Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)
Notice Number:
NOT-OD-21-097

Key Dates

Release Date:
March 29, 2021

Related Announcements

NOT-OD-21-065 - Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)

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

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this Notice is to alert the community that NIH plans to publish a Research Opportunity (RO) as part of the Rapid Acceleration of Diagnostics for Underserved Populations (RADxSM-UP) initiative to solicit research on COVID-19 diagnostic testing approaches to safely return children and staff to the in-person school setting in underserved and vulnerable communities (NOT-OD-21-065).

This open solicitation will be an opportunity to start new cohorts or approaches to gain data related to safe return to the in-person learning environment. A letter of interest will be required to be considered for the opportunity to participate in the Research Opportunity. Guidance on the development and submission of the letter of interest is available at the following web address: https://grants.nih.gov/sites/default/files/RADx-UP-LOI.pdf.The letters of interest will be reviewed by NIH staff and specific programs will be invited to submit and compete with full proposals. The letters of interest will be due by April 16, 2021, 5 PM local time of the applicant organization.

The NIH will hold a webinar to review this research opportunity and the letter of interest requirements on Thursday, April 1, 2021 from 11:00 AM to 12:00 PM EST. Questions can be pre-submitted at RADx-UPR2Sinfo@nih.gov by 11:59 local time on Wednesday, March 31, 2021. Register and learn more about this webinar at:

https://deloitte.zoom.us/webinar/register/WN_FyFYH5ALTWChle2OWSQZKQ.

Applicants will be invited for the full proposal stage by April 23, 2021 with a receipt date for the full proposal on May 14, 2021. The goal is to make awards by June 2021 for planned implementation in the 2021-2022 school year.

Awards under this funding opportunity will be issued as Other Transaction Agreements (OT2), which are not grants, contracts or cooperative agreements. Other Transactions awards will involve active NIH program management. Furthermore, the OT funding mechanism provides NIH with the flexibility to design unique collaborations with private sector entities that may not have experience with commonly used assistance mechanisms such as grants and cooperative agreements.

Research Initiative Details

The goal of RADxSM-UP is to reduce COVID-19 associated morbidity and mortality disparities for those vulnerable and underserved populations that are disproportionately affected by, have the highest infection rates of, and/or are most at risk for adverse outcomes from contracting the virus. This Notice encourages researchers to leverage existing partnerships and build new partnerships with key stakeholders to develop and implement specific, targeted approaches for school testing strategies to safely return children and staff to in-person school environments in underserved communities.

Strategies should be scalable, sustainable, and take into account the multiple stakeholders (e.g., children, parents/guardians, teachers, support personnel, and administrators) and the overlapping policy environments, including federal, state, local, and school district policies. Key issues to be addressed include but are not limited to: determining appropriate testing approaches (surveillance, screening, and/or diagnostic testing); barriers to testing; perceptions of testing among the key stakeholders in school-based settings; timely return of test results to the child and/or their parent or guardian; sharing of results with schools and public health departments; understanding the implications of a negative or positive test result; stigma related to testing; direct and indirect financial burdens arising from positive test results and follow-up care; feasibility of effective self-isolation following positive results; referrals for contact tracing in under-resourced communities; issues related to vaccine engagement and hesitancy in staff and older children who may become eligible over the project period; and privacy, confidentiality and data sharing.

The NIH intends for the awardees to join the RADxSM-UP consortium of interlinked, community-engaged, intervention projects across the United States and will be expected to partner and align with the RADxSM-UP Coordination and Data Collection Center (CDCC) at Duke University for guidance on data collection, benchmarking, harmonization, and sharing to the extent possible.

As with all NIH supported research, details regarding human subjects research are expected, including data safety and monitoring plans and, if needed, plans for a Data Safety and Monitoring Board (DSMB). Studies that have a DSMB are expected to coordinate with the CDCC (RFA-OD-20-013) for DSMB activities.

Funding Information

TBD

Estimated Total Funding

TBD

Expected Number of Awards

TBD

Estimated Award Ceiling

$5 million total costs

Anticipated Eligible Organizations

Non-domestic (non-U.S.) Entities (Foreign applicants) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components are not allowed. Foreign consultants are allowed if approved by the NIH official in advance of the full application submission. Individuals not affiliated with an organization, or who want to submit an application independently of their current organization, may not apply.

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)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession Other
  • Independent School Districts
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

RADx-UPR2Sinfo@nih.gov


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