NIH Tribal Consultation on COVID-19 Research
The rapid-response NIH Tribal Consultation on COVID-19 Research was held on May 28, 2020 to seek input from Tribes about ways NIH can support time-sensitive research that will provide vital information to help address COVID-19 in Tribal communities. The Consultation focused primarily on the developing Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) initiative and a new serology study proposed by the All of Us Research Program. Input was collected during the video conference and through written feedback submitted by Friday, June 5, 2020.
Watch the recording: https://videocast.nih.gov/watch=37778
Post-Consultation Decision
American Indian and Alaska Native (AI/AN) Involvement in the NIH RADx for Underserved Populations (RADx-UP) COVID-19 Initiative
Key Points:
- More information on RADx-UP is now available at the new RADx website and through several pre-application webinars.
- Due to the urgent nature of the COVID-19 response, Phase I of RADx-UP will primarily expand on existing NIH grants. NIH looks forward to receiving applications from our currently funded awardees associated with Tribal nations for additional funding through RADx-UP. New partnerships with other applicants are also encouraged in Phase I. Phase II is expected this fall and will offer opportunities for new awards.
- RADx-UP awardees will only be using diagnostic tests that are FDA-approved or have received an emergency use authorization (EUA) from the FDA. There will be an opportunity to be among the first to access newly developed, but EUA cleared, technologies resulting from the other RADx efforts (e.g., RADx-tech). This way, it will provide an opportunity to make the latest technologies available to populations who may need their unique capabilities most.
- RADx-UP applicants are expected to demonstrate knowledge of, and to comply with, Tribal requirements on testing, reporting, and surveillance policies in study protocols. When required, Tribal resolutions should be included with the application, if possible, but before funds are awarded in all cases.
Post-Consultation Decision
American Indian and Alaska Native (AI/AN) Inclusion in the All of Us Research Program COVID-19 Serology Study
Key Points:
- The NIH All of Us Research Program consulted with Tribal leaders about including existing AI/AN participant samples in a COVID-19 Serology Study looking for SARS-CoV-2 antibodies.
- Responding to Tribal concerns, All of Us has decided not to include these samples and will continue focusing on finalizing consultation about the main program.