PREVENTION OF HEALTH RISK BEHAVIORS IN MIDDLE CHILDHOOD

Release Date: September 2, 1999

RFA:  HD-99-014

National Institute of Child Health and Human Development
Office of AIDS Research
National Institute of Mental Health

Letter of Intent Receipt Date:  October 15, 1999
Application Receipt Date:  December 10, 1999

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The National Institute of Child Health and Human Development (NICHD), the
National Institutes of Health (NIH) Office of AIDS Research (OAR), and the
National Institute of Mental Health (NIMH) invite applications proposing
studies of behavioral strategies to prevent sexual health risk behaviors in
middle childhood, with the intention of preventing pregnancy and the
transmission of HIV and other sexually transmitted diseases during
adolescence.  The purposes of this Request for Applications (RFA) are to: (1)
identify the interactions of innate cognitive, developmental and psychological
characteristics of children ages 6-12 years which, in conjunction with known
sociocultural and economic conditions, facilitate and predispose children to
participate in high- risk sexual behaviors; (2) identify the characteristics
which provide resilience to developmentally inappropriate sexual risk-taking
behavior; and (3) develop, implement, and evaluate interventions to reverse,
ameliorate or compensate for the risk factors involved and/or enhance the
resilience factors.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This RFA is related to several priority
areas.  Potential applicants may obtain "Healthy People 2000" at
http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public or private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of
the Federal government.  Foreign institutions are not eligible to apply for
these grants; however, applicants may collaborate, through consultation or
contractual agreements, with investigators at foreign institutions. 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project
grant (R01) award mechanism.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.  This
RFA is a one-time solicitation.  Future unsolicited competing continuation
applications will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.  The anticipated
award date is July 2000.

Specific applications instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm.

FUNDS AVAILABLE

The NIH OAR, through the NICHD, intends to commit approximately $1.2 million
in total costs (direct plus Facilities and Administrative) in FY 2000 to fund
three or four new grants in response to this RFA.  The NIMH intends to commit
$750,000 (total costs) in FY 2000 to fund two or three new awards in response
to this RFA.  An applicant may request a project period of up to five years
and a budget for direct costs of up to $250,000 per year.  Because the nature
and scope of the research proposed may vary, it is anticipated that the size
of awards also will vary.  Although the financial plans of the OAR and NIMH
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
applications of outstanding scientific and technical merit.

The National Institute of Drug Abuse (NIDA) and the National Institute of 
Alcohol Abuse and Alcoholism (NIAAA) share an interest in this RFA
and may contribute (contingent upon the availability of funds) to the support
of selected grants to be determined following peer review.

RESEARCH OBJECTIVES

Background

Little is understood about the development, expression, and prevention of
health risk behaviors during the middle childhood years that contribute to
unwanted pregnancy and sexually transmitted diseases, including HIV, in
adolescence and adulthood.  Research suggests that health risk behaviors
exhibited during adolescence and adulthood have their origins earlier in
childhood and that preventive interventions are only minimally successful when
applied after the high-risk behaviors are established.

In January of 1997, a panel of research experts met at the NIH to discuss
applied behavioral analytical approaches for preventing AIDS risks in
childhood.  The panel overwhelmingly endorsed the concept that early
prevention efforts, initiated during the first decade of life, could have a
greater impact on health risk behavior than interventions introduced in
adolescence.  They recommended that the NICHD initiate studies to investigate
the role of family, school, peer, and community factors that influence health
risk behaviors, as well as studies on the development of behaviors during
middle childhood that increase the risk of unprotected sexual activities.  The
panel identified  a need for a developmental, epidemiological, contextual
model as the basis for hypotheses that could guide community intervention and
prevention studies.  The panel identified academic success as a major
protective factor against high-risk behaviors and recommended that school
success be a goal in any comprehensive prevention effort targeted toward
middle childhood.

Middle childhood, once described as the time when a child's character is built
and consolidated or is not, has not benefitted from extensive research on
health risk behaviors as has the period of adolescence.  Recent research
indicates that later elementary school-age children may be more interested in
and amenable to learning about AIDS than middle-school children.  Thus, the
nine- to eleven-year-old may be in a transition time critical for the
development of health habits.  Using the existing research on social and
behavioral factors that influence adolescents' high-risk sexual activities,
this RFA seeks new efforts directed at the identification of precursors of
health risk factors in children between the ages of six and twelve years.

In view of the early age of initiation of sexual intercourse, especially among
urban, minority youth, the real and expanding risk of HIV infection for youth
engaging in high-risk sexual practices, and the significantly increased
efficacy of interventions initiated prior to sexual debut, effective AIDS
prevention initiatives must begin during middle childhood and address social
influences on sexual behaviors.  Additionally, the Centers for Disease Control
and Prevention, the Surgeon General, and the American Academy of Pediatrics
have endorsed the need for AIDS education within the elementary grades,
beginning in kindergarten and continuing throughout the school years.

Risk-Taking Behavior Among Adolescents:  What Is Known

As previously noted, there exists little information on sexual risk-taking
behaviors and their precursors in children ages six to twelve years.  However,
extensive research on the different stages and developmental tasks of
adolescents has provided us with a wealth of biopsychosocial information. 
This information should prove useful in informing research efforts that will
be directed to the middle childhood years, seeking precursors of health risk
behaviors and preventive interventions for sexual risk-taking behaviors.  The
following statistics reveal the significance of the health concerns
experienced by adolescents as a result of participation in high-risk sexual
behaviors:  Adolescents represent one of the fastest growing risk groups for
HIV in the United States, with approximately 25 percent of sexually
transmitted diseases (STDs) and 25 percent of new HIV infections occurring in
teenagers.  Inner-city, minority youths are at particular risk because of the
greater concentration of HIV in inner-city areas, the higher rates of sexually
transmitted diseases, the earlier age of initiation of high-risk sexual
practices (including intercourse in ten-year-olds), and the disproportionate
impact of AIDS on minorities.  Over the past 20 years, increasing numbers of
adolescents have engaged in unprotected sexual experimentation at earlier ages
and with more partners.  It is not clear whether these trends are observed in
children during middle childhood.

The 1997 national Youth Risk Behavior Surveillance System (YRBSS) reported
that many high school students were already actively participating in high-
risk behaviors.  For example, 50.8 percent of high school students had
consumed  alcohol, 26.2 percent had used marijuana , and  36.4 percent had
smoked cigarettes in the 30 days before the survey.  The YRBSS results
indicated that in 1997, 48.4 percent of high school students had engaged in
sexual intercourse, 43.2 percent of sexually active students had not used a
condom at last intercourse, and 2.1 percent had ever injected an illegal drug. 
Research  reveals an alarming prevalence of risk behaviors already evident by
seventh grade and the trend increases throughout high school.

Sexual activity is the major risk factor for HIV transmission.  Youth
exhibiting the most high-risk behavior, including frequent, unprotected sexual
intercourse with numerous partners, drug use, and intercourse with intravenous
drug users,  are at the highest risk for AIDS.  In many urban centers in the
U.S., significant numbers of children are already sexually active by the
completion of elementary school.  Predictors of high-risk sexual behavior
include alcohol and substance use, antisocial behaviors, delinquency,  and
family and peer influences.

Risk Factors For Adolescents

The determinants of early initiation of sexual activity include societal
factors such as region, race, and media, as well as family characteristics
including socioeconomic status or social class, number of siblings, family
structure, the quality of the parent-child relationship, lower maternal
education, attendance at a school with a high drop-out rate, having fewer
years of high school education, having a mother who was a teen parent, living
with a single parent, being less religious, having poor parental communication
and discipline, being less goal oriented, being influenced by peer pressure,
and being the victim of sexual abuse.  Whether these or additional risk
factors are equally predictive for children ages six to twelve is not yet
known.

Alcohol and drug use, which also may begin in late middle childhood as well as
adolescence, 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.  Risk factors for drug use among males include
perceived use by peers, peer approval of drug use, low family pride, and the
adolescent's general willingness to engage in non-normative behavior.  Early
initiation of drug use is associated with family substance use problems and
parental smoking.  Having peers who are serious drug users, beginning drug use
at an early age, and social and developmental problems (poor relationships
with peers, parents, and authority figures) are associated with use of
increasingly problematic drugs.

Subpopulations of adolescents at increased risk of acquiring AIDS through
participation in high- risk activities include street and homeless youths,
adolescent prostitutes, homosexuals, sexually abused youths, and detained
youths.  Street youth are at elevated risk for medical disorders, drug
dependency, STDs, and HIV.  Homeless youths frequently report one or more of
the following risk factors:  multiple sex partners; high-risk partners;
inconsistent condom use; history of STD; anal sex; prostitution; and/or
intravenous drug use.  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.

Resilience Factors For Adolescents

Resilience has been defined as functional competence in the presence of
multiple risk factors, such as poverty, stress, and low educational
attainment.  It is the result of a complex interplay between an individual's
personal characteristics, skills, and abilities to cope and his/her
environmental stresses or risk factors.  Resilience factors are the qualities
that foster successful adaptation and transformation processes, despite risk
and adversity.  It is personal resilience that facilitates the development of
social competence, problem-solving skills, a critical consciousness, autonomy,
and a sense of purpose.  Recent studies indicate that resilient adolescents
are less likely than nonresilient adolescents to initiate a variety of risky
behaviors.

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.  The effect of parental support
is mediated through more behavioral coping and academic competence, and less
tolerance for deviance and behavioral undercontrol.  The resilience provided
by parental support occurs even in the presence of negative life events and
deviant peer affiliations, although resilience may be attenuated by negative
peer influence during late adolescence.  For maltreated children, positive
self-esteem, ego resilience, and ego overcontrol predict resilience.

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.

It is not known at what ages these variables may exert their maximum effect. 
Information is needed now regarding resilience in children in middle
childhood.

Current Research Needs
Health risk behaviors are linked to both the child's psychological development
(incorporating cognition, perceptions, and values) and social environment
(including family, peers, school, community, and media).  Important factors in
the formation of risk-taking behaviors include gender, social and racial
norms, chronological age, and level of biological maturation.  It is the
combination of social and psychological factors with sexual maturation and
genetic disposition that  influence an individual's behavior.  What is needed
now is the identification of the personal, sociocultural, cognitive,
psychological, and economic factors and their interactions in middle childhood
that predispose some adolescents in certain situations to engage in sexual
risk behaviors.  In addition, complementary research is needed to identify
which resilience factors are operating in middle childhood to protect children
living in high-risk environments.

The AIDS educational efforts which have been effective in reducing high-risk
behaviors are those that provide individuals with the skills they need to
negotiate in sexual situations, not those that focus solely on disseminating
factual information.  Efforts to identify and understand the social and
behavioral factors associated with the precursors of high-risk sexual
behaviors are critical for the development of relevant and effective AIDS
prevention plans.  Opportunities for self-reflection, critical inquiry,
problem solving, the discovery of consequences of one's actions, and dialogue
are important for both academic success and effective AIDS prevention
programs.

Beneficial AIDS prevention efforts must begin prior to the age when children
and adolescents initiate high-risk behaviors that place them in jeopardy of
acquiring HIV.  Developmentally appropriate interventions, responsive to
changing cognitive capabilities, social skills, peer pressure, and exposure to
sexual experiences, need to be developed and implemented.

Research Focus

This RFA has three major research aims.  Applicants are encouraged to address
all three aims or a combination of aims (1) and (3) or aims (2) and (3):

(1) To identify the various combinations of factors (societal, psychological,
cognitive, and developmental) that interact with sociocultural and economic
factors to predispose certain children, ages six to twelve, to participate in
sexual health risk behaviors.

(2) To identify the qualities that foster resilience to sexual risk-taking
during middle childhood, in the presence of factors promoting health risk-
taking.

(3) To develop, implement, and evaluate effective interventions for children
between the ages of six and twelve years, to reduce or prevent the
transmission of HIV in middle childhood and adolescence by reversing,
ameliorating, or compensating for risk factors and/or enhancing resilience
factors.

Critical Questions

The following critical questions are examples of research questions to be
considered by applicants.  It is not necessary to respond to every question,
but it is hoped that answers to these questions will become apparent through
the combined efforts of the individual projects funded as a result of this
RFA.

Which combination of factors contributes significantly to risk-taking
behaviors in middle childhood?

Do certain risk factors (i.e., social, psychological, developmental, or
cognitive) carry more weight than others?

Do certain resilience factors (i.e., personal versus family or school) exert
more influence than others, and at which developmental stages?

Can resilience factors accommodate increasing risks?  If so, how many, which
ones, and for how long?

Do high-risk subpopulations (homeless, abused, institutionalized, emotionally
disturbed youths) respond to or require different approaches to increase
resiliency and reduce risk?

Which factors in middle childhood are the strongest predictors of subsequent
early sexual initiation?

Which interventions most effectively reduce the risk of early sexual
initiation?

Are different interventions necessary at different ages in middle childhood?

Which interventions promote and enhance resilience and mental health?

Which interventions increase knowledge of HIV and STDs, social and negotiation
skills, perception and understanding of high-risk situations?

Which children benefit from which kinds of interventions (family-based,
school-based, peer-based)?

At what ages and developmental stages are interventions most effective?

What is the optimal timing for delivery of the intervention and by whom should
it be delivered?

Do interventions need to be reinforced and updated to address developmental
issues; if so, when and how often?

SPECIAL REQUIREMENTS

Applicants should plan to participate in twice-yearly conference calls among
grantees funded through this RFA to share progress.  In addition, annual
collaborative meetings for Principal Investigators will be held in the
Washington D.C. area.  The first collaborative meeting will occur within one
year of the grant awards and 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 RFA 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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided 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 research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research" which was published in the Federal Register of March 28, 1994 (FR 59
14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.11,
March 18, 1994, available on the Internet at
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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/or 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available on the Internet at:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may also obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning these policies.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, telephone
number, and E-mail address of the principal investigator, the identities of
other key personnel and participating institutions, and the 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 NICHD staff to estimate the potential
review workload and avoid conflict of interest in the review.

The letter of intent is to be sent to Dr. Lynne Haverkos at the address listed
under INQUIRIES by October 15, 1999.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  These forms are available at most institutional
offices of sponsored research, on the Internet at:
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-
0714, E-mail:  GrantsInfo@nih.gov.

Application Instructions

The modular grant concept establishes specific modules in which direct costs
may be requested, as well as a maximum level for requested budgets.  Only
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there
is a possibility for an award.  It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers, and Institute
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.

Applications responding to this RFA, will request direct costs in $25,000
modules, up to a total direct cost request of $250,000 per year.  The total
direct costs must be requested in accordance with the program guidelines and
the modifications made to the standard PHS 398 application instructions
described below:

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the initial
budget period.  Items 8a and 8b should be completed indicating the Direct and
Total Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. See http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.  At the top of the page, enter the total direct costs requested for
each year.  This is not a Form Page.

Under Personnel, list key project personnel, including their names, percent of
effort, and roles on the project.  No individual salary information should be
provided.  However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus Facilities and Administrative) for each year, each rounded to the nearest
$1,000.  List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of key personnel,
and the role on the project.  Indicate whether the collaborating institution
is foreign or domestic.  The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount. 
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team.  A Biographical Sketch is required for
all key personnel, following the instructions below.  No more than three pages
may be used for each person.  A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST - This page should be completed and submitted with the
application.  If the F&A rate agreement has been established, indicate the
type of agreement and the date.  All appropriate exclusions must be applied in
the calculation of the F&A costs for the initial budget period and all future
budget years.

o The applicant should provide the name and telephone number of the individual
to contact concerning fiscal and administrative issues if additional
information is necessary following the initial review.

Submission Instructions

The RFA label available in the PHS 398 (rev.4/98) application form must be
stapled to the bottom of the face page of the application and must display the
RFA number HD-99-014.  A sample modified RFA label is available at
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  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.

Submit a signed, typewritten original of the application, including the
Checklist, and three 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)

At the time of submission, two additional copies of the application should be
sent to:

Scott Andres, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)

Applications must be received by December 10, 1999.  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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and
for responsiveness by the NICHD, NIMH, and OAR.  If the application is not
responsive to the RFA, NICHD 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 review cycle.

Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NICHD in accordance with the review criteria stated below.  As part of the
initial merit review, a process may be used by the scientific review group in
which applications receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit will be
discussed, assigned a priority score, and receive a second level review by the
National Advisory Child Health and Human Development Council.

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 the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative, but is essential to move a field forward.

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

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

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

(4) Investigator:  Is the investigator appropriately trained and well suited
to carry out this work?  Is the work proposed appropriate to the experience
level of the Principal Investigator and other researchers (if any)?

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

In addition to the above criteria, in accordance with NIH policy, all
applications also will be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects also will be
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research.

o 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.

The initial review group also will examine the provisions for the protection
of human subjects and the safety of the research environment.

SCHEDULE

Letter of Intent Receipt Date:    October 15, 1999
Application Receipt Date:         December 10, 1999
Peer Review Date:                 April 2000
Council Review:                   June 2000
Earliest Anticipated Start Date:  July 2000

AWARD CRITERIA

Criteria that will be used to make award decisions include scientific and
technical merit, as determined by peer review; programmatic priorities; and,
availability of funds.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.  Contact information
for inquiries regarding both programmatic and fiscal matters may be found at: 
http://www.nichd.nih.gov/rfa/HD-99-014/HD-99-014.htm

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.865, Research for Mothers and Children, and 93.242 for NIMH research
grants.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC
241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-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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