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

Policy-Related

1. How many trainees can be supported by a K12 grant?
As many as can be accommodated by the $700,000 cap on each K12 grant and by the resources available to the program.

2. Who should be on the Advisory Committee?
The K12 program requires representation by each oncology discipline participating in the program. The individual members of the committee should be K12 program faculty, preferably with well-established grant supported programs and with substantial track records in training the types of individuals who will be appointed to the K12 program.

3. Since human subjects are to be involved in every K12 program, must each trainee obtain his/her own Institutional Review Board (IRB) approval?
If the trainee will be participating in a larger research program that already has received IRB approval, new IRB approval is not needed. If the research proposed is not part of an ongoing research project with an IRB approval, new IRB approval is needed.

4. Is there a preference in the oncology disciplines represented in the K12 program?
No. The only requirement is that at least 2 oncology disciplines must be represented in the program.

5. Can I assign a trainee to a laboratory project with a basic research component?
Yes. However, this should not comprise a major proportion of the total planned research experience of the trainee,; and the basic research component ideally would be integrated with the patient-oriented clinical research project. The actual assignments of trainees will depend on prior experience. For example, if a trainee has already had significant laboratory/basic research experience, then there is no reason to provide more of this experience as part of the K12.

6. Can the trainee's salary be supplemented?
Yes, but the funds may only come from non-PHS sources. A trainee can be compensated for work while receiving salary support from the K12 grant. However, the percent effort committed to the work for which they are being compensated cannot exceed 25 percent of full-time professional effort.

7. Can a K12 grant be awarded for less than 5 years?
No. The length of the award is 5 years.

8. What are the K12 requirements for Training in the Responsible Conduct of Research?
K12 grants do not have any mandatory requirements. However, it is strongly recommended that trainees deficient in this area obtain training in the responsible conduct of research.

Application Process/Review Related

9. Can the support provided for OTHER EXPENSES be used to offset costs incurred in advertising and recruiting for the program?
No. The OTHER EXPENSES are to be used only to partially support supplies, equipment, travel, and other expenses related to an individual trainee's individual career development.

10. Will a CSR study section review my grant application?
No. Applications for the NCI Institutional Clinical Oncology Career Development Program (K12) are reviewed by an NCI peer review group that is particularly sensitive towards training and career development needs in patient-oriented and translational cancer research.

11. 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.

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.

Policy/Post Award

12. Does the NCI K12 grant operate under Expanded Authority?
Yes. However, automatic carryover of unexpended funds is not permitted. If there is a need for carryover, prior approval by NCI Grants Administration Staff is required. Under most circumstances, each K12 is fully funded each year and there is little need for carryovers.

13. If I have a K12 award and 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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