NIH GUIDE, Volume 24, Number 31, August 25, 1995

P.T. 34


  Human Reproduction/Fertility 



National Institute of Child Health and Human Development


The purpose of this notice is to reannounce the broad programs of the

National Institute of Child Health and Human Development (NICHD) and

to highlight priority research areas therein that for the next two

years, the NICHD will consider of high program relevance.  Background

information, details of the process, and a description of these areas

are given below.


The NICHD has primary responsibility for supporting basic, clinical,

and applied research and research training in maternal and child

health; human development; reproductive biology and fertility

regulation; population dynamics; developmental biology and

teratology; clinical nutrition; perinatal and infant morbidity and

mortality; human learning and behavior; mental retardation and

developmental disabilities; pediatric, adolescent, and maternal AIDS;

and medical rehabilitation.  Although the NICHD will continue to fund

those projects that are deemed to be scientifically excellent and

innovative within the full scope of its mission, this notice

highlights areas of particularly high program relevance to achieve

the following goals:

o  Given fiscal constraints, formal identification of areas of high

program relevance will enable the NICHD to encourage submission of

applications on these topics and foster emerging areas of science.

Establishing and publishing priorities, to be used as part of a

select-pay process, will help the NICHD meet program needs and take

advantage of scientific opportunities, while still ensuring that high

quality applications are funded.

o  Support of research and special consideration in funding in the

areas of high program relevance, along with studies that are

innovative or high-risk/high payoff, maintain critical ongoing

research efforts, or are conducted by new investigators, will ensure

that broader opportunities exist for meritorious research to be


o  It is anticipated that this process will reduce the need to

publish Requests for Applications (RFAs) and Program Announcements.

This notice reflects the commitment of the NICHD to inform the

scientific community and the public of areas identified as high

priority or of high program relevance and to indicate that any

decision to fund a grant out of percentile order will be based on

scientific merit and program goals.


All applications that are ranked highly by initial peer review will

ordinarily be paid in percentile rank order, up to the point where

the NICHD obligates 75 percent of the funds available for each

National Advisory Child Health and Human Development Council (NACHDC)

round.  From the point where 75 percent of the funds are expended to

the 20th percentile is the "discretionary zone" (DZ).  The staff will

recommend paying selected grants from the DX with the remaining 25

percent of funds with the advice of the NACHDC.  The areas of high

program relevance listed below will be used as the first criterion

guiding any decision to pay grants that are in the DZ.  These high

priority areas will be used as a guide for FY 1996 and FY 1997.

Priorities and procedures will be revised, as appropriate, at the end

of that time.

Areas of High Program Relevance

The following areas of high program relevance are organized according

to the three extramural research centers of the NICHD.

Center for Research for Mothers and Children

Pregnancy:  Research is needed to better understand how several

factors, both external and internal to the maternal-fetal unit,

affect pregnancy outcomes and maternal well being, especially in

different ethnic and racial populations.  Within this broad area, the

priorities are:

o  High Risk Pregnancy - including studies of factors responsible for

maintaining pregnancy and initiating labor.

o  Therapeutics During Pregnancy - particularly research to develop

and evaluate maternal therapies targeted to ensure optimal pregnancy


o  Maternal-Fetal-Placental Unit - particularly studies to

investigate the anatomic and physiologic role of the placenta in the

well-being of both the mother and fetus and the pathogenesis of

intrauterine growth retardation.

o  Vertical Transmission of Infections - especially research to

elucidate the mechanisms by which infectious agents, including HIV,

are transmitted to the fetus/neonate.  Priority would extend to

studies that develop and evaluate therapies that prevent or interrupt

this transmission.

Growth and Development:  The NICHD supports basic and clinical

research to better understand many facets of normal and abnormal

growth and development.  Special consideration will be given to

studies in areas that represent opportunities for understanding

various aspects of growth, maturation, and adaptation, ranging from

genetic/molecular interactions to the development of the whole

organism.  The selected areas are:

o  Early Development and Fetal Growth - particularly studies on

signal transduction and identification of regulatory factors that are

responsible for defining intra- and intercellular interactions,

pattern formation, organogenesis, and tissue differentiation.

Brain and Nervous System Development - particularly research on the

cellular, molecular, genetic, and physiological aspects of central

nervous system (CNS) development; and cognition, motor function, and

behavior of the child.  Also of interest is the impact of insults

during gestation on CNS development.

Nutrition and Growth - particularly studies of optimal nutrition

during the fetal and neonatal periods, with emphasis on the preterm

infant, delineation of the biological role of human milk, and the

impact of various nutritional factors on physical, cognitive, and

behavioral development.

Prevention, Diagnosis, and Treatment of Developmental Abnormalities:

The NICHD is interested in developing and evaluating modern

technologies that assess the cause and pathogenesis of developmental

abnormalities and provide the basis for developing novel strategies

to treat and prevent these conditions.  Two specific areas of

interest are:

Prenatal/Perinatal/Infant/Early Childhood Screening, Diagnosis,

Assessment and Therapy - including research to develop (1)

methodologies that can assess fetal well being, genetic disorders,

gestational or neonatal infections, behavioral abnormalities, and

congenital anomalies; and (2) new behavioral, genetic, nutritional,

pharmacological, and surgical therapies.

o  Antecedents of Adult Disease - particularly studies to understand

the interaction of environment and genotype in the developing human,

as predictors of adult well-being.

Behavioral Development:  A variety of mortality and morbidity

statistics for children and youth highlight the need to develop

effective, theory-based, behavioral prevention and intervention

strategies.  The areas with high program relevance are:

Biobehavioral Interactions - including studies on the interactions

between biological  (i.e., genes, hormones, CNS) and behavioral


o  Risk Taking and Compliance - including studies on the

psychological and behavioral factors associated with risk taking and

compliance/adherence, particularly during middle childhood and

adolescence.  One major interest area is unintentional injuries.

o  Factors Influencing Normal and Aberrant Learning, Perception and

Cognition - particularly studies that investigate the genetic,

biological, and behavioral mechanisms involved in learning.

o  Destructive Behavior - including studies on the underlying

neuropathology and behavioral antecedents of maladaptive behaviors

(e.g., those that are self-injurious, repetitive and aggressive), and

on their diagnosis, treatment and management.

o  Race and Ethnicity - particularly studies to clarify the

relationships between minority status and social, emotional and

cognitive development in children and their families.

Center for Population Research

Reproductive Biology:  New knowledge is needed to provide innovative

contraceptive leads, improve means of alleviating infertility, and

enhance the effectiveness and pregnancy outcomes of assisted

reproductive technologies.  Selected research topics are targeted to

the unique features of the male and female reproductive systems.

o  Male fertility/infertility - particularly studies that address the

(1) molecular, genetic, hormonal, and intracellular factors affecting

spermatogenesis; (2) pathophysiology of male infertility, including

studies on how the male genome contributes to gonadal, fertilization,

or implantation failure; and (3) diagnosis and treatment of male


o  Female fertility/infertility - particularly studies that address

(1) molecular, genetic, and hormonal events controlling oocyte and

follicular development; (2) fertilization, preimplantation genetics

and development, and cell-to-cell interactions regulating

implantation; and (3) cervical factor infertility, uterine

dysfunctions associated with infertility, the relation of

endometriosis to infertility, and the treatment of benign gynecologic


Epidemiology and Evaluation of Infertility:  As research improves the

ability to treat millions of individuals with infertility, studies

are needed to better understand ways to prevent the condition and

evaluate the potential long-term impact of related treatments.

Selected research is needed in two areas:

o  Prevalence and Risk Factors - including studies on the (1)

prevalence of infertility and reduced fertility; and (2) risk factors

for these conditions (e.g., occupational, environmental, and medical

factors, including such conditions as leiomyomata or endometriosis).

o  Treatments:  Efficacy/Adverse Outcomes - particularly

epidemiologic studies to (1) determine the efficacy and adverse

effects of infertility treatments on men, women, and their offspring,

and (2) establish the mechanisms and rates of occurrence of adverse

effects and evaluate ways to reduce their incidence.

Development and Evaluation of Contraceptives:  The widespread use of

long-acting contraceptives, such as Depo-Provera or other injectable

progestins, raises important scientific issues. In addition, given

that at any point in time most women in the U.S. wish to prevent

pregnancy and that rates of heterosexual transmission of HIV and new

HIV cases among women are increasing, it is critical that new and

improved contraceptive methods be developed and evaluated that

prevent both pregnancy and transmission of disease.

o  The Impact of Depo-Provera - particularly studies on the causes

and treatment of the side effects of Depo-Provera (e.g., bone loss,

weight gain, bleeding problems, and extended infertility after

discontinuing use).

o  Vaginal Physiology and Immunology - particularly studies on the

influence of intravaginal contraceptive products on the vaginal

ecosystem and the relationship of these factors to disease


o  Comparative Protection/Risk of Various Methods - including studies

to (1) clinically evaluate currently available spermicides or to

epidemiologically assess their protective value for HIV infection;

(2) develop and evaluate new topical spermicides/microbicides for

contraceptive efficacy and relative protection against disease; (3)

define the degree of protection or increased risk for HIV infection

associated with using other contraceptive methods and the mechanisms

by which these effects are achieved.  Special emphasis is placed on

hormonal contraceptives and how they affect the acquisition and

progression of HIV infection.

Behavioral Studies of Pregnancy and Family Formation:  U.S. rates of

teen pregnancy and childbearing are among the highest in the

industrialized world; over two-thirds of births to teens and nearly

one-third of all births in this country now occur outside of

marriage.  To strengthen the research base to address these closely

related issues, U.S. or comparative studies are needed in three


o  Men's Behavior - particularly research on the influence of gender

roles and relationships, male and couple influences on fertility-

related behavior, and male involvement in parenting.

o  Determinants/Consequences of Non-Marital Childbearing - including

research on marriage and cohabitation and the factors underlying the

changing relationship of marital status to fertility behavior.

o  Prevention - particularly behavioral research on factors that

contribute to improved contraceptive use and the prevention of

unintended pregnancy.

Immigration:  Meeting the challenge created by the flow of immigrants

across U.S. borders requires improved demographic information about

population movement, its causes, and its consequences.  Areas of high

program relevance are:

o  Measurement Issues - including studies to develop improved methods

to better measure and analyze U.S. immigration and emigration trends.

o  Immigration Processes and Their Impact - including research on the

(1) processes through which migrants attach and adapt to the

population; (2) selectivity of immigrants in terms of health,

socioeconomic status, and resilience; (3) intergenerational

transmission of skills and resources; and (4) impact of international

migration on the health and well-being of both immigrant and native-

born individuals, families, communities, and populations.

National Center for Medical Rehabilitation Research

Medical Rehabilitation Outcomes Research:  Research is needed to

strengthen scientific evidence about the outcomes of therapeutic

practices relevant to the rehabilitation and health care of people

with disabilities.  Special consideration will be given to the

following areas:

o  Assessing Outcomes - particularly studies that (1) assess outcomes

valued by consumers, providers, and payers of medical rehabilitation

services; and (2) design and evaluate flexible methods for weighing

the findings of specific outcome studies.

o  Models and Measures - particularly studies that 1) develop and

validate theory-based models, classification systems, and measures of

rehabilitative interventions; and (2) develop measures of social,

physical, and attitudinal environments that may influence the medical

rehabilitation outcomes of individuals.

Habilitation of Infants and Children with Early-Onset Physical

Disabilities:  Improved interventions must be developed and evaluated

that promote independence, gender identity, and self-esteem in

children with early-onset physical disabilities.  Two areas of

special interest are:

o  Behavioral Adaptation - particularly studies to assess the

behavioral characteristics of both children and caregivers that are

associated with successful adaptation to physical disability over the

developmental period.

o  Secondary Impairments - particularly studies to develop and

evaluate interventions that prevent secondary impairments and

disabilities among children with early-onset physical disabilities.

Health of Women with Physical Disabilities:  Because the

effectiveness of most interventions for meeting the unique health

needs of women with chronic impairments or disabilities has not been

established, the following research areas of special interest have

been identified:

o  Reproductive Health - particularly studies that (1) assess the

obstetrical management and family planning needs of women with

disabilities; (2) investigate access to, and the effectiveness of,

current contraceptive methods, and (3) develop new contraceptive

methods for women with various chronically disabling impairments.

o  Stress and Abuse - particularly studies that identify and

characterize the (1) types of stressors experienced by women with

physical disabilities; (2) relationships that exist between stressors

and women's perception of stress, their coping responses, and their

physiological and neurohumoral stress responses; and (3) factors that

predispose females of all ages with disabilities to becoming victims

of abuse.  Studies to develop interventions that will prevent abuse

or mitigate its effects are also encouraged.

Rehabilitation of Persons with Chronic Disorders of the Central

Nervous System:  Currently, most research focuses on clinical

interventions during the acute phases of central nervous system

injuries, rather than on interventions to restore useful functioning

later, in the chronic phases of injury.  Thus, additional research is

needed to develop and evaluate the effectiveness of biomedical

interventions that promote the functional reorganization and

respecification of the chronically injured central nervous system to

improve functioning that is useful in daily life.

Chronic Pain as a Secondary Condition:  Little evidence exists

concerning the effectiveness of therapeutic practices that are

currently used to manage chronic pain of persons with various

physically disabling conditions. Thus, studies are needed to

determine the relative contributions of biological, psychological,

behavioral, and environmental factors to (a) the course of pain, (b)

pain dysfunction, (c) expressive behavior, and (d) responses to

treatment by persons with various physical disabilities.

Prosthetics and Orthotics:  Systematic research is needed to

determine how best to develop, evaluate, and prescribe orthoses and

prostheses that will be fully and appropriately used by people in

their daily lives.  Research is needed in two areas:

o  Factors Influencing the Use and Outcomes of Orthoses and

Prostheses - particularly studies that (1) formulate and test

theories of aided ambulation; 2) develop biomaterials for the

human/device interface and joint components that replicate human

movement; (3) encourage practices that promote the behavioral

adaption to and the optimal use of assistive technology; and (4)

evaluate the contributions of biological, psychological, behavioral,

environmental, and design factors that promote optimal use of

prostheses and orthoses.

o  Neuroprostheses - particularly outcome studies of neuroprostheses

for enhancing limb movement, pulmonary functioning, and bowel or

bladder control that consider personal priorities and life styles.

Biomaterials to Restore Useful Functioning to People with Physical

Disabilities: Advances in developing biocompatible materials and in

characterizing their tissue interactions provide a foundation for

developing novel materials that can be used for several purposes.  To

build on these advances, research is needed in two areas:

o  Coating Materials - particularly studies to develop coating

materials that can be used on implanted devices such as indwelling

catheters or electrodes to render them biocompatible and to reduce


o  Scaffolding for Tissues - including developmental studies to

modify natural products that can serve as scaffolding to support the

regeneration of neurons, cartilage and bone, skin, and other tissues.


Inquiries regarding this announcement are encouraged.  The NICHD

welcomes the opportunity to clarify any issues or questions from

potential applicants.  The acronym "AHPP96" should be placed on line

of 2 of an unsolicited application if the applicant thinks that the

topic of the application is within an area of high program priority

as defined in this notice.  However, applications will be assigned

according to PHS Referral Guidelines and formal determination of high

program priority will be made by NICHD staff.

Direct inquiries regarding the priorities of the Center for Research

for Mothers and Children to:

Sumner J. Yaffe, M.D.

Center for Research for Mothers and Children

National Institute of Child Health and Human Development

6100 Executive Boulevard, Room 4B05, MSC 7510

Bethesda, MD  20892-7510

Telephone:  (301) 496-5097

FAX:  (301) 402-2085


Direct inquiries regarding the priorities of the Center for

Population Research to:

Florence P. Haseltine, M.D.

Center for Population Research

National Institute of Child Health and Human Development

6100 Executive Boulevard, Room 8B07, MSC 7510

Bethesda, MD  20892-7510

Telephone:  (301) 496-1101

FAX:  (301) 496-0962


Direct inquiries regarding the priorities of the National Center for

Medical Rehabilitation Research to:

Marcus Fuhrer, Ph.D.

National Center for Medical Rehabilitation Research

National Institute of Child Health and Human Development

6100 Executive Boulevard, Room 2A03, MSC 7510

Bethesda, MD  20892-7510

Telephone:  (301) 402-2242

FAX:  (301) 402-0832



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