General Career Development Award Frequently Asked Questions (FAQ)
Pre-Application
Can someone apply for only the independent R00 phase of an award?
No. Applications requesting only the independent R00 phase will not be accepted. Only active K99 awardees are eligible to submit applications for the R00 phase of the award.
Do postgraduate clinical training experiences count toward the research training eligibility limit?
No. Time spent conducting postgraduate clinical training that does not involve research is not considered as part of the research training eligibility limit of applicable awards. Only time dedicated to research activities would count toward the limit (specific to each award). Therefore, applicants with postgraduate clinical training experience are encouraged to apply for all awards for which they are eligible. Potential applicants are encouraged to discuss time spent conducting research during their postgraduate clinical training experience with an NCI program contact person before applying.
Does postgraduate research work conducted outside of the United States count toward the research training eligibility limit?
Yes. Time spent conducting postgraduate research, whether inside or outside of the United States, is considered part of the research eligibility limit.
Will the visa status of applicants’ matter?
Yes, it will. Only the K99/R00 award allows the PI to accept the award while in the United States on a visa. The PI’s visa must allow them to remain in the U.S. for the duration of the of the award.
Who is responsible for determining and documenting that the applicant investigator’s visa will allow them to remain in this country long enough to complete the K99 and R00 phases of the award?
The applicant institution is responsible for determining and documenting the candidate’s visa status for the duration of the award. For awards with more than one phase or a change in institution, it is the responsibility of the institution where the research will be performed (i.e., R00 phase, new institution) to document visa status.
Will NIH assist with visa-related matters so that applicants or awardees can remain in the U.S.?
No. NIH will not intercede on behalf of non-citizens whose stay in the United States may be limited by their visa status. As a result, NIH requires the applicant institution or organization to determine and indicate, in its application, that such individuals’ visas will allow them to remain in this country long enough to be productive on the project. If a grant is awarded based on this information and the individual’s visa does not allow for such a stay, the NIH may terminate the grant.
Will funding preference be given to U.S. citizens?
No. The distribution of awards will depend upon the merit of the applications received, the results of the scientific peer review process, the availability of funds, and the program priorities of awarding components. Please make note of applicant eligibility criteria for award prior to submission of your application.
What type of information should I include in the application?
Please read the funding opportunity and SF424 instructions for relevant application type (e.g. K for Career Development) carefully and follow them closely to determine what information must be included in an application.
Who should I contact if I have problems applying?
If you or your Authorized Organization Official (AOR) encounter any problems during application submission, please contact the eRA Commons HelpDesk. Only complete applications will move forward to review. Once the application due date has passed, there is nothing the NCI Program Officer can do to alter or fix an application.
What should my application contain if it deals with human subjects, clinical or vertebrate animals?
If the study deals with human subjects, you must answer all parts of item 4 on the face page of the PHS 398 Form (Revised 03/2020) application. NIH requires documentation of Institutional Review Board (IRB) approval at the time of award. The application should also address the points concerning Gender and Minority Inclusion and Inclusion of Children as Participants OR provide sufficient information/justification for exemptions. This information can be found in the Human Subjects Research section of the instructions for preparing a PHS 398 Form (Revised 03/2020) application.
Include an abbreviated data and safety-monitoring plan showing that the sponsoring institution has an operational mechanism for data and safety monitoring of clinical trials. Without the proper information on Gender and Minority Inclusion and Inclusion of Children, an award cannot be made. If an application is fundable, the NCI must be provided with the human subject IRB certification before an award can be made; and, where appropriate, a detailed data and safety monitoring plan.
Post Application/Pending Review
Can I provide additional information after I have applied?
Allowable post-submission materials, such as news on accepted publications can be sent by the Authorized Organizational Representative (AOR) directly to the NCI Scientific Review Officer (SRO) no later than 30 calendar days before the review meeting. For the full list of allowable post-submission materials, refer to https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-083.html.
How will reviewers evaluate my application?
Refer to “Section V. Application Review Information” of the corresponding funding opportunity.
How will my application be scored and reported?
Details are provided about the NIH Scoring System. The impact score will usually be released by the SRO within 2-3 days after the review meeting and reported in eRA Commons. Because applications are reviewed at NCI in one study section, applications are not given a percentile score. A summary statement containing critiques from the assigned reviewers will usually be issued within 2-8 weeks after the review meeting in eRACommons.
Post Review
I received an ND instead of an overall impact/priority score. What does this mean?
ND stands for Not Discussed. The decision not to discuss an application is usually made at the review meeting based on the preliminary scores of the assigned reviewers. The decision not to discuss an application must be unanimous, i.e., all reviewers on the panel (whether assigned or not) must agree with the decision not to discuss the application. You will get a summary statement with written critiques by the assigned reviewers.
Whom should I contact if my summary statement has not been released within 8 weeks?
Please contact the NCI SRO to inquire about the status of your summary statement.
When can I discuss the outcome of the peer-review meeting with NCI program official?
After your summary statement is released by the SRO and you read it carefully, you can email your NCI Program Official named on your summary statement to discuss the outcome of the review meeting and your next steps/options.
Should I submit JIT materials when I receive an NIH system-generated email?
NIH sends an automatic email requesting JIT material for applications with an overall impact score of 30 or less. That range includes applications that are outside NCI paylines. This email is not an indication of NCI’s intent to fund your application. When funding is likely, NCI staff (Program Official or Grants Management Specialist) will send a separate direct JIT request – it is important to follow up on this direct request.
Does the council make a funding decision on my application?
The second-level review by NCI Council (National Cancer Advisory Board - NCAB) is not a second scientific review. Rather, the council examines applications with potential barriers to funding such as human subjects and animal concerns, or special circumstances such as foreign applications, etc. The council recommends an application for funding. NCI makes the final decision based on many considerations, one of which is the availability of funds for the given fiscal year.
Post Award
What is a no cost extension, and can I submit one?
A No-Cost Extension is a request to extend the project period end date by up to 12 months without requesting extra funding, provided the Notice of Award does not prohibit the extension and the project's approved scope will not change. Information on submitting a No-Cost Extension (NCE), either through the Status screen or via the Prior Approval module in eRA Commons, is available here.
If I plan to move to a different institution, what do I need to do?
Notify your NCI Grants Management Specialist and your NCI Program Official about the upcoming move. They will provide you with the instructions. Your current institution will need to submit a relinquishing statement. After that and upon your request, your new institution should submit a type 7 application for Change of Grantee Organization (PA-21-268).
Can I apply for an independent research grant?
Yes, NIH encourages career development awardees to apply for an independent research award. The relevant NIH policy can be found here.
Resubmission
What should be included in a resubmission application?
In a resubmission application include a one-page Introduction section describing your responses to reviewers’ criticisms in the summary statement and summarizing substantial additions, deletions, and changes to the application. However, do not duplicate the Introduction Section in which you respond to the reviewers’ comments in the summary statement. Resubmissions should be complete applications with new/updated letters of support and letters of reference. It is optional to mark changes made to the application compared to the original submission to make the application review process easier for the reviewers. However, beware of “overcrowding” the text and making it more difficult to read for the reviewers.