April 19, 2022
NOT-HD-22-047 - Notice of Training and REDCap Demonstration for the Implementation of NICHD's CDE Recommendations for COVID-19 Research in Pediatric, Pregnant, and Lactating Populations Published Through the NIEHS Disaster Research Response (DR2) Portal
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Institute of Neurological Disorders and Stroke (NINDS)
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.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
The COVID-19 pandemic continues to be the source of much mortality and morbidity creating and contributing to both physical and mental health issues. Recent data suggest that nearly one million individuals have died from COVID-19 in the United States. However, the impact of the SARS-CoV-2 virus as well as the associated measures to prevent and treat this infection extend well beyond the issue of mortality. Although much needed information regarding the epidemiology, transmission and potential acute treatments including the development of an effective vaccine have been gleaned in unprecedented time, important issues remain to be elucidated including, but not limited to the effect of the virus and its treatment on menstrual health, fertility and the offspring of infected and/or vaccinated parents, the impact of the Delta and Omicron variants and other emerging variants, the occurrence of viral co-infections and the many physical and mental health issues created by the pandemic itself.
As the pandemic continues to evolve, new viral variants have emerged, innovative treatments have been administered, widespread vaccination has been implemented and social practices have changed all creating new knowledge gaps and the need for additional data. Common examples include questions arising around vaccination responses including post-vaccination myocarditis, neurological sequelae, immune responses in vulnerable populations and the occurrence of viral co-infections. Less obvious questions have also been stirred including the impact of the virus and vaccine on vulnerable populations such as women with polycystic ovarian syndrome and endometriosis. Beyond the viral pathophysiology itself, questions remain to be addressed regarding the overall impact of the pandemic including challenges in maintaining the necessary clinical work force. Although much work has already been directed in assessing the impact of the pandemic on domestic violence, more work remains in the field. Additionally, the illness caused by SARS-CoV-2 may have a disproportionate impact on some populations, including those with substance use disorders and/or human immunodeficiency virus (HIV). Because SARS-CoV-2 attacks the lungs, it may be an especially serious threat to those with histories of smoking tobacco or marijuana or of vaping. People who use opioids or methamphetamine may also be vulnerable due to those drugs effects on respiratory and pulmonary health and potential effects on immune mechanisms. Further, recent national surveys report increased alcohol use during the pandemic including a 40% increase in heavy drinking among women and the concern that there will be a corresponding increase in children with fetal alcohol spectrum disorder (FASD). Moreover, changes in unintentional injury rates during the pandemic warrant further investigation. For example, available data suggest that fatal motor vehicle collision rates are the highest in over a decade despite less overall automobile driving during the pandemic.
The purpose of this funding opportunity is to provide an opportunity for funded researchers in these various fields to pursue supplemental funding to conduct research addressing these emerging and other existing COVID-related issues among pregnant and lactating people, infants, children and adolescents, and individuals with physical and/or intellectual disabilities. The goal of this NOSI is to not replace or to compete with the various COVID-related funding opportunities currently available. Instead, the purpose is to complement them by offering a funding opportunity for currently funded investigators to address key issues not currently covered by available COVID-related funding announcements among these populations. It is hoped that the use of administrative supplements will foster research in these key areas in the most timely manner. Research projects addressing issues that are the focus of currently available or future COVID funding opportunity announcements will be encouraged to submit to those announcements. Also, applicants responding to this NOSI are strongly encouraged to describe plans for the rapid sharing of data and results as well as innovative data analytics approaches. The sharing of COVID-related data and resources and the effective communication of results are a high priority of the NIH.
Selected Research Examples:
This NOSI is encouraging the submission of applications to support research on the SARS-CoV-2 virus and the associated COVID-19 pandemic that address the following areas of interest including, but not limited to:
Menstrual Health, Fertility, Pregnancy and Perinatal Issues
- Studies that assess the impact of the virus and vaccination on menstrual health
- Studies that assess the impact of the virus and vaccination on fertility in both males and females
- Basic science research on the placenta in relationship to SARS-CoV-2 and other viral co-infections (e.g. HIV, cytomegalovirus (CMV))
- Studies assessing the complications of COVID-19 and/or vaccination in pregnant populations and their offspring
- Perinatal projects that aim to determine the relationship between the timing of contracting the virus in newborns (before/during/after birth) and the impact on development
- Projects assessing pregnancy outcomes after vaccination in women during pregnancy including in mothers living with HIV
Vaccination Studies
- Research into improving vaccination rates among pediatric and pregnant populations particularly as vaccination approval expands into younger populations and FDA approval supplants Emergency Use Authorization (EUA) including interventional trials
- Projects investigating EUA/FDA approval of vaccines in children under 12 years of age
- Studies evaluating post-vaccine myocarditis
- Projects assessing the impact of a third (or more) booster vaccine and ongoing boosters including mixing and matching various vaccines
- Research assessing the immune response to vaccination among those with and without previous SARS-CoV-2 infection
- Investigations into the administration of other vaccinations to children and potential delays as a result of COVID-19 infection, COVID-19 vaccination and /or the pandemic itself
- Studies focused on the immune response from vaccinations
- Research assessing the immune response to vaccination among those with co-infections and comorbidities including immunosuppressed conditions and HIV
- Projects assessing neonatal and infant immunity after maternal vaccination during pregnancy and/or while breastfeeding including in mothers living with HIV and their exposed infants
- Research on the outreach and engagement of the hard to reach population with substance use in COVID-19 vaccination programs
Pharmacology Issues
- Pharmacokinetic, pharmacodynamic, efficacy and safety investigations regarding the use of remdesivir in pregnant and lactating individuals, infants, children and adolescents
- Investigation of new therapeutics to treat SARS-CoV-2 infections including other antiviral medications (e.g. molnupiravir)
- Studies assessing drug-drug interactions of co-administration with antiretroviral therapy medications including pharmacokinetic modeling
Developmental and Schooling Impacts
- Evaluations of the impact of return to in-person schooling and implementation practices on COVID-19 incidence rates
- Projects studying the impact of the pandemic on access to services and mainstream schooling for children with developmental disabilities, learning disabilities and/or other related needs
- Research addressing the developmental and social impacts of masking, social distancing and the pandemic overall on children
- Research addressing the effect of virtual learning and online environments on learning and social development
- Research addressing the impact of return to in-person schooling on the need for, and delivery of, substance use prevention interventions, particularly for students who have risk factors for early initiation
Testing Studies
- Investigations into the data and accuracy of COVID-19 home testing and the impact of testing mandates on home and point-of-care testing availability
- Biomarker research that holds the promise to develop prognostics for COVID and COVID-related conditions such as the Post-Acute Sequelae of COVID (PASC) including the multi-inflammatory syndrome in children (MIS-C)
- Projects developing improved diagnostic testing on placental tissues and cord blood
Mental Health Concerns
- Investigations assessing depression, anxiety and other mental health concerns in pregnant and postpartum individuals as well as children and adolescents during COVID-19 including interventional trials
- Studies that propose to conduct long-term follow up (e.g. surveys) of psychosocial conditions among participants identified as having COVID as part of electronic health care record or other large database research
- Research addressing the psychological impacts of masking, social distancing and the pandemic overall on children
- Studies assessing depression, anxiety and other mental health concerns among the clinical workforce, teachers and other professionals caring for pregnant and postpartum individuals as well as infants, children and adolescents during COVID-19
Viral Strains and Other Viral Issues
- Investigations into the impact, severity and transmission of the Delta and Omicron variants and other emerging COVID strains
- Research projects aimed at providing timely analysis of changes in the pandemic based on the most prevalent variant strain(s)
- Vaccine-related escape pressure on variants and the emergence of new strains
Viral Co-Infections
- Research assessing the epidemiology, incidence and severity of viral co-infections among these unique populations including HIV and CMV in maternal co-infections
- Research assessing the impact of other prevalent viruses in the community as well as the pandemic itself on outcomes for pregnant and lactating individuals, as well as for infants, children, and adolescents, and individuals with physical and/or intellectual disabilities
Pandemic Effects
- Studies investigating health care disparities and the impact of unequal access to care on health outcomes among pregnant and lactating people, infants, children, and adolescents and individuals with physical and/or intellectual disabilities
- Studies assessing the impact of the pandemic on the incidence and severity of domestic violence and childhood maltreatment
- Research addressing the pandemic effect on childhood poisonings and other intentional and unintentional pediatric injuries
- Studies of the impact of the SARS-CoV-2 infection as well as the pandemic on children with chronic, complex health care needs and those with developmental, intellectual, and/or physical disabilities
- Studies addressing the effect of the pandemic on the clinical workforce and training
- Research on the impact of misuse of alcohol and other substances during pregnancy related to the COVID-19 pandemic
- Research on the misuse of alcohol and other substances among adolescents related to the COVID-19 pandemic
- Investigations into the impact of the death of a parent, grandparent or caregiver from COVID-19 on infants, children and adolescents including bereavement studies
- Studies that assess global health in light of the pandemic
- Studies that assess the effect of the pandemic on childcare before school age (e.g. Day Care Settings, Preschools, etc.) and its impact on the health, development and well-being of both these preschool aged children and their parents
- Studies to understand the impact of the pandemic on substance use risk factors and opportunities for prevention intervention with the return to school
- Research addressing equitable access to mental health services for pregnant and postpartum women to mitigate the emergence or increase in substance use
- Research to assess the sustainability of innovative strategies deployed during COVID restrictions to initiate and retain pregnant and postpartum women in substance use disorder treatment
Neurological effects (including, but not limited to, the following):
- Investigations of the new appearance or exacerbation of existing neurological disorders (e.g., headaches, epilepsy, movement disorders, neuroinflammatory diseases, neurodegenerative diseases of childhood)
- Research on the etiology, diagnosis, and treatment of vascular diseases (e.g., stroke, microvascular complications)
- Studies on systemic signs and symptoms with neurological manifestations (e.g., fatigue, encephalopathy)
- Research on the autonomic and peripheral nervous systems
- Studies of sensory disorders (e.g., pain)
- Studies of sleep disorders
- Investigations on nervous system complications of systemic disease
Description of circumstances for which administrative supplements are available.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
- PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:
- For funding consideration, applicants must include NOT-HD-22-003 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
- Requests may be for one year of support only.
- The Research Strategy section of the application is limited to 6 pages.
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The sharing of COVID-related data and resources and the effective communication of results are a high priority of the NIH. Applicants responding to this NOSI are strongly encouraged to describe plans for rapid sharing of data and results as well as innovative data analytics approaches. In addition, applicants are strongly encouraged to include Pediatric and/or Pregnancy-related COVID Common Data Elements available via the Disaster Research Response (DR2) Resources Portal in their data collection. See:
- Recommendations for Common Data Elements for COVID-19 Studies Including Pediatric Participants
- Recommendations for Common Data Elements for COVID-19 Studies Including Pregnant Participants
- Recommendations for Common Data Elements for Post-Acute Sequelae of SARS-CoV-2 infection (PASC) Studies Including Pregnant Participants
- Applicants choosing not to include these common data elements in their project must provide a clear rationale for their choice not to do so, and an explanation of what data elements will be used instead.
- Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.
- Applicants may request administrative supplement applications with budgets exceeding the parent award for COVID-19 and other Public Health Emergency research. Budgets must be reasonable and reflect the actual needs of the project. Individual Institutes/Centers may have their own specific guidance and limits for the funding of these supplements.
- For NINDS: In general, supplements will be limited to a single year and will not generally be made in excess of $100K Direct Costs (DC). Investigators planning to apply in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with the Program Official for the Parent Award in advance to better determine appropriateness and interest of the NINDS. The project award and budget periods for this revision/supplement must be within the currently approved project period for the original/parent award (the original award must be active and not in a no cost extension for the entire extent of the supplement).
- The Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed for inquiries regarding the suitability of the proposed project for the FOA and the IC’s research portfolio.
Robert Tamburro, MD, MSc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-2619
Email: robert.tamburro@nih.gov
and Human Services (HHS)
