PATHWAYS LINKING EDUCATION TO HEALTH  

RELEASE DATE:  January 8, 2003
 
RFA:  OB-03-001
 
Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/) 
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
 
LETTER OF INTENT RECEIPT DATE:  February 28, 2003

APPLICATION RECEIPT DATE:  March 26, 2003 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

A substantial number of epidemiological and social science research 
studies have consistently found a moderate to strong association 
between educational attainment and a wide variety of illnesses, health 
problems, health behaviors and indices of overall health.  There is, 
however, considerably less research on the mechanisms and pathways by 
which education - particularly for non-health education - influences 
health. For this RFA, education refers to the comprehensive formal 
instruction that occurs in any level of schooling from kindergarten or 
before through graduate studies and includes the social and behavioral 
processes that are combined with formal instruction in educational 
environments.   The goal of this RFA is to increase the level and 
diversity of research directed at elucidating the causal pathways and 
mechanisms that may underlie the association between education and 
health. Better scientific understanding of the causal pathways between 
education and health could lead to additional and improved prevention 
and therapeutic intervention strategies for important health problems.  
In order to better understand these pathways, validation of specific 
measures of abilities crucial to educational attainment, such as level 
of cognitive or language skills, may be needed. Further exploration is 
needed of intervening neuro- or psychobiological mechanisms, such as 
impact on frontal lobe structure or function or psychological 
characteristics, and how these relate to a significant health outcome 
or important health related behavior or expected outcome. In addition, 
it will be necessary to explore what components or dimensions of 
education are important to health.  The association or pathway between 
formal education and either important health behaviors or diseases may 
not be causal. Instead it may reflect the influence of confounding or 
co-existing determinants or may be bi-directional. Research considered 
responsive to this solicitation may involve pilot studies, new analyses 
of existing data, small-scale intervention studies or innovative 
approaches tailored for the study hypotheses. It may involve new teams 
of multidisciplinary teams (e.g., education specialists, developmental 
psychologist, neurobiologists, and economists). However, This RFA is 
not directed at studies which limit their focus to the impact of 
specific health education courses or programs on health behaviors; 
rather, the focus is on the impact of the more general education 
experiences.
 
RESEARCH OBJECTIVES

Nature of Research Problem and Background:

Education along with income and occupation has been used repeatedly to 
define the social gradient in health that persists despite marked 
improvement in the health of the American population over 
the last hundred years. Generally individuals with lower income, less 
education and lower-status occupation/employment, requiring less 
education and/or providing less income, have poorer health.  The 
gradient is also generally monotonically related to education, income, 
or occupationally defined social class. The social gradient as defined 
by either education or income exists in all of the developed countries 
of the world, despite markedly different health care financing and the 
different ethnic/racial composition of these diverse countries. Both of 
these observations suggest that, regardless of the importance of other 
factors, education contributes directly and indirectly to the social 
gradient in health. Studies which have attempted to parcel out the 
independent contribution of education versus income generally have 
found that there is an apparent independent contribution of each 
factor, although it is clear that education also has a major impact on 
income and wealth. Greater understanding of the nature of the 
independent [non-income] relationships between education and health 
depends on increasing knowledge about the mechanisms and pathways that 
explain the association between education and health. Recent summaries 
of the scientific information on these possible relationships, however, 
have concluded that pathways and mechanisms by which education 
influences health are infrequently studied, poorly delineated, and 
deserve further study. Presentations from a workshop entitled 
"Education and Health: Building a Research Agenda," co-sponsored by 
Center for Health and Wellbeing, Princeton University, MacArthur 
Network on Socioeconomic Status and Health, and National Institutes of 
Health are available at 
http://www.wws.princeton.edu/~chw/conferences/conf1002/Agenda.html 

A review of the scientific literature shows associations between 
education and health across a broad range of illnesses, including 
coronary heart disease, many specific cancers, Alzheimer's disease, 
some mental illnesses, diabetes, and alcoholism. Some of these 
diseases, such as asthma, also have a strong environmental determinant. 
In addition, many important health risk factors for disease, such as 
use of cigarettes, have been linked to education. While for most 
diseases, the segments of the population with lower levels of education 
have higher risks of these diseases; there are a few diseases such as 
malignant melanoma where the incidence is higher in the most highly 
educated. 

However, more often education appears to be a protective factor. In 
some but not all studies of clinical treatments, those with lower 
levels of educational attainment demonstrated poorer outcomes. In a few 
studies of chronic diseases such as HIV or diabetes, the effectiveness 
of self-management and the adherence to medical treatment appears 
related to educational attainment. It also appears that some intensive 
treatment regimes may reduce the education gradient in treatment 
outcome. In other studies the apparent effectiveness of treatment such 
as studies of postmenopausal hormone replacement therapy and the 
primary prevention of cardiovascular disease, the treatment 
effectiveness was significantly reduced when adjusted for socioeconomic 
status. There is also little research on what specific aspect of the 
educational process or experience is linked to health. 
Therefore, research on education could be focused on either broad 
measures of health such as mortality or morbidity or focused on 
specific diseases such as cardiovascular disease, lung cancer, 
depression, diabetes, Alzheimer's disease, alcoholism, drug addiction, 
or environmentally related disorders. The research could focus on the 
pathways from education to the disease incidence, the disease severity, 
or the effectiveness of treatment in specific diseases. The research 
could also focus on health behaviors strongly associated with elevated 
risk of premature mortality or morbidity such as cigarette smoking or 
risky drinking or obesity. In addition the impact of education or the 
educational level of family members on health behaviors or disease 
could be examined at the different stages of the life cycle from 
childhood to late in adulthood. Because of the large number of 
associations between educational attainment and diseases or health risk 
factors, it will be important for research studies to focus on 
clarifying whether or not the associations that are already known to 
exist or new associations that are found are causal; such information 
will be critical in providing a basis for developing possible 
interventions. The research could also focus on the specific aspect of 
the educational process or experience that is most strongly linked to 
health.  

Several different types of biological, psychological and social 
pathways have been proposed as possibly explaining the association 
between education and health. Examples of possible psychological or 
social pathways include the following: 

o Education leads to higher incomes which allows the purchase of more 
health insurance, better housing, and other goods and services. This is 
one of few well-studied pathways. 

o Education might lead to greater optimism about the future, self-
efficacy sense of control, or different time preferences. Any of these 
psychological characteristics might alter health behaviors or adherence 
to medical treatments or ability to self manages chronic illnesses. 

o Education might improve important cognitive skills including 
literacy, enhanced decision-making, analytical skills, or other 
cognitive skills which in turn allow individuals to be more successful 
in managing their health problems,  in interacting with the health care 
system, or in preventing future health problems. 

o Education may improve health by laying the foundation for the 
individual's integration in to society, not only in terms of the 
learning acquired for effective functioning, but in terms of social 
competencies and the ability to function in hierarchical, structured 
settings.

o Because formal education often occurs at the stage of the life cycle 
when significant formation of health behaviors is also occurring, these 
behaviors may be either directly or indirectly influenced not only by 
specific formal educational experiences but also by the social context 
provided by the school. Individuals maybe affected by the behavior and 
norms of the other students. 

Education might influence the biological pathways including neurologic, 
inflammatory, and endocrinologic processes or structures.  Examples of 
possible biological pathways include the following: 

o Education may influence the level of the allostatic load in adult 
life  by switching the balance between protective and damaging effects 
of stress mediators. 

o Education may influence the structure or functioning of the 
prefrontal cortex, temporal lobe, or other parts of the brain, which in 
turn might effect stress related changes in  the immune, 
cardiovascular, or endocrine systems.

o Education might influence function or structure of these potential 
pathways during the period of formal education or prior to formal 
education but these changes might persist in adulthood and only become 
apparent later in the life cycle. 

o Education may influence cognitive reserve and thereby influence the 
risk of neurological diseases such as Alzheimer's Disease. 

Research Objectives

Because of the importance of additional information on the pathways 
that link education with a variety of diseases and health risk factors, 
researchers are encouraged but are not required to include in any 
research project both objectives directed at (1) better understanding 
the relationship between education and a specific disease or important 
health risk factor and (2) better understanding the relationship 
between one or more pathways that explain the association between 
education and health. Examples of possible relevant topics might 
include the following (but are in no way limited to this suggested 
list): 

o Studies to more accurately or completely characterize or measure 
education, since it is often measured simply as years of education 
without regard to the characteristics or nature of the educational 
experience.   Relevant aspects of the educational experience include 
the quality, content, and style of instruction, the structure of 
schools, and the socialization experiences associated with formal 
education. The purposes of these studies would be to increase the 
understanding of the relationship of education to diseases, health 
behaviors or prevention/treatment outcomes. Studies might also want to 
develop improved measures of cognitive, language, or analytical skills, 
acquired through education, that may mediate the effects of education 
on health.

o Studies of children or adults seeking to determine how education 
improves the ability of the individual to effectively prevent health 
problems. Studies might evaluate the relationship between education and 
health while also examining the impact of education on social networks, 
social support, skills in obtaining information, or traditional health 
behaviors e.g., diet) and utilization of preventive services (e.g., 
cancer screening). However, This RFA is not directed at studies which 
limit their focus to the impact of specific health education courses or 
programs on health behaviors; rather, the focus is on the impact of the 
more general education experiences. 

o Studies of whether and how education influences a patient's selection 
of type of treatment, ability to participate in the therapeutic regime, 
adherence and response to treatment, and health and therapeutic 
outcomes across different groups in the population, such as those with 
chronic illnesses or the elderly. 

o Studies of possible other psychological pathways such as self-
efficacy, self-esteem, coping effectiveness, depression, or sense of 
well-being. 

o Studies of education's impact on postulated physiological pathways 
such as those between the stress and cardiovascular disorders or 
significant change in inflammatory processes or CNS regulation of heart 
rate. 

o Studies of the timing of education and it's possible impact on 
psychological and physiological effects. For example, do the 
consequences for health outcomes differ if education is obtained in 
adulthood as compared to during the more traditional educational 
trajectory of grade school and high school? 

o Studies of how specific aspects, components, or dimensions of the 
educational process affect health.  For example, the relationship among 
school "tracking" policies, peer networks, and health-related behaviors 
in adolescence; the relationship between instructional styles and 
quality of teaching and health outcomes.

o Studies to determine whether the strength of the association between 
quantity and quality of education and better health varies across the 
population, time periods, and countries.

o Studies to determine the unique or independent contribution of 
education on mortality or morbidity, separate from other measures of 
socioeconomic status such as family income, wealth, occupation or 
social class during the different periods of life.  Similarly studies 
of whether education is a marker for some other causal factor such as 
pre-school experiences or health status.

o Studies to determine the role of education in the intergenerational 
transmission of  disease and the pre-disposition to disease over the 
life course. 

In summary the goal of this RFA is to increase the level and diversity 
of research directed at elucidating the causal pathways and mechanisms 
that may underlie the association of educational attainment and health. 
In order to advance the field, this type of research should include 
valid measures of education, assessments of key intervening mechanisms 
or pathways, and one or more significant health outcome or important 
health related behavior. Research in response to this RFA may include 
pilot or preliminary studies, new analyses of existing data, innovative 
approaches or comparisons between countries. It may involve teams of 
multidisciplinary researchers ranging from education or economics to 
molecular biology or neurobiology. It may involve one or more than one 
stage of the life course.  A better scientific understanding of the 
causal relationship between education and health, such as that which 
this solicitation seeks to support, could lead to additional prevention 
and therapeutic strategies for a wide range of important health 
problems.  

MECHANISM OF SUPPORT
 
This RFA will use NIH RO1 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, 
competing-continuation applications based on this project will compete 
with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures. The anticipated 
award date is September 30, 2003 to March 31, 2004. 

This RFA 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.

FUNDS AVAILABLE 
 
The participating IC(s) intends to commit approximately one and half 
million dollars in FY 2003 and an additional one million in FY 2004 to 
fund 5 to 10 new and/or competitive continuation grants in response to 
this RFA. An applicant may request a project period of up to 4 years 
and a budget for direct costs of up to $350,000 per year.  Because the 
nature and scope of the proposed research will vary from application to 
application, it is anticipated that the size and duration of each award 
will also vary. Although the financial plans of the IC(s) provide 
support for this program, awards pursuant to this RFA are contingent 
upon the availability of funds and the receipt of a sufficient number 
of meritorious 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 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
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.   
 
SPECIAL REQUIREMENTS 
 
The applications should include sufficient funds for one annual two-day 
trip for one or two investigators from the research team to meet with 
other funded investigators from this RFA in the Washington DC area. 
While there is no requirement for any coordination among funded 
projects from this RFA, because of the paucity of past research in this 
area, ongoing discussions among funded researchers should strengthen 
the overall research program and will be useful for NIH. 
 
WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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 to:

Lawrence J. Fine MD, Dr.PH.
Office of Behavioral and Social Science Research, Office of Director 
National Institute of Health 
Building 1 Room 256 MSC 0183
Bethesda, MD  20892
Telephone:  (301) 435-6780
FAX:  301-402-1150
Email: Finel@od.nih.gov

Georgeanne E. Patmios
National Institute on Aging, Behavioral and Social Research Program
NIH GATEWAY Building Room 533 
Bethesda, MD  20892
Telephone:  (301) 496-3138
FAX:  301-402-0051
Email: PatmiosG@nia.nih.gov

Helen I. Meissner, Ph.D., Chief 
Applied Cancer Screening Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Suite 4102
6130 Executive Boulevard, MSC 7331
Bethesda, MD  20892-7331
Rockville, MD  20852 (for express mail)
Telephone:  (301) 435-2836
FAX:  (301) 480-6637
Email:  hm36d@nih.gov

V. Jeffery Evans Ph.D., J.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1176
FAX:  (301) 496-0962  
Email:  evansvj@mail.nih.gov

o Direct your questions about peer review issues to:

Yvette M. Davis, V.M.D., M.P.H.
Center for Scientific Review, NIH/DHHS
6701 ROCKLEDGE Drive, Rm. 3152, MSC 7770
Bethesda, MD  20892
Telephone:  (301) 435-0906
Fax: (301) 480-3962
Email: DavisY@csr.NIH.GOV

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

Lawrence J. Fine MD, Dr.PH.
Office of Behavioral and Social Science Research, Office of Director 
National Institute of Health 
Building 1 Room 256 
Bethesda, MD  20892
Telephone:  (301) 435-6780
FAX:  301-402-1150
Email: Finel@od.nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows IC staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Lawrence J. Fine MD, Dr.PH.
Office of Behavioral and Social Science Research, Office of Director 
National Institute of Health 
Building 1 Room 256 
Bethesda, MD  20892
Telephone:  (301) 435-6780
FAX:  301-402-1150
Email: Finel@od.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.
 
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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and five signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
  
APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA 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 substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the (IC). Incomplete applications will be 
returned to the applicant without further consideration.  And, if the 
application is not responsive to the RFA, CSR staff may contact the 
applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.

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

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

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  What will be the effect of these studies on the concepts or 
methods that drive this field?

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

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

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

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

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

o 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.

o 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)

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

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

o OTHER REVIEW CRITERIA:  

The research must include at least one clearly defined measure of 
education, a potential pathway, and one or more risky or beneficial 
health behavior, or disease(s) endpoint. 

The research may be of a pilot or preliminary nature.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: February 28, 2003
Application Receipt Date: March 26, 2003
Peer Review Date: May 2003
Council Review: September or October 2003 or February 2004
Earliest Anticipated Start Date: October 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic 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.

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 RFA 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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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