 2 
diabetes,

o strategies to promote the adoption of healthy lifestyles, which will reduce 
obesity and diabetes,

o strategies for less burdensome and more cost effective methods to identify 
those with or at risk of type 2 diabetes,

o studies that test interventions to enhance long-term maintenance of weight 
loss and prevention of weight regain after weight loss,

o studies that test interventions within the changing health care delivery 
system and changing patient demographics,

o studies to determine the role of patient/provider communication on diabetes 
outcomes, and strategies to facilitate such communication,

o strategies to enhance patient or provider education, 

o studies of information technology and decision-support to facilitate 
evidence-based prevention and management,

o the testing of community-based programs to provide education and behavior 
modification at lower cost,

o studies that test interventions to treat childhood and adolescent 
obesity in primary care or community settings,

o strategies to alter health care system features that reduce the 
efficiency or effectiveness of patient/provider interaction and health 
outcomes.

Of particular interest are studies to improve self-management and enhance 
health care delivery to underserved and minority populations. Such studies 
may seek to improve outcomes in populations (with either type 1 or type 2 
diabetes) that historically have had poor glycemic, blood pressure, and other 
risk factor control, or promote effective prevention strategies in minority 
populations known to be at high risk for the development of type 2 diabetes 
and/or its complications.

These studies will provide pilot and feasibility data to be used in 
developing full-scale trials that would be submitted as research 
demonstration and dissemination projects (R18) under PA 02-153 
(http://grants.nih.gov/grants/guide/pa-files/PA-02-153.html). These R18 
projects should be effectiveness trials and will generally have the same 
research design as a single-center randomized clinical trial. The R34 
submitted in response to this PAR should be designed to develop convincing 
preliminary data that show that the intervention has the potential to alter 
behavior or impact care, that the intervention can feasibly be carried out, 
and/or provide other data needed for the design of the full-scale trial.  
Applicants are encouraged to review the guidance regarding the requirements 
for the R18 to help investigators understand the long-terms goals of the R34 
project. Clearly, some of the information required for the R18 will not be 
necessary in the R34 application, but an outline of the key features of the 
subsequent full-scale trial that is envisioned should be included together 
with a discussion of how the R34 project addresses a key issue regarding 
feasibility of the subsequent R18 proposal.  Applicants who do not require 
support for a feasibility study may apply for an R18 directly under PA 02-
153.

The rationale for the future large-scale intervention should be clearly 
described. Applicants should provide a description of key elements of the 
design of that study, including the population to be studied, the setting for 
delivery of the intervention, primary and secondary outcomes to be assessed, 
the duration of follow-up, and the statistical analysis to be employed. 
Investigators may wish to consider assessment of cost-effectiveness as a 
secondary outcome measure.  Applicants should discuss how the proposed pilot 
and feasibility study, planning project or other effort for which R34 support 
is requested is related to the full scale trial envisioned under the 
subsequent R18.  

For the project to be supported under the R34, applicants should provide a 
detailed description of the target population to be studied, with 
justification, including a definition of the cohort by age, gender, sex and 
race/ethnicity.  The ability to recruit this target population and the 
methods to be used should be described.  Sample size needs and the 
assumptions and calculations used to estimate sample size should be detailed.  
Applicants must state their plans for reporting accrual by gender, race and 
ethnicity and for the reporting of results that examine differences in 
treatment effects across these subgroups (see below, "Inclusion of Women and 
Minorities in Research Involving Human Subjects"). Methods for assuring 
privacy and maintaining confidentiality should be included. There must be a 
data and safety monitoring plan. 
 
Studies may utilize methodology from the fields of biomedical, social or 
behavioral sciences, epidemiology (including clinical trials), and health 
services research. The primary outcome will generally be some form of 
behavior change, health care status, or health care use. An intervention 
aimed at producing a behavioral change should be grounded in behavior change 
theory, which should be incorporated into the intervention. The application 
will be strengthened by the inclusion of a process evaluation – i.e., an 
evaluation of whether the intervention is actually delivered as intended. 

Investigators should provide detailed evidence that the research team has the 
experience and expertise to conduct the research study.  Most translation 
research will require a multidisciplinary research team.  Thus, a variety of 
researchers may be required for these studies, including, but not limited to, 
endocrinologists, public health physicians, primary care physicians, 
epidemiologists, statisticians, psychologists, health educators, 
sociologists, nurses, nutritionists and other health related professionals. 
The interdisciplinary nature of the research team should be fully described 
and justified.  

Brief descriptions, as appropriate, of the process for biologic sample 
collection, storage and handling; the laboratory tests that are needed; 
physical facilities, data management and computer resources, and facilities 
for data retrieval and storage; and a plan for randomization of patients or 
settings for delivery of interventions into protocols should be provided.  

Investigators located at existing Diabetes Research and Training Centers 
(DRTC) should include a complete description of how the research being 
proposed in response to this PA will utilize the core facilities funded 
through the their DRTC.  A central purpose of the DRTCs is to support 
translation research into the barriers that restrict the adoption of advances 
in diabetes treatment into practice.  It should therefore be made clear how 
the research being proposed integrates into the DRTC, its cores and overall 
biomedical research focus.

Investigators who are not affiliated with a DRTC may, but are not required 
to, form collaborations with such centers in order to utilize the core 
resources, which may provide support for such aspects of the proposed 
research as statistical analysis and instrument development. A list of DRTCs 
is available at http://www.niddk.nih.gov/fund/other/centers.htm. 

Potential applicants are also encouraged to develop collaborative 
relationships with CDC-supported Diabetes Control Programs (DCPs) that offer 
access to high risk populations in community-based research settings. 

Investigators located at existing CDC-DDT supported "Translating Research 
into Action for Diabetes (TRIAD)" sites should include a full description of 
how the TRIAD sites will be advantageously utilized. TRIAD investigators 
should also describe how they will integrate the TRIAD sites and cohort 
without adversely affecting or overlapping the current and future multicenter 
collaborative goals of the TRIAD Study (e.g., primary hypotheses, cohort 
follow-up). The testing of interventions to prevent or treat disease among 
individuals from the TRIAD cohort is encouraged.

SPECIAL REQUIREMENTS

Upon initiation of this program, annual meetings will be held to encourage 
exchange of information among investigators. These meetings will include 
grantees awarded R18s under PA 02-153, as well as DRTC investigators 
conducting translation research. A goal of these meetings would be to foster 
collaborative efforts among program grantees, and to enhance dissemination of 
successful translation research programs by sharing of study designs, data 
and experiences. Applicants must budget for travel funds that will allow 
principal investigators to participate in these one-day meetings in Bethesda, 
Maryland. 

MECHANISM OF SUPPORT

This PAR will use the National Institutes of Health (NIH) clinical trial 
planning grant (R34) award mechanism, which will provide up to $150,000 in 
direct costs per year. The total project period for an application submitted 
in response to this PAR may not exceed 2 years.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely 
that of the applicant. These grants may not be renewed. It is anticipated 
that the data collected using these grants will provide the basis for a full-
scale trial, which would be submitted as a research demonstration and 
dissemination project (R18) under PA 02-153 
(http://grants.nih.gov/grants/guide/pa-files/PA-02-153.html).

This PA 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.

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 
o Foreign Institutions are not eligible
o Faith-based or community-based 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. Investigators new to diabetes and 
digestive and kidney diseases are encouraged to apply. Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PAR and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research, and financial or grants management issues.

o Direct your questions about scientific/research issues to:

Sanford Garfield, Ph.D. 
Senior Advisor for Biometry and Behavioral Research Program
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 685
Bethesda, MD 20892-5460
Telephone:  (301) 594-8803
FAX:  (301) 480-3503
E-mail:  sg50o@nih.gov

Barbara Linder, M.D., Ph.D. 
Clinical Endocrinology and Diabetes Complications Program Director
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 699
Bethesda, MD 20892-5460
Telephone:  (301) 594-0021
FAX:  (301) 480-3503
E-mail:  bl99n@nih.gov

Peter Dudley, Ph.D.
Vision Research Program 
National Eye Institute
Executive Plaza South, Rm. 350
Bethesda, MD 20892
Telephone:  (301) 496-0484
FAX:  (301) 402-0528
E-mail:  pd8n@nih.gov

Venkat Narayan, M.D.
Center for Disease Control
Division Of Diabetes Translation
4770 Buford Highway NE
Atlanta, GA  30341
Telephone:  (770) 488-1051
FAX:  (770) 488-1148
E-mail:  kav4@cdc.gov 

o Direct your questions about peer-review issues, to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD 20817)
301-594-8897 (voice)
301-480-3505 (fax)
fc15y@nih.gov

o Direct your questions about financial or grants management matters to:

Florence Danshes
Grants Management Specialist
Division of Extramural Activities 
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 734
Bethesda, MD 20892-5456
Telephone:  (301) 594-8861
FAX:  (301) 480-3504
E-mail:  fd39j@nih.gov

Margie Baritz
Division of Extramural Activities
National Eye Institute
Executive Plaza South, Rm. 350
Bethesda, MD 20892-6600
Telephone:  (301) 496-5884
FAX:  (301) 496-9997
E-mail: mb615b@nih.gov

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.

APPLICATION RECEIPT DATES: All application instructions outlined in the PHS 
398 application kit are to be followed, with the following requirements for 
R34 applications:  

1.  R34 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" 
concepts, with direct costs requested in $25,000 modules, up to the total 
direct costs limit of $150,000 per year. 

2.  Although preliminary data are not required for an R34 application, they 
may be included.

3.  Sections a-d of the Research Plan of the R34 application may not exceed 
15 pages, including tables and figures.  

4.  R34 appendix materials should be limited, as is consistent with the 
exploratory nature of the R34 mechanism, 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 manuscripts (submitted or accepted 
for publication), 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: Applications with 
direct costs in each year of $250,000 or less 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.

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 
appendix material must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone:  (301) 594-8885
FAX:  (301) 480-3505
Email:  fc15y@nih.gov

APPLICATION PROCESSING: Applications must be received by/or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not 
accept any application in response to this PA that is essentially the same as 
one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS 

Applications submitted for this PAR will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score 
o Receive a second level review by the appropriate national advisory council 
or board.

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

(1) Significance:  Does this study address an important problem?  If the aims 
of your 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?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Do you acknowledge potential problem areas and consider alternative 
tactics? 

(3) Innovation:  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies? 

(4) Investigator:  Are you appropriately trained and well-suited to carry out 
this work? Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)? 

(5) Environment:  Does the scientific environment in which your 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? 

(6)  Translation:  Does the intervention strategy proposed have the ability 
to be translated into primary care, community, family or other patient 
care/support settings?

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application. Your 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. 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  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 included in the 
section on Federal Citations, below).

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

The following will be considered in making funding decisions: 
o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities

The NIDDK has recently announced it will decrease the use of one time 
solicitations (i.e., the request for application, or RFA, mechanism) and 
substitute use of special emphasis funding for selected program announcements 
(PA) to stimulate research in areas of particular importance. Applications in 
response to these Special Emphasis PAs will receive automatic consideration 
for funding beyond the regular grant payline.  The NIDDK is strongly 
committed to the support of translation research and has selected this PAR to 
be a special emphasis PA. Further information about NIDDK Special Emphasis 
PAs can be found at: http://grants.nih.gov/grants/guide/notice-files/
NOT-DK-03-001.html. Funding will also depend on the receipt of applications
of high scientific merit and the availability of funds for this purpose.

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND 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 audit 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 
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 RESEARCH INVOLVING HUMAN SUBJECTS:
It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," 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: 
It is the policy of NIH 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 the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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.

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. Reviewers are 
cautioned that their anonymity may be compromised when they directly access 
an Internet site.

HEALTHY PEOPLE 2010

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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.847 (NIDDK), 93.837 (NEI), 93.988 (CDC) and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review. Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulation 
42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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, and 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


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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