NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT AREAS OFHIGH PROGRAM RELEVANCE NIH GUIDE, Volume 24, Number 31, August 25, 1995 P.T. 34 Keywords: Human Reproduction/Fertility Pregnancy 0775013 National Institute of Child Health and Human Development PURPOSE 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. Background 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 funded. 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. PROCESS 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 outcomes. 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 processes. 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 infertility. 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 diseases. 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 transmission. 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 areas: 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 infection. 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 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 Email: YAFFES@HD01.NICHD.NIH.GOV 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 Email: HASELTIF@HD01.NICHD.NIH.GOV 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 Email: FUHRERM@HD01.NICHD.NIH.GOV .
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