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Frequently Asked Questions
Policy-Related
Application Process/Review Related
Policy/Post Award
1. Can a K05 be awarded for less than 5 years?
Yes. The peer review committee determines the length of the award. However, we
recommend that everyone submit an application requesting five years of support.
It would be highly unusual for a review committee to perceive a problem that
would result in a reduction of the grant period to less than five years.
2. I do not have an NIH research grant, but do have independent research support
from other sources. Am I still eligible to apply for a K05?
You are eligible to apply for a K05 award as long as you can document
independent support for your program, regardless of the source. Examples of
appropriate sources of funding could include private foundations and
pharmaceutical companies. Funding may also come from your institution, if you
can document that the use of these funds is completely under your control.
3. I am the Principal Investigator (PI) on a subproject of a cooperative
agreement research grant (U01) awarded to our institution. Is this considered
independent support?
It depends on whether the U01 is comparable to a single project R01 grant or to
a multi-project Program Project Grant (P01). If the U01 resembles an R01 in
size and complexity, a subproject would not be regarded as independent support.
But if you are a leader of a subproject of a grant such as the U01, which is
peer-reviewed as a freestanding project, then this subproject is clearly
equivalent to an R01 and would be considered your independent support. These
kinds of interpretations are difficult to make; if you are unsure of your
independent support, contact the NCI (see
NCI Staff Contacts).
4. I am an established senior investigator who is the PI of a cooperative
agreement grant (U01). The U01 involves the establishment, maintenance and
analysis of a surveillance research database. Since the U01 is not entirely
research-based but does have a research component, am I still eligible to apply
for a K05 award?
If you are the principal investigator, the grant has a research component, and
the research support on the grant provides you with a base of support upon
which to expand and refine your research as well as provide a research
environment in which to mentor new scientists, you are eligible.
5. How strong must the statement of institutional commitment be to the percent
effort required by the K05?
It is important that the institution provide a very specific plan for reducing
your current duties and providing you with the protected time for conducting
your research and mentoring new scientists. Peer reviewers will want to know
how others will accommodate your previous duties. Letters of support for this
plan from key people who must support it in the institution are also important
to include with your application.
6. I have an established record of independently funded research, but do not have
a track record in mentoring. Should I apply for a K05?
Most applicants for the K05 will have extensive mentoring experience. The best
course of action is to develop a mentoring track record and then apply.
7. What happens if I am not able to maintain independent research support during
the tenure of the award?
The K05 requires that you have independent support at the time of the award and
throughout the entire grant period. If you lose your support, you will lose the
K05. Without support you can neither expand, refine your own research program,
nor provide a suitable environment for mentoring new scientists.
8. As part of the mentoring component of the K05, am I allowed to mentor
individuals at another institution?
This could be done, but the arrangements would have to be very carefully
considered to ensure that the trainee(s) can function off-site and benefit from
your funded research environment.
9. If human subjects are to be involved in my K05 program, and I currently have
Institutional Review Board (IRB) approval for my ongoing research, do I still
need IRB approval for this award?
You will be required to obtain IRB approval for any NEW research that is being
proposed involving human subjects. Ongoing research with prior IRB approval
does not need additional action.
If the study is new and 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.
10. Where do I send my application?
All grant applications are sent to one address that is cited in the PHS 398
Form (Revised 9/2004) application kit. The Center for Scientific Review (CSR)
receives all applications and distributes them to the appropriate institutes
and centers. The institutes and centers operate and manage the peer review
groups that review your application for scientific merit.
11. At the time of the application, do I have to provide a list of the
individuals I plan to mentor?
While you are not required to provide specific names of trainees in the
application, providing the names at the time of the application may increase
the enthusiasm of the reviewers for your application. In any case, you should
provide information about the pool of candidates for mentoring, the types of
individuals you would be looking for, and the probable assignments of these
individuals on patient-oriented research projects.
12. I am planning to submit a K05 application but will be moving to another
institution. Should I submit the application now, or should I wait until I make
the move to the new institution?
Please wait until you move to the new institution before submitting the
application. Moving the application from one institution to another would
require a statement from the new institution guaranteeing you protected time.
If reviewers know you are going to move, this would complicate their evaluation
of the application.
13. If I receive additional independent support prior to the review of my K05
application, should I provide the NCI with this information?
Yes. You should contact the Scientific Review Administrator in the NCI, who is
responsible for organizing and managing the review of your application, and
arrange a time and method for providing this information. This kind of
information can only strengthen the peer reviewers' enthusiasm for the
application.
14. If I have a K05 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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