Policy-Related
Application Process/Review Related
Policy/Post Award

Policy-Related

1.Do I have to be a U.S. citizen to receive a career award?
At the time of award, you must be a U.S. citizen, U.S. noncitizen national, or have been lawfully admitted into the U.S. as a permanent resident. Please see the bottom of the Research Career Development Award Table of Contents Substitute Form Page 3, which can be downloaded in MS Word or PDF format. You are required to use this Substitute page to indicate your citizenship status. No award can be made until this is confirmed.

2. Can I apply for a research grant from the PHS and still keep my career development award?
Yes, however the rules regarding salaries have changed as of 2/1/04 (NOT-OD-04-007). Please contact NCI Staff for your particular situation.

3. How are the salary levels and other costs associated with Career Development Awards determined?
Each Institute and Center at the NIH has the authority to determine the upper salary levels and other cost levels for Career Development Awards (i.e., K-awards) as a matter of institute policy. Thus, the NCI's levels do not necessarily equal or match the levels supported by another institute. For the NCI, all individual career awards for "mentored" postdoctoral scientists and for junior faculty establishing their first independent research programs use the same salary and other cost levels.

4. Should I apply for 3, 4 or 5-year Career Development Award?
Unless it is very clear that you do not need five years of support, it is always better to apply for the maximum of 5 years. Let the peer reviewers delete future years based on their professional assessment of your need for "mentored" training before you can become independent investigator.

5. What happens if I already have considerable postdoctoral experience and want to pursue additional training or change fields?
This will depend upon the strength of your rationale for extending your period of postdoctoral training and on the perceptions of reviewers. If reviewers see your application as just another postdoctoral experience, it is not likely to succeed. But if they view your application as an essential step in a carefully considered career development plan to gain the multi-disciplinary skills necessary to become an independent investigator in your field of choice, this will be considered positively.

There are some unexplainable tendencies in peer review. For example, if you are trained as an M.D./Ph.D. versus obtaining an M.D. and then a Ph.D., reviewers are much more favorably inclined toward multiple postdoctoral experiences. We do not know the reason for this, but if you are in the second category, your application will have to present a very convincing career development plan.

6. What's the difference between a "mentor" and a "sponsor"?
The various announcements and the Form PHS 398 use mentor, sponsor and preceptor interchangeably. There is no difference.

7. What is the importance of the sponsor(s) or mentor(s)?
The sponsor will be critical to the success of your application in terms of how well the sponsor's research matches your career goals and objectives AND how good the track record of the sponsor is in training individuals who have become successful independent investigators. With today's increasingly multi-disciplinary, translational research emphases, it may be more logical and a stronger application to develop a program that includes more than one sponsor over the period of training.

Application Process/Review Related

8. What is the "career development plan" that is always referred to in the NIH Announcements?
The career development plan is the combination of the candidate's goals and objectives, combined with the specific opportunities available in the mentor's research group within the environment of the institution. In addition, it incorporates those elements of the research plan needed to achieve the objectives of the career development plan. For additional information, see PHS 398 Form, Section IV, Part 3 THE CANDIDATE for additional information.

9. Why do I need to send extra copies of my career award application?
These extra copies are vitally important to the timely processing and review of your application. The copies to the Center for Scientific Review (CSR), which is the central receipt point for all grant applications to the NIH, ensures that the application is given the appropriate grant number and assigned to the National Cancer Institute for peer review. CSR does the critical logging in and processing of the paperwork. Unlike the regular research grants (e.g., R01s), CSR does NOT ORGANIZE and conduct the peer review system for career awards. Each institute and center at the NIH manages its own peer review system for career awards. The extra copies that you send directly to the NCI ensure that the review process is initiated in a timely way and avoids the possibility that CSR can mishandle or lose your application.

10. Should I send a cover letter with my career award application?
The first processing step by the Center for Scientific Review (CSR) is to assign funding responsibility for your application to an institute; this is called the "referral" process. If your research is obviously cancer research, then it will be assigned to the NCI. But if you feel that your application is cancer research and are concerned that it could be assigned to an institute other than the NCI, then a cover letter explaining the significance of the research to cancer will be helpful. Also, if you feel that your research is related to cancer research and other areas of research, it may be to your advantage to provide an explanation. CSR can give an application a "dual referral" and make an assignment to two or more institutes. For example, if your application is related to cancer and aging, the grant number would begin with a CA/AG or an AG/CA, reflecting CSR's view of the primary emphasis of the research. When there is a dual assignment, this ensures that more than one institute can consider your application for funding.

11. How important is the font size in preparing the application?
This is very important. Follow the directions for Format Specifications in the instructions for the PHS 398 Form (Revised 9/2004), or your application will be returned by CSR.

12. Can I supply additional information after I have submitted my Career Award application to the NIH?
Yes, but this must be submitted after receiving approval from the NCI Scientific Review Administrator (SRA) in charge of reviewing your grant application. You must identify the SRA, explain your situation, receive approval and send the additional information in time to provide reasonable opportunity for the reviewers to include it in their evaluations. Examples of additional information that is important for reviewers to examine would be new experimental data that strengthen the rationale for pursuing the research project and manuscripts that have been accepted for publication, especially if they are to peer-reviewed journals.

13. Should the signature of the Sponsor be included with Statement of the Sponsor in a research career development award application?
Yes. Reviewers want verification of everything in the plan by the signature of the sponsor. The absence of the signature could compromise the review of your application.

14. Who will review my career award application?
A scientific review group organized by an NCI Scientific Review Administrator will review your application. It will have the necessary expertise to judge the merit of your application, the suitability of the sponsor, the institutional commitment, and your potential to develop into an independent investigator.

15. How will reviewers evaluate my application?
The reviewers will evaluate your application using the review criteria provided in the NIH/NCI announcement that corresponds to the particular career development award that applies to you. In this case it is the K08 award. It is very important that you prepare your application in response to these criteria because your ultimate success in receiving funding will depend upon how well your application addressed these criteria. For review criteria for the K08 grant mechanism, see the REVIEW CRITERIA section of the Program Announcement: PA-06-512 MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD (K08) .

16. What will happen if I report independent research support at the time of submission of "just in time" information?
It will depend on the type of support. Please refer to the ELIGIBILITY REQUIREMENTS in the Program Announcement: PA-06-512 MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD (K08). If the support does not meet eligibility criteria, an award will not be issued.

17. Does my career plan have to include Training in the Responsible Conduct of Research?
Yes. This is an NIH requirement. There should be either clear documentation that you have completed this training at a previous time or substantive activities related to instruction on the responsible conduct of research that will be incorporated into your research training plan. Most programs consider training in the following areas: conflict-of-interest, responsible authorship, policies for handling scientific misconduct, policies regarding use of human and animal subjects, and data management/record keeping. This aspect of your training will not affect the merit score given to your application, BUT if this training in not in the application, it cannot be funded until proper arrangements have been made.

18. What should my application contain if it deals with human subjects, clinical trials 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 9/2004) 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 9/2004) application.

If the study involves a clinical trial, you will need to include an abbreviated data and safety-monitoring plan showing that the sponsoring institution does have an operational mechanism for data and safety monitoring of clinical trials.

If you are using vertebrate animals, you must answer all parts of item 5 on the face page of the PHS 398 Form (Revised 9/2004) application and follow the instructions in the Vertebrate Animals section of the instructions for preparing a PHS 398 Form (Revised 9/2004) application.

Without the proper information on Gender and Minority Inclusion, Inclusion of Children and Vertebrate Animals, 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.

Policy/Post Award

19. If I submit a research grant application (e.g., R01) after receiving a Career Development Award, how does NCI reconcile the percent level of effort commitment and salary on the research grant application with the requirements of the Career Development Award?
The total percent level of effort commitment on the Career Award and the research grant cannot exceed 100 percent. The percent effort commitment permitted on the research grant will be negotiated at the time of award and will depend on the degree of overlap between the specific aims of the two funding sources. (Please contact the NCI Staff Contacts for the Career Award for additional detailed information on this issue.)

20. If I have an award and I would like to ask for post award changes, how do I go about this?
You must contact the NCI Grants Administration official to determine the appropriate procedures to use in making a request for post award changes in your grant. This also applies to any of your needs that require a prior approval from the NCI. In general, you will have to make a request that is signed by you and a business official of your institution. After receiving the request, the Grants Administration official will consult with the NCI scientific program staff as necessary to determine whether the request can be approved.

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