NIA PILOT RESEARCH GRANT PROGRAM

RELEASE DATE:  January 24, 2002 (supercedes PA-01-037, superceded by PAR-03-056)

PA NUMBER:  PAR-02-049

EXPIRATION DATE:  November 15, 2002, unless reissued.

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute on Aging

Application Receipt Dates:  March 15, 2002, July 15, 2002, November 15, 2002

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism 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 National Institute on Aging (NIA) is seeking small grant (R03) 
applications in specific areas to: (1) stimulate and facilitate the 
entry of promising new investigators into aging research, and (2) 
encourage established investigators to enter new targeted, high 
priority areas in this research field.  This Small Grant (R03) Program 
provides support for pilot research that is likely to lead to a 
subsequent individual research project grant (R01) that is focused on 
aging and/or a significant advancement of aging research.  

RESEARCH OBJECTIVES  

The topics in this announcement are grouped according to their 
relevance to the different priority areas within NIA's five-year 
strategic plan:  http://www.nia.nih.gov/AboutNIA/StrategicPlan/.  You may 
apply for a small grant in one of the numbered topics below.  
Applications for support in other areas will be returned to you without 
review.  You should follow the instructions described under APPLICATION 
PROCEDURES to identify the topic on which the application is focused.  

Improve Health and Quality of Life of Older People:

1. HIV/AIDS and Aging:  Behavioral, social, clinical, neuroscientific, 
and/or biological research on older people at risk for, or infected by, 
or affected by, HIV/AIDS.  Social, economic, comorbid and other health 
risks and consequences of HIV/AIDS for older persons as parents and 
relatives of HIV infected adults, in both developed and developing 
countries. Prevention sciences research is encouraged, and both basic 
and applied research are welcomed.  

2. Cardiovascular and Cerebrovascular aging: Behavioral, social, 
cellular, and molecular studies of cardiovascular and cerebrovascular 
aging.  N.B. Applications for clinical studies, exclusively on the 
aging cardiovascular system, will not be accepted in response to 
this announcement.

3. Alzheimer's Disease Drug Discovery:  Studies for preclinical 
research in the discovery, design, development and testing of novel 
compounds aimed at immunological and other approaches to delaying 
decline in cognitive function, and to preventing, slowing the 
progression of, or delaying the onset of Alzheimer's disease. 

4. Transmissible Spongiform Encephalopathies (TSEs):  Research is 
encouraged on the development of methods for screening, diagnosis, and 
mechanisms of action of prions in the production of TSEs in the aging 
organism.  Of special interest are understanding the susceptibility of 
the aging nervous system to these agents, and the roles played by the 
normal cellular forms of prions in the functioning of the aging brain.

5. Vaccine Development: Preliminary basic and clinical studies, and 
therapeutic trials of vaccines for use in elderly populations: Vaccines 
may be prophylactic or therapeutic in nature.  These may include 
studies of methods to enhance the immune response in older persons 
including alternative administration schedules with existing vaccines, 
the use of adjuvants, and/or new vaccines.  

6. Health-related Consequences of Female Reproductive Aging: Basic 
molecular and cellular research to elucidate underlying neuroendocrine, 
endocrine and physiologic mechanisms of the female reproductive aging 
process, especially 1) changes across the hypothalamic-pituitary-
ovarian axis leading to menopause in women, 2) hormonal and other 
changes in the menopausal process associated with increased risk for 
peri- and postmenopausal health problems and conditions, and 3) age-
related changes in the biology of hormone action and metabolism.

7. Cancer in the elderly:  Studies in persons aged 70 years and older 
regarding incidence, survival, and clinical impact in cancers of the 
breast, prostate, colorectal, lung, ovarian, and pancreas are 
encouraged.  Research topics include tumor-related tissue studies, 
autopsy investigations, characterization of cancer as it interfaces 
with pre-existing health conditions (i.e., comorbidity), overcoming the 
practical problems of acquiring data on this age segment of cancer 
patients, and quality of survival.  Studies with a focus on home and/or 
nursing home settings are appropriate. Patterns of care and treatment, 
development of clinical evaluation tools specific for the elderly 
(e.g., prognostic indicators, geriatric assessment) that can be used by 
physicians to determine the patients' overall physical and physiologic 
health status are also included in this solicitation. 

8. Basic Research in Behavioral Medicine:  Pilot studies of basic 
processes in behavioral medicine are solicited.  These may include bio-
behavioral linkages, social and psychological risk factors of illness 
and disease, the role of social support, social networks, and social 
stressors in the etiology and epidemiology of disease, and processes 
leading to disease illness recognition.  Pilot research in these areas 
is intended to develop basic principles, methods, and approaches for 
more generalizable research on behavioral medicine related topics.  
Multi-level approaches, integrating social, psychological, and 
biomedical concepts and approaches is especially solicited (see:  New 
Horizons in Health: An Integrative Approach. National Academy Press, 2001). 

9. Impact of Research on Health or Public Policy: Studies are solicited 
that will assess the impact of research and its translation on, for 
example, public policy, and the health, well-being and economic status 
of the elderly in terms suggested by the Government Performance and 
Results Act (GPRA).   Historical, bibliometric and econometric studies 
of the determinants and rate of progress in social and behavioral 
sciences related to aging are also welcomed.   

Understand Healthy Aging Processes:

10. Stems Cells, Tissue Repair, and Cell Replacement in Aging:  Studies 
on the biology of stem cells as a function of aging and disease; 
genetic and environmental effects on tissue stem cells; stem cell 
plasticity; development of cell markers and imaging techniques to 
identify and monitor stem cells in vivo; and transplantation of stem 
cells to effect tissue repair. Of interest is research that focuses on 
various aging tissues or physiological systems, including 
cardiovascular, musculoskeletal, immune, urogenital, endocrine and 
nervous systems. NIH has published guidelines for research using human 
pluripotent and embryonic stem cells and procedures to be used in 
applying for NIH research funding for this activity. If you intend to 
use these cells please read the relevant federal citation at the end of 
this announcement.

11. Sensory and Motor Processing:  Mechanisms underlying age-related 
and age-related disease changes in sensory and motor processing in the 
central nervous system. 

12. Cognition in Context: Studies to understand how different 
contextual factors produce systematic variation in cognitive 
functioning and performance. Of particular interest is what happens in 
the contexts of school, workplace, or social networks to shape the mind 
and brain, bringing about differences in cognition that endure through 
the life span.  Additional contextual factors of interest include early 
life experiences, physical and social characteristics of the 
environment at home, and the attitudes and beliefs of others about 
cognitive aging. 

13. Membranes, Extracellular Matrix and Cytoskeleton: Studies on age-
related changes in the structure, content, or function of cell 
membranes, the extracellular matrix and cytoskeleton, including 
regulation of cell signaling cascades, intracellular transport 
mechanisms, cell motility and morphology, and cell death. 

14. Functional Senescence: Genetic, physiological, cellular and 
biochemical mechanisms that underlie age-related changes leading to 
dysfunction in tissues, systems, or organs. 

15. Psychoneuroimmunology: Studies of how neural and neuroendocrine 
mechanisms interact with immune pathways to modulate the aging immune 
system response to psychological and pathological challenges, and 
studies to understand the mechanisms underlying "placebo" effects 
with age. 

16. Caloric Restriction and Aging: Studies that explore whether 
intermediary metabolism changes with advancing age and/or caloric 
restriction, and whether there is a relationship between age-related 
and caloric restriction-related changes in metabolism. Studies on 
changes in neuroendocrine, neuropeptide or neurochemical pathways as 
possible mediators of caloric restriction effects.  (N.B. Applications 
for clinical studies responding to this topic will not be accepted, 
with the exception of responses to topic #21 below.)

17. Basic Underlying Mechanisms of Musculoskeletal Aging (muscle, bone, 
cartilage, neuromuscular junction, peripheral nerve, and motorneuron): 
Applications for clinical studies on the aging musculoskeletal system 
will be considered non-responsive to this research bullet. 
Investigators interested in submitting exploratory/pilot clinical 
studies of the aging musculoskeletal system are encouraged to contact 
the Geriatrics Program (E-mail:  Gpquery@exmur.nia.nih.gov) to explore 
other options.

18. Exceptional Human Longevity: Studies of genetic and other factors 
contributing to exceptional longevity and/or exceptional healthy 
longevity (i.e., maintenance of health through very advanced ages) in 
humans. Study populations of interest include very old individuals, 
their offspring, and other family members.

19. Genetics, Behavior and Aging: Genetic studies to advance our 
understanding of behaviors that affect aging (e.g., response to 
interventions, health behaviors, personality, social functioning and 
coping, everyday functional competence, cognition) using humans or non-
human models.  Research is solicited that examines aging and behavior 
from diverse levels of genetic analysis including evolutionary, 
population, biodemographic, quantitative or molecular approaches. 
Considerable pilot work is needed to develop and apply new 
methodologies to study genes and environments in developmentally 
dynamic ways, design approaches that combine different levels of 
genetic analysis, and to identify and construct meaningful measures of 
environmental contexts that modify genetic risk and are of particular 
relevance for healthy aging.

Reduce Health Disparities Among Older Persons and Populations:

20.  Racial/Ethnic Differences and Health Disparities:  (a) Research 
leading to identification of underlying mechanisms, including cellular 
and molecular mechanisms, linked to racial/ethnic differences in late 
life function or disease e.g. cognition, Alzheimer's disease, 
cardiovascular disease, osteoporosis, cancer, infectious diseases, and 
diabetes. (b) Research to disentangle the effects of socio-economic 
status, social and environmental factors, health behaviors, and race 
and ethnicity on health; and (c) Research to develop and improve 
instruments and methods, including standardization across population 
groups, to measure disorders, disease and disability in minority groups 
that will lead to an understanding of the causes of these conditions. 
NIA's strategic plan for addressing health disparities is available 
from:  http://www.nia.nih.gov/AboutNIA/StrategicPlan/StrategicPlanHD/.

Enhance Resources to Support High Quality Research:
 
21. Refinements in Doubly-Labeled Water Methods for Human Studies of 
Effects of Altered Caloric Intake and Physical Activity:  Optimization 
(e.g., changes in isotope dose, frequency of dosing and sampling, etc.) 
of existing doubly-labeled water (DLW) protocols to assess changes in 
energy expenditure in humans following dietary modifications; 
development and validation of new DLW protocols for monitoring 
adherence to dietary or physical activity interventions in community-
dwelling individuals.    

22. Animal Models of Aging: Development of new and informative animal 
models for aging research, including genetically defined and or 
genetically altered animals. 
 
23. Tools for Research on the Genetics and Proteomics of Aging: 
Development of tools such as cDNA full length libraries, single 
nucleotide polymorphism (SNP) analysis, and conditional gene expression 
systems for studying the genetic basis of aging; and development of 
tools such as protein microarrays, antibody-based amplification 
methods, and fluorescent-based techniques for studies on proteomics 
(protein expression, modification, and interaction) of aging. 

24. Improved Measures and Methodologies:  Improved measures are needed 
of adaptation to chronic and acute illnesses and associated disability, 
including the costs of adaptation and coping on well-being. Innovative 
methods are needed that reconcile changes in objective and subjective 
measures of well-being over the natural history of aging-related 
diseases. Summary measures of health and the burden of illness that can 
be used in a national health accounts system are badly needed. Measures 
of cumulative social, psychological and cultural advantage or adversity 
are also sought.  Cross-national studies to harmonize and validate 
measures are also welcomed, as are innovative methods for melding 
laboratory, clinical or ethnographic approaches with large-scale 
population studies. 

The National Institute on Aging will modify the selected topic areas 
annually by reissuing the program announcement. Information on other 
initiatives supported by NIA may be found at the following internet 
address:  http://www.nia.nih.gov/.  

MECHANISM OF SUPPORT  

This PA will use the NIH R03 award mechanism. As an applicant, you will 
be solely responsible for planning, directing, and executing the 
proposed project. You may request either $25,000 or $50,000 in direct 
costs for one year.  These awards are not renewable. Before completion 
of the R03, you are encouraged to seek continuing support for research 
through a research project grant (R01).  This PA uses just-in-time 
concepts.  It also uses the modular budgeting format. (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).

Replacement of the Principal Investigator on this award is not 
permitted.  Revisions of applications previously reviewed under this 
initiative but unfunded are not permitted.  A new application must be 
substantially different from one previously reviewed and have a 
different title in order to be accepted for review. It must focus on 
one of the topics in the announcement that is active when the new 
application is submitted. All applications will be reviewed as 
new applications.  

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations, including faith-based 
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  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

New or established investigators are eligible to apply for this award.  
(1) You are considered a new investigator when you are neither a 
current nor former principal investigator on an NIH research project 
(R01), FIRST Award (R29), sub-project of program project (P01) or 
center grant  (P50), or the equivalent. If you are in the final stages 
of training you may apply for an R03 but no award will be made to 
someone who is still in training or fellowship status at the time of 
award (see reference to Biographical sketch under Application 
Procedures). (2) To be eligible as an established investigator you must 
propose research that is unrelated to any federally-funded research 
project in which you participate. Women, 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, peer review, and 
financial or grants management issues:

o Direct your questions about scientific/research issues with primary 
emphasis on the biology of aging to:

Dr. David B. Finkelstein
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C231, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-6402
FAX:  (301) 402-0010
Email:  BAPQuery@nia.nih.gov

o Direct your questions about scientific/research issues with primary 
emphasis on behavioral and social research on aging to:

Ms. Angie Chon-Lee
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 5C533, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 594-5943
FAX:  (301) 402-0051
Email:  BSRQuery@nia.nih.gov

o Direct your questions about scientific/research issues with primary 
emphasis on the neuroscience and neuropsychology of aging to:

Dr. Judy Finkelstein
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email:  NNAQuery@nia.nih.gov

o Direct your questions about scientific/research issues with primary 
emphasis on geriatric research to:

Ms. Wanda Solomon
Geriatrics Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3E327 MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 435-3046
FAX:  (301) 402-1784
Email:  GPQuery@nia.nih.gov

o Direct your questions about peer review issues to:

Dr. Mary Nekola
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Telephone:  (301) 496-9666
FAX:  301-402-0066
Email:  NekolaM@nia.nih.gov

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

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  WhippL@nia.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.

Applications 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 
responding to this PA request either one or two $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.

Abstract: The first line of the abstract must list the number and title 
of the particular research topic (see RESEARCH OBJECTIVES) being 
responded to.   

Biographical sketch:  If you are in training or in fellowship status at 
the time of application you should list in your biographical sketch the 
position you will occupy at the time of award with the expected start 
date in that position. If the position is contingent on receipt of the 
award then you should describe it as "contingent on award".  

Research plan: Do not exceed a total of ten pages for the following 
parts (a-d): Specific Aims, Background and Significance, Preliminary 
Studies/Progress Report, and Research Design and Methods.   Tables and 
figures are included in the 10 page limitation.   Applications that 
exceed the page limitation or PHS requirements for type size and 
margins  (Refer to PHS 398 application for details) will be returned to 
you.  The 10 page limitation does not include parts e through i. (Human 
Subjects Research, Vertebrate Animals, Literature Cited, 
Consortium/contractual Arrangements, Consultants).  

Appendix: The only items that may be included in an appendix are 
original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (that may be reduced in size) is also 
included within the 10 page limit of items a-d in the research plan. No 
photographs or color images may be included in the appendix that are 
not also represented in the research plan. Do not include publications 
or preprints.  

Materials submitted after the receipt date. No additional materials 
pertaining to a particular application will be accepted after the 
receipt date for which the application is submitted except for 
certifications of Institutional Review Board (IRB) or Institutional 
Animal Care and Use Committee (IACUC) approval. As specified in the PHS 
398 form, certifications of IACUC approval must be received within 60 
days after the receipt date for which the application is submitted. IRB 
approval is no longer required prior to review. Institutions should 
proceed with IRB review of those applications identified as in the 
fundable range following review. See 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the checklist, and three signed 
photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

In addition, to prepare for review of the application, submit two 
additional exact photocopies of the application directly to:  

Dr. Mary Nekola
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD  20892-9205  

It is important that you submit two additional copies to the Scientific 
Review Office as requested.  Amended applications will not be accepted.  

APPLICATION PROCESSING: Applications must be received by one of the 
dates listed on the first page. Applications for this PA must focus on 
one of the 24 topics identified (see Research Objectives).  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

PEER REVIEW PROCESS

Upon receipt applications will be reviewed for completeness by CSR. An 
appropriate scientific review group convened by NIA 
(http://www.csr.nih.gov/Committees/cmtelist2.asp?ABBR=NIA) 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 and may 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.

REVIEW CRITERIA

The NIA R03 pilot grant program supports discrete well-defined projects 
that may be completed in one year, that focus on one of the numbered 
topics listed in this announcement, and that require the specified 
level of funding. Because the research plan is limited to 10 pages, a 
small grant application will not have as much detail as an R01 
application. Accordingly, review will focus on the conceptual framework 
and general approach to the problem, placing less emphasis on 
methodological details and certain indicators traditionally used in 
evaluating scientific merit (e.g., supportive preliminary data). 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 the 
stated 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?

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).

DATA SHARING:  The adequacy of the proposed plan to share data, 
if appropriate.
 
BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

OTHER REVIEW CRITERIA:  The initial review group will also examine: the 
likelihood that the pilot project will lead to the development of an 
R01 application, or significant advancement of aging 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 

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 auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998:  
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

All investigators proposing clinical research should read the 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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at 
http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).  It is the responsibility of the applicant to 
provide the official NIH identifier(s)for the hESC line(s)to be used in 
the proposed research.  Applications that do not provide this 
information will be returned without review. 

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

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

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. 93.866 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 
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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Research (OER)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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