March 4, 2020
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
National Institute of General Medical Sciences (NIGMS)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Research on Women's Health (ORWH)
Sexual and Gender Minority Research Office (SGMRO)
The Office of Research on Women's Health (ORWH) and the National Institute of General Medical Sciences (NIGMS), along with Institutes and Centers (ICs) of NIH participating in this Notice, announce the availability of administrative supplements to IDeA awards to expand research and research capacity in the IDeA states to address important issues of women’s health across the lifespan. The proposed research must address at least one of the strategic goals of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women." Research on maternal and infant morbidity and mortality is of particular interest.
ORWH is the first Public Health Service office dedicated specifically to promote women's health research within and beyond the NIH scientific community. ORWH was established in September 1990 by Congressional mandate. Congress assigned a far-reaching leadership role for ORWH by mandating that ORWH serves as the focal point for coordinating women’s health research at NIH. ORWH crafts and implements the NIH Strategic Plan for Women's Health Research in partnership with NIH ICs and co-funds research on the role of sex and gender on health with the ultimate goal of advancing rigorous research relevant to the health of women. ORWH also collaborates with NIH ICs, the NIH Office of Extramural Research, and the NIH Office of Intramural Research to monitor adherence to NIH's Inclusion Policies for Research Involving Human Subjects, which ensure that women and minorities are represented in NIH-supported clinical research.
ORWH's interdisciplinary research and career development initiatives stimulate research on sex and gender differences and provide career support to launch promising women's health researchers. These programs set the stage for improved health for women and their families and career opportunities and advancement for a diverse biomedical workforce.
The Institutional Development Award (IDeA) program is congressionally mandated and administered by NIGMS. It supports research and research capacity building in states that historically have had low levels of NIH funding through a variety of funding mechanisms. The IDeA program has been instrumental in increasing the pool of Early Stage Investigators (ESIs) from IDeA states who apply for NIH research project grants and in strengthening research infrastructure in those states.
Residents in IDeA states, especially those living in rural areas, often have less access to health care and suffer from poorer health outcomes, including health outcomes for women and children, than the average American. For example, several IDeA states are among the states with the highest maternal and infant mortality rates. These administrative supplements aim to increase research specifically directed at women’s health and health disparities and to expand the capacity of IDeA states to conduct women’s health research.
This NOSI encourages a broad range of research addressing important issues of women’s health with a special interest in maternal and infant morbidity and mortality, including their underlying causes.
Eligibility for this supplement program is limited to current awardees of the following NIGMS programs:
The Centers of Biomedical Research Excellence (COBRE) program, which supports the establishment and development of innovative, state-of-the-art biomedical and behavioral research centers at institutions in IDeA-eligible states through awards for three sequential five-year phases.
The IDeA Networks of Biomedical Research Excellence (INBRE) program, which supports a statewide biomedical research development network in each IDeA-eligible state that partners research-intensive institutions with primarily undergraduate institutions, community colleges and tribally controlled colleges and universities, providing access to biomedical research experiences for promising undergraduate students.
The IDeA Program Infrastructure for Clinical and Translational Research (IDeA-CTR), which enhances the ability of IDeA state institutions and investigators to develop competitive clinical and translational research programs and address health conditions that affect the medically underserved and/or are prevalent among populations in IDeA states.
Only one supplement request per COBRE, INBRE, or IDeA-CTR grant will be accepted. Each request may include only one research project, which must be within the scope of the parent grant and appropriate for the duration of one year.
Institute-, Center-, and Office-Specific Research Interests
The mission of the National Center for Complementary and Integrative Health (NCCIH) is to determine, through rigorous scientific investigation, the fundamental mechanisms, usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. For purposes of this FOA, NCCIH is interested in research investigating complementary and integrative health approaches to improve maternal health outcomes. Natural products include botanicals, probiotics/microbials, naturally-derived peptides, dietary supplements, and special diets. Mind-body approaches include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR), or complex interventions including music and art therapy.
Areas of programmatic interest to NCCIH include, but are not limited to, the following:
NCCIH will accept projects proposing secondary analyses, observational studies, basic, and mechanistic studies (animal and human). NCCIH will not accept assignment of applications that propose new clinical trials. NCCIH will not accept single-site or multi-site efficacy or effectiveness research through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). Investigators are strongly encouraged to discuss their plans with NCCIH Scientific/Research contact prior to submitting their application to identify the most appropriate FOA for their research.
The National Eye Institute (NEI) is interested in supporting research in its programmatic areas (https://www.nei.nih.gov/grants-and-training) that addresses important issues of women’s health especially those focused on maternal and infant morbidity.
The National Heart, Lung, and Blood Institute (NHLBI) supports basic, preclinical, translational, and clinical research that leads to improvement of heart, lung, blood, and sleep (HLBS) health outcomes for women.
Research areas of particular interest to NHLBI for this NOSI include approaches that are relevant across more than one HLBS area including but not limited to:
The National Human Genome Research Institute (NHGRI) supports the development of resources, approaches, and technologies that accelerate and support studies focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; genomic data science and bioinformatics; training, developing, and expanding the diversity of the genomics workforce; and ethical, legal, and social issues related to genomic advances. More details about the institute’s vision and priority areas can be found in the 2020 NHGRI Strategic Vision.
The National Institute on Aging (NIA) will accept applications for research projects in areas within the Institute's mission, including genetic, biological, behavioral, social, and economic research on aging. In addition, NIA encourages applications on Alzheimer’s disease (AD) and AD-related dementias (ADRD). The NIA website provides further information about the Institute’s mission and areas of research interest. A specific priority is understanding the environmental, sociocultural, behavioral and biological drivers of health inequities and disparities related to aging among older women, as outlined in NIA’s strategic directions for health disparities research and reflected within NIA’s Health Disparities framework. For additional scientific program information and for pre-application guidance, potential applicants are encouraged to contact the NIA Program Director whose portfolio covers the scientific topic of interest.
Specific areas of interest include:
The National Institute of Allergy and infectious Diseases (NIAID) supports basic and translational research to better understand, diagnose, prevent, and treat infectious and immune-mediated diseases, including diseases that impact maternal and infant mortality and morbidity. Areas of programmatic interest to NIAID include, but are not limited to, the following:
Interests of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission.
If work is proposed involving clinical trials, NIBIB will only consider funding support for in-scope early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development or mechanistic trials where the primary focus of the project is on technology development.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports a broad range of research addressing important issues in women’s health, including maternal and infant mortality and morbidity. Areas of particular interest to NICHD include, but are not limited to:
The National Institute on Drug Abuse (NIDA) supports and conducts biomedical research to understand, prevent and treat drug use and its consequences. For this announcement, NIDA is interested in basic and clinical research projects in females or sex/gender differences in drug use and addiction, its etiology and prevention, its consequences and the underlying neurobiological, social and behavioral mechanisms.
The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people to promote healthier lives. For this announcement, NIEHS is interested in supporting research that addresses or seeks to understand how exposures to toxic chemical and non-chemical environmental insults alter biologic processes that may be linked to disease in women, particularly maternal and infant mortality and morbidity. Equally important is research examining women’s health at the intersection of chemical, physical, built, and social environments. Examples of environmental exposures relevant to the mission of the NIEHS include, but are not limited to, industrial chemicals, e-waste, emerging and legacy endocrine-disrupting chemicals, indoor air pollutants from cooking and other sources, climate variability and the environmental impacts of natural and man-made disasters.
The National Institute of Nursing Research (NINR) supports research that builds the scientific foundation for nursing practice and policy across clinical and community settings, and advances the prevention, detection, and management of disease and disability. NINR-funded research draws on nursing’s holistic perspective, to carry out basic, clinical, population, and translational studies that integrate factors at multiple levels – from molecules at the biological level up to social determinants and macro level factors – to identify their role in health, health improvement and health inequities. For this announcement, NINR is interested in projects aimed at improving the health of women as individuals, or in populations, translating science in order to maximize the impact of findings on practice and policy, and will give priority to projects examining health disparities in maternal health.
The mission of the Office of Disease Prevention (ODP) is to improve public health by increasing the scope, quality, dissemination, and impact of prevention research supported by the NIH. The ODP is interested in supporting research to test interventions that address risk factors associated with maternal and infant morbidity and mortality and address maternal and infant health disparities. In addition, the ODP encourages applications to support projects led by early stage investigators. For more information about ODP strategic priorities, visit:https://prevention.nih.gov/about-odp/strategic-plan-2019-2023.
Information on Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions is available at https://researchmethodsresources.nih.gov/.
The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. ORWH is interested in research that addresses maternal health risks and morbidities, with emphasis on examining connections between pathogenic factors and disease development in the context of the life course, for example pregnancy complications linked to subsequent risks to the health of women, e.g.:
ORWH encourages interdisciplinary approaches and partnerships to support research that examines ways to integrate evidence-based practices, interventions, and application of evidence and implementation of policies into practice settings to improve the health of women across the life course.
For more information on ORWH and The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 – 2023, please visit ORWH website (https://www.nih.gov/women/strategicplan) for additional guidance.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
Applications that are not responsive to the terms of this Notice will be not be considered for this initiative.
We anticipate a 2-step administrative review process:
Before developing a research project in response to this NOSI, applicants are strongly encouraged to discuss the scientific focus of their application with the relevant staff below.
Applicants are strongly encouraged to notify the NIGMS contact listed below that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.