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
https://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 https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
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
https://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
https://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:
https://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:
https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://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
https://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
https://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
https://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 https://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.