and Human Services (HHS)
EXPIRED
THE IDENTIFICATION AND PREVENTION OF MIDDLE CHILDHOOD PRECURSORS OF RISKY
SEXUAL BEHAVIOR
RELEASE DATE: April 30, 2002
PA NUMBER: PA-02-101
EXPIRATION DATE: February 1, 2005, unless reissued.
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
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 of Child Health and Human Development (NICHD), the
National Institute of Mental Health (NIMH), the National Institute of Nursing
Research (NINR), and the National Institutes of Health (NIH) Office of AIDS
Research (OAR) invite applications proposing biobehavioral and neuroimaging
studies of children ages six to 12 years to identify the precursors of risky
sexual behavior. Risky sexual behavior is defined for this Program
Announcement (PA) as any sexual intercourse before the child or adolescent is
cognitively, emotionally, and physically prepared for the potential
consequences. The goal is to prevent early, unwanted pregnancy and the
transmission of sexually transmitted diseases (STDs), including HIV, during
childhood and adolescence by identifying antecedents of risk, resilience
factors, and effective interventions. The specific aims of this PA are to:
(1) identify the interactions of individual characteristics (biologic,
behavioral, cognitive, developmental, gender, genetic, and temperament) with
environmental factors (family, peers, community, culture, school, religion,
media, and socioeconomic status) during the middle childhood years that
increase the likelihood that certain children will engage in risky sexual
behavior, (2) identify the characteristics (biologic, behavioral, cognitive,
developmental, emotional, genetic, social, cultural, and environmental) that
protect children from participation in risky sexual behavior, and (3)
develop, implement, and evaluate interventions designed for children between
the ages of six and 12 years to promote healthy sexual development and
prevent risky sexual behavior. Principal Investigators may elect to study
any one or a combination of the aims stated above. This PA particularly
encourages interdisciplinary approaches to research, and the design and
evaluation of theory-driven, effective interventions.
RESEARCH OBJECTIVES
Risky sexual behavior is occurring at earlier ages, at higher rates in
minority youths, and with serious potential consequences such as pregnancy
and STDs. This PA encourages research to study the antecedents of risky
sexual behavior, the influences promoting resilience, and the processes by
which intrinsic and extrinsic factors influence sexual development and
behavior. Investigations of the development of sexuality and sexual health
behavior in middle childhood are also of interest. This knowledge of
antecedents, processes, and influences will guide the development of
effective prevention programs to delay the onset of risky sexual behavior.
Applications proposing epidemiologic studies are invited to study the
processes by which biological and environmental characteristics, and
interactions among them, influence sexual health behavior in children. Also
highly encouraged are intervention studies that promote academic success,
support effective, nurturing parenting and mentoring, and identify effective
motivational strategies to deter the early onset of risky sexual behavior.
Gene, neuroendocrine, and neuroimaging studies to delineate the links between
risky sexual behavior and biological underpinnings are also welcomed.
This PA is designed to further stimulate research involving children ages six
to 12 years designed to 1) identify antecedents of risky sexual behavior, 2)
understand and encourage healthy sexual development and behavior, and 3)
prevent sexual behavior before the child or adolescent is cognitively,
emotionally, and physically prepared for the potential consequences.
Research proposals may address the entire middle childhood age spectrum (six
to 12 years of age) or selected years within this age range.
Background
Health behaviors, including sexual health behaviors, are normal aspects of
human development that begin in childhood and adolescence, and influence
physical and mental health throughout life. The rate of sexual development,
although fairly standard for humans, shows remarkable variability among
individuals and influences sexual health behavior. When sexual development
precedes cognitive and emotional development, sexual experimentation may lead
to unintended pregnancy and/or exposure to a variety of STDs.
The teen pregnancy rate in the United States is among the highest of the
industrialized nations. An early, unintended birth can disrupt the
adolescent"s life and that of her siblings, parents, and the infant"s father.
Teenage mothers face potential limitations on educational achievement and
employment opportunities, and an increased likelihood of need for public
assistance. For young fathers, premature marriage and/or parenthood can
profoundly disrupt their earning patterns. Four potential concerns for the
children born to teenage mothers include low birth weight, prematurity,
infant mortality, and developmental problems.
Adolescents represent one of the fastest-growing risk groups for HIV in the
United States, with approximately a quarter of all new STD infections
occurring in teenagers. According to the Youth Risk Behavior Surveillance of
1997, nearly half of all high school students surveyed had initiated sexual
intercourse. Sexual experience and age at first intercourse are critical
indicators of the risk of pregnancy and sexually transmitted diseases. Inner
city, minority youths are at particular risk because of the documented
greater concentration of HIV and STDs, the earlier age of initiation of
unplanned, unprotected sexual practices with multiple partners, and the
disproportionate impact of AIDS on minorities.
Little is understood about the identification, development, expression, and
prevention of precursors of risky sexual behavior occurring during middle
childhood. Between ages six and 12 years, children spend more time with
peers, in formal learning environments, and away from parents. This period
of expanding cognitive competence may be the ideal time for the development
of sound health habits. Recent research indicates that later elementary
school-age children may be more receptive to learning about AIDS than
children in junior high school.
What is known is that risky sexual behavior occurs at younger ages and
contributes to unwanted pregnancy and sexually transmitted diseases,
including HIV, in adolescents. With only palliative treatment for HIV
available, it is imperative that researchers identify preventive measures to
halt the AIDS epidemic, especially among minority adolescents and
marginalized populations. One effective method to prevent STDs and pregnancy
is to deter the initiation of early sexual intercourse. Because
interventions are more effective when initiated prior to sexual debut than
after sexual activity has begun, new interventions should be introduced
during middle childhood prior to sexual experimentation in adolescence. The
Surgeon General, the American Academy of Pediatrics, and the Centers for
Disease Control and Prevention (CDC) all concur with the need for AIDS
education beginning within the elementary grades and continuing throughout
the school years. In June of 2001, the Surgeon General issued his Call to
Action to Promote Sexual Health and Responsible Sexual Behavior. In this
document, he encourages the promotion of basic research across the lifespan
in areas of human sexual development, sexual health, and reproductive health,
as well as social and behavioral research on risk and protective factors for
sexual health.
Promising Elements of Sexual Education Programs:
The majority of sexual education and abstinence education programs have been
developed for adolescents, there are currently few programs being developed
and tested for middle school populations. Early findings reveal that in
order for educational programs to be likely to change behavior, they must
incorporate factual information, provide a theoretical basis, pay attention
to the social context of the participants, and assure conceptual
understanding by the children. Promising sexuality education curricula
targeting younger adolescents incorporate a broad-based skills-building
approach that addresses the biological, sociocultural, psychological, and
spiritual dimensions of sexuality in the cognitive, affective, and behavioral
domains. According to the CDC, elements of promising HIV/AIDS prevention
programs include the following: a clearly defined target population,
cultural relevance, a theoretical framework, equal emphasis on abstinence and
on lowering risk behavior rather than on abstinence alone, specific skills
training, active rather than passive learning, and the cooperation of the
community and community leaders. This information may help inform the
development of new, innovative sexual education and HIV/STD/pregnancy
prevention programs for children of middle childhood.
Psychosocial and Contextual Influences on Adolescent Sexual Behavior:
There are several psychosocial and contextual factors that influence
adolescent sexual behavior and may also exert an influence on younger
children. Psychosocial factors associated with early sexual intercourse
among adolescents include the following: self-esteem, self-efficacy,
temperament, values, involvement in prosocial activities, religiosity, early
and steady dating, and stress. School factors influencing sexual behavior
include the following: poor school performance, lack of motivation, lack of
future educational plans, low educational level of parents, lack of school
safety, and diminished sense of attachment to school. Living in impoverished
areas or with high levels of violence is also related to the onset of sexual
activity. Factors associated with early sexual debut in males include:
racial and ethnic characteristics, with rates higher for blacks than for
Hispanics or whites, being retained a grade in school, low church attendance,
and maternal work outside the home during the formative years.
Much research has been done on the influence of parents, families, and peers
on the sexual behavior of adolescents. Lowered parental monitoring and
presence, single parenting, parental divorce or separation during early
adolescence, homes without mothers, being the child of a teen mother, and
maternal employment outside the home during the formative years are
associated with early sexual behavior. Poor parent-child relationships,
parent-child communication, and parental attitudes about premarital sex also
influence adolescents" sexual behavior. Sexually active peers and siblings
increase the risk of early sexual behavior for adolescents, as does the
perception of friends" involvement in sexual activity. It is not known
whether these same psychosocial and contextual influences serve as precursors
of risky sexual behavior for six- to 12-year-olds.
Risk and Resilience in Adolescents:
Resilience factors are the qualities that foster successful adaptation and
transformation processes, despite risk and adversity. Recent studies
indicate that nonresilient adolescents are more likely to initiate a variety
of risky behaviors than resilient adolescents. These factors may also
operate during middle childhood.
Protective factors within the individual child include problem-solving
abilities, trust, helpfulness, positive self-esteem, feeling of control over
one"s life, planning for future events, optimism, social and academic
competence, cognitive skills, creativity, and easy temperament. Caring
relationships exhibited by parent(s), caregivers, mentors, and teachers
provide resilience and support for children.
High academic expectations from parents and school personnel likewise have a
positive effect on students and promote lower rates of problem behaviors such
as dropping out of school, drug abuse, teen pregnancy, and delinquency.
Better family functioning, higher intelligence, and psychological well-being
are markers of fundamental adaptation systems protecting child development in
the presence of severe adversity. Other resilience factors include closer
parental monitoring, more adults in the household, higher educational
aspirations, and student engagement.
Many of the risk factors and their antecedents identified in adolescents have
not been studied in younger children. Not all children exposed to risk
factors go on to participate in risky sexual activity, perhaps because of
resilience factors, personality types in combination with parenting styles,
or developmental and environmental assets.
Research Scope
Research to address the three key research issues (antecedents of risk,
resilience factors, and effective interventions) includes, but is not limited
to, the following topics and examples:
(a) Developmental, Biobehavioral, Genetic, and Imaging Studies
The role of individual cognitive abilities, personality characteristics,
motivational factors, the influence of the family, peers, community,
religion, school, sports and extracurricular activities, genetic and
neuroendocrine factors are all potential influences on risky sexual behavior.
Understanding children"s cognitive, social, emotional, and physical
development in a contextual manner should be considered. Genetic,
neuroendocrine, and neuroimaging studies may provide insight into the
development of the risk-taking personality and behavior, and are encouraged.
Examples of relevant research topics include:
o Theoretical models that influence behavior change in the context of
development (cognitive, social, emotional, and physical).
o Behavioral and developmental studies of risk-taking personality types,
self-regulation, emotion-regulation, behavior change, and motivation.
o Timing of pubertal development in relation to peers and implications for
risky sexual behavior.
o Genetic, neuroimaging, and/or neuroendocrine studies of children in middle
childhood, including those with risk-taking personality types.
o Gender identity and its relationship to early sexual risk behavior.
(b) Psychosocial and Contextual Influences
The role of psychosocial and contextual influences on the sexual risk
behavior of adolescents is well studied. It is not known if these same
influences, when present in middle childhood, function as precursors to
subsequent risky behavior. Examples of relevant research issues include:
o Psychosocial factors of middle childhood that influence risk-taking
behavior in preadolescents and adolescents.
o The significance of academic success and religiosity in the avoidance of
risky sexual behavior.
o The influence of parents, family, and peers during middle childhood in the
context of sexual development and behavior.
o Contextual studies of neighborhood, socioeconomic status, school, and
extracurricular opportunities in relation to precursors of risky sexual
behavior.
(c) Substance Use
Alcohol and drug use, currently being initiated by some middle school
children, are important indirect risk factors for early and unprotected sex,
as they lower inhibitions and cloud judgment. Drug use, the exchange of sex
for drugs, and disregard for safe sexual practices in adolescents are factors
in HIV transmission. Studies and questions of interest include the
following:
o Do risk-taking individuals (for drugs, sex, accidents, etc.) share common
characteristics or identifiers (genetic, neuroendocrine, neuro-anatomical,
behavioral)?
o What role do inhaled, injected or ingested drugs play in the sexual
behavior of pre-teens?
o Examine the influence of substance use or abuse by parents, siblings,
and peers on subsequent sensation-seeking activity by pre-teens.
(d) Subpopulations
Victims of sexual abuse have been recognized as a population at higher risk
for earlier onset of sexual activity and a greater number of lifetime sexual
partners. Subpopulations of adolescents at increased risk of acquiring AIDS
through participation in high-risk activities include street and homeless
youths, adolescent prostitutes, detained youths, gay, lesbian, bisexual, and
transgendered youth. Examples of relevant research include:
o Investigate the effects of early sexual abuse or exposure to sexually
explicit material on subsequent sexual behavior of young children and teens.
o Can intervention programs prevent early sexual activity in high-risk
youths?
(e) Risk and Resilience Factors
It is not known at what ages risk and resilience factors exert their maximum
effect. Caregiving in the child"s first year of life has been seen by some
as the most powerful predictor of childhood resilience. Social relationships
among family members have been cited as the best predictors of behavioral
outcomes in children. Additional information is needed regarding middle
childhood resilience and risk factors, and may include the following studies
and questions:
o The identification of precursors of risky sexual behavior, of protective
factors, and the influences and interactions of these forces.
o Which risk factor or combination of factors (social, psychological,
developmental or cognitive) in middle childhood are the strongest predictors
of and/or contributors to early sexual initiation?
o Do certain resilience factors (i.e., personal versus family or school)
exert more influence than others, and at which developmental stages?
o Do high-risk subpopulations (homeless, abused, institutionalized,
emotionally disturbed or marginalized youths) respond to or require different
approaches to increase resiliency and reduce risk?
(f) Intervention Studies
Few evaluation studies have been done on interventions for preadolescents to
promote healthy sexual development and to delay sexual initiation, although
there is compelling evidence that educational efforts should begin early.
Developmentally and culturally appropriate, effective interventions are
needed to reduce risky sexual behavior and subsequent problems of pregnancy
and STDs. Relevant questions include:
o Which interventions most effectively reduce the risk of early sexual
initiation, and for which children?
o Which interventions promote and enhance resilience and mental health?
o Which interventions increase knowledge of HIV and STDs, social and
negotiation skills, perception and understanding of high-risk situations?
o Which children benefit from which kinds of interventions (church-based,
family-based, school-based, peer-based, multisystemic, individual or group)?
o At what ages and developmental stages are interventions most effective?
o What is the optimal timing for delivery of the intervention and by whom
should it be delivered?
o Do interventions need to be reinforced and updated to address
developmental issues, if so, when and how often?
MECHANISM OF SUPPORT
This PA will use the NIH research project grant (R01) award mechanism. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This PA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular format. Otherwise follow the instructions for non-
modular research grant applications.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based 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
Applicants should plan to participate in twice-yearly conference calls among
investigators funded through this PA to share progress. In addition, annual
collaborative meetings for Principal Investigators funded through this PA and
through RFA HD-99-014 will be held in the Washington D.C. area. The meetings
will focus on research designs, objectives, and possible collaborative
arrangements that might foster increased productivity or efficiency in
addressing the objectives proposed by the applicants. Funds for the
Principal Investigator"s travel to these annual meetings should be included
in the application budget request.
This PA deals with sensitive issues of sexuality and young children, and will
require investigators to use a thoughtful and developmentally appropriate
approach to research and to issues of informed consent of parents and
children. Issues of confidentiality and Data Safety and Monitoring should be
considered.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research and financial or grants management issues:
o Direct your questions about NICHD scientific/research issues to:
Lynne Haverkos, M.D., MPH
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6881
FAX: (301) 480-0230
Email: [email protected]
o Direct your questions about NIMH scientific/research issues to:
Nicolette Borek Ph.D.
Program Director
National Institute of Mental Health
6001 Executive Boulevard, Room 6206, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-4526
FAX: (301) 443-9719
Email: [email protected]
o Direct your questions about NINR scientific/research issues to:
Hilary D. Sigmon Ph.D., R.N.
Program Director
National Institute of Nursing Research
45 Center Drive, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-5970
FAX: (301) 480-8260
Email: [email protected]
o Direct your questions about NICHD fiscal matters to:
Mary E. Daley
Lead Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1305
FAX: (301) 402-0915
Email: [email protected]
o Direct your questions about NIMH fiscal matters to:
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: [email protected]
o Direct your questions about NINR fiscal matters to:
Cindy McDermott
Grants Management Officer
National Institute of Nursing Research
45 Center Drive, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-6869
FAX: (301) 480-8260
Email: [email protected]
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) 710-0267,
Email: [email protected].
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted at the standard application deadlines,
which are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least six weeks before submitting the
application, i.e., as you are developing plans for the study,
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award, and,
3) Identify, in a cover letter sent with the application, the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by or mailed on or
before the receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm.
The CSR will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept any
application that is essentially the same as one already reviewed. This does
not preclude the submission of a substantial revision of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council
or board
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of 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:
PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below.)
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
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 is
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, 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 PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance Nos. 93.865 (NICHD), 93.242 (NIMH) and 93.361
(NINR) and is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review. Awards are made under
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and administered under NIH grants policies
described at http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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