Frequently Asked Questions
Policy-Related
Application Process/Review Related
Policy/Post Award
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.
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.
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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