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:  haverkol@mail.nih.gov

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:  nborek@mail.nih.gov  

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:  hilary_sigmon@nih.gov 

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:  md74u@nih.gov

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:  Diana_Trunnell@nih.gov 

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:  cindy_mcdermott@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.

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.


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