SOCIOBEHAVIORAL DATA ANALYSIS AND ARCHIVING IN AGING 

RELEASE DATE:  July 7, 2004

PA NUMBER:  PA-04-123

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. Accordingly, this funding opportunity 
expires on the date indicated below. A replacement R03 (PA-06-102) funding 
opportunity announcement has been issued for the submission date of June 1, 2006 
and submission dates thereafter. 

EXPIRATION DATE:  March 2, 2006 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Aging (NIA) 
 (http://www.nih.gov/nia/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.866
 
THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this PA
o Research Objectives
o Mechanism of Support 
o Funds Available
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 to: 1) stimulate and facilitate data archiving and secondary 
analyses of data related to caregiving, cognition, demography, economics, 
epidemiology, behavioral genetics and other behavioral research on aging; 2) 
provide support for preliminary projects using secondary analysis that could 
lead to subsequent applications for other research project grant award 
mechanisms; 3) provide support for rapid analyses of new databases and 
experimental modules for purposes such as informing the design and content of 
future study waves; 4) provide support for the development, enhancement and 
assembly of new databases from existing data; and 5) provide support for 
pilot research on under-utilized databases. This announcement updates and 
replaces a previous Program Announcement, Data Analysis and Archiving in 
Demography, Economics and Behavioral Research (PA-01-082, issued April 12, 
2001).  

RESEARCH OBJECTIVES

The NIA has supported the development of major data collection efforts in 
areas such as cognition, genetics, long term care, retirement and economic 
status, caregiving, behavioral medicine, and the dynamics of health and 
functional change in the very old.  This Program Announcement encourages 
secondary analysis and archiving of these data sources.  

In February 2003 NIH reaffirmed its support for the concept of data sharing 
and stated that data should be made as widely and freely available as 
possible while safeguarding the privacy of participants, and protecting 
confidential and proprietary data 
(http://grants.nih.gov/grants/policy/data_sharing/index.htm).  Many datasets 
have been assembled prior to the implementation of this policy and have not 
been made available to the research community. This Program Announcement 
provides the opportunity to archive such data to make the data available to 
the research community. 

Applications which are innovative and high risk with the likelihood for high 
impact are especially encouraged.  See also NIH Small Research Grant Program 
which permits original data collection on several of the topics below.

Examples of Areas of Investigation:

A. Archiving 
The NIH supports making data publicly available to the research community. 
Research teams can request funds under this Program Announcement for data 
archiving of previously un-archived data. Additionally, many analyses can be 
conducted on sensitive datasets which cannot be made publicly available in 
their original form, because they include geographic information or data 
linked to administrative records. Such data can be made available as a 
synthetic dataset which can be useful for data exploration by researchers. 
Work on creating synthetic datasets can also be supported. 

B. Biodemography of Aging 
Biodemography of aging:  including the demographic aspects of heritability 
and familial aggregation of disease and longevity and genetic variants; 
incorporation of genetic, biological, and disease variables into demographic 
models and age-specific mortality rates; the social roles of the elderly in 
nature; and biological mediators of the relationship between socio-economic 
status and health.  Of particular interest are analyses of biological 
measures which have been included in social and behavioral data collections 
as recommended by Cells and Surveys: Should Biological Measures Be Included 
in Social Science Research? (Washington, DC: National Academy Press, 2001.  
Also available at http://www.nap.edu.)  Analyses should target the correlates 
of these biomarkers with social and behavioral outcomes.   

C. Behavioral Genetics 
Ethical, legal, social, and economic implications of human genetic studies on 
aging. How would attrition rates be affected in longitudinal projects, how 
does collection of DNA influence willingness to participate in aging studies 
in general, and what are the larger factors (i.e, health insurance and 
privacy issues) that pose concern to study participants? Research assessing 
the role of demographic factors (e.g., age, sex, race/ethnicity) is also 
needed to understand cultural differences in perceptions of genetic research. 

D. Dementia 
Studies examining the impact of social relationships (e.g., social network 
structures, types, levels and quality of social support) on cognitive decline 
and dementia.  Also, demography and economics of dementia and Alzheimer's 
Disease in older populations.

E. Trends in Chronic Disease and Disability 
Investigation of the factors underlying the recent trend in declining 
disability in the older population. Determination and quantification of the 
causal factors underlying the trend (e.g. medical technological 
interventions, healthcare access and use, early life experiences, education, 
biomedical and social research advances, healthy  lifestyle behaviors and 
public health measures). International comparative analyses of declining 
disability in countries with different institutional and family structures 
are encouraged.

F. Living Arrangements 
Analysis of the factors that trigger movement of the elderly through various 
living arrangements, from independent living through the various forms of 
long- term care, and the functional and health-related outcomes associated 
with  residential options available to older persons. 

G. Healthcare and Policy Stimulations 
Economic analyses of the impact of aging-related biomedical and social 
research and resulting new technologies and interventions. Estimation of the 
impact of medical interventions on future lifetime health care costs.   
Estimation of the impact of health (including links with geography and 
demography) on economic development, especially in developing countries. (See 
The World Health Report  1999: Making a Difference.  World Health 
Organization.  Also available at  http://www.who.int/whr.).  Estimation of 
the impact of changes in the functional status of the older population on 
Medicare and other health care costs. Evaluations and simulations of the 
impact of changes in DHHS and SSA  policies (e.g. changing the age of 
eligibility for Medicare and Social Security  benefits, and expanding 
coverage to include prescription drugs) on the health  and functioning of the 
older population.

H. Burden of Illness 
Measurement of the magnitude and socio-economic consequences of burden of  
illness in the older population. Improved analysis and methodology to 
allocate and impute burden of illness, given the importance of comorbidity in 
the older population.  This may also include modeling risk factor 
trajectories and trends in non-communicable disease, disability and mortality 
in developed and developing countries, with emphasis on aging populations. 
Analyses and projections of the epidemiological transition in developing 
countries and research examining the demographic and economic impact of 
HIV/AIDS on population structure and the elderly, particularly in Africa and 
other developing countries. 

I. Health, Work and Retirement 
Implications of population aging for public and private retirement programs 
and for income security of future retirees; implications of women's life 
history (e.g., temporary exits from the labor force for child rearing and 
caregiving of older parents) on retirement income and savings adequacy;  
implications for late-life health and financial security of the timing of 
demographic events such as marriage, child-rearing, widowhood, etc.;  
determinants of retirement, family labor supply, and saving; consequences of  
retirement for health and functioning; comparative studies of labor force 
activity; effects of psychological factors (e.g. expectations, risk taking,  
personality, altruism, time preferences, etc.) and mental health  
characteristics (e.g. depression) on economic behaviors (e.g. savings and  
transfers); and economic and demographic analyses of employer- and 
organizational- level determinants of labor force participation at older 
ages. 

Research on the nature of work from the worker’s perspective is also 
encouraged. NIA cosponsored a report by the National Academy of Sciences 
titled the Health and Safety Needs of Older Workers.  This report suggested 
areas that merit investigation in this field and research on work and on 
older workers can consult this report. Copies can be obtained at 
http://books.nap.edu/catalog/10884.html. 

J. Race, Ethnicity and Socioeconomic Status 
Interactions between health and socio-economic status (and their cumulative 
relationship) over time and across generations.  Relationship among health, 
wealth and education; role of social cohesion as a mediating factor.  
Improved measures of socioeconomic position for aging populations; improved 
understanding of the mechanisms underlying associations between socio-
economic status and health including the economic determinants of health 
promotion and disease prevention behaviors. Research to disentangle the 
effects of socio-economic status, social and environmental factors, health 
behaviors, and race and ethnicity on health. 

Studies of the health of diverse racial and ethnic older populations and the 
health of small geographic areas.  Variables of interest include the effects 
of lifelong poverty, birth weight, access to and  utilization of employer-
provided health insurance, recency and circumstances of  immigration; the 
strain of physically demanding work; occupation; wealth, income and early-
life health status; and experiences of discrimination.  

Studies of the changing composition and conceptualization of race and 
ethnicity in the US and the effects on population health and health 
disparities; issues related to the development of racial and ethnic identity 
and to interactions among racial/ethnic identification and demographic, 
health, and other outcomes; and issues related to the measurement of race and 
ethnicity, including racial and ethnic self-identification. 

The National Academies of Science recently concluded a panel on Racial and 
Ethnic Differences in Health in Later Life in the United States. A report 
will be issued in June of 2004.  Applicants are encouraged to consult the 
findings of the report (see 
http://www7.nationalacademies.org/cpop/Race_Ethnicity_Heatlh.html) 

K. General Demography 
General demographic analyses of population aging, including: cohort analyses 
of aging, including the baby boom cohort; implications of changing family 
structures on caregiving needs; historical demographic and epidemiological 
research on the aging process and on the determinants of health and mortality 
in older populations; forecasting life and active life expectancy, health, 
medical services and long term care usage; migration and immigration; the  
impact of state and small area characteristics on health; improved 
descriptive analyses of centenarian populations; macro and micro dynamics of 
intergenerational exchanges; use of public and private resources in the 
period before death; and comparative international analyses of population 
aging using Census and other data.  

L. Meta-analysis 
Linking data sets for the purpose of conducting analyses (i.e. meta- 
analyses, mega-analyses). Applications are encouraged that combine raw data 
from different data collections to be explored in new and innovative ways in 
order to achieve new research aims, and/or to permit more breadth, precision, 
and reliability than can be achieved by the analysis of data from an isolated  
research study.

M. Caregiving 
Research on informal caregiving.  Research is encouraged on the transitions 
between various phases of the caregiving role, especially research on changes 
as a consequence of acquiring the caregiving role (pre- and post-caregiving).  
Research is also encouraged on the dyadic relationship between caregiver and 
care recipient.  Research is needed on the embedded nature of the caregiver 
in the community structure.  Such multi-level analysis is especially 
important.

N. Elder Mistreatment  
Research is encouraged using existing databases such as aggregated Adult 
Protective Service records or state-level data on incidence and prevalence of 
elder mistreatment.  Where adequate and existing data permit, research on the 
social determinants or risk factors associated with differential types of 
elder mistreatment is also needed.   

O. Behavioral Medicine and Interventions
Research is encouraged that examines the dynamic interrelationships among 
aging, health, and behavior processes and that emphasizes the influence of 
the socio-cultural environment on the development and maintenance of health 
and illness behaviors (e.g., healthy lifestyle practices, medical self 
management, and coping with chronic illnesses and disabilities).  Preliminary 
analyses that could lead to social, behavioral and environmental 
interventions for health promotion, disease prevention, and disability 
postponement are especially encouraged.

P. Cognitive Aging 
Research is encouraged that examines changes in cognitive functioning over 
the life course. Examples include studies that: examine the influence of 
contexts (behavioral, social, cultural, and technological) on the cognitive 
functioning and life performance of aging persons; investigate the effects of 
age-related changes in cognition on activities of daily living, social 
relationships, and health status; and develop strategies for improving 
everyday functioning through cognitive interventions.  Research is also 
encouraged on higher-order cognitive processes (e.g., problem-solving, 
decision-making), social cognition, memory strategies, perceptual skills, and 
reading and speech comprehension. Research is also welcomed that explores the 
role of individual difference factors in cognitive functioning (e.g., 
motivation, self-efficacy, beliefs about aging, emotions, sensory 
limitations, experience and expertise). 

Q. Psychological Development and Integrative Science.  
Research is encouraged that combines diverse levels of analysis and examines 
reciprocal interactions among these levels, such as the effects of 
sociocultural, psychological (social, personality), biological, and genetic 
processes on behavioral and functional aging.  

R. Early Life Determinants of Late-Life Health 
Research is encouraged that examines the influence of early life 
characteristics (e.g. childhood health, SES or exposure to infectious 
disease) on morbidity and mortality in later life. Comparative and historical 
work in this area is also encouraged. 

Priority will be given to proposals undertaking secondary analysis of 
publicly available datasets that NIA has supported.  Such datasets include: 
the  Alameda County Health and Ways of Living Study 1965, 1974, 1994, 1995 
Panel; Early Indicators of Later Work Levels, Disease, and Death; Health and 
Retirement Study; Hispanic EPESE; Human Mortality Database; Longitudinal 
Employe rHousehold Dynamics; Mexican Health and Aging Study; National 
Longitudinal Mortality Study; National Long-Term Care Survey;; Panel Study of 
Income Dynamics; 1990 Public-Use Microdata Sample for the Older Population 
and  the Comparable Samples from ECE Countries (collected by the UN/ECE/PAU); 
Resources for Enhancing Alzheimer’s Caregiver Health (REACH); Social 
Environment and Biomarkers of Aging Study (SEBAS); Swedish Adoption/Twin 
Study of Aging (SATSA) and the Wisconsin Longitudinal Study (WLS). 
Information about these and other datasets that have been supported entirely 
or in part by the NIA, and instructions on how the data can be accessed, can 
be found in the “Publicly Available Databases for Aging-Related Secondary 
Analyses in the Behavioral and Social Sciences,” available in hard copy or on 
the web at  http://www.nia.nih.gov/NR/rdonlyres/D2DC41DF-
3608-4785-A9BA-62B1138EB520/0/datasets.pdf.  
A number of NIA supported datasets are currently being developed and 
archived; research on these new data sources is encouraged. Information about 
new data sources can be found in the above-referenced document which is 
updated to include newly available data sources.   

Applicants are especially encouraged to refer to the Minority Aging and 
Health CD-Rom from the National Archive of Computerized Data on Aging (NACDA) 
offered to the research community through funding provided by NIA. A number 
of the datasets mentioned above are made available through NACDA at 
http://www.icpsr.umich.edu/NACDA/. 

Information on other initiatives supported by NIA may be found at the 
following Internet address: http://www.nia.nih.gov/ResearchInformation/
FundingAndTraining/CurrentFunding.htm

MECHANISM OF SUPPORT

Applicants responding to this PA will use the NIH Small Research Grant (R03) 
award mechanism.  The applicant will be solely responsible for planning, 
directing, and executing the proposed project. 

A project period of up to two years and a budget for direct costs of up to 
two $25,000 modules or $50,000 per year may be requested.  Some preference 
may be given to one year projects.  It is expected that most of the analyses 
proposed in response to this announcement can be completed within a year. 
However, a few analyses, especially those that propose to link multiple 
datasets, involve restricted confidential data, or involve collaborations 
among several sites may take more than one year.  For these reasons, up to 
two years of research may be supported. The particular reason or reasons for 
requesting the second year of support must be stated in the budget 
justification. 

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).   All 
applications submitted in response to this announcement must use the modular 
budget format. This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 
 
Competing continuation applications will not be accepted. Small grant support 
may not be used for thesis or dissertation research. Only one revision of a 
previously reviewed small grant application may be submitted. 

ELIGIBLE INSTITUTIONS
 
Application(s) may be submitted by institutions with 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 institutions/organizations
o Faith-based or community-based organizations 

A number of important datasets and archives are based in European and other 
countries (e.g., British birth cohorts, country-specific population 
registers).  Many of these data sets offer unique insights into aging and are 
important aids in interpreting patterns of aging in the U.S.  Domestic 
investigators are encouraged to collaborate with researchers at these foreign 
sites in order to access these datasets. Foreign-based investigators are also 
encouraged to apply for funding directly where it is clear that both the 
expertise and the data are at the foreign institution and of value to 
understanding aging in the U.S.

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

o Direct your questions about scientific/research issues to:

Elayne Heisler, Ph.D. 
Behavioral and Social Research Program
National Institute on Aging 
7201 Wisconsin Ave, Suite 533
Bethesda, MD 20892-9205
Telephone: (301) 496-3138
FAX : (301) 402-0051
Email:  eh164f@nih.gov  (e-mail correspondence is preferred) 

o Direct inquiries regarding financial or grants management matters to:

Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  lw17m@nih.gov (e-mail correspondence is preferred)

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. 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.

The title and number of this program announcement must be typed on line of 
the face page of the application form and the YES box must be checked.

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.

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

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 10 pages.  Please note that a Progress Report is not needed; competing 
continuation applications for a small grant will be not accepted.

o  Appendix. 
The appendix may include original, glossy photographs or color images of 
gels, micrographs, etc. provided that a photocopy (may be reduced in size) is 
also included within the page limits of the research plan.  No publications 
or other printed material, with the exception of pre-printed questionnaires 
or surveys, may be included in the appendix.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  All R03 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 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.

For the NIH Small Grant (R03), applicants may request direct costs in $25,000 
modules, up to a total, annual direct cost request of $50,000 for project 
periods up to two years.  

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 unfunded version 
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 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 written critique
o Receive a second level review by an appropriate national advisory council 
or board.  

REVIEW CRITERIA

The NIH R03 small grant is a mechanism for supporting discrete, well-defined 
projects that realistically can be expected to be completed in two years and 
that require limited levels of funding. Because the research plan is 
restricted to 10 pages or less, a small grant application will not have the 
same level of detail or extensive discussion found in an R01 application. 
Accordingly, reviewers should evaluate the conceptual framework and general 
approach to the problem, placing less emphasis on methodological details and 
certain indicators traditionally used in evaluation 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 from investigator-generated data. 
Preliminary data are not required, particularly in applications proposing 
pilot or feasibility studies. 

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 the application’s overall score, weighing 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:

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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH: The adequacy of plans to 
include subjects from both genders, and all racial and ethnic groups (and 
subgroups) as appropriate for the scientific goals of the research will be 
assessed.  

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   

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.

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

The 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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