TRANSLATIONAL RESEARCH FOR THE PREVENTION AND CONTROL OF DIABETES

RELEASE DATE:  August 22, 2002 

PA NUMBER: PA-02-153 (Reissued as PAR-06-457)
                     (Expiration date extended, see NOT-DK-05-011)
                     (see correction NOT-DK-02-008)

EXPIRATION DATE:  June 9, 2006

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
National Eye Institute (NEI)
 (http://www.nei.nih.gov)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov)
Agency for Healthcare Research and Quality (AHRQ)
 (http://www.ahrq.gov)
Centers for Disease Control and Prevention   Division of Diabetes Translation 
(CDC)  
 (http://www.cdc.gov)
American Diabetes Association (ADA)
 (http://www.diabetes.org)

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 
the National Eye Institute (NEI), the National Institute of Nursing Research 
(NINR), the Office of Behavioral and Social Sciences Research (OBSSR), the 
Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease 
Control and Prevention   Division of Diabetes Translation (CDC-DDT), and the 
American Diabetes Association (ADA) solicit research to translate recent 
advances in the prevention and treatment of type 1 or type 2 diabetes into 
clinical practice for individuals and communities at risk. This program 
announcement expands a diabetes prevention and control program established 
under PA 01-069, and seeks applications for 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.  Studies should focus on 
testing 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 clinical 
practice. Translational research related to obesity, a major risk factor for 
type 2 diabetes, is also needed. In particular, 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 diabetes 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 advances of these studies have not been successfully 
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 adult patients with diabetes, the risk of cardiovascular disease 
(CVD) is two to four fold greater than in nondiabetics. For cardiovascular 
disease, comorbid conditions (hypertension, dyslipidemia and 
hyperinsulinemia) combine with hyperglycemia to contribute to accelerated 
atherosclerosis. These additional risk factors may also contribute the 
microvascular disease. Thus, control of hyperglycemia, although critical, is 
not sufficient to substantially reduce morbidity and mortality. Available 
data demonstrate that patients with diabetes would benefit from more 
aggressive and 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., obesity and a sedentary lifestyle. The Diabetes 
Prevention Program (DPP) was designed 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 study results have been 
reported recently (NEJM, 346:393-403, 2002) and 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 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 (Pediatrics, 96: 
786-787, 1995, Health Psychol, 14:109-115, 1995). 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 (Addict Behav, 24:219-227, 1999, Int J Obes Relat 
Metab Disord, 24:893-898, 2000) 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 
near 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, the NINR, the OBSSR, AHRQ, the CDC-DDT, and the ADA 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, diabetes self 
control and reduction in risk at the health care system level, the provider 
level and the patient level. Trials 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 
laboratory or clinical investigations (e.g., intensive glycemic control, 
increased physical activity in individuals at risk for diabetes), and extend 
or adapt these interventions to larger populations or other settings. 

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 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 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 prevention and control projects should be effectiveness trials and will 
generally have the same research design as a single-center randomized clinical 
trial. There should be convincing preliminary data that show that the 
intervention has the potential to alter behavior and that the intervention can 
feasibly be carried out. The intervention should be clearly described. 
Applicants should provide a detailed description of the design of the study, 
including what eligibility, baseline and follow-up tests are to be done, what 
surrogate markers and endpoints will be examined, the duration of follow-up, 
and the statistical analysis to be employed. The process for biologic sample 
collection, storage and handling needs should be included. A description of 
the laboratory tests that are needed with appropriate methods for performing 
them should be provided. Applicants should describe their physical facilities, 
data management and computer resources, and facilities for data retrieval and 
storage.  Examples of data forms, questionnaires and software/computer 
programs should be included and described.  Methods for data collection, 
management and quality control procedures must be detailed. Applicants must 
include a plan for randomization of patients or settings for delivery of 
interventions into protocols.  Methods for assuring privacy and maintaining 
confidentiality should be included. There must be a data and safety monitoring 
plan. 

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, with an estimation of the 
potential number of patients who fit the eligibility criteria and expected 
accrual rates. 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").
 
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 may wish to consider assessment of cost-effectiveness as a 
secondary outcome measure.

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.  

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 Prevention and Control (P&C) Division of their DRTC.  A central 
purpose of the P&C Divisions 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 resources 
of a P&C Division, 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. 

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.

MECHANISM(S) OF SUPPORT 

This PA will use the National Institutes of Health (NIH) research 
demonstration and dissemination project (R18) award mechanism. This mechanism 
is designed to support the testing and evaluation of interventions and 
activities that lead to application of existing knowledge to disease control 
and prevention.  Responsibility for the planning, direction, and execution of 
the proposed project will be solely that of the applicant.  The total project 
period for an application submitted in response to this PA may not exceed 5 
years.  This PA uses just-in-time concepts.  

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 and 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.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

Letter of Authorization

Following notification by CSR of the Institute assignment, applicants should 
submit a brief letter to the appropriate program official (see below, 
"Inquiries") indicating whether or not they wish their application to be 
considered for funding by the ADA, the CDC and/or AHRQ. While applicants may 
request that their applications be considered only by the NIH and not by 
these other agencies, it is necessary that the record indicate the 
applicant"s consideration of this opportunity. For those applicants who wish 
to have these agencies consider their application, all materials relating to 
the application will be promptly forwarded to these agencies and the summary 
statements for such applications will be shared with these agencies when 
available.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
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. (for NIDDK-supported behavioral research) 
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK 
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. (for NIDDK-supported medical research)
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK 
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 
NEI
Executive Plaza South, Rm. 350
Bethesda, MD 20892
Telephone: (301) 496-0484
FAX: (301) 402-0528
E-mail: pd8n@nih.gov

Nell Armstrong, Ph.D., R.N.
NINR
Building 45, Room 3AN12
Bethesda, MD 20892 6300
Telephone, (301) 594-5973
FAX: (301) 480-8260
E-mail:  na21f@nih.gov

Lawrence J. Fine, M.D., Dr. P.H.
OBSSR
Building 1, Room 256
Bethesda, MD 20892
Telephone: (301) 435-6780
FAX: (301) 402-1150
E-mail: lf128x@nih.gov

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

Florence Danshes
Division of Extramural Activities 
NIDDK
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
NEI
Executive Plaza South, Rm. 350
Bethesda, MD 20892-6600
Telephone: (301) 496-5884
FAX: (301) 496-9997
E-mail: mb615b@nih.gov

Robert L. Tarwater
Office of Grants and Contracts Management
NINR
Building 45, Room 3AN12
Bethesda, MD 20892-6300
Telephone: (301) 594-2807
FAX: (310) 480-8260
E-mail: rt28o@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) 710-0267, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study, 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award, and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
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 PA 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 your 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 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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 your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your 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?

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

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

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 AMENDMENT "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. 

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.

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 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), 93.361 (NINR), 
93.226(AHRQ), and 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 284and administered under NIH 
grants policies described at http://grants.nih.gov/grants/policy/policy.htm 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

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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NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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