March 5, 2021
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)
NOT-OD-21-090 - Notice of Correction to NOT-OD-21-071
Office of The Director, National Institutes of Health (OD)
The Office of the Director of the National Institutes of Health (NIH), on behalf of the NIH Maternal Mortality Task Force, announces the opportunity for investigators with relevant active NIH-supported grants to address the following scientific priorities for Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) in the context of the ongoing COVID-19 pandemic for pregnant persons and up to one year postpartum:
IMPROVE aims to understand the biological, behavioral, environmental, sociocultural, and structural factors that affectpregnancy-related and pregnancy-associated morbidity and mortality by building an evidence base for improved care and outcomes. This initiative will promote research to address health disparities associated with pregnancy-related and pregnancy-associated morbidity and mortality (MM).
Over a 25-year period, the global maternal mortality ratio (MMR) declined from 385 per 100,000 live births in 1990 to 216 deaths per 100,000 live births in 2015, a relative decline of 44 percent. In contrast, in the United States (U.S.) the MMR increased during the same period and is currently the highest among developed nations. An estimated 700 persons die each year in the U.S. from conditions related to or associated with pregnancy or childbirth, and over 50,000 experience severe maternal morbidity (SMM). High rates of pregnancy-related and pregnancy-associated MM and SMM disproportionately affect specific racial/ethnic populations. In particular, Black or African American (AA) and American Indian/Alaska Native (AI/AN) pregnant or postpartum persons are 2 to 4 times more likely to die from pregnancy-related causes compared to White persons. Furthermore, Black or African American, Hispanic/Latina/x, Asian, Pacific Islander, and American Indian/Alaska Native persons all have higher incidence of SMM compared to White persons. Age, disabilities, and geographical disparities also affect MM/SMM, as do social determinants of health (SDoH), including education and socioeconomic standing. Another important SDoH is SRD, or macro-level conditions (e.g., residential segregation) that limit opportunities, resources, and well-being of less privileged groups on the basis of race/ethnicity and/or other statuses, including but not limited to gender, sexual orientation, gender identity, disability status, social class or socioeconomic status, religion, national origin, immigration status, limited English proficiency, or physical characteristics or health conditions.
Many of these populations are also disproportionately affected by the COVID-19 pandemic. Pregnant persons have an increased risk of severe COVID-19 disease and are more likely to experience adverse pregnancy outcomes when infected with SARS-CoV-2. Compared to those who gave birth without COVID-19, infected pregnant persons experienced a considerably higher risk of in-hospital death, thrombotic events, preterm birth and preeclampsia, with the highest risk experienced by Black or African American and Hispanic/Latina/x, older persons, and those living in geographic areas without adequate maternity care. Additionally, pregnant Asian and Native Hawaiian/Pacific Islander persons experienced a disproportionately higher risk for ICU admission. Prior to the COVID-19 pandemic, higher rates of preterm birth and pregnancy-associated or -related maternal morbidity and MM have been experienced by Black or African American persons, who also show elevated rates of anxiety and depression in the prenatal period. The risk of anxiety and depression following adversity is increased in pregnancy, and the COVID-19 pandemic places pregnant persons at risk for adverse emotional health outcomes. Black or African American women were more likely to report negative impact on jobs, knowing people who died from COVID-19, and worrying about dying from COVID-19.
Psychosocial factors and SDoH contributing to pregnancy-related and pregnancy-associated morbidity and MM (e.g., stress, social isolation, mental health, intimate partner violence, substance use, quality of life) may be amplified by the pandemic, particularly in racial/ethnic minorities, less privileged socioeconomic status groups, and other vulnerable populations that have been disproportionately impacted by COVID-19. SRD could have a profound negative impact on maternal health and well-being outcomes during pregnancy and up to one year postpartum in these disproportionately affected and COVID-19 vulnerable populations. Risk could be conferred through intergenerational transmission of effects of stressors related to the COVID-19 pandemic mediated through pregnancy consequences and inequities in healthcare and social service delivery (e.g., poorer healthcare resulting from clinician bias, rationing of care to uninsured patients). Additional structural factors that contribute to negative impacts on disproportionately affected and COVID-19 vulnerable populations include residential segregation that restricts access to healthcare and healthy living environments; occupational segregation that limits access to health insurance, sick or maternity leave, and safe working conditions; and criminal justice inequities that lead to a greater risk of incarceration or fewer legal protections for persons who are victims of violence, among others.
The goal of this NOSI is to accelerate our understanding of the effects of SARS-CoV-2 infection and the COVID-19 pandemic on maternal mental health, well-being, functioning and quality of life. This research will seek to identify psychosocial and behavioral health risk factors related to the COVID-19 pandemic that affect mental health and functioning outcomes during pregnancy and up to one year postpartum and how they may contribute to increased pregnancy-related and pregnancy-associated morbidity and MM. IMPROVE will support research that addresses the impact of SRD in the context of the COVID-19 pandemic on maternal health outcomes for pregnant persons and up to one year postpartum. This new knowledge will advance the IMPROVE long-term goal of risk stratification approaches and mitigation strategies. By encouraging the use of a set of common data elements and outcomes measurement instruments, this initiative will facilitate the creation of a set of harmonized data across existing NIH projects and infrastructure related to the COVID-19 pandemic and pregnant and postpartum persons. NIH expects applicants to include a focus on underrepresented, underserved, and vulnerable pregnant/postpartum populations, address SRD, and to consider community-engaged research approaches.
Areas of Research Interest
NIH is soliciting the submission of applications for Administrative Supplements or Urgent Competitive Revisions to active awards that include or could extend to pregnancy and COVID-19. Applications in response to this NOSI should be aligned with one or more of the areas of interest below. Example research questions are provided for each area of interest:
To accelerate research, NIH encourages investigatorsto leverage ongoing significant investments made on domestic resources, cohorts, and research infrastructure studying pregnant persons, or studies examining SRD that could be expanded to include a focus on pregnancy and COVID-19. Some examples of currently funded projects that may be leveraged include:
SRD can be assessed directly (e.g., indexes of residential segregation, unequal treatment in healthcare settings, etc.) or through self-reported experiences of study participants.
Administrative supplements must be within the scope of the project that is already supported. Urgent competitive revisionsallow the expansion of the scope of the parent award to address the urgent needs identified in this NOSI. Clinical trials are allowed. Foreign institutions may not apply, and foreign components are not allowed. Supplements for a project that will be carried out by collaborating investigators as part of a larger network (e.g., the Maternal-Fetal Medicine Units) may submit a single, combined application through the coordinating center or equivalent entity. The applicant must be able to collect or obtain COVID-19 related data from pregnant or postpartum persons and/or conduct coordination of study sites that manage such projects. Applicants must demonstrate how the additional NIH funding will advance science and/or medicine above their current funding level.
Application and Submission Information
Applications in response to this NOSI must be submitted using the following targeted funding opportunities or subsequent re-issued equivalents:
When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide, PA-20-272, and PA-18-935 must be followed, with the following additions:
To maximize comparisons across datasets or studies and facilitate data integration and collaboration where appropriate to study aims, researchers funded through this NOSI are strongly encouraged to use the following data resources below. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded where they address questions of interest. Existing COVID-19 survey items are publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Investigators are strongly encouraged to use these data resources. In particular, the use of the collections detailed below is strongly encouraged where applicable:
Each IC will conduct administrative reviews of applications that will then be prioritized by NIH staff on the NIH Maternal Mortality Task Force. Applications for competitive revisions will be evaluated for scientific and technical merit by an appropriate internal review panel convened by staff of the NIH awarding component.
Priority will be given to projects that incorporate SRD and community-identified needs and perspectives in populations disproportionately affected by MM/SMM. NIH staff will review the following:
Budget and Period of Support
NIH staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.
Please direct inquiries to: