NOT-OD-20-131 - Notice of Pre-Application Webinar for the RADx-UP Initiative
PA-20-135 - Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)
NOT-OD-20-121 - Notice of Special Interest (NOSI): Limited Competition for Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations
NOT-OD-20-120 - Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations
RFA-OD-20-013- Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional)
NOT-OD-20-138 - Notice of Correction to NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section
NOT-HL-20-803 - Notice of NHLBI Participation in NOT-OD-20-119
NOT-HL-20-804 -Notice of NHLBI Participation in NOT-OD-20-120
NOT-HL-20-805 - Notice of NHLBI Participation in NOT-OD-20-121
NOT-OD-20-157 - Notice to Clarify and Correct Eligibility in Notices of Special Interest under the Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) Program
Office of The Director, National Institutes of Health (OD)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute on Aging (NIA)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
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.
Sexual and Gender Minority Research Office (SGMRO)
Tribal Health Research Office (THRO)
Office of The Director, National Institutes of Health (OD)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
Environmental Influences on Child Health Outcomes (ECHO)
All of Us Research Program - New participating organization as of 7/10/2020 for due dates on/after 8/7/2020
This Notice of Special Interest (NOSI) highlights the urgent need to understand the social, ethical, and behavioral implications (SEBI) of COVID-19 testing among underserved and/or vulnerable populations across the United States through the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) initiative. The overarching goal is to understand factors that have led to disproportionate burden of the pandemic on these underserved populations so that interventions can be implemented to decrease these disparities. The funding for this supplement is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.
The Office of the Director is therefore offering Emergency Competitive Revisions to active eligible grants and cooperative agreements addressing the objectives described below. This NOSI is one of four related RADx-UP opportunities. The purpose of this SEBI NOSI is to identify, analyze, and address the social, ethical, and behavioral factors likely to influence access and uptake of COVID-19 testing in underserved and/or vulnerable populations. Single or mixed methods approaches involving community partners will inform the development and evaluation of such testing programs. These studies will assess the ethical, historical, healthcare, social and contextual factors surrounding COVID-19 testing, as well as how cultural beliefs and attitudes, perceived expectations, and preferences influence the ability and willingness to get tested and participate in follow-up evaluations. Findings will be used to develop interventions to mitigate barriers to access and increase uptake of testing. Studies focused on unintended consequences of COVID-19 testing in these groups are also of interest when related to social and ethical issues.
The related program initiatives include:
Collectively, projects funded under these three NOSIs will serve as one consortium of interlinked community-engaged research projects across the United States to understand COVID-19 health disparities, and to deploy implementation strategies to improve the reach, acceptance, uptake, and sustainability of COVID-19 testing.
NIH expects that all supplements funded under this NOSI and the related NOSIs will actively coordinate and share data (where allowed) with other grantees, the CDCC, and other research supported by the RADx-UP program.
Research that specifically develops or implements novel COVID-19 testing programs for the UP populations as defined below under Key Definitions should be submitted under either NOT-OD-20-120 or NOT-OD-20-120instead of this NOSI. Applicants to this SEBI NOSI are allowed, but not required, to apply to the other RADx-UP opportunities. Researchers applying to this NOSI are strongly encouraged to read all four of these interrelated funding opportunities.
Researchers applying to this NOSI are strongly encouraged to read all four of these interrelated funding opportunities.
This NOSI is applicable to those populations that are underserved as well as populations that are COVID-19 vulnerable due to medical, geographic, and social factors, as defined below (referred to as “underserved and/or vulnerable” elsewhere in this NOSI):
Underserved: NIH-designated health disparity populations and/or other groups known to experience barriers to needed health care services, or to have inadequate health care coverage. A full description can be found at https://www.nimhd.nih.gov/about/overview/.
COVID-19 medically and/or socially vulnerable populations: Residents of nursing homes and assisted living facilities; community-dwelling older adults; individuals with intellectual, developmental, sensory, or physical disabilities, cognitive impairment or dementia, or communication disorders; homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); individuals with medical comorbidities known to increase risk of severe COVID-19, including heart failure and related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant and post-partum women; children and adolescents; individuals living in congregate housing such as shelters or residential treatment facilities; individuals in overcrowded or public housing; individuals with substance use disorders or serious mental illness; detainees in immigration detention centers; migrant and immigrant communities; residents of tribal lands or reservations; communities exposed to high rates of air pollution or other toxic exposures; and rural and remote communities.
SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in Children (MIS-C), acute kidney injury, thrombotic disorders and serious cardiac, cerebrovascular and vascular complications. United States Food and Drug Administration (FDA)-authorized COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. Growing evidence suggests that underserved and/or vulnerable populations are more susceptible to COVID-19 infection, severe COVID-19 complications, and associated death, as well as the social, behavioral and economic impacts of the pandemic.
Over the next six months, advances in testing technology and vaccine development are anticipated. Strategies to accelerate the dissemination of these improved tests and vaccine trials in underserved and/or vulnerable populations also must be developed. However, these populations experience multilevel barriers to testing arising at individual, interpersonal, institutional (e.g., health care system), community, and policy levels – that reduce access to and acceptance of COVID-19 testing. Similar concerns have the potential to limit the uptake and public health impact of future vaccination trials and implementation programs, and dissemination of effective therapeutics in ambulatory care settings.
Against that backdrop, COVID-19 testing programs in underserved and/or vulnerable populations must design communication strategies, consent materials, data governance plans, processes to return results, and informational and referral resources that are responsive to the communities they will serve. To inform the development and evaluation of such testing programs, the studies solicited here will focus on assessing how ethical, historical, healthcare, social, economic, and contextual factors surrounding COVID-19 testing, as well as cultural beliefs and attitudes, expectations, and preferences for testing and test results influence these groups’ ability and willingness to get tested. These factors may include but are not limited to individual and proximal environmental factors such as normative beliefs, peer influence, and incentive/disincentive structures in the social and community environment that may influence testing uptake. The SEBI studies also will focus on factors at the interpersonal, institutional (e.g., health system), community, and policy levels that affect access to COVID-19 testing among underserved and/or vulnerable populations. Findings will be used to inform development of intervention strategies and tools to increase access to and acceptability of testing in specified populations. These findings may help guide the design of implementation strategies in other domains of the consortium (see, NOSI NOT-OD-20-121 and NOSI NOT-OD-20-120, respectively]) or in Phase II of the RADx-UP initiative (to be announced at a later date), which will address developments in diagnostics and vaccination.
Studies supported under this NOSI should work closely with communities to support in depth examination of social, ethical and behavioral factors related to COVID-19 testing and vaccination research. Projects are also expected to specify strategies to address social determinants of health (SDOH) that present barriers to participation in testing and follow-up. RADx-UP projects are expected to demonstrate their ability to leverage existing partnerships (such as with Tribal governments and organizations, academic and community medical centers or health systems, safety-net health or social service systems, grassroots organizations, public health departments, community and faith-based organizations, and schools or child care settings) to complete the study aims. Applicants should provide evidence of collaboration with community organizations with whom they will work and must describe the roles of all partners. Study budgets should include funds for the community partners to be fully engaged and successfully participate in research design and implementation.
To address the expected impacts of COVID-19 on the scientific workforce, projects are also strongly encouraged to support early stage investigators, specifically targeting the ability to enhance diversity in their research workforce.
Applicants are strongly encouraged to contact SEBI program officials prior to developing an application to determine programmatic responsiveness to the NOSI.
Areas of Research Interest
Supported studies should address key questions at more than one level of analysis (e.g., individual, interpersonal, institutional [e.g., health system], community, and policy). Scientific questions of interest include, but are not limited to:
Applicants are encouraged to consider and investigate:
Where possible, applications should work towards outcomes or products that could be used to improve access to and acceptability of COVID-19 diagnostics. Examples of possible study outcomes are included below. However, researchers should address outcomes identified as high priority by the communities being studied.
These studies will focus on specific communities, yet they should also consider the extent to which findings can be generalized or adapted and implemented across other underserved and/or vulnerable populations. Applications should briefly describe the generalizability, where possible, of study approaches and findings to broader populations and include plans for the development of materials or toolkits to facilitate adaptation, dissemination, and implementation.
Applications should detail community-engaged methods to assess barriers to COVID-19 test access, uptake and follow-up, and develop and evaluate strategies or interventions to address those barriers. Applications should include dissemination activities that maintain bi-directional feedback loops with community experts about RADx-UP study findings. Development and pre-testing of potential interventions to increase testing access, acceptability, feasibility, and uptake would be of interest. However, they should not be the primary aim of the application. Potential applicants considering applications focused on interventions to increase access and uptake of COVID-19 diagnostics should consult
Applications may propose studies using either single or mixed methods. Proposed approaches may include, but are not limited to hypothesis-generating qualitative and quantitative approaches, observational research, randomized efficacy studies, policy, economic and normative analyses, and other types of analytical and conceptual research methodologies, such as those involving the direct engagement of stakeholders.
Sample Research Topics and Products
Broad research topic areas are listed below, followed by examples of specific issues within that area. The list of research topics and issues are not exhaustive, and the order listed does not indicate relative priority. Also listed are possible outcomes, products and tools that could be used to improve access and uptake of COVID-19 testing. Applicants should develop aims and products appropriate to the goals of this NOSI, in close collaboration with community partners.
Decision-Making about COVID-19 Diagnostics
Return of COVID-19 Test Results
Data Stewardship, Data Sharing and Privacy
Health Communication, Literacy, and Language Increasing understanding about COVID-19 testing and vaccination are precursors to uptake. Approaches should make use of multiple formats and channels and address linguistic and cultural barriers.
Vaccine Preparedness in Underserved and/or Vulnerable Populations
Applications nonresponsive to terms of this NOSI will not be considered. The following types of projects would generally not be appropriate and may be deemed non-responsive:
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 resources:
Additionally, researchers with funding through this NOSI will be required to share their survey items, data collection instruments and methods for other researchers to consider by submitting these resources to
Applications will be evaluated for scientific and technical merit by an appropriate internal NIH staff review panel, in accordance with the review criteria specified in PA-20-135 as well as these additional review criteria:
Application and Submission Information
Applications in response to this NOSI must be submitted using the Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement – Clinical Trial Optional) mechanism (PA-20-135 https://grants.nih.gov/grants/guide/pa-files/PA-20-135.html), or its subsequent reissued equivalents.
Eligible existing grants that can be revised in response to this NOSI are limited to eligible non-fellowship active research or resource grants and cooperative agreements. Currently funded grantees may apply for work that is related to their funded project, whether within the scope or outside of the scope of the current project, regardless of the time remaining on the current project. Grants currently in a no-cost extension are eligible to apply.
must be followed, with the following additions:
Specific to applications that target PA-20-135 (Emergency Supplements):
Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with Program staff listed on this NOSI well in advance of the application receipt date to better determine appropriateness and interest of the relevant Institute. Applicants are also strongly encouraged to notify the Program staff listed on this NOSI that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.
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 below for inquiries regarding the suitability of the proposed project for the FOA and the IC's research portfolio.
Office of the Director, Environmental Influences on Child Health Outcomes (ECHO):
Scientific Program Contact: Carol Blaisdell, MD, MEd, firstname.lastname@example.org,
Grants Management Contact (ECHO Cohorts): Donna Sullivan, email@example.com,
Grants Management (ECHO ISPCTN) Contact: Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 301-435-6975 , firstname.lastname@example.org
Office of Behavioral and Social Science Research (OBSSR):
Scientific Program Contact: Deborah Young-Hyman, PhD, email@example.com;
The Office of Disease Prevention (ODP/DPCPSI/OD):
Scientific Program Contact:Jacqueline Lloyd, PhD, MSW, 301.827.5559 firstname.lastname@example.org,
Office of Research on Women’s Health (ORWH):
Scientific Program Contact: Damiya S. Whitaker, PsyD, MA, email@example.com,
Sexual and Gender Minority Research Office (SGMRO):
Scientific Program Contact:Christopher Barnhart, PhD, 301-594-8983Christopher.firstname.lastname@example.org,
Tribal Health Research Office (THRO):
Scientific Program Contact:Maria Jamela Revilleza, PhD, 301-451-0724MariaJamela.Revilleza@nih.gov,
All of Us Research Program:
Sheri D. Schully, Ph.D., 301-827-1691, email@example.com
Kimberly Stanton, 301-827-8054, firstname.lastname@example.org