RFA-OD-22-011 - Emergency Award: Rapid Acceleration of Diagnostics Tribal Data Repository (RADx TDR) (U24 Clinical Trial Not Allowed).
NOT-OD-21-064 - Notice of Intent to Publish Funding Opportunity Announcements for the RADx-UP Initiative (Phase II)
NOT-HL-20-806 - NHLBI confirms participation in NOT-OD-20-119, NOT-OD-20-120, and NOT-OD-20-121 (Research on COVID-19 Testing among Underserved and/or Vulnerable Populations)
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
NOT-OD-21-038 - Updated Instructions on Interim Reporting and Carryover for RADx-UP Recipients
NOT-OD-21-103 - Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations RADx-UP Phase II (Emergency Supplement - Clinical Trial Optional)
NOT-OD-21-101 - 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
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:
- NOT-OD-20-121which encourages community-engaged Testing Research Projects to supplement large scale networks, consortia, or centers, will examine SARS-CoV-2 infection patterns and efforts to increase access and effectiveness of diagnostic methods.
- NOT-OD-20-120 with a similar focus, but shifts the pool of eligible grants for supplementation to individual research awards that include community collaboration or partnership, generally targeting specific populations.
- RFA-OD-20-013 which is a U24 Coordination and Data Collection Center (CDCC) as a key component of the consortium
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.
Key Definitions
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.
Background
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:
- Which social, ethical and behavioral facilitators and barriers substantially influence decisions about whether and when to offer or seek COVID-19 testing?
- What strategies mitigate barriers, and increase access to and acceptability of testing and repeat testing?
- What are implications of both positive and negative COVID-19 diagnostic tests for underserved and/or vulnerable groups, and how do they influence testing decisions and downstream beliefs and behaviors?
- How are test results interpreted and used in these underserved and/or vulnerable communities?
- What are the risks and benefits of implementing new COVID-19 testing technologies in underserved and/or vulnerable communities from the perspectives of those populations?
- What population specific social, ethical, or behavioral factors should be addressed before deploying novel testing strategies?
- What factors should be addressed before vaccine trials can be considered?
- What strategies can be developed and tested to increase acceptability of vaccine trials and vaccinations in underserved and/or vulnerable populations?
Applicants are encouraged to consider and investigate:
- Social, economic, ethical, cultural, historical, contextual factors and beliefs and behaviors associated with testing/diagnostic technologies
- Collection, storage, use and public health reporting requirements for COVID-19 test data, considering Tribal data sovereignty where appropriate
- Return of results, repeat testing, and implications of and provision of support for negative and positive test results for under-resourced populations, individual patients, and their families
- Availability of tests and referral networks for follow-up care and social services to address basic needs related to COVID-19 (e.g., patient referral and navigation services)
- Stigma, discrimination, and financial burden associated with accessing testing and a positive test result and follow-up care
- Implications of contact tracing including mistrust and privacy considerations
- Health-related beliefs and behavior regarding willingness to be vaccinated against SARS-CoV2 if or when an effective vaccine is made available
- The most effective community engagement strategies to inform the culturally sensitive implementation of diagnostic testing in underserved and/or vulnerable populations
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
- Assess factors influencing the ability and willingness of underserved and/or vulnerable communities to access available diagnostic services and follow-up care and services following positive results. Enumerate key facilitators and barriers, and strategies to harness facilitators and mitigate barriers.
- Assess reasons for testing decisions, including perceived/actual harms and benefits of different testing decisions. Assess how these factors are weighed and determine who is most/least likely to get tested under various scenarios and locations (e.g., health status, family member test status, employment and health insurance status, rural/urban).
- Examine perceived and actual risks of testing to other parties including family members, traced contacts, and broader communities, and how those risks influence decision-making.
- Assess variations in provider, health system, or employer protocols for COVID-19 test eligibility, and how they are influenced by socio-contextual factors.
Products
- Validated and reliable assessment tools to determine the likelihood of seeking COVID-19 testing
- Strategies to acknowledge or influence contextual/health-related beliefs and attitudes about testing
- Strategies to make testing more accessible and acceptable to communities of interest
Return of COVID-19 Test Results
- Determine information community members want to learn and believe they would need about their COVID-19 status from diagnostic tests. Assess perceived utility of diagnostic test result information, and how those perceptions influence uptake.
- Determine information and resource needs at the time of return of results, and develop and assess communication methods with varied languages, literacy levels, and modes of delivery.
- Assess and improve understanding, misunderstanding and retention of key information using multimodal resources and delivery channels.
- Assess how test recipients interpret and act on their results, including mitigation behaviors as a result of negative findings (e.g., less vigilance about social distancing, wearing a mask in public, handwashing, etc.), and information-seeking or resources that lead to referral of at-risk contacts for testing.
Products
- Results templates and toolkits designed in collaboration with communities
- Strategies and resources to increase use and utility of results and accompanying information and resources
- Strategies to encourage testing of at-risk contacts
- Strategies to encourage repeat testing and follow-up services, when appropriate
Data Stewardship, Data Sharing and Privacy
- Explore community understanding, expectations, concerns and preferences for governance, privacy, security, use and sharing of participant COVID-19 data (including sharing with secondary users, such as third-party payers, employers, housing managers or authorities, public health departments, law enforcement, etc.).
- Determine how specified communities view the balance of public health benefits of sharing test results (e.g. for contact tracing) with cultural norms and personal opinions about privacy; explore how these views influence testing decisions.
- Develop transparent governance policies for COVID-19 test data that meet scientific and public health goals, while addressing or acknowledging community concerns and limitations.
Product
- Community-informed data governance policies
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.
- Assess trust in local, regional and national sources of COVID-19 data and testing information among underserved and/or vulnerable populations. Test the impacts of information source(s) and beliefs about veracity on theoretical antecedents (e.g., motivation, agency, and intentions) of behavior.
- Examine the role of health literacy, including limited English language literacy, in COVID-19 testing disparities.
- Assess and address current sources and content of messaging leading to key understanding, misunderstanding and misrepresentation in these communities about COVID-19 testing, contact tracing, and vaccination. Identify messaging targets to help improve testing uptake and vaccination acceptance when available.
- Assess interpersonal (e.g., healthcare provider) COVID-19 communications when working with underserved and/or vulnerable populations and address social and ethical implications.
- Develop and test community and culturally appropriate COVID-19 messages with specific foci on social and ethical considerations
- Assess and address long-held beliefs and attitudes about science, government, health care and public health that enhance or deter uptake of testing and vaccination.
Products
- Create trusted local or regional COVID-19 communication networks to reach underserved and/or vulnerable populations; develop a strategy to aid similar partnership development in other localities.
- Tested strategy to improve quality, consistency and quantity of COVID-19 communication
- Tested materials and approaches to ameliorate distrust, fear, stigma and discrimination surrounding COVID-19
- Tested materials and approaches to address current misrepresentations or misunderstandings inhibiting uptake of COVID testing and vaccination.
- Ensure these products are available or readily adaptable for other communities and languages
Vaccine Preparedness in Underserved and/or Vulnerable Populations
- Understand population specific beliefs, attitudes, and intentions towards future COVID-19 vaccination including individual, familial, community, economic, and structural influences on vaccine acceptability and hesitancy.
- Assess misinformation and the design of countermeasures to misinformation regarding vaccination
- Examine and assess implementation strategies for vaccine trial scale-up in underserved and/or vulnerable communities, including the roles of organizations and institutions in the community.
- Develop culturally competent strategic communication about COVID-19 vaccination that averts stigma and ensures effective exchange and dissemination of information.
- Develop methods to ensure appropriate consent for vaccine trials including approaches for children and parents/guardians and other underserved and/or vulnerable populations
Products:
- Resources and strategies to assess vaccine trial acceptability in specified communities
- Resources and strategies for addressing community concerns regarding vaccine trials
- Resources for community engagement and collaboration for vaccine trials
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:
- Projects primarily increasing delivery of COVID-19 testing (see NOSINOT-OD-20-121 and NOSI NOT-OD-20-120)
- Projects without a focus on one or more underserved and COVID-19 vulnerable populations
- Projects that have limited population reach (taking into account the size of the target populations and its COVID-19 epidemiologic profile)
- Projects that do not demonstrate an equitable relationship or engagement strategy with the underserved and/or vulnerablepopulations of interest
- Projects that do not include community engagement efforts
- Projects that involve COVID-19 testingor SEBIoutside of the United States
- Projects that do not address social, ethical, and behavioral consequences of their proposed design and methods and may exacerbate health disparities in COVID-19 diagnostic testing
- Projects that do not consider more than one level of analysis (individual, interpersonal, institutional, community, and policy)
- Projects that are exclusively qualitative (though mixed quantitative and qualitative are acceptable)
- Projects that do not have an infrastructure to rapidly report study findings and impact to the CDCC
- Projects that have limited testing capacity, that do not include FDA-authorized testing strategies or present a plan to incorporate approved testing strategies
- Projects supplementing grants that are not eligible for this NOSI (see Eligibility section below under Application and Submission Information
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:
- Guidance provided by the CDCC for data acquisition, collection and curation, including appropriate consent for data sharing and implementation of the schemas proposed under the ABOUT ML effort ( Annotation and benchmarking on understanding and transparency for machine learning lifecycles ; available at https://www.partnershiponai.org/about-ml/).
- Data Harmonization for Social Determinants of Health (SDOH), COVID-19, and other relevant measures via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on SDOH across studies. In particular, human-subject studies should 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).
- A trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded where they address questions of interest.
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
Review Process
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:
- Is there evidence of strong established research collaborations with proposed community partners? How feasible and appropriate are the plans for integrating community partners into the study?
- Urgency and significance of research: Will successful completion of the aims contribute to or complement public health efforts for the control of SARS-CoV-2 (COVID-19) infection and related pathogenic processes? Does the proposed research fit within the mission of an emergency response to provide critical expertise, resources or activities?
- Feasibility of research: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Is the emergency time frame feasible for the proposed research?
- Is the proposed approach dynamic and responsive to evolving changes in COVID-19 diagnostics in the United States?
- Outcomes: Will outcomes or products result that could be used to improve access, acceptability, and uptake of COVID-19 testing?
- Will the study contribute to understanding how diagnostic testing may be clinically and personally useful to individuals, households and communities?
- Are the proposed approaches likely to yield important contributions applicable to a range of populations and healthcare settings?
- Is the timeline (with milestones) appropriate and feasible to support the aims and goals of the study?
- Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project?
- How feasible and appropriate are the plans for sustainability of project infrastructure and partnerships that may be leveraged for future engagement work surrounding public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts?
- Data sharing plan: Are there timely plans consistent with the goals of the program to make instruments, products, results and data findable and accessible to the research community, where not limited by Tribal data sovereignty?
- Coordination plans: How feasible and appropriate are the plans to submit data, data collection instruments and outcomes/products to the CDCC (FOA RFA-OD-20-013)? How feasible and appropriate are the plans to collaborate with the RADx-UP field sites (NOSI NOT-OD-20-121 and NOSI NOT-OD-20-120).
- Is the management plan well-described and commensurate with the level of complexity required for this NOSI?
- Are timely and feasible remediation plans for adverse outcomes included as appropriate?
Pre-award costs
- Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.
Reporting
- OD plans to make awards using funds provided in the emergency supplemental appropriations for COVID-19 and coronavirus research: Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139 . Funds awarded using appropriations provided by the Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139 will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.
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.
- Applications are invited from investigators representing a wide range of disciplines, including but not limited to ethics, health disparities research, health communication and communication science, implementation science, clinical care, home and community-based services, infectious disease, community-based participatory research, policy studies, public health, epidemiology, bioinformatics and health information sciences, behavioral and social sciences (e.g., psychology, sociology, social work, anthropology, political science, economics, communication science).
- This Notice supports collection of multiple types of data including qualitative and quantitative methods, as well as reviews of documents and available data where appropriate. Where possible, primary or alternate methods that are robust or unaffected by shelter-in-place and other restrictions on research environments is encouraged, although evidence of availability and acceptability for communities and individuals should be provided, along with the capacity to maintain standards of ethical research conduct.
- Applicants should describe in the Research Strategy their ideas for working with other SEBI and RADx-UP sites to accomplish project goals, and their willingness to adhere to policies and procedures determined in cooperation with the CDCC ( RFA-OD-20-013)
- Projects must focus on and include one or more underserved and/or vulnerable populations (identified above). Applicants should demonstrate a successful record of collaboration with existing community partners.
- The funding instrument, or activity code, will be the same as the parent award.
- NIH reminds applicants that the appropriate consideration of sex and gender as described in NOT-OD-15-102 is NIH policy and a consideration for NIH support.
Eligibility
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.
All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-20-135)
must be followed, with the following additions:
- Individual requests can be no more than $400,000 in direct costs per year for up to two years.
- The Research Strategy section of the application is limited to 12 pages.
- Applicants may request supplements with budgets that exceed the parent award. Budgets must be reasonable and reflect the actual needs of the project.
- To be eligible for a competing revision award under this NOSI, the parent award on which the revision application is based must be an active award (including those in a no-cost-extension period) managed by one of the participating institutes or centers.
- Applicants should address whether and how ongoing or potential future public health restrictions (e.g., closures, physical distancing, ability to hold large meetings) might affect the research approach and, if so, include a plan to prevent or mitigate any effect on the proposed study.
- Applications may be submitted beginning on July 8, 2020 for Application Due Dates of August 7, 2020 (5:00 PM local time of the applicant organization) OR September 8, 2020 (5:00 PM local time of the applicant organization). Applications received after September 8, 2020 will not be considered. The earliest start date for applications received on or before August 7, 2020 will be September 2020, and for applications received on August 8, 2020 or later will be November, 2020. An application submitted in response to this NOSI that is received on September 9, 2020 or later will be withdrawn.
Specific to applications that target PA-20-135 (Emergency Supplements):
- IMPORTANT: For funding consideration, all applicants must designate "NOT-OD-20-119" (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.
- All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package
-
- Competitive revision applications to PA-20-135 must use the application form package with the Competition ID that contains "FORMS-F-COMP-REV".
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.
Grants Management Contact: Kwesi Wright, 301-451-4789, Kwesi.Wright@nih.gov
Office of the Director, Environmental Influences on Child Health Outcomes (ECHO):
Scientific Program Contact: Carol Blaisdell, MD, MEd, 301-435-5606, carol.blaisdell@nih.gov
Grants Management Contact (ECHO Cohorts): Donna Sullivan, 240-669-2979, dsullivan@niaid.nih.gov
Grants Management (ECHO ISPCTN) Contact: Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 301-435-6975, clarkb1@mail.nih.gov
Office of Behavioral and Social Science Research (OBSSR):
Scientific Program Contact: Deborah Young-Hyman, PhD, 301-451-0721; deborah.young-hyman@nih.gov
The Office of Disease Prevention (ODP/DPCPSI/OD):
Scientific Program Contact:Jacqueline Lloyd, PhD, MSW, 301.827.5559, lloydj2@nih.gov
Office of Research on Women’s Health (ORWH):
Scientific Program Contact: Damiya S. Whitaker, PsyD, MA, 301-451-8206, damiya.whitaker@nih.gov
Sexual and Gender Minority Research Office (SGMRO):
Scientific Program Contact:Christopher Barnhart, PhD, 301-594-8983, Christopher.barnhart@nih.gov
Tribal Health Research Office (THRO):
Scientific Program Contact:Maria Jamela Revilleza, PhD, 301-451-0724, MariaJamela.Revilleza@nih.gov
All of Us Research Program:
Sheri D. Schully, Ph.D., 301-827-1691, schullys@mail.nih.gov
Kimberly Stanton, 301-827-8054, stantonk@nhlbi.nih.gov
and Human Services (HHS)
