Key Dates

Related Announcements

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-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-184- NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-185- NIH Research Project Grant (Parent R01 Clinical Trial not Allowed)

PA-20-194, NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196- NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

Issued by

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 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)

Purpose

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. 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 avenue for researchers to pursue funding to conduct research addressing these and other emerging and 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 compete with the various COVID-related funding opportunities currently available. Instead, the purpose is to complement them by offering a funding opportunity to address key issues in a most timely manner not currently covered by available COVID-related funding announcements among these populations. 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 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 neonatal and infant immunity after maternal vaccination during pregnancy and/or while breastfeeding

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 and potential delays in conjunction with COVID-19 and COVID-19 vaccination among children
• 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 vaccination during pregnancy and/or while breastfeeding including in mothers living with HIV and their exposed infants
• Projects assessing pregnancy outcomes after vaccination in women during pregnancy including in mothers living with HIV
• 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 school 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-19 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
• 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
• Research assessing the immune response to vaccination among those with co-infections and comorbidities including immunosuppressed conditions

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/physical disabilities
• Studies addressing the effect of the pandemic on the clinical workforce and training

• 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
• Research on the multitude of factors surrounding the COVID-19 pandemic among pregnant and lactating people, infants, children and adolescents in health and disease in response to environmental exposures
• Projects focused on better understanding the role of environmental exposures on the multitude of factors surrounding the COVID-19 pandemic in relation to pregnancy, children and adolescent health and well-being, reproductive disorders, metabolic diseases, cancers, cardiovascular disease, and other disease conditions
• 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 related to COVID-19 (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

For NINDS:

• Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only the following types of clinical trials will be accepted:
  • Mechanistic trials, defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).
  • Basic Experimental Studies with Humans (BESH), defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena.

• Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions will not be accepted under this Notice of Special Interest or the corresponding FOAs. Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific FOA for such clinical trials.

For NIEHS:

• Research areas must focus on interests within the mission of NIEHS. Examples include research on the multitude of factors surrounding the COVID-19 pandemic among pregnant and lactating people, infants, children and adolescents in health and disease in response to environmental exposures.

• Research focused on better understanding the role of environmental exposures on the multitude of factors surrounding the COVID-19 pandemic in relation to pregnancy, children and adolescent health and well-being, reproductive disorders, metabolic diseases, cancers, cardiovascular disease, and other disease conditions.

For OBSSR:

• 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.

Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.

In addition, applicants using NIH Parent announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

Application and Submission Information

This notice applies to due dates on or after June 5, 2022 and subsequent receipt dates through June 6, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.

• PA-20-183- NIH Research Project Grant (Parent R01 Clinical Trial Required)

• PA-20-184- NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-185- NIH Research Project Grant (Parent R01 Clinical Trial not Allowed)
• PA-20-194, NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-195- NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196- NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-HD-22-002 (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.

• The sharing of COVID-related data and resources and 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.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Robert Tamburro, MD, MSc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-2619
Email: [email protected]