Key Dates

RFA-OD-22-011 - Emergency Award: Rapid Acceleration of Diagnostics Tribal Data Repository (RADx TDR) (U24 Clinical Trial Not Allowed).

NOT-OD-21-125 - Notice of Correction to NOT-OD-21-103

NOT-OD-21-064

NOT-OD-21-072

NOT-OD-21-097

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

NOT-OD-22-051

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

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 (RADx-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. The RO will consist of two phases: 1) a targeted solicitation to rapidly accelerate ongoing research already in place in the school setting; 2) an open solicitation to start new cohorts or approaches to gain data related to safe return. The targeted solicitation will be by invitation only and will include programs currently in place in the school setting; applications will be accepted through early March 2021 for FY21 funding with the goal to make awards no later than April 2021. The open solicitation is expected to be published in mid-April and we will accept applications through early May 2021 for FY21 funding. 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.

The goal of RADx-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 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; and privacy, confidentiality and data sharing.

The NIH intends for the awardees of the RO to join the RADx-UP consortium of interlinked, community-engaged, intervention projects across the United States and will be expected to partner and align with the RADx-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.