August 28, 2024
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is updating its current (2020-2024) strategic plan (https://www.nichd.nih.gov/about/org/strategicplan ). The updated plan for 2025-2029 will help guide the research NICHD will support over the next five years. The purpose of this Request for Information (RFI) is to solicit feedback on the scientific goals and opportunities under consideration for the refreshed NICHD strategic plan.
Background
For more than six decades, NICHD has provided both national and international leadership for research involving children, pregnant and lactating people, and individuals with disabilities. In the fields of developmental biology, reproductive health, child development, pediatrics, population health, and medical rehabilitation, the institute's broad research portfolio has advanced the biomedical and behavioral health of our nation.
Today, the United States (U.S.) and the global community face an array of challenges that threaten to erode gains in public health. For example, many individuals in the U.S. are affected by lifelong physical, cognitive, and developmental disabilities and congenital anomalies. Although reproductive health conditions are now recognized as major public health concerns, effective, non-invasive treatment options have proven elusive. The U.S. maternal mortality rate is still unacceptably high and exceeds that of most high-income countries. Children in the U.S. face threats to their physical, cognitive, and mental health. All too often, therapeutic approaches for pregnant and lactating individuals, people with disabilities, and children are extrapolated from interventions developed and tested exclusively in other populations.
At the same time, technology breakthroughs, such as advances in imaging technology, artificial intelligence and machine learning, and the rise in -omics technology, offer unprecedented opportunities for innovative scientific discovery and advancements in health and well-being. NICHD is committed to accelerating the pace of the basic, translational, and clinical science needed to capitalize on these opportunities and address the nations public health challenges. There is a great need for transformative work to harness new technologies and methods that address health disparities and improve prevention efforts among the populations we serve. Therefore, in October 2023, NICHD launched a collaborative process involving internal and external stakeholders to refresh the NICHD strategic plan to reflect the institutes progress and emerging areas of opportunity.
Information Requested
NICHD seeks input from researchers in academia and industry, health care professionals, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole. Specifically, NICHD seeks comments and suggestions on the following research goals, opportunities, and cross-cutting themes.
Research Goal #1: Understanding the Molecular, Cellular, and Structural Basis of Development
Enhance knowledge of developmental processes and understanding of critical periods in human development, improving understanding of the origins of congenital anomalies, neurodevelopmental disorders, and intellectual and developmental disabilities.
Opportunities: This goal includes a focus on understanding developmental processes by describing the intrinsic events that contribute to early human development. This goal will also focus on exploring how extrinsic factors can influence developmental and physiological processes, particularly in the context of congenital anomalies, neurodevelopmental disorders, and intellectual and developmental disabilities. Additionally, this goal aims to enhance collaborative developmental biology research by investing in improved infrastructure—along with novel tools and technologies—to analyze and validate data derived from model systems research, biophysics, biomechanics, optogenetics, and other emerging scientific areas. This research area will also support the use of genomics, proteomics, and metabolomics to profile gene and protein expression and regulation at the single-cell level and characterize regulatory networks across tissues and time during development.
Research Goal #2: Promoting Gynecologic, Andrologic, and Reproductive Health
Enable individuals to manage their fertility and minimize the impact of reproductive health conditions.
Opportunities: Recent gains in scientific knowledge have created opportunities to improve understanding of reproductive stages across the life cycle, with particular emphasis on typical and atypical initiation, timing, and symptomatology of critical windows such as puberty, andropause, and perimenopause. This research also aims to characterize reproductive aging and its impact on reproductive outcomes, particularly infertility. Furthermore, this goal will focus on identifying biologic and environmental factors that can lead or contribute to idiopathic infertility with the goal of applying this knowledge to expand technologies or methods for fertility stimulation, fertility preservation, and contraception. This goal encompasses a broad emphasis on gynecologic conditions, including identifying the mechanisms underlying generalized and pelvic pain in gynecologic conditions. This goal will also identify interventions for the treatment of gynecologic conditions and assess the impact of new and existing treatment approaches on gynecologic health disparities. Finally, this goal will improve understanding of the factors affecting contraceptive use and non-use as well as preferences for specific contraceptive methods. This knowledge will be applied in developing new contraception options and advance understanding of the effects of contraceptives on human health.
Research Goal #3: Setting the Foundation for Healthy Pregnancies and Lifelong Wellness
Improve pregnancy outcomes to maximize the lifelong health of women and their children.
Opportunities: This goal is focused on improving outcomes for women and children, including those associated with maternal health conditions, labor and delivery complications, and postpartum conditions. It includes enhancing interdisciplinary collaborations aimed at understanding mechanisms and causes of preterm birth. This goal also includes improving the long-term outcomes of infants born preterm or with aberrant fetal growth. This work includes integrating and analyzing diverse types of data, such as genomic, social and behavioral, and/or exposure data, to inform interventions for adverse maternal conditions and complications of pregnancy, such as preeclampsia, gestational diabetes, and placental anomalies. Furthermore, this requires supporting community-informed research to develop maternal health interventions that are widely applicable and that address health disparities. Continued study of the placenta, including basic and translational science approaches, will play a key role in this opportunity, particularly understanding the role of the placenta in pregnancy outcomes and in the long-term health of the mother and infant. This goal will also support the development of prevention strategies for labor and delivery complications that contribute to maternal morbidity and mortality (such as hemorrhage, infections, and cardiovascular conditions). Moreover, this goal will focus on identifying new approaches to mitigate maternal and paternal risk factors for conditions associated with pregnancy with effects that extend through the postpartum period and beyond.
Research Goal #4: Improving Child and Adolescent Health and the Transition to Adulthood
Advance understanding of typical and atypical child development, address leading causes of childhood illness and death, improve the transition from adolescent to adult healthcare, and strengthen the evidence base for pediatric primary care practice.
Opportunities: This goal is focused on improving child, infant, and adolescent health. This will involve identifying and assessing risk-reduction strategies to address the systemic and individual causes of infant mortality both domestically and globally, including new approaches to prevent Sudden Infant Death Syndrome, Sudden Unexplained Infant Death, and stillbirth. This will also require knowledge of how social and environmental factors affect infant, child, and adolescent health and development. This knowledge will be used to develop new (and improve the effectiveness of existing) early intervention approaches. Furthermore, this goal aims to advance understanding of physical, social, and emotional development across the lifespan and understanding of how to optimize timing of interventions for healthy development. This goal will also focus on developing and assessing prevention and treatment strategies to address trauma, injury, and violence, which are the leading causes of death in children and adolescents. To better support integration of pediatric and adult systems of care, this goal focuses on conducting research to determine successful transition at the individual, provider, and system level to ultimately improve care for adolescents and emerging adults. This goal also aims to enhance the evidence base for pediatric primary care by identifying practices and features of healthcare delivery associated with positive child health outcomes and supporting dissemination and implementation research for pediatric prevention strategies with demonstrated efficacy.
Research Goal #5: Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities
Develop, test, and validate safe and effective therapeutics and devices, specifically for pregnant and lactating people, children, and/or individuals with disabilities.
Opportunities: Pregnant and lactating people, children, and individuals with disabilities have specific needs that can only be addressed through their inclusion in the development, testing, and validation of therapeutics and devices. This goal includes a focus on conducting and supporting foundational research to support the development of interventions targeted to the needs of these patient populations. This goal also focuses on identifying and validating biomarkers, modeling approaches, and outcome measures that can be used to support rigorous testing and/or regulatory approval of pharmacotherapies and devices for these populations, increasing access to treatments suited to the individuals needs. Clinical research and dissemination and implementation will be needed to evaluate scalable and accessible therapeutics, diagnostics, and devices for these populations. This opportunity includes the potential to use data science techniques to assess patient outcomes, therapeutic safety or effectiveness, patient engagement, and/or health care delivery in datasets that include pregnant and lactating people, children, and/or people with disabilities.
Cross-Cutting Themes
In addition to the research goal areas noted above, there are several cross-cutting topics that are intended to integrate with the scientific research goals. The success of the scientific research goals will depend on the institutes ability to consider these topics across research areas.
How to Submit a Response
To ensure consideration, responses should be submitted via email to [email protected] no later than Friday, October 11, 2024. Please indicate RFI Response in the subject line of the email. Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The U.S. Government will use the information submitted in response to this RFI at its discretion. The U.S. Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitations, grants, or cooperative agreements, or in the development of future funding opportunity announcements.
This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the U.S. Governments use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this RFI or from the Governments use of such information.
Please direct all inquiries to:
NICHD Strategic Planning Group
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: [email protected]