Child Health and Human Development Extramural Research


To conduct and support laboratory research, clinical trials, and studies with people that explore health processes. NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people. To examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury. To sponsor training programs for scientists, doctors, and researchers to ensure that NICHD research can continue. By training these professionals in the latest research methods and technologies, the NICHD will be able to conduct its research and make health research progress until all children, adults, families, and populations enjoy good health. The mission of the NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.

General information about this opportunity
Last Known Status
Program Number
Federal Agency/Office
National Institutes of Health, Department of Health and Human Services
Type(s) of Assistance Offered
B - Project Grants
Program Accomplishments
Fiscal Year 2016 Post third quarter reallocation: Fiscal year 2016 competing and noncompeting research project grants estimates are 1,567. Of this number, 85 are expected to be SBIR/ STTR awards. Approximately 50 research centers will be awarded. A planned 462 other research grants are anticipated to be awarded. Projected institutional training awards are 489 in fiscal year 2016. The individual training award are projected for fiscal year 2016 to be 114. Fiscal Year 2016: Fiscal year 2016 competing and noncompeting research project grants actuals were 1,551. Of this number, 87 were SBIR/ STTR awards. A total of 50 research centers were awarded. 450 other research grants were also awarded. There were institutional training grants to support 476 trainees that were awarded in fiscal year 2016. The individual training awards were 109 for fiscal year 2016.
Fiscal Year 2017 Budget Actuals: Fiscal year 2017 competing and noncompeting research project grants actuals were 1,655. Of this number, 86 were for SBIR/ STTR awards. Exactly 49 research centers were awarded. A total of 401 other research grants were awarded. There were institutional training grants support provided for 439 trainees in fiscal year 2017. The individual training awards for fiscal year 2017 were 132.
Fiscal Year 2018 Budget Estimate: Fiscal year 2018 competing and noncompeting research project grants actual awards were 1,805. Of this number, 107 were SBIR/ STTR awards. Precisely 51 research centers were awarded. A total of 418 other research grants were awarded. There were institutional training grants that supported 423 trainees that were awarded in fiscal year 2018. The individual training award for fiscal year 2018 were 174.
Fiscal Year 2019 Budget Request: Fiscal year 2019 competing and noncompeting research project grants were 1,871. Of this number, 95 were SBIR/ STTR awards. Exactly 54 research centers were awarded. Exactly 415 other research grants were awarded. There were institutional training grants which supported 416 trainees during fiscal year 2019. The individual training awarded during fiscal year 2019 were 217.
Fiscal Year 2020 Budget Request: Fiscal year 2020 competing and noncompeting research project grants estimates were 1,941. Of this number, 81 were SBIR/ STTR awards. Precisely 53 research centers were awarded. 442 other research grants were awarded. There were institutional training grants which supported 438 trainees awarded in fiscal year 2020. Individual training awards for fiscal year 2020 were 257.
Fiscal Year 2021 Budget Actual: Fiscal year 2021 competing and noncompeting research project grants awarded were 1,854. Of this number, 69 were SBIR/ STTR awards. Exactly 51 research centers were awarded. Precisely 366 other research grants were awarded. There were projected institutional training grants to support 433 trainees that were awarded in fiscal year 2021. The individual training awards were for fiscal year 2021 #290.
Fiscal Year 2022 Budget Actual: Fiscal year 2022 competing and noncompeting research project grants totaled 1,903. Of this number, 79 were SBIR/ STTR awards. Exactly 48 research centers were awarded. There were 395 other research grants awarded. There also were institutional training grants which supported 424 trainees that were awarded in fiscal year 2022. The individual training awards funded 303 grants in fiscal year 2022.
Fiscal Year 2023 Budget Request: Fiscal year 2023 competing and noncompeting research project grants estimates are 1,891. Of this number, 81 are expected to be SBIR/ STTR awards. Approximately 58 research centers will be awarded. A planned 423 other research grants are anticipated to be awarded. There are projected institutional training grants to support 438 trainees that are planned to be awarded in fiscal year 2023. The individual training award are projected for fiscal year 2023 to be 299.
Fiscal Year 2024 Budget Request: Fiscal year 2024 competing and noncompeting research project grants estimates are 1,905. Of this number, 81 are expected to be SBIR/STTR awards. Approximately 54 research centers will be awarded. A planned 437 other research grants are anticipated to be awarded. There are projected institutional training grants to support 420 trainees that are planned to be awarded in fiscal year 2024. The individual training awards are projected for fiscal year 2024 to be 310.
Public Health Service Act, Section 301, 448 and 487, as amended, Public Laws 78-410 and 99-158, as amended, 42 U.S.C. 241; 42 U.S.C. 285g; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564, Public Law 117-328
Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both nonprofit and for-profit, and individuals. National Research Service Award: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. Individuals with a professional or scientific degree are eligible (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Predoctoral research training grants to institutions are also supported. Proposed study must result in biomedical or behavioral research training in a specified shortage area and which may offer opportunity to research health scientists, research clinicians, etc., to broaden their scientific background or to extend their potential for research in health-related areas. Applicants must be citizens of the United States or be admitted to the United States for permanent residency; they also must be nominated and sponsored by a public or private institution having staff and facilities suitable to the proposed research training. Domestic nonprofit organizations may apply for the institutional NRS grant. SBIR: SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one- half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Beneficiary Eligibility
Any nonprofit or for-profit organization, company, or institution engaged in biomedical or biobehavioral research.
Applicants should submit electronically via as directed in the relevant NIH Funding Opportunity Announcement. All required forms specified in the application kit are to be completed by the applicant and submitted with the application package. National Research Service Award: Individual Award: The applicant's academic record, research experience, citizenship, and institution sponsorship should be documented in the application. Institutional Award: the applicant organization must show the objectives, methodology, and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for awards, and a detailed budget and justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations, 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan.
What is the process for applying and being award this assistance?
Pre-Application Procedure
Preapplication coordination is not applicable.
Application Procedure
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. National Research Service Award: Prior to formal application, an individual must arrange for acceptance at a sponsoring institution by a sponsor who will supervise the training. Individuals must be sponsored by a domestic or foreign institution. SBIR/STTR: Same as for grants (above). Applications are submitted electronically via following the general guidance provided at: and the specific instructions for the respective Funding Opportunities Announcement which may be found at:
Award Procedure
Each application receives a dual scientific review by non-NIH scientists. Awards are issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). National Research Service Awards: Applications are reviewed for scientific merit by an appropriate study section committee or by an institute review committee. If recommended for approval and a decision is made to make an award, a formal award notice will be sent to the applicant and sponsor. Institutional Awards are issued by the Eunice Kenney Shriver National Institute of Child Health and Human Development (NICHD). All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for the available SBIR/STTR set-aside funds on the basis of scientific and technical merit and the commercial potential of the proposed research, program relevance, and program balance among the areas of research. Contact the headquarters or regional office, as appropriate, for application deadlines, or consult the specific Funding Opportunity Announcement listed in the NIH Guide for Grants and Contracts at: General guidance about application due dates may be found at:
Contact the headquarters or regional location, as appropriate for application deadlines
Approval/Disapproval Decision Time
More than 180 days. From 6 to 9 months: National Research Service Awards: From 6 to 9 months. SBIR/STTR: approximately 6 months.
Not applicable.
More than 180 days. Renewal applications are accepted, as described in the relevant Funding Opportunity Announcement (FOA) found at: National Research Service Awards: awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years. Institutional Awards may be renewed.
How are proposals selected?
The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.
How may assistance be used?
Grantee agrees to administer the grant in accordance with the regulations and policies governing the research grant programs of the Public Health Service as stated in the terms and conditions on the application for the grant. National Research Service Awards: Awarded to individuals for full-time research training in specified behavioral and biomedical shortage areas. Awardees may utilize some of their time in academic and clinical duties if such work is closely related to their research training. Awards may be made to institutions to enable them to make NRS awards to individuals selected by them. Each individual awardee is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and which are likely to result in commercial products or processes. STTR Phase I grants (normally of 1- year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential on Phase II application.
What are the requirements after being awarded this opportunity?
Performance Reports: The grantee institution is required to submit a progress report on an annual basis for each grant award, which includes monitoring of performance.
In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
Other Assistance Considerations
Formula and Matching Requirements
Statutory formula is not applicable to this assistance listing.

Matching requirements are not applicable to this assistance listing.

MOE requirements are not applicable to this assistance listing.
Length and Time Phasing of Assistance
Awards are usually made annually with no project period to exceed 5 years in length. National Research Service Awards: From 1 to 3 years. SBIR: Phase I awards are generally for 6 months; Phase II awards normally may not exceed 2 years. STTR Phase I awards are generally for 1 year; Phase II awards normally may not exceed 2 years. Each year, submitted progress reports for awarded grants are reviewed, and if satisfactory progress is demonstrated, a Notice of Grant Award is issued.
Who do I contact about this opportunity?
Regional or Local Office
None/Not specified.
Headquarters Office
Ana Del Valle
NICHD FMB Suite, 2nd floor - Building 31 - NIH Main Campus
Bethesda, MD 20892-7510 US
Phone: 301-496-8392
Website Address
Financial Information
Account Identification
(Project Grants) FY 22$1,155,268,956.00; FY 23 est $1,226,394,000.00; FY 24 est $1,232,387,000.00; FY 21$1,149,630,203.00; FY 20$1,133,277,384.00; FY 19$1,083,582,000.00; FY 18$1,040,649,876.00; FY 17$979,273,038.00; FY 16$945,498,160.00; - For FY 2022, of the $1,155,268,956 for Total Research Grants, $49,616,789 was for SBIR/STTR activities and awards. For FY 2023, of the estimated $1,226,394,000 for Total Research Grants, $51,128,000 is planned for SBIR/STTR activities and awards. For FY 2024, of the estimated $1,232,387,000 for Total Research Grants, $50,998,000 is planned for SBIR/STTR activities and awards. NOTE: these amounts do not include training, R&D contracts of operating funds.(Cooperative Agreements (Discretionary Grants)) FY 22$83,924,358.00; FY 23 est $84,765,000.00; FY 24 est $84,765,000.00; -
Range and Average of Financial Assistance
For research project grants, fiscal year 2022, range is $50,000 to $5,000,000; average is $492,442. Individual research fellowship awards: Basic stipend (first year beyond the doctoral degree) of approximately $45,000. The sponsoring institution will be provided, on application, with an allowance of up to approximately $8,000 per year to help defray the cost of training. No dependency allowances. SBIR: Average Phase I awards are for approximately $225,000 (grant activity R43 - for up to six months); Phase II awards may be made for amounts up to $1,500,000 (grant activity R44 - for up to two years).
Regulations, Guidelines and Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Grants Policy Statement, (Rev.) March 1, 2001, available on the NIH website at; NIH Guide to Grants and Contracts, available on the NIH website at Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Examples of Funded Projects
Fiscal Year 2016 In FY 2016, NICHD will also support broad NIH scientific efforts: Pregnancy and Birth - NICHD recently announced funding to launch the Human Placenta Project, an initiative that will develop technologies to assess, in real time, the structure and function of the human placenta. Critical for both maternal and fetal health, the placenta also has substantial implications for long-term health of both mother and child. The Project’s goals include understanding normal and abnormal placental development, developing biomarkers to predict adverse pregnancy outcomes, and developing interventions to prevent abnormal placental and fetal development. The Project will also examine the effects of environmental factors, such as pollution, medications, or diet on the placenta. In the coming year, NICHD will launch “MyPregnancy,” a longitudinal, crowd-sourced, citizen science approach that gathers information about pregnancy from the experts - pregnant women. This will deepen our knowledge about what women experience physically and emotionally during pregnancy and after giving birth, the effects of pregnancy on women’s lives, the challenges pregnant women face, such as health issues related to disability or a chronic health condition, and what features are common to many pregnancies. Participants will use web-based or mobile devices to enter information via online questionnaires and will be able to print out reports to share with their health care team and view summaries of de-identified data to see how they compare to other women. MyPregnancy will also provide links to evidence-based information about pregnancy from trusted partner agencies and organizations and about other ways to participate in research about pregnancy. MyPregnancy will inform pregnant women while involving them in finding ways to improve pregnancy care. Infancy - Through the Hunter Kelly Newborn Screening Research Program, NICHD has long provided much of the evidence for determining whether a health condition can be detected in newborns, and whether it can be treated or cured. Currently, most states screen newborns for a panel of 29 conditions, thus preventing extensive disease and disability. However, the newest technologies, such as genome sequencing, raise new social and ethical questions. NICHD recently hosted a meeting to discuss the research implications of new informed consent requirements mandated by the 2014 Newborn Screening Saves Lives Act reauthorization, and is providing guidance about how to meet the law’s requirements while preserving this lifesaving research. Building on two decades of research that has helped decrease United States infant mortality rates, NICHD continues to expand its work to prevent sudden unexplained infant deaths, both through research on risk factors and a major public education campaign. Because of this ongoing research, the original “Back to Sleep” message has evolved to “Safe to Sleep,” encouraging parents and infant caregivers to create safe sleep environments throughout the day and night while continuing other health-promoting practices, such as breastfeeding. NICHD is supporting particular outreach efforts to tailor culturally sensitive messages to underserved populations. Pediatric Development and Rehabilitation from Injury - NICHD studies of brain development shed light on how human brains function, including insights into abnormal function, so that effective interventions can be developed. One new study found that overweight or obese children are slower than children of healthy weight to recognize when they have made an error, and are slower to correct that error. Although the effects of childhood obesity on later chronic health conditions has been well documented, this is one of the first studies to show that being overweight can affect how well a child organizes and prioritizes thoughts. Other NICHD-funded researchers used new technologies to track myelination, the development of the brain’s “white matter,” in children from kindergarten through third grade. The developmental course of the children’s white matter predicted ability to read, raising the possibility that this method could be used to diagnose children with dyslexia and other reading disorders before they experience problems in school. Understanding human development in adolescence, with its substantial physical, mental, and behavioral changes, poses a particular challenge. While many programs encourage physical activity, concerns have arisen about the long-term effects of activity-related traumatic brain injury (TBI) in young people, who often quickly recover basic intellectual functioning and learning ability, but may have longer-term trouble with complex tasks, such as schoolwork, driving, or social interactions. Recently, NICHD-funded researchers developed a way to shorten TBI recovery time through “gist training,” which helps young people extract the fundamental meaning of a conversation or article while leaving out the details, a skill basic to everyday functioning. Individuals with Special Needs - NICHD has long supported research on intellectual and developmental disabilities, and on developing therapies for these conditions. With the support of the trans-NIH Down Syndrome Working Group and the public-private Down Syndrome Consortium, NICHD launched DS-Connect™: The Down Syndrome Registry. DS-Connect™, now including 2,800 registrants, is a web-based, voluntary, secure health registry that provides anonymized information to families and clinicians. This year, DS-Connect™ added a special subsite for researchers and health care professionals. Researchers may sign up for free access to de-identified data, or work with the registry coordinator to find participants for clinical trials, to help increase our understanding of Down syndrome and how to treat its accompanying health issues across the lifespan. Embracing Research Opportunities - Increasingly, researchers need to work in transdisciplinary teams, manage massive amounts of data, and acquire new and diverse skill sets. Therefore, NICHD is establishing a new publicly accessible, online data and specimen hub to enable sharing of data and biospecimens from NICHD-supported studies. This archive will maximize use of research findings, not only for the original study purposes, but through secondary analyses as well. We expect to add data from eight to ten studies a year, eventually creating a rich information source for the entire research community. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports a broad research portfolio uniquely focused on human health and development, from before birth through adulthood. In scientific domains encompassing developmental biology, reproductive health, pediatrics, population sciences, and medical rehabilitation, NICHD supports research that helps us better understand how health and disease develop over time, to prevent, reduce and treat illness and disability in current and future generations. The lifelong process of human development is shaped by an array of complex physiological processes that interact with behavioral, social, and environmental factors. Fundamental scientific knowledge about how these processes work may not yield commercially-viable new treatments quickly – or at all. Yet fundamental research is the foundation of medical progress. Basic research helps identify crucial points in the disease process for treatment or prevention; reveals new compounds for testing as candidate therapies; pinpoints previously unsuspected risk factors for multiple conditions; and generates new approaches to prevention and cure. NICHD’s support for fundamental science emphasizes technologies and tools to understand both normal development and disease, as well as creating new ways to measure progress in improving health. NICHD actively promotes data sharing and supports publicly-available databases and biobanks to help ensure that relevant materials are available for translational research in maternal, pediatric, and reproductive health. NICHD’s continuing efforts to understand the crucial role of the human placenta has already begun to provide an unprecedented wealth of information on how placental function affects maternal and fetal health. NICHD also continues to prioritize continuing investment in basic and translational research related to structural birth defects, which are a major cause of infant death in the United States. Populations of primary interest to NICHD -- children, pregnant women, and persons with physical and intellectual disabilities – have too often and for too long been prescribed drugs, devices, and other treatments that were designed for and tested in groups from which they differ physiologically. Parents, pregnant women, individuals with disabilities, and their health care providers are often put in an extremely difficult position in which they have little or no information to assess whether the treatment is more dangerous than the disease. NICHD supports clinical research that specifically focuses on these populations, in the real-world settings where they receive treatment—including neonatal and pediatric intensive care units; fertility, rehabilitation, and HIV clinics; day care and schools; and physicians’ offices. For example, the neonatal intensive care units across the United States that form NICHD’s Neonatal Research Network are currently conducting clinical trials on potential treatments for neonatal sepsis, necrotizing enterocolitis, and anemia to help the smallest and most vulnerable infants. The Zika in Infants and Pregnancy (ZIP) study intends to enroll 10,000 pregnant women in areas where Zika virus is prevalent, including Puerto Rico, Brazil, and Colombia. Continuing this line of research will allow scientists to obtain data on the developmental effects of the virus on children, including understanding the relationship btween timing of exposure and development of microcephaly. This will help clinicians, parents, and educators to better support children affected by prenatal exposure to Zika. Fundamental biomedical and behavioral science is essential to prevention and health promotion. Recent scientific findings show that pregnancy is a “stress test” that indicates a higher risk for more serious problems as women age. For example, NICHD-supported research has shown that women with pregnancy complications such as preeclampsia and gestational diabetes have a higher risk of developing heart disease and type 2 diabetes later in life. NICHD research has also demonstrated that lifestyle factors such as nutrition and exercise can mitigate these risks. Physical activity is a key component to maintaining physical health and decreasing secondary health conditions throughout life. However, individuals with disability experience a number of physical, social, and environmental barriers that make it more difficult for them to participate in physical activity. NICHD’s National Center for Medical Rehabilitation Research (NCMRR) studies interventions that can promote, monitor, and sustain physical activity programs for people with disabilities in real-world settings (e.g., home, community, workplace, and school). This includes the use of engineering and social-science approaches to understand the effect of environmental factors, monitor individual participation, and promote overall health and independence. NICHD continues to prioritize funding for new and early-stage investigators, to ensure that there is a pipeline of scientists and clinicians who are focused on the health problems of the communities NICHD serves, and to make certain that scientific progress continues to the next generation. Over the past two years NICHD has convened a Training Task Force that has examined outcomes for a variety of different training pathways. NICHD will use the evidence gathered from the Task Force’s analysis to preferentially fund mechanisms that require individuals, rather than institutions, to apply for training opportunities. The broad scientific opportunities at NICHD come with the recognition that thoughtful prioritization and careful stewardship are essential. NICHD has implemented data-driven approaches to portfolio analysis, program evaluation, and performance assessment. This will help the Institute make strategic funding choices, focusing on areas that hold the most promise to improve the health of children, pregnant women, individuals with disabilities, families, and communities. Through a visioning process that has occurred over the past several years, NICHD has identified scientific research priorities that have been shared with the research community and the public. NICHD will use these priorities to identify key areas for continued support.
Fiscal Year 2020 Reproductive Health, Pregnancy, and Perinatology: The NICHD program in reproductive health, pregnancy, and perinatology supports basic, clinical, and translational research on gynecologic and andrologic disorders; contraception; fertility and infertility; pregnancy; and newborn care. NICHD manages a broad research portfolio to understand, treat, and prevent common, painful, and costly gynecologic health conditions, including endometriosis, uterine fibroids, chronic pelvic pain, and pelvic floor disorders. A recent genome-wide study of fibroid subtypes discovered multiple mutations that alter the expression of three genes. This research calls into doubt the long-standing characterization of fibroids as a single condition; instead, uterine fibroids may be more similar to breast cancers—a group of similar conditions that arise in a variety of ways. Such basic biology insights may lead to more targeted and more effective treatments. The new NICHD-supported centers of excellence in endometriosis research will also focus on understanding the basic biology of endometriosis to help scientists develop non-invasive diagnostics, improved treatment, and ultimately, a cure for this painful condition that affects 10 percent of women. Millions of couples across the United States have difficulty conceiving and establishing a healthy pregnancy, yet only limited information is available to understand the causes of infertility, minimize risk factors, and improve treatment options. Scientists recently discovered a key protein, SKP1, that drives a crucial step in the sperm production process. The discovery may inform strategies to treat certain forms of male infertility. As NIH’s leader in pregnancy research, NICHD supports scientific studies on clinical treatments to reduce the risk of pregnancy complications for both pregnant women and their offspring. For example, scientists found that negative pressure wound therapy—placing a low-pressure pump over a closed surgical wound to create negative air pressure—did not appear to lower the risk of infection for women with obesity after cesarean delivery. Scientists are also working on basic and translational studies to understand, and ultimately prevent, adverse pregnancy outcomes. For example, researchers recently found that high concentrations of platelet factor 4—a chemical released by small cell fragments in blood that start the first stage of chemical blood clotting—could serve as a predictor of risk of placenta-mediated pregnancy complications. NICHD led the Congressionally-mandated Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), which sought to address gaps in understanding how to guide treatment decisions during pregnancy and breastfeeding. In September 2020, PRGLAC submitted its Implementation Plan to the HHS Secretary with pragmatic steps for carrying out the Task Force’s earlier recommendations. NICHD is emphasizing obstetric pharmacology studies; in 2020-2021 NICHD is launching a new effort to provide more researchers with obstetric and pediatric pharmacology expertise, basic science research, and technology platforms to advance clinical research with pregnant and lactating women and children at all stages of development. Perinatal research supported by NICHD continues to yield important advances, including early detection of and protection against disorders that threaten the survival and development of newborns. Scientists showed that in children born between 22-26 weeks of gestation, a combination of antenatal treatment with both corticosteroids and magnesium sulfate was associated with lower rates of severe neurodevelopmental impairment or death compared with antenatal corticosteroids alone. Researchers recently developed a new imaging system, Electromyometrial Imaging (EMMI), to model fetal kicks, contractions, and fetal/maternal movements in utero. The system uses individualized body-uterus geometry mapped by Magnetic Resonance Imaging (MRI), a large number of electrodes placed around the abdomen, and specialized software for 3D mapping of electrical activation signals across the entire surface of the uterus during labor. Child Health: Research on child health explores basic biological processes that control healthy or atypical development, translational research from the bench to the bedside, behavioral and social science research, and clinical studies in pediatric pharmacology, infectious diseases, nutrition, endocrinology, trauma and critical illness, and other aspects of pediatric medicine. As described above, children infected with the SARS-CoV-2 virus are vulnerable to serious complications like MIS-C. NICHD’s longstanding expertise in pediatric critical care and pediatric pharmacology has positioned the Institute to lead efforts to accelerate understanding of how COVID-19 affects children. Additional funds in the FY 2022 budget request will facilitate expansion of these efforts. Moreover, the COVID-19 pandemic affects many aspects of child health and development for children who remain uninfected. One of the greatest upheavals caused by the COVID-19 pandemic was the sudden shutdown of elementary, middle, and high schools to prevent the spread of the virus. Across the country, as many as three-quarters of large school districts were employing a fully-online learning model over some period. The move to online learning raised concerns about access to computers and the internet, potential increases in food insecurity for children who received free or reduced-price lunches, changes in physical activity, and lack of social interactions with peers. Suspension of classroom time disproportionately affects children with intellectual and developmental disabilities, who often require special educational services, increased teacher-student ratios, and specialized interventions, many of which need to be administered in person by skilled professionals. Beyond educational changes, children have been affected by pandemic-related changes in family and social interaction (e.g., less time with peers and grandparents), nutrition, and other changes. NICHD-supported researchers are assessing the impact of these changes on child development. For example, one group of scientists is researching the impact of prolonged school closures from COVID-19 on health, nutrition and weight of low-income children, and determining the effects of emergency food programs. NICHD’s basic research portfolio on developmental biology has led to a better understanding of normal embryonic development, as well as mechanisms that underlie causes of structural and functional birth defects. For example, scientists have long suggested that neural tube defects like spina bifida can be associated with multiple developmental “signaling pathways,” genetically controlled processes in cell interactions that lead to organ formation. However, mutations in such pathways have been identified in few cases of neural tube defects, leaving the underlying causes unclear. Scientists recently identified eight rare genetic variants associated with spina bifida and are exploring ways to enhance the functions that are critical for normal neural tube closure. Pediatric clinical researchers recognize that children are not small adults – often, children react differently than adults do to both disease and to treatment. For example, children’s growing bodies and changing metabolism affect how the body processes and reacts to medications. Ongoing activities under the Best Pharmaceuticals Act for Children (BPCA) include identifying off-patent drugs in need of further study of dosing, safety, and efficacy for pediatric indications, prioritizing needs in pediatric therapeutics, and sponsoring clinical studies of prioritized drugs, with a goal of the U.S. Food and Drug Administration (FDA) labeling for use in children. Recent FDA label changes supported by this research provide clinicians with evidence-based prescribing information on the antibiotics doxycycline and clindamycin to treat serious infections in children. The NICHD-supported Pediatric Trials Network (PTN) quickly began collecting data on COVID-19 drugs that clinicians at approximately 40 PTN sites are using to treat infants, children, and adolescents, including a group of children with Down syndrome. Intellectual and Developmental Disabilities: Intellectual and developmental disabilities (IDDs) were once thought to be permanent and untreatable, but new science discoveries have challenged this belief, inspiring renewed efforts to improve the lives of individuals with IDDs. NICHD’s program on IDDs supports research and research training aimed at preventing and ameliorating both common and rare disorders, such as Down syndrome (DS), Fragile X syndrome (FXS), Rett syndrome, and muscular dystrophy; inborn errors of metabolism; autism spectrum disorders (ASD); congenital conditions currently or potentially detectable through newborn screening; and IDDs that have no identified cause or are not associated with a specific syndrome. NICHD’s IDD portfolio includes a broad array of investigator-initiated research and also incorporates key programs that support larger-scale innovative projects. For example, the trans-NIH Autism Centers of Excellence supports large-scale multidisciplinary studies on ASDs, with the goal of determining the disorders' causes and potential treatments. The Centers for Collaborative Research on Fragile X will study FMR1-associated conditions, as well as the FMR1 gene, the role of the gene in development and progression of these conditions, and other aspects of the NIH Strategic Plan for Research on FMR1-Associated Conditions. NICHD’s Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Centers offer a wide range of research services to scientists, including informatics and biostatistics; genomic, proteomic, and metabolomics facilities; cellular neuroimaging and optogenetic services; neuroimaging; and animal and human behavioral testing. The INCLUDE program, to be transferred from the NIH OD to NICHD, is designed to support targeted, high-risk, high-reward basic science and clinical studies to address the needs of individuals with DS. In FY 2022, INCLUDE will continue to support promising research and will update the INCLUDE Research Plan, integrating it with the NIH Research Plan on Down Syndrome (for release in 2021), signifying INCLUDE’s important role in continuing a trans-NIH approach to DS. A priority for NICHD is advancing the inclusion of individuals with IDDs in clinical research from which they typically are excluded, even though their developmental disability may co-exist with cardiovascular, metabolic, and other disorders and health risks of the general population. For example, a recent NICHD grant supports research on the most effective way to optimize weekly COVID-19 testing of students with IDDs and staff. Prompted by challenges in recruiting an adequate research cohort of infants and toddlers with tuberous sclerosis complex (TSC), researchers developed a remote model for research participation. A rare, multi-system genetic disease, TSC affects the central nervous system, resulting in combinations of symptoms including ASD, seizures, impaired intellectual development, behavioral issues, and physical symptoms. Working with TSC children’s caregivers, researchers modified their experimental intervention so that caregivers could provide the intervention to children at home, alongside weekly videoconferences with researchers. Within a year, study enrollment increased tenfold and the cohort of affected infants was more diverse and clinically representative. Through the INCLUDE program and NICHD’s Down Syndrome Registry (DS-Connect™), expanded opportunities for individuals with Down syndrome to participate in research are now available. Lessons from the success of these programs can be applied to other IDD conditions. Demography and Behavior: The program in demography and behavior incorporates NICHD's strong portfolio on behavioral and social influences on health. For example, one NICHD-funded study assessed whether stricter state standards for school nutritional programs were associated with improved eating habits and obesity in more than 2,000 adolescents. Teens in states with strong “farm-to-school” laws to increase the amount of fresh produce in schools consumed more whole fruits, fewer snacks, and less soda that those in states with weak or no such laws. A key priority for child development and behavior research at the NICHD is to investigate the impact of the digital age on child development. When researchers studied children’s “screen time” behavior at one to three years of age and at eight years of age, the scientists found that the amount of screen time greatly exceeded levels recommended by the American Academy of Pediatrics. The research results also showed that patterns of screen time behavior developed at early ages, often as early as infancy. Over 85 percent of the children in the study had higher screen use than recommended for their age, and the average time the children spent in front of screens increased as they grew, from nearly 1 hour per day at 12 months to nearly 2 hours a day at 3 years. This study was conducted prior to the COVID-19 pandemic, and child use of digital media has increased significantly during the past year. NICHD also supports behavioral research related to reproductive health. For example, in response to Delaware reporting the highest rate of unintended pregnancies in the United States, NICHD-funded researchers assessed the impact of a public-private partnership initiative to increase women’s use of contraceptives. The program was designed to ensure free, same-day access for all women to all contraceptive options and address provider inexperience in inserting and removing long-acting reversible contraceptives. The program was associated with a 40 percent increase in the use of recommended, long-acting contraception. Rehabilitation: The NICHD’s National Center for Medical Rehabilitation Research (NCMRR) fosters research and research training to enhance the health, productivity, independence, and quality of life of people with physical disabilities. With its leadership role in trans-NIH and broader medical rehabilitation research collaborations, NCMRR takes a collaborative approach to advance a broad range of research and research training, including efforts to understand the underlying biology of injury and disability and the body’s own mechanisms of recovery and adaptation. Bioelectronic devices that can modulate nervous system functioning have shown promise in treating neurological disorders. However, the use of these devices in children has been limited, because of the need to adapt devices as children grow. Recently, NCMRR-supported scientists designed and implanted a “morphing” bioelectronics device, MorphE, under the sciatic nerve of experimental rats in their most rapid period of growth, adolescence. A series of tests indicated that MorphE was capable of actively adapting to the animals’ tissue growth. Further evaluation over longer duration of implantation of the new technology could pave the way to better efficacy and reduced complications of implantable bioelectronic devices for young patients. Through basic, translational, and clinical research, NCMRR aims to foster development of scientific knowledge needed to create and refine real-world interventions. The Medical Rehabilitation Research Resource (MR3) Network is funded through NCMRR with support from NICHD and five other NIH ICs. The MR3 Network builds research infrastructure in medical rehabilitation by providing researchers with access to expertise, technologies, and resources to foster clinical and translational research in medical rehabilitation. The network focuses on several key areas, including pediatric rehabilitation, technology to improve real-world outcomes, regenerative rehabilitation promoting tissue engineering and function, stimulation of nerve activity to restore function and relive pain, and translational/dissemination.
Fiscal Year 2021 Director’s Overview The public health crisis driven by the coronavirus (COVID-19) pandemic has intensely highlighted the crucial role of biomedical research to improve human health. By March 2022, the pandemic caused more than 78 million confirmed cases and over 950,000 associated deaths in the United States, with more than five times these figures globally. The mission of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) – to “lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all” – has never been more imperative. The NICHD supports a strong foundation of scientific expertise, a carefully developed research infrastructure, and creative, highly dedicated, scientific research communities. Because NICHD had previously laid the groundwork, NIH’s rapid pandemic response was able to include children, pregnant women, and people with disabilities in its research efforts. To study the impact of COVID-19 infection and vaccination on pregnant women rigorously but rapidly, several NICHD-supported research networks and large medical centers pivoted to respond. Their results showed that COVID-19 vaccines are highly effective in producing antibodies in pregnant women, and that antibodies produced after vaccination are present in breast milk and travel across the placenta, indicating that vaccination during pregnancy confers immunity to newborns. Another study found no serious adverse events from the COVID-19 vaccine in breastfeeding women or their children. Data from these studies have reassured pregnant women and their families about the safety of vaccine use. NICHD also supports a trial of therapeutics for COVID-19 in pregnancy and this work is ongoing. Through the Researching COVID to Enhance Recovery (RECOVER) effort, scientists, clinicians, patients, and caregivers are coming together to improve our understanding, treatment, and prevention of the long-term effects of COVID-19. NICHD will study pediatric, pregnant and postpartum people who are among those experiencing “long COVID.” NICHD has also brought its specialized expertise and existing research infrastructure to identify how to prevent and treat COVID-19 in children. Children and youth continue to face the potential for frequent exposure to COVID-19, and many have not yet been vaccinated. Although early in the pandemic it was assumed that children did not get ill from COVID-19, cases among children increased rapidly as the delta variant of SARS-CoV-2 moved across the country. During the Omicron variant predominance beginning in late December 2021, U.S. infants and children aged 0–4 years were hospitalized at approximately five times the rate of the previous peak during Delta variant predominance. Moreover, a post-infection immune response, known as multi-system inflammatory syndrome in children (MIS-C), can create deadly consequences; over 7.400 cases and 63 deaths due to MIS-C have been reported. Researchers quickly mobilized efforts to diagnose MIS-C and distinguish it from other related childhood conditions such as Kawasaki disease.
Fiscal Year 2022 For six decades, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has provided dedicated national leadership and scientific expertise for research across the life span to ensure health at all stages of life for all people. Scientific research is the key to achieving NICHD’s mission -- to “lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.” To attain our ultimate goals, we need a talented, diverse, multi-generational scientific research workforce. Scientific research is the key to advancing reproductive health. Both men and women need safe, reversible, convenient, effective contraception and targeted treatments for infertility. Addressing contraceptive and infertility treatment in men has been especially difficult, but a new generation of scientists is eager to take on this challenge. Research on an effective male contraception has now reached clinical trials and is showing promising results. In addition, advances in fundamental reproductive sciences are pointing the way to the next generation of contraceptives and infertility treatments. Intramural scientists at NICHD, working with colleagues at the National Institute on Allergy and Infectious Diseases (NIAID), designed several small compounds called cyclic peptides that can block the activity of a protein that is found in the testes and is essential for making healthy sperm. This research may ultimately yield new approaches not only for non-hormonal male contraception, but also for male infertility, where it is often difficult to pinpoint a specific cause. Gynecologic conditions such as endometriosis, uterine fibroids, vulvodynia, and pelvic floor disorders affect many women. Because these conditions often have origins earlier in life but are diagnosed only later, taking a life course approach to prevention is especially important. NICHD-funded researchers have developed a prototype genetic test for uterine fibroids (noncancerous tumors in the uterus). Fibroids are frequently misdiagnosed or underdiagnosed. This test could be used to identify fibroid cases early and to help treat them before painful symptoms become debilitating. Detecting fibroids at earlier stages will also help scientists understand why Black women are more likely to experience fibroids and why their fibroids tend to be more severe. To mitigate this health disparity, NICHD plans to establish new multidisciplinary research centers and expand its portfolio of studies on uterine fibroids. NICHD has already begun to see the returns on its recent investment that more than doubled the size of the research portfolio in endometriosis, which causes debilitating pain and infertility in millions of women. To move towards new non-surgical treatment approaches, scientists adapted an experimental cancer therapy to develop a less-invasive treatment for endometriosis. Using a mouse model of endometriosis, the researchers applied an alternating magnetic field that could safely remove all the endometriosis tissue within 20 minutes without affecting other tissues. Further research is anticipated to determine if this type of treatment could be used in people.
Fiscal Year 2023 NICHD has also been providing evidence-based information on any potential risk to reproductive health posed by coronavirus disease 2019 (COVID-19) infection and subsequent vaccinations. In a new study of more than 2,000 couples, researchers found no differences in the chances of conception if either male or female partner had been vaccinated, compared to unvaccinated couples. However, couples had a slightly lower chance of conception if the male partner had been infected with SARS-CoV-2 within 60 days before a partner’s menstrual cycle, suggesting that COVID-19 could temporarily reduce male fertility. In two other studies, NICHD-supported scientists showed that COVID-19 vaccination was associated with a small, temporary increase in the length of the interval between menstrual cycles, but no change in the number of days of bleeding. Scientific research is the key to making the U.S. a safer country for giving birth. As many as 900 U.S. women die each year from conditions related to or associated with pregnancy or childbirth, a high rate among developed nations. More than 50,000 U.S. women experience severe maternal morbidity, life-threatening health problems that are present at delivery. NICHD, along with NINR and ORWH, is leading the NIH-wide Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) effort to expand maternal health research. New initiatives under IMPROVE include: (1) Maternal Health Research Centers of Excellence, a national network to develop, implement, and evaluate community-tailored interventions to address health disparities in maternal morbidity and mortality; (2) the Rapid Acceleration of Diagnostics (RADx®) Tech for Maternal Health Challenge, to accelerate the development of advanced maternal health technologies (e.g., wearable devices, sensors, smartphone-enabled tools) for use in geographic areas where maternity care is more difficult to access; (3) Connecting the Community for Maternal Health Challenge, a prize competition to help community and advocacy organizations build research infrastructure; (4) Community Implementation Program, where researchers and community organizations will work together to integrate interventions of known effectiveness into community settings; (5) research to study dissemination and implementation of maternal health efforts, and (6) a “Connectathon” to work towards electronic health record standards to enable real world maternal health research before and after pregnancy. Pregnant women represent a high-risk population for severe and critical COVID-19 infection. In a study of nearly 2,400 pregnant women infected with the virus that causes COVID-19, scientists found that those with moderate to severe infection were more likely to have a cesarean delivery, to deliver preterm, to die around the time of birth, or to experience serious illnesses. The findings underscore the need for women of child-bearing age and pregnant individuals to be vaccinated and to take other precautions against becoming infected. Over the past several years, NICHD has emphasized tackling the undiscovered secrets of the placenta. The investment in the multidisciplinary Human Placenta Project (HPP) is now paying dividends. In just one example, researchers demonstrated that it is possible to measure placental blood flow to help identify at-risk pregnancies. The scientists used a measurement method called “T2*”, which can measure blood oxygenation to areas in the body. They found that in pregnancies with adverse primary outcomes (such as hypertensive disorders of pregnancy, low birth weight, or stillbirth), placental blood flow was reduced starting at 15 weeks and continuing through 33 weeks of gestation. This demonstrates that scanning using T2* has potential to help identify at-risk pregnancies so that treatment can begin before adverse outcomes occur. A different team of researchers recently developed a new method to detect genetic material from the placenta in the blood of pregnant people, allowing physicians to identify the risk for gestational, or pregnancy-related, diabetes earlier than current methods allow.
Fiscal Year 2024 Scientific research is the key to improving survival and long-term health for infants. Thanks in part to medical advances from NICHD-supported research, survival rates have improved for extremely preterm infants. However, the rate of preterm births is particularly high in the United States at approximately 10 percent of deliveries. Researchers found that concentrations of certain metabolites of phthalates (synthetic chemicals used in consumer products) were associated with the risk of preterm birth. The risk of stillbirth – fetal death at 20 or more weeks of gestation – is associated with vascular lesions in the placenta and with some forms of chromosomal structural abnormalities. However, scientists do not fully understand how these factors increase the risk of stillbirth, or how the two issues may be related. Researchers used data from a previous stillbirth study to examine the associations of placental pathological lesions (PPLs) with placental and fetal DNA copy number variants (CNVs, which are changes in the number of copies of a particular gene or segment of DNA). The scientists found that of 387 stillborn fetuses, 327 (about 85 percent) had maternal vascular PPLs and 60 (about 16 percent) had abnormal CNVs. Maternal vascular PPLs were more common in stillborn fetuses with abnormal CNVs than in those with normal CNVs. These results may help physicians develop new ways to identify risk for stillbirth and prevent tragedies. Preterm and low birthweight infants have an increased risk of life-threatening intestinal disorders. Scientists assessed surgical options for infants with necrotizing enterocolitis (NEC), in which intestinal tissue dies, and intestinal perforation, where a hole forms in the intestinal wall. They found that one of the two surgical options was more effective for infants with NEC, although there was no difference in outcomes for infants with intestinal perforation. NICHD’s upcoming renewal of the long-standing Neonatal Research Network will continue to emphasize rigorous clinical trials, with more opportunities for a wider range of scientists from all over the United States. Scientific research is the key to keeping children healthy. NICHD researchers quickly developed an extensive evidence base to support efforts to return children to school and to minimize quarantine-related disruptions during the COVID-19 pandemic. Researchers rigorously studied an on-site SARS-CoV-2 school testing program in North Carolina and found that providing access to in-school testing following within-school SARS-Co-2 exposure reduced the number of missed school days. In a study including more than 1.1 million students attending in-person school across nine states, scientists found that schools with mandatory masking during the Delta surge had approximately 72 percent fewer cases of in-school transmission of SARSCoV-2 when compared to schools with optional or partial masking policies. NICHD also funded a multicenter follow-up study of U.S. children and adolescents hospitalized with COVID-19 or multisystem inflammatory syndrome in children (MIS-C), a serious condition some children develop after exposure to the virus. They found that more than 1 in 4 patients had persistent symptoms or activity impairment 2 to 4 months after their illness, highlighting the need to study “Long COVID” in children as well as in adults. In addition to its direct effects, the pandemic has amplified concerns about the time away from the in-person learning and peer interactions that are so important to child development. An international study funded by NICHD confirmed that children engaged with screens more during the pandemic than before, but also found that a greater proportion of this increase was driven by screen use for entertainment purposes compared to use of educational applications. However, researchers also found that electronic applications can be used to improve health. For example, scientists found that a mobile app could be used to teach parents activities to help children’s motor skill development. Compared to children who did not partake in the intervention but who performed the same amount of physical activity, children’s motor skill performance increased after 3 months, and these increases remained 3 months later. While the relationship of interaction with digital media and child development has varied across studies, we do know the pandemic had a significant impact on child mental health. Scientists found that although the number and proportion of youth suicide varied among states, when data from 14 states were considered together, there was an increase during the pandemic in the number of youth suicides.


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