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

Is there a possibility to begin before June 30th

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

Do we need to submit IRB approval from our institution with the application?

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. 

If applicants/ awardees receive in-kind contributions from stakeholders (local DOH supplies test kits), do we need to include this in the application?

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

Is survey data considered quantitative or qualitative, given the limit on the qualitative portion to 40% of the total budget? 

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.   

Could you please clarify what information is intended to be included in Section 5 of the Application, which references the appropriateness of the budget? 

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.   

Does the application include a Specific Aims page? 

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.   

What is the RADx-UP expectation to share identifiable data? We are concerned about the effect of this requirement on testing consent.

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.   

Is there anything specific that should be included in the Additional Information one page document?  

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.   

Have the common data elements for pediatrics been already developed or is the team expected to participate in the development of these CDEs?

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.   

Will study design and write ups go in the additional information one-pager?

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

Can you provide clarification the 40% of the budget required to go to minority serving institutions?

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.   

Are the milestones included as part of the page limit?

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

Can you elaborate on the difference between a deliverable and "exit criteria"?

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.

Could you explain the plan for authenticating key biological and chemical resources?

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.   

Is there any recommendation for cost/test pricing for the school setting?

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. 

For the inclusion of the approved IRB document with the submission, where would this be included within the ASSIST website application?  Is there a page limit allowable?

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..."

Is this referring to efforts in general (i.e. in the US/based on literature) or efforts specific to our setting (i.e. in the schools we’re partnering with)?

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.

Would 1) funding staff that are stationed 100% at the school sites and 2) testing school students/staff meet the requirement for 40% of the budget allocated to the partner site serving underserved minorities?

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

The ROA (on page 9) states that a draft Data Use Agreement is required that supports the rapid deposit of data with the CDCC and the NIH RADx Data Hub.  Is this DUA in addition to the data sharing plan that was mentioned in the slides during the presentation? 

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

Is the expectation that there will only be 5 PDFs attachments - to match the sections listed in the ROA?

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.

What should be included in the Bibliography (under Additional Information)?

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

Does the NIH have any plans to contact individual applicants to suggest potential partnership among those invited to submit, or are partnerships solely arranged by the applicants themselves?

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. 

Will an extension to the May 14 submission deadline be granted?

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

This page last reviewed on May 11, 2021