Physician-Scientist (PS) Research Award for Early Stage Investigators (ESIs) (R01 - Clinical Trial Optional)

A.1. To clarify, NIH policy requires a modular budget for applications that request $250K or less in direct costs per year (https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/develop-your-budget/modular.htm). Therefore, since a modular budget must be used, and since modules consist of $25K increments, the maximum budget is effectively $225K/year. In summary, applications may only request a top budget $225,000 to meet the modular budget requirement and for the electronic system to accept the application. Use of the modular budget will apply to all submission cycles.

A.2. No, US citizenship/permanent resident status is not required for this RFA.

A.3. At the time of initial submission, the applicant(s) must be an Early Stage Investigator (ESI). You can confirm ESI status in eCommons. It is determined by the dates you enter for your terminal research degree and/or the end of your post-graduate clinical training period. Once you have applied as an ESI, you are eligible to submit an amended application (A1) if needed.

A.4. There is no strict definition of junior faculty. Eligible applicants must meet these requirements:

1. Physician-scientists with an MD, MBBS, or DO degree and training in clinical care and biomedical research. U.S. licensure is required to conduct clinical trials.

2. Full-time, non-tenured or tenure-track faculty whose appointment is not contingent upon this award, but who can devote at least 6.0 person-months to biomedical research upon its receipt.

3. At the time of initial submission, applicant must be an ESI (see above).

4. For multi PD/PI applications, all PDs/PIs must meet these eligibility requirements.

A.5. Yes, if all MPIs are ESIs. Each of the MPIs would need to devote a minimum effort level of 6.0 person-months over each 12-month period of the award.

A.6. As Institutional/Departmental/Divisional control of Junior faculty assignments, salaries, and resources varies, the best source of the letter would be the person(s) with authority over clinical vs. research duties, and who is able to provide administrative support. If the letter is from the Division Chief, we ask the Department Chair or Dean to cosign for concurrence.

A.7. This RFA requires 50% effort dedicated to this research award. The rationale is to protect time for PDs/PIs who want to do research, yet are hampered by clinical duties. If applicants already have research funds that can be used for expenses other than PD/PI salary support, e.g. technical help or supplies, this RFA should be used to fund at least 6.0 person-months over each 12-months of the award. However, if other support specifies salary coverage for >50% effort (e.g. AHA career award), those grantees are ineligible. Current K awardees transitioning to an R award should contact NIH about subsuming efforts.

A.8. In the last two years of a K, the awardee can reduce his/her K effort to 50% per year -https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html. If the R01 complements the K project, some R01 effort may be subsumed under the K, according to Section 12.3.6.1 of https://grants.nih.gov/grants/policy/nihgps/HTML5/section_12/12.3_eligibility.htm?Highlight=subsume. Also, K award recipients may devote effort not directly committed to the K award to another grant as long the specific aims of the other grant differ from those of the K award -https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-094.html.

A.9. Normally, receipt of an R01 award ends ESI status, but if an A0 application to this RFA had been submitted before receipt of that award, eligibility to resubmit as an A1 to this RFA would be retained. There should be no scientific overlap, however, between any R awards.