Biomedical Data Translator Performance Phase — Questions and Answers

May multiple principal investigators (MPIs) be included on our award?

Yes. Given the highly collaborative nature of the program, MPIs are encouraged. If an applicant uses MPIs, an MPI leadership plan is required. Any given investigator may be named as the contact PI on only a single application.

May investigators from foreign institutions apply for this funding opportunity?

Foreign institutions and nondomestic components of U.S. organizations are not eligible to apply for this funding opportunity; however, a foreign organization may be included as a foreign component of an eligible organization’s application. Foreign components are defined as institutions or organizations that perform any significant element or segment of the project outside of the United States, either by the recipient or an individual employed by a foreign institution, whether or not award funds are expended.

The Research Opportunity Announcement (ROA) states that there will be no written feedback from the review. How may I get feedback about my application?

Because this is a unique, one-time Other Transactions solicitation and there will not be an opportunity to resubmit, no feedback (written or verbal) will be provided.

Who will review my application?

Responsive applications will be reviewed by an evaluation group convened by NCATS. The evaluation group will consist of NIH and other federal government staff who are subject-matter experts. The evaluation group will focus its review on the “Objective Review Considerations” included in the ROA.

Who will decide whether my application is funded?

NIH will use the objective review outcomes to select a subset of applications and/or subsections of applications to negotiate potential award terms. Final funding decisions will be based on the outcome of the objective review and negotiations between the selected recipients and NIH.

I have never used the eRA Application Submission System & Interface for Submission Tracking (ASSIST) site before. May I submit my application via email instead?

No. Only applications submitted through the ASSIST site will be considered for funding. Details on how to submit applications through that site may be found in the ASSIST User Guide. Learn more about the application process from these video tutorials.
Note: Only an authorized organizational representative may submit the application.

The ROA states that an optional Letter of Intent (LOI) is due two weeks before the application. Will it hurt my chances of being funded if I do not submit an LOI?

No. If you can provide an optional LOI, we encourage you to do so as it helps with planning the objective review. If you are unable to submit a LOI by the deadline, your application will be considered for review under the same responsiveness and objective review considerations as all other applications.

I am proposing user studies on the utility of my software as part of the application. Am I required to indicate that human subjects are involved?

That strongly depends upon what users are being asked to do and how the data generated by the study will be used. The determination of whether a study constitutes human subjects research should be made by the applicant organization and may require approval by the applicant organization’s Institutional Review Board (IRB). The NIH Human Subjects Research website provides resources, including a helpful decision tool, for determining whether activity is considered human subjects research.