Frequently Asked Questions (FAQs): RADx-UP Phase II Return to School ROA (OT-21-007)

This will be negotiated with NIH staff. The earliest start date will be no later than July 1^st if possible. 

Although we would like to launch these projects as soon as possible, an IRB is not a requirement to apply. However, a project where an IRB approval process is expected to be significantly delayed, is not likely to be feasible. 

Awardees will need to detail any cost sharing in their application.   

It depends on what data the survey is collecting. For example, if a survey is collecting attitudes and preferences, that would be seen as qualitative. If the survey is collecting absenteeism rates that would be quantitative. In the application, be clear on the study approach and the survey outcomes in order to adequately evaluate whether it is quantitative or qualitative.   

There are a number of things included in Section 5 of the application.  The first is information on human subjects and clinical trials that may be conducted as part of the project.  As with any clinical trials performed as a part of an NIH project, there are certain policy requirements that must be fulfilled; additional information can be found in the guidance.  The second is the budget details required.  The budget must be in a PDF document, which is PDF readable.  The budget table must also include categorical information on how the money will be spent, including: sub-awards, direct costs, total costs, etc.  It must also include a milestone and deliverable table with a payment schedule.  You cannot exceed $2M in total costs for twelve months, nor $3M total costs for the two-year proposal, unless prior approval had already been granted.  If you have received prior authorization, ensure that at least 40% of the costs are going to the collaborator institution(s) that receive no more than $6M NIH RPG funding.   

There is no Specific Aims page required.  A cover is page required, and the application must address all of the sections of the ROA.  The Specific Aims of the project should fall within the Scientific Questions and resultant Impact of Section 1.   

The CDCC provides guidance on data acquisition, collection, and curation, including appropriate consent for data sharing.  there is a requirement to collect the NIH RADx-UP Tier 1 Common Data Elements (CDEs). Part of that is collecting identifiable information that will allow for future contact for future research.  Each awardee will be assigned to an engagement impact team at the CDCC and they will assist with working through any issues or questions.   

No specifics. If there is anything else that needs to be included in the application that doesn’t meet any of the other criteria this is the opportunity to include that information.  The additional information section may be no more than one page.   

Pediatric CDEs have been in development for some time and depending on the status when an award is issued there may be an expectation to participate in the development or modification of those CDEs.   

No, the study design should be in the main part of the application, specifically in Section one.

For those applicants who received prior approval to submit budgets up to $5M in total costs, in the budget you must show that a proportion of the funding will be going towards the collaborating institutions, whether that be school system, or providing funds for supplies, lab capabilities, etc.,  and justify the personnel costs, etc. in the budget justification.  If the other institution is a University, you must show that they are a historically black college or university, or other minority serving institution.  The other organization must not have received more than $6 million from the NIH in other awards.  The intent is to engage communities and to involve them in this research.   

No, the milestones are not included as part of the 12-page limit.   

A deliverable  is a product that will be produced, it may be a paper, or a post on a public facing website, or data to be shared in a presentation.  This should have an impact to the public.  The exit criteria is that the deliverable has been completed or that you have completed a phase of the project.  There may not necessarily be a deliverable associated with exit criteria.

This may not apply to your application.  This sometimes refers to the test or the material and potential exposure.  If that is not included in your project, then it does not apply.   

No, testing paradigms can include any of the FDA-authorized/approved modalities, for diagnostic, screening, and surveillance testing. Therefore, costs will be determined through your project. Potential resources for testing will be discussed as they become available and during negotiations of the awards. 

IRB documents may be included within the PDF of the application, or as a separate pdf submitted in ASSIST. 

In section 2 it asks the applicant to "Describe efforts to address social, behavioral, and ethical factors that drive disparities within school settings..."

The application should address the impact of the proposed research on addressing disparities in vulnerable and underserved populations and addressing social, behavioral, and ethical factors that drive disparities within school settings.

Potentially yes. Please reach out to the Agency Contacts on the ROA. 

Correct – the application should include a description of the Data Sharing Plan, as well as a draft Data Use Agreement. 

The 12 page application could be submitted as a single pdf, organized into the Sections 1-5 as described in the ROA. Additional information (e.g., budget, Letters of Support, Bibliography, etc.) may be submitted as separate attachments.

A one-page bibliography may be included to list cited sources, referenced in the application. 

As the Other Transactions Award mechanism allows NIH to fund projects of two or more entities (potentially across different applications), NIH may initiate teaming arrangements prior to submission or after awards are issued. Partnerships are encouraged by the applicants themselves, if appropriate. 

Permission will not be granted in advance for submission of a late application.