CHRONIC ILLNESS SELF-MANAGEMENT IN CHILDREN

RELEASE DATE:  August 6, 2003

PA NUMBER: PA-03-159 (Reissued as PA-07-098[R03], PA-07-099[R21] and  PA-07-097[R01])

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for R01 Non-AIDS Applications: November 2, 2006 
EXPIRATION DATE for R01 AIDS and AIDS-Related Applications: January 3, 2007

National Institute of Nursing Research (NINR) 
 (http://www.ninr.nih.gov)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (http://www.niddk.nih.gov)
National Heart, Lung and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.361 (NINR), 93.865 
(NICHD); 93.849 (NIDDK), 93.837 (NHLBI)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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 purpose of this initiative is to solicit research to improve self-
management and quality of life in children and adolescents with chronic 
diseases. The study of children within the context of family and family-
community dynamics is encouraged. Children with a chronic disease and their 
families have a long-term responsibility for self-management of their health 
and illness. The child with the disease will have a life-long responsibility 
to maintain and promote health and prevent complications of the chronic 
disease. Research related to sociocultural, environmental, and behavioral 
mechanisms as well as biological/technological factors that contribute to 
successful and ongoing self-management of particular chronic diseases in 
children is encouraged. Proposals that include factors specific to age, 
developmental stage, family, community, culture, race/ethnicity, or social-
contextual issues are also encouraged. 

RESEARCH OBJECTIVES

Chronic diseases, for this announcement, are defined as illnesses that are 
lifelong in duration, treatable but rarely cured completely, and require 
persistent self-management behaviors that are shared by the child and family. 
The disease and health self-management behaviors required are ongoing rather 
than infrequent and intermittent. Note also that the NIH definition of 
children is anyone under the age of 21.

The first goal of Healthy People 2010 is to help individuals of all ages 
increase life expectancy and improve their quality of life. Chronic diseases 
that begin in childhood present a special challenge to both quality of life 
(QOL) and life expectancy. For example, severely obese children and 
adolescents have lower health-related QOL than children and adolescents who 
are healthy. Overweight is a chronic health condition that often begins in 
childhood, contributes to the risk of disease-associated morbidity, and 
requires self-management activities. The prevalence of overweight among 
children in the United States is continuing to increase in most populations, 
and especially among Mexican-American and non-Hispanic black children and 
adolescents. Chronic diseases and other chronic health conditions are 
estimated to occur in 20 to 30%, or 12 to 18 million, of the children and 
adolescents in this country. Seven to eight percent of children aged 5 to 17 
have activity limitations due to one or more chronic health conditions. These 
limitations often go beyond the physical state.  There can be a social stigma 
among affected children who often are socially ostracized.  This tends to 
intensify the underlying psychosocial determinants that lead to inappropriate 
self-management behaviors.  Enhanced awareness and greater self-management 
early on could help prevent exacerbation of the chronic illness or condition, 
and the associated adverse health outcomes. Children are affected by numerous 
chronic conditions, including, but not limited to, diabetes, chronic kidney 
disease, juvenile rheumatoid arthritis, epilepsy, cystic fibrosis, asthma, 
developmental disabilities, obesity, cerebral palsy, sickle cell disease, 
hemophilia, congenital heart disease, HIV/AIDS, genetic and other birth 
defects, low birth weight sequelae, and traumatic injuries. Although each 
chronic illness has distinct biological processes, there are numerous 
commonalities with respect to psychosocial, lifestyle, economic, quality of 
individual and family life, and health that have impacts on the child and 
family. 
 
Chronic illnesses affect the child throughout his/her life and also affect 
the family unit. The impact of day-to-day requirements, complexity of disease 
management activities, lifestyle, and family dynamics all may influence the 
effectiveness and long-term success of self-management and the health 
outcomes. Furthermore, chronic health conditions may affect the financial 
status, and social, community, and school interactions of the child and the 
family. The effectiveness of the management of the chronic illness, and its 
related health outcomes, depends on many family and health care system 
factors. 

The child or adolescent is affected personally by the pathology of the 
disease and by the required lifestyle and health management adaptations. The 
family are involved in the child's chronic illness management through 
requirements for care assistance, supervision/guidance, travel and time from 
work for health visits or hospitalizations, cost of care, and the impact of 
these requirements on family dynamics and lifestyle. It may be that health 
care providers have underestimated the complexity of the child and family 
needs related to personal responsibility and self-management actions.

Although there has been a focus in recent years on the self-management of 
chronic illness, most of this research has occurred in adult populations. 
Adherence studies that focus on a subset of the self-management process in 
children are most evident in the areas of asthma, diabetes, and HIV/AIDS. 
More research is needed on chronic illness self/family management in children 
and adolescents and intervention testing for relevance in this population, 
including diverse groups within the larger population of children with 
chronic diseases. 

This section describes a few examples of the many chronic health conditions 
that occur in children and require long-term self-management to reduce 
associated morbidity and mortality. The Health and Retirement Study, conducted 
in 1996, found that poor childhood health increases morbidity in later life. 
This association was found for lung disease, cardiovascular conditions, 
arthritis/rheumatism, and cancer. There is other evidence that children with 
poorly controlled diabetes could be included in this list as well. While there 
are little sound epidemiological data on childhood chronic illnesses as a 
group, there are data for individual diseases. 

In the US, asthma is the most common chronic disease of childhood and, in 
1999, the estimated annual cost of treating asthma in children in the US was 
$3.2 billion. Children with asthma miss about 10 million school days each 
year. The prevalence of asthma in children aged 0 to 17 years is reported in 
MMWR (2000) as 68% with increases of 5% per year for the years 1980-1995. 
About 1.6 million children have diabetes. There is a significant increase in 
type 2 diabetes in children and adolescents. Data culled from diabetes clinics 
in several locations suggest that the percentage of children diagnosed with 
diabetes who are classified as having type 2 diabetes has risen from less than 
5 percent (prior to 1994) to 20 to 30 percent (after 1994). Children who go 
undiagnosed until they become symptomatic may have been hyperglycemic for many 
years and are at high risk of developing diabetic micro- and macrovascular 
complications. These potential long-term and serious complications support the 
need for proactive self-management from diagnosis onward. Children who have 
insulin-requiring diabetes are three times more likely than their classmates 
to be hospitalized. 

About 285,000 children have juvenile arthritis. Juvenile arthritis has long-
term functional ability implications that may be improved with appropriate 
self-management behaviors. The incidence of end-stage renal disease (ESRD) in 
patients age 0 – 19 years in the United States is 15 per million people, 
according to the 2002 USRDS Annual Data Report. Exact numbers for patients who 
have chronic kidney disease, but do not yet require dialysis are not 
available, but are certainly higher than for those with ESRD. 

Children with a chronic disease face a lifetime of careful health management 
requirements and lifestyle adaptations to prevent or manage related health 
complications. Interventions that make a difference in childhood disease 
self-management may set the stage for health outcomes later in life. 

Scope

This announcement invites proposals for research focused on self-management 
in children with chronic diseases. Within this larger population of interest, 
it is desirable to see a range of study populations including representative 
as well as understudied groups including, but not limited to, specific racial 
or ethnic, rural, or economically disadvantaged groups.  The chronic diseases 
identified in this announcement should not be viewed as the only chronic 
diseases of interest. Interventions that have broad application across child 
and adolescent populations and chronic diseases are of particular interest. 
Understanding of heretofore unexplained cultural meanings/behaviors, family, 
child viewpoint, socio-contextual, psychosocial, and other factors relevant 
to child and adolescent chronic disease self-management are also of interest.

This announcement is open to descriptive studies that address important gaps 
in knowledge in order to provide direction for future interventions and to 
interventional studies that have strong translation potential for diverse 
settings and groups.

Areas in which such scientific opportunities exist include but are not limited 
to:

o Examine the influence of common management factors such as quality of life, 
psychosocial, culture, ethnicity, age, socioeconomic status, developmental 
stage, or social-contextual issues on chronic disease self-management in 
children.

o Examine factors that promote the transfer of different levels of self-
management responsibility to the child, including the relationship of age or 
stage of development.

o Determine whether approaches to self-management established in adults may 
be adapted to children with chronic diseases (examples: improved self-
efficacy, cognitive strategies, social support, provider/child/family 
partnership). 

o Test interventions that improve child and family functioning, self-
management, quality of life, biologic status, and health outcomes with 
management requirements of a child's chronic condition.

o Test self-management interventions for children in rural areas, medically 
underserved settings, and in racial/ethnic groups or explore factors that 
create barriers to self-management in these groups.

o Examine factors that are effective in sustaining proactive self-management 
behaviors and integrating them into routine lifestyle (school, home, 
community) activity across developmental stages of the child.

o Explore the impact of a child having a chronic illness on peer 
relationships, siblings, parents, and on family member roles and how that 
impact may affect self-management effectiveness. 

o Examine whether, or in what ways, diverse family constellations such as 
single parent, extended families, grandparents as guardians, or same-sex 
parents affect self-management of the child's chronic illness.

o Evaluate the impact of advances in treatment and technology on the 
management of chronic illness conditions in childhood and adolescence.

o Test interventions for family coping in chronic conditions that result in 
periodic acute illnesses, hospitalizations, or invasive therapies in regard 
to seamless care, coping during acute phases, and the child/family/provider 
partnership.

MECHANISMS OF SUPPORT 

This PA will use the NIH R01 and R21 award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the proposed 
project.  The objective of the R01 mechanism is to support a discrete, 
specified circumscribed project. The objective of the 
exploratory/developmental mechanism (R21) is to encourage applications from 
individuals who are interested in testing innovative or conceptually creative 
ideas that are scientifically sound and may advance our understanding of self-
management for children with chronic diseases. Investigators are encouraged to 
explore the feasibility of an innovative research question or approach that 
will provide a basis for future research projects. Exploratory/developmental 
grants (R21) are limited to 2 years of support with a combined budget for 
direct costs of up $275,000 for the two year period.  For example, the 
applicant may request $100,000 in the first year and $175,000 in the second 
year.  The request should be tailored to the needs of the project. Normally, 
no more than $200,000 may be requested in any single year.  Please see the 
NIH-wide R21 program announcement (PA-03-107) (see 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Please see the 
"Submitting an Application" section for more details. 

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (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.  Otherwise follow the instructions for non-
modular research grant applications.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.

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

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Dr. Nell Armstrong
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-5973
FAX:  (301) 480-8260
Email:  armstrongn@mail.nih.gov

Dr. Lynne M. Haverkos
Behavioral Pediatrics and Health Promotion Research Program
National Institute of Child Health and Human Development
6100 Executive Blvd., Rm. 4B05, MSC 7510
Bethesda, MD  20892-7510 
(Rockville, MD  20852 for Fed Ex or UPS)
Phone:  (301) 435-6881
FAX:  (301) 480-0230
E-mail:  haverkol@mail.nih.gov

Dr. Marva Moxey-Mims
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 639, MSC 5458
Bethesda, MD  20892-5458
Phone:  (301) 594-7717   
FAX:  (301) 480-3510
E-mail:  Moxey-MimsM@extra.niddk.nih.gov

Dr. Susan Czajkowski
Behavioral Medicine Research Group
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge 2, Room 8114
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 435-0406
FAX: (301) 480-1773 
E-mail: CzajkowS@nih.gov

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

Ms. Diane Drew
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-2807
FAX:  (301) 451-5651
Email:  dianedrew@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.

SUPPLEMENTAL INSTRUCTIONS:  All instructions for the PHS 398 (rev. 5/2001) 
must be followed, with these exceptions for R21 applications:

o Research Plan

Items a - d of the Research Plan (Specific Aims, Background and Significance, 
Preliminary Studies, and Research Design and Methods) may not exceed a total 
of 15 pages.  No preliminary data is required but may be included if it is 
available.  Please note that a Progress Report is not needed; competing 
continuation applications for an exploratory/developmental grant will not be 
accepted.  

Appendix. Use the instructions for the appendix detailed in the PHS 398 
except that no more than 5 manuscripts, previously accepted for publication, 
may be included.

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 MODULAR GRANT APPLICATIONS: 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.

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 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.  

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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review groups 
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

The scientific review groups 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? 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?

INNOVATION: Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

The NIH R21 exploratory/developmental grant is a mechanism for supporting 
novel scientific ideas or new model systems, tools or technologies that have 
the potential to significantly advance our knowledge or the status of health- 
related research.  Because the research plan is limited to 15 pages, an 
exploratory/developmental grant application need not have extensive 
background material or preliminary information as one might normally expect 
in an R01 application.  Accordingly, reviewers will focus their evaluation on 
the conceptual framework, the level of innovation, and the potential to 
significantly advance our knowledge or understanding.  Reviewers will place 
less emphasis on methodological details and certain indicators traditionally 
used in evaluating the scientific merit of R01 applications including 
supportive preliminary data. Appropriate justification for the proposed work 
can be provided through literature citations, data from other sources, or, 
when available, from investigator-generated data.  Preliminary data are not 
required for R21 applications.    

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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data. 

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 

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 and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
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, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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 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 PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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