RFA-OD-21-009-Full-Announcement-Text.pdf

5/5/2021 RFA-OD-21-009: Emergency Award: RADx-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 … https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-009.html 1/30

Department of Health and Human Services

Part 1. Overview Information Participating Organization(s) National Institutes of Health (NIH (http://www.nih.gov))

Components of Participating Organizations Office of The Director, National Institutes of Health (OD (https://www.nih.gov/institutes-nih/nih-office-director))

National Eye Institute (NEI (https://www.nei.nih.gov/))

National Heart, Lung, and Blood Institute (NHLBI (https://www.nhlbi.nih.gov/))

National Human Genome Research Institute (NHGRI (https://www.genome.gov/))

National Institute on Aging (NIA (https://www.nia.nih.gov/))

National Institute on Alcohol Abuse and Alcoholism (NIAAA (https://www.niaaa.nih.gov/))

National Institute of Allergy and Infectious Diseases (NIAID (https://www.niaid.nih.gov/))

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS (https://www.niams.nih.gov/))

National Institute of Biomedical Imaging and Bioengineering (NIBIB (https://www.nibib.nih.gov/))

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD (https://www.nichd.nih.gov/))

National Institute on Deafness and Other Communication Disorders (NIDCD (https://www.nidcd.nih.gov/))

National Institute of Dental and Craniofacial Research (NIDCR (https://www.nidcr.nih.gov/))

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK (https://www.niddk.nih.gov/))

National Institute on Drug Abuse (NIDA (https://www.drugabuse.gov/))

National Institute of Environmental Health Sciences (NIEHS (https://www.niehs.nih.gov/))

National Institute of General Medical Sciences (NIGMS (https://www.nigms.nih.gov/))

National Institute of Mental Health (NIMH (https://www.nimh.nih.gov/index.shtml))

National Institute of Neurological Disorders and Stroke (NINDS (https://www.ninds.nih.gov/))

National Institute of Nursing Research (NINR (https://www.ninr.nih.gov/))

National Institute on Minority Health and Health Disparities (NIMHD (https://www.nimhd.nih.gov/))

National Library of Medicine (NLM (https://www.nlm.nih.gov/))

National Center for Complementary and Integrative Health (NCCIH (https://nccih.nih.gov/))

National Center for Advancing Translational Sciences (NCATS (https://ncats.nih.gov/))

National Cancer Institute (NCI (https://www.cancer.gov/))

Tribal Health Research Office (THRO (https://dpcpsi.nih.gov/thro))

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.

http://www.nih.gov/ https://www.nih.gov/institutes-nih/nih-office-director https://www.nei.nih.gov/ https://www.nhlbi.nih.gov/ https://www.genome.gov/ https://www.nia.nih.gov/ https://www.niaaa.nih.gov/ https://www.niaid.nih.gov/ https://www.niams.nih.gov/ https://www.nibib.nih.gov/ https://www.nichd.nih.gov/ https://www.nidcd.nih.gov/ https://www.nidcr.nih.gov/ https://www.niddk.nih.gov/ https://www.drugabuse.gov/ https://www.niehs.nih.gov/ https://www.nigms.nih.gov/ https://www.nimh.nih.gov/index.shtml https://www.ninds.nih.gov/ https://www.ninr.nih.gov/ https://www.nimhd.nih.gov/ https://www.nlm.nih.gov/ https://nccih.nih.gov/ https://ncats.nih.gov/ https://www.cancer.gov/ https://dpcpsi.nih.gov/thro

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Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP (https://prevention.nih.gov/))

Office of Behavioral and Social Sciences Research (OBSSR (https://obssr.od.nih.gov/))

Sexual and Gender Minority Research Office (SGMRO (https://dpcpsi.nih.gov/sgmro))

Office of Research on Women's Health (ORWH (https://orwh.od.nih.gov/))

Environmental Influences on Child Health Outcomes (ECHO (https://www.nih.gov/research-training/environmental-influences-child-health-outcomes-echo-program))

Funding Opportunity Title

Emergency Award: RADx-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing among Underserved and Vulnerable Populations (U01 Clinical Trials Optional)

Activity Code U01 (//grants.nih.gov/grants/funding/ac_search_results.htm?

text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity) Research Project – Cooperative Agreements

Announcement Type New

Related Notices April 22, 2021 - Notice of Pre-Application Webinar for Phase II of the RADxSM-UP Initiative. See Notice NOT-OD-21-115 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-115.html).

Funding Opportunity Announcement (FOA) Number

RFA-OD-21-009

Companion Funding Opportunity RFA-OD-21-008 (https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-008.html) U01 (https://grants.nih.gov/grants/funding/ac_search_results.htm?

text_curr=U01&&Search.x=0&&Search.y=0&&Search_Type=Activity) Research Project (Cooperative Agreements) NOT-OD-21-103 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html) NOT-OD-21-101 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-101.html)

Number of Applications See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93.310, 93.865, 93.838, 93.839, 93.840, 93.233, 93.837, 93.393, 93.394, 93.395, 93.396, 93.399, 93.350, 93.213, 93.867, 93.172, 93.846, 93.121, 93.847, 93.113, 93.143, 93.859, 93.242, 93.853, 93.361, 93.866, 93.273, 93.173, 93.279, 93.307, 93.313, 93.286, 93.879, 93.855 https://prevention.nih.gov/ https://obssr.od.nih.gov/ https://dpcpsi.nih.gov/sgmro https://orwh.od.nih.gov/ https://www.nih.gov/research-training/environmental-influences-child-health-outcomes-echo-program https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-115.html https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-008.html https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=U01&&Search.x=0&&Search.y=0&&Search_Type=Activity https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-101.html

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Key Dates

Application Due Dates Review and Award Cycles

New

Renewal / Resubmission / Revision (as allowed) AIDS

Scientific Merit

Review

Advisory Council Review

Earliest Start Date

July 07, Not Applicable Not Applicable

July 2021 Not Applicable

December

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Late applications will not be accepted for this Funding Opportunity Announcement.

Funding Opportunity Purpose High rates and disparities of COVID-19 infection, morbidity, and mortality continue among underserved and vulnerable populations across the United States. The overarching goal of the Rapid Acceleration of Diagnostics for Underserved Populations (https://www.nih.gov/research-training/medical-research-initiatives/radx/radx-programs#radx-up) (RADx-UP) initiative is to understand and ameliorate factors that have placed a disproportionate burden of the pandemic on underserved and/or vulnerable populations, specifically by implementing programs that expand the scope and reach of COVID-19 testing interventions to reduce these disparities. To address barriers to testing and vaccination, social, ethical, and behavioral research is urgently needed to inform related mitigation efforts. This Phase II RADx-UP Funding Opportunity Announcement (FOA) is designed to expand research to understand and address the social, ethical, and behavioral implications (SEBI) of COVID-19 testing interventions among underserved and vulnerable populations. Desirable studies for Phase II will move beyond descriptive health disparities research to focus on developing interventions and other actionable solutions in collaboration with community partners and stakeholders. The funding for this initiative is provided from the American Rescue Plan Act of 2021.

Posted Date April 13, 2021

Open Date (Earliest Submission Date) June 07, 2021

Letter of Intent Due Date(s) Not Applicable

Expiration Date https://www.nih.gov/research-training/medical-research-initiatives/radx/radx-programs#radx-up

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Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide (//grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts (//grants.nih.gov/grants/guide/)).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST (https://public.era.nih.gov/assist) system to prepare, submit and track your application online.

Apply Online Using ASSIST

2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons (http://public.era.nih.gov/commons/) to track your application. Check with your institutional officials regarding availability.

3. Use Grants.gov (https://www.grants.gov/web/grants/applicants/download-application-package.html#search=true&oppNum=RFA-OD-21-009) Workspace to prepare and submit your application and eRA Commons (http://public.era.nih.gov/commons/) to track your application.

Table of Contents Part 1. Overview Information

Key Dates Part 2. Full Text of Announcement

Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

July 08, 2021

Due Dates for E.O. 12372 Not Applicable https://grants.nih.gov/grants/guide/url_redirect.htm?id=12000 https://grants.nih.gov/grants/guide/ http://public.era.nih.gov/commons/ https://www.grants.gov/web/grants/applicants/download-application-package.html#search=true&oppNum=RFA-OD-21-009 http://public.era.nih.gov/commons/ https://public.era.nih.gov/assist https://public.era.nih.gov/assist https://public.era.nih.gov/assist

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Section I. Funding Opportunity Description The National Institutes of Health (NIH) is issuing this funding opportunity announcement (FOA) in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19).This FOA uses an emergency U01 mechanism to support the Rapid Acceleration of Diagnostics-Radical (RADx -UP) initiative.

The Office of the Director (OD) is issuing this FOA to address the objectives described below. This FOA is one of four related RADx -UP funding opportunities. This SEBI research FOA will support research teams with established community engaged partnerships to address the scientific objectives described herein.

The related program initiatives include:

RFA-OD-21-008 (https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-008.html)- Emergency Awards:

Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations- RADx -UP Phase II (U01, Clinical Trial Optional) NOT-O (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html)D-21-103 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html) – Notice of Special Interest (NOSI):

Emergency Competitive Revisions for NIH Grants to Add or Expand Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations – RADx -UP Phase II (Emergency Supplement- Clinical Trial Optional) NOT-OD-21-101 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-101.html)- Notice of Special Interest (NOSI): Administrative Supplements for Rapid Acceleration of Diagnostics-Underserved Populations (RADx -UP) Phase I Projects to Address Vaccine Hesitancy and Uptake NOT-OD-21-097 (//grants.nih.gov/grants/guide/notice-files/NOT-OD-21-097.html) - Notice of Intent to Publish a Research Opportunity Announcement for RADx -UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional

Collectively, projects funded under these FOAs will join the RADx-UP (https://www.nih.gov/research-training/medical-research-initiatives/radx/radx-programs#radx-up) consortium of community engaged research projects across the United States to understand COVID-19 health disparities, and to test interventions that improve the reach, uptake, and sustainability of COVID-19 testing in various settings.

NIH expects that all projects funded under this FOA will actively collaborate with other SEBI projects, the Testing Research Projects, collect common data elements (CDEs) and share data (as allowed and with considerations under tribal IRB and data sovereignty processes) with the Coordination and Data Collection Center (https://radx-up.org/) (CDCC (https://radx-up.org/)). Researchers applying to this FOA are strongly encouraged to read all interrelated funding opportunities.

Research proposed in response to this FOA should address social, ethical, behavioral, structural, environmental, historical and policy factors, including structural racism within public health and health care delivery systems, that lead to disparities in access to and uptake of COVID-19 testing in underserved and/or vulnerable populations. Even with the availability of vaccines, testing for the SARS CoV-2 virus will remain a critical aspect of pandemic control. It is also important to understand whether and how the availability of COVID-19 vaccines affects the need for, and propensity to seek testing in both symptomatic and asymptomatic testing programs. Phase II projects should focus on SARS CoV-2 testing and consider the roles testing may play in the dynamic environment of the pandemic, where vaccine availability, distribution, and uptake, and the need to monitor and document COVID-19 status continue to evolve. The influences of cultural beliefs, expectations, mistrust, and communication norms and preferences on underserved, medically and/or socially vulnerable populations willingness to get tested, get vaccinated, and participate in follow-up evaluations are of interest. Multi-level barriers to testing and vaccination should be addressed in these applications, including barriers at the interpersonal, institutional (e.g., health care system), community, and policy levels.

Key Definitions

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https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-008.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-101.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-097.html https://www.nih.gov/research-training/medical-research-initiatives/radx/radx-programs#radx-up https://radx-up.org/ https://radx-up.org/

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This FOA is applicable to underserved and vulnerable populations that are COVID-19 vulnerable due to medical, geographic, and social factors, as defined below (referred to as “underserved and vulnerable” elsewhere in this FOA):

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/ (https://www.nimhd.nih.gov/about/overview/).

COVID-19 medically and/or socially vulnerable populations: Homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); pregnant and post-partum women;

children and adolescents; individuals living in congregate housing such as shelters or residential treatment facilities;

individuals in overcrowded housing; individuals with substance use disorders or serious mental illness; migrant and immigrant populations; residents of tribal lands or reservations; communities exposed to high rates of air pollution or other toxic exposures; communities with high levels of social vulnerability; 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; 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; and rural and remote communities.

Discrimination: A socially structured action that is unfair or unjustified and harms individuals and groups.

Discrimination can be attributed to social interactions that occur to protect more powerful and privileged groups or institutions at the detriment of other groups. Racism refers to discrimination based on race or ethnicity.

Structural discrimination refers to macro-level conditions (e.g., residential segregation) that limit opportunities, resources, and well-being of less privileged groups (Healthy People 2020, https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-health/interventions-resources/discrimination (https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-health/interventions-resources/discrimination)).

Structural racism and discrimination (SRD): For the purposes of this FOA, SRD refers to structural discrimination 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.

Background

SARS-CoV-2 is the novel coronavirus and causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe complications and death. COVID-19 diagnostic testing with emergency use authorization (EUA) or (eventually) approval from the United States (U.S.)

Food and Drug Administration (FDA) remains critical for tracking and slowing the spread of the virus and preventing future outbreaks. NIH is committed to applying scientific methods to ensure that all populations have optimal access to and uptake of COVID-19 diagnostic and seroprevalence testing —with the goal of reducing health disparities— and to build enhanced point-of-care infrastructures that can be sustained beyond the current pandemic.

Phase I of the Rapid Acceleration of Diagnostics – Underserved Populations (RADx-UP) initiative established a consortium of community engaged research projects focused on increasing access and uptake of COVID-19 testing among U.S. underserved and vulnerable populations as well as understanding the social, ethical, and behavioral implications on testing and testing related outcomes. Phase I includes 69 funded projects and a Coordination and Data Collection Center (CDCC).

Phase II of the RADx-UP initiative will maintain the focus on COVID-19 testing while responding to the dynamics of case, hospitalization, morbidity and mortality rates across the U.S. Projects should work to understand, inform, and improve SARS CoV-2 testing interventions and other mitigation strategies (e.g., contact tracing, testing combined with behavioral mitigation strategies, education programs, self-isolation after exposure).

Projects should build on knowledge and experience gained to date both by the research team and other relevant studies, and address actionable social, ethical, behavioral, structural, environmental, historical and policy factors that are sources of COVID-19 disparities, including inequities in testing access resulting from multiple levels of influence.

https://www.nimhd.nih.gov/about/overview/ https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-health/interventions-resources/discrimination

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Projects should focus on the factors above while considering vaccine availability, distribution, and uptake across populations.

Research Objectives

Incidence, hospitalization, and mortality rates from COVID-19 remain higher in underserved and vulnerable populations. Availability and uptake of high-quality, affordable, accurate, and rapid SARS CoV-2 testing is important to ensure that new cases are identified, tracked, and supported in a timely way. Where data are reported, disparities for racial/ethnic populations in accessibility and uptake of vaccinations are observed. Access and uptake of testing are also critical in communities demonstrating inadequate vaccination uptake. If these shortfalls continue, they are likely to exacerbate the spread of COVID-19, worsen outcomes, and perpetuate the current, well-recognized disparities.

Many SEBI grants in the initial phase of RADx-UP focus on how individual, person-level beliefs and behaviors contribute to disparate access to, and uptake of COVID-19 testing. Phase II encourages applications that address multiple levels of influence (e.g., individual, interpersonal, institutional, community, and policy levels) and lead to actionable solutions to address COVID-19 disparities. Applications should inform the distribution, accessibility, acceptability and use of COVID-19 testing resources in underserved and vulnerable populations. This FOA solicits applications aimed at understanding the social, ethical, behavioral, structural, environmental, historical and policy factors surrounding COVID-19 testing. Addressing the roles of structural racism and discrimination and other ideologies that may contribute to observed disparities is also important. Research is needed to examine institutional decisions, practices, and biases that can be modified to recognize and better meet communities’ preferences and goals related to COVID-19 testing. Studies can inform policymakers, providers, and communities about strategies to ensure equitable access to the resources and data necessary to prevent COVID-19.

SEBI applications should be developed to inform distribution, implementation, uptake, and evaluation of COVID-19 testing and vaccination programs. The development of pragmatic, ethically congruent guidance for COVID-19 testing and vaccine resource sharing and allocation is encouraged. Research may assess tailored testing programs and develop and examine communication strategies to mitigate barriers to testing and vaccination. Studies may develop consent materials, referral resources, and processes to deliver tests and return COVID-19 testing results that reflect community needs or practices. Studies focused on unintended positive and negative consequences of COVID-19 testing, including factors that contribute to vaccine uptake and reinforce protective behaviors, are also of interest.

Studies may also examine and address the effects that mistrust of medical and public health research associated with COVID-19 testing and vaccination programs is having on the uptake of COVID-19 related public health services.

RADx -UP Phase II projects must demonstrate relevance of the scientific questions to underserved and vulnerable populations. Projects should utilize rigorous research designs and describe research strategies that reflect the evolving landscape and availability of COVID-19 tests and vaccines. Applications should articulate clear research goals, but also demonstrate the ability and flexibility to address new questions that may arise as the pandemic, access to testing and vaccination, and behavioral norms and recommendations continue to change. Applications should delineate concrete outcomes that can be rapidly shared with communities and other stakeholders.

Studies supported under this FOA should work closely with community leaders, community-based organizations, and other relevant stakeholders to support in-depth examination of social, ethical, behavioral, structural, environmental, historical and policy factors related to COVID-19 testing and vaccination. Use of existing resources and expansion of extant community partnerships (e.g., tribal leadership, academic, private, safety-net health systems, community organizations, public health departments, state and local governments, test and vaccination providers, faith-based organizations, and school or child care settings) is strongly encouraged. Applicants should document existing collaboration with community organizations and must describe the roles of all community partners. Study budgets should provide appropriate levels of funding for community partners commensurate with the level of effort of the community partners in research design and implementation. Applicants are encouraged to collaborate where appropriate with RADx-UP studies funded through Phase I.

Applications to this SEBI FOA are not required to administer COVID-19 testing. However, in all cases where a SEBI project proposes to provide COVID-19 testing as part of the project, or to partner with a COVID-19 testing program (e.g. to study its participants), the COVID-19 testing being offered must use FDA-authorized/approved test kits, SM

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To address expected impacts of COVID-19 on the scientific workforce applications are also strongly encouraged to involve early stage investigators, including those from diverse backgrounds (NOT-OD-20-031 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html)).

Areas of Research Interest

Proposed studies should examine social, ethical, behavioral, structural, environmental, historical and policy implications of testing in underserved and vulnerable populations with disparities in COVID-19 testing. Applications are encouraged to address more than one level of analysis (e.g., individual interpersonal, institutional, community, and policy levels). Topics may include, but are not limited to:

Assess and address SEBI factors and barriers that result in disparities in COVID-19 testing, vaccination, and outcomes. Factors could include but are not limited to

Systemic and policy factors (e.g., current and historical structural racism and discrimination; variations in testing and vaccination policy; community mistrust; inequitable resource distribution) Geographic (place-based) factors (e.g., residential segregation, concentrated social stressors, inadequate transportation) Communication challenges (e.g., health literacy levels, language access, exposure to misinformation, digital access) Social and community-level influences (e.g., state and local policies in healthcare, and social services;

workplace and school policies; cultural beliefs, community and family norms) Test characteristics and processes - differences in quality (accuracy, mode, burden, time to results); cost and availability; dependence on digital tools; and experiences related to the tests and vaccination processes (e.g., appointment registration, proof of residency) Motivations and barriers that affect salient behaviors including the use of testing and mitigation strategies.

Understand and incorporate the perceptions, attitudes, beliefs, and intentions of community leaders, community-based organizations, religious faith-based institutions, city council/local government/state level agencies, grassroot organizations’ and other stakeholders towards COVID-19 testing and vaccination strategies and programs Address individual, family, and household impact and sequelae of COVID-19 diagnostic tests and results (e.g., mental health and psychosocial consequences; stigma; challenges and implications in multigenerational households; occupational testing implications) as well as unique testing needs of multi-generational households, close social networks, etc.

Assess information needs, as well as the impact of misinformation regarding the COVID-19 pandemic, testing, and vaccines; design messages to mitigate the impact of exposure to misinformation Develop and disseminate culturally competent communication about COVID-19 testing and vaccination that addresses safety concerns, fear, and distrust Assess state and local testing and vaccination programs’ frameworks to prioritize resource allocations and determine characteristics of these programs that perpetuate or mitigate disparities Design, assess, and deploy reliable, community-congruent disease surveillance systems and accompanying metrics to improve tracking of testing, vaccination, and outcomes in underserved and vulnerable communities Address SEBI concerns (e.g., distrust of medical research, transparency, privacy) regarding the conduct of biomedical and public health research within COVID-19 testing and vaccination programs, to ensure COVID-19 research does not inhibit uptake of COVID-19 related public health services Assess how the presence and prevalence of COVID-19 vaccinations will affect societal views, roles, and uptake of SARS CoV-2 testing https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-008.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html

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Examine whether and why testing and/or vaccination may, as an unintended and adverse consequence, reduce adherence to other prevention behaviors (e.g., mask-wearing, and physical distancing), and implement interventions to ameliorate these effects Understand and address the SEBI issues related to pediatric vaccine trials Address unique SEBI issues associated with testing children and results reporting in children/pediatric/school-based contexts

Research to assess outcomes and impact of school-based testing programs on root causes of stigma and inequity, and to identify characteristics of effective programs in promoting equity

Applications should focus on well-defined problems and actionable strategies and develop outcomes or products that could be used by communities, COVID-19 service providers, institutions, and public health agencies to improve equity, access, acceptability and uptake of COVID-19 testing and vaccines.

NIH is striving for consistency and high levels of rigor and reproducibility in all research, particularly in programs related to COVID-19 pandemic. All RADx-UP researchers engaging human participants in their projects are required to use a set of Common Data Elements (CDEs) to standardize the collection of data and ensure that data can be aggregated and compared across study populations and research topics (where not otherwise prohibited such as by Tribal authority). This data standardization will permit evaluation of the overall RADx -UP consortium and impacts on COVID-19 disparities in specific populations, facilitate analysis of research questions and may inform policy at the local, community, and/or Tribal levels. Details for researchers about the RADx-UP Common Data Elements including FAQs can be found at https://radx-up.org/learning-resources/cdes/ (https://radx-up.org/learning-resources/cdes/).

Where it is appropriate, projects responding to this funding opportunity are required to collect the NIH RADx-UP Tier 1 Common Data Elements or a modification of the Tier 1 Common Data Elements for pediatric populations (https://radx-up.org/learning-resources/cdes/). Permission from participants to collect and share these CDEs will be given through specific language in the informed consent process.

Recipients will work closely with the CDCC on data sharing activities as part of the RADx-UP consortium to advance the science of health disparities research in COVID-19 testing across the country. As an initiative that prioritizes community engagement, awardees will work with the CDCC to identify the scope of data sharing agreements that are acceptable to community partners, that allow recruitment and retention of participants, and that build trust, while contributing to consortium activities. The scope of data sharing may include the following : 1)?depositing de-identified data in the CDCC and NIH RADx Data Hub, 2) sharing de-identified data with the CDCC and NIH for future scientific research, 3) sharing identifiable data to?permit re-contact of participants for future follow-up and participation in future research; and/or 4) sharing identifiable data to perform linkages with population and clinical data sets to understand health outcomes of the COVID-19 pandemic among underserved and vulnerable populations.? Applicants are encouraged to discuss acceptability of one or more of these options for data sharing prior to application.

These data to be archived in the NIH RADx Data Hub will enable properly authorized community members, health researchers, and the Federal government to understand the impact of the COVID-19 pandemic on the well-being, risk, resilience and disparities in vulnerable communities across the United States and U.S. Territories. Funded projects will share study instruments and other research products with other RADx -UP funded projects through the

CDCC.

Projects funded through this FOA are also strongly encouraged to use the following resources as applicable:

Data Harmonization for Social Determinants of Health (SDOH), COVID-19, and other relevant measures via the PhenX Toolkit: Investigators are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on SDOH across studies. Studies involving human-subjects are encouraged to incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org (http://www.phenxtoolkit.org/)).

Existing COVID-19 survey items and investigator contact information are publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) https://dr2.nlm.nih.gov/ (https://dr2.nlm.nih.gov/) and the PhenX Toolkit https://www.phenxtoolkit.org/index.php (https://www.phenxtoolkit.org/index.php). Researchers addressing COVID-19 questions, whether population-

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https://radx-up.org/learning-resources/cdes/ https://radx-up.org/learning-resources/cdes/ http://www.phenxtoolkit.org/ https://dr2.nlm.nih.gov/ https://www.phenxtoolkit.org/index.php

5/5/2021 RFA-OD-21-009: Emergency Award: RADx-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 … https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-009.html 10/30 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.

Additionally, researchers with funding through this FOA are strongly encouraged to share their survey items to make them public for other researchers to consider by submitting their surveys to NIHCOVID19Measures@nih.gov (mailto:NIHCOVID19Measures@nih.gov).

The NIH also recognizes that other federal agencies who support research or demonstration projects may be strong collaborators for these types of research. NIH encourages collaboration with investigators funded by other agencies, as appropriate, including, but not limited to those funded by the Substance Abuse and Mental Health Services Administration, the Health Resources and Services Administration, the Administration for Children and Families, the Administration on Community Living and its divisions, the Centers for Disease Control and Prevention, the Indian Health Service, the Agency for Health Research and Quality, the Office on Minority Health, the Department of Defense, the Department of Agriculture, the Department of Education, the Department of Justice, the Department of Interior’s Bureau of Indian Affairs, and the Department of Veterans Affairs.

Additional Requirements

NIH is requiring data sharing for all COVID-19 projects, where it is not prohibited (i.e., Tribal data sovereignty). The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products, and procedures to improve human health https://grants.nih.gov/grants/policy/data_sharing/ (https://grants.nih.gov/grants/policy/data_sharing/).

Where projects are collecting data on COVID-19 testing-related outcomes and implementation, the grant recipients are required to work with the RADx -UP Coordinating and Data Collection Center (CDCC) to submit common data elements (CDEs) on COVID-19 testing-related outcomes and implementation to the CDCC. Recipients should identify staff responsible for these data coordination and reporting activities.

Recipients are expected to obtain and retain personal identifiers on all research participants where it is not prohibited (e.g., Tribal data sovereignty) for future longitudinal follow-up and to be leveraged for intervention research. Data collected from this program will be protected by a Certificate of Confidentiality.

Recipients are expected to use guidance provided by the CDCC for data acquisition, collection, and curation, including consent for data sharing and implementation of methods to enable data collected to be AI (artificial intelligence) ready.

Recipients are expected to work with the RADx -UP consortium members, as appropriate.

Projects must include a description of sustainability of their infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts.

Applications must include milestones towards progress and a timeline for completion. The timeline must include plans for regular submission of data and reports of progress to be submitted to the CDCC and meetings with Community Advisory Boards As with all NIH supported research, details regarding human subjects research are expected, including, where needed, plans for data safety and monitoring and a Data Safety and Monitoring Board (DSMB). Studies that have a DSMB are expected to coordinate with CDCC (RFA-OD-20-013 (//grants.nih.gov/grants/guide/rfa-files/RFA-OD-20-013.html)) for DSMB activities Recipients are expected to participate in CDCC-organized activities, including monthly cross-site meetings, cross-site working groups, and dissemination activities (of effective implementation strategies, tools, and measures, etc.).

Recipients are expected to demonstrate knowledge of and to comply with federal, state, local, and/or Tribal requirements on testing, reporting and surveillance policies in study protocols.

Recipients must provide letters of support from the community partners and should include community partners (where possible) as investigators. Budgets should reflect active participation by community partners to the extent possible. When required, Tribal resolutions should be included with the application if possible, but before funds are awarded in all cases. If school or childcare settings are incorporated, recipients must provide letters of support from the school setting, school district or state Department of Education as applicable.

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mailto:NIHCOVID19Measures@nih.gov https://grants.nih.gov/grants/policy/data_sharing/ https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-20-013.html

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The major focus of these SEBI applications must be to address social, ethical and behavior factors associated with COVID-19 testing disparities. SEBI applications are not required to conduct or administer COVID-19 testing and should not propose the actual administration COVID-19 testing or vaccination as the primary activity or aim.

Applications nonresponsive to terms of this FOA will not be considered. The following types of projects would generally not be appropriate and may be deemed non-responsive:

Projects that do not have a primary focus on SEBI issues Projects where the primary activity or aim is to conduct or administer COVID-19 testing.

Projects without a focus on one or more underserved and COVID-19 vulnerable populations Projects focusing exclusively on vaccination Applications offering COVID-19 testing or working with COVID-19 testing or vaccination programs that are not FDA authorized or approved Applications offering COVID-19 testing or working with testing or vaccination programs that are not being assayed in CLIA certified laboratories (e.g., hospital, public health, or commercial) Projects that do not discuss generalizability and public health impact Projects that do not demonstrate a strong equitable relationship or engagement strategy with populations and stakeholders of interest (e.g., community organizations, health care systems, schools, and other institutions) Projects that propose to study populations or COVID-19 testing outside the United States Projects that do not include a plan to rapidly report study findings and impact to the CDCC

Applications nonresponsive to terms of this FOA will be withdrawn from consideration before review. .

Investigators planning to submit an application in response to this FOA are strongly encouraged to contact and discuss their proposed research/aims with Program staff listed on this FOA well in advance of the application receipt date to better determine appropriateness and interest.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Funding Instrument Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed New

The OER Glossary (//grants.nih.gov/grants/guide/url_redirect.htm?id=11116) and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? (https://grants.nih.gov/grants/guide/url_redirect.htm?

id=82370)

Funds Available and Anticipated Number of Awards https://grants.nih.gov/grants/guide/url_redirect.htm?id=11116 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370

5/5/2021 RFA-OD-21-009: Emergency Award: RADx-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 … https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-009.html 12/30

NIH grants policies as described in the NIH Grants Policy Statement (//grants.nih.gov/grants/guide/url_redirect.htm?id=11120) will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations Higher Education Institutions

Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses For-Profit Organizations (Other than Small Businesses)

Local Governments

Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized)

Other

Native American Tribal Organizations (other than Federally recognized tribal governments)

Foreign Institutions

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH intends to commit $24 Million over 2 years to fund approximately 16 awards.

Award Budget Application budgets are limited to $400,000 per year in Direct Costs and need to reflect the actual needs of the proposed project.

Award Project Period The maximum period is 2 years.

https://grants.nih.gov/grants/guide/url_redirect.htm?id=11120

5/5/2021 RFA-OD-21-009: Emergency Award: RADx-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 … https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-009.html 13/30

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement (//grants.nih.gov/grants/guide/url_redirect.htm?

id=11118), are not allowed.

Required Registrations Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications (//grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html) states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) (http://fedgov.dnb.com/webform) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (https://www.sam.gov/portal/public/SAM/) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code (//grants.nih.gov/grants/guide/url_redirect.htm?id=11176) – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

eRA Commons (//grants.nih.gov/grants/guide/url_redirect.htm?id=11123) - Applicants must have an active DUNS number to register in eRA Commons.