Introduction
NCI Special Notes
Funded K12 Grants
Submitting an Application
Peer Review Process
Frequently Asked Questions
NCI Staff Contacts
Introduction
The Paul Calabresi Award (K12) is a multi- and transdisciplinary institutional training award supporting the research career development of clinicians only or clinicians and Ph.D. basic scientists to: 1) perform clinical oncology therapeutic research that develops and tests scientific hypotheses based on fundamental and clinical research findings; 2) design and test hypothesis-based, clinical therapeutic protocols and adjunct biological analyses and for clinician candidates to administer all phases (i.e., pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical trials; and (3) conduct cancer therapeutic research in team research settings in which basic and clinical scientists collaborate and interact to expedite the translation of basic research discoveries into patient-oriented therapeutic cancer research. Awards (renewable) for up to $750,000 annually in direct costs (clinician programs) or up to $1,050,000 annually (programs combining clinicians and Ph.D.'s) are made to institutions for up to five years.
The Award requires that at least 2 oncology disciplines are represented in the appointments to a K12 Program and the participating K12 Program faculty, didactic and research core requirements in basic science and clinical research for each appointee; and a basic science mentor and a clinical mentor for each appointee. All clinician candidates or trainees must currently be physicians holding the M.D. or D.O. degrees, or be nurses with a Ph.D. degree; and must have completed the necessary clinical training (i.e., completed residency and are board eligible) to engage in clinical oncology research. All basic science candidates must have doctoral-level degrees (e.g., Ph.D., D.V.M.) or the equivalent, a minimum of 2 years of postdoctoral research training, and a total basic research experience that is clearly preparatory (e.g., experience with animal models or preclinical research) for devoting a career to human therapeutic cancer research.
All candidates must be committed to a minimum of 75 percent full-time professional effort conducting research and engaging in activities directly related to research career development, which includes all relevant didactic activities during the period of the award. They must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary visas are not eligible.
Candidates may be former or current principal investigators on NIH Small Grants (R03) or Development and Innovation Grants (R21) or non-NIH equivalents to these grants/awards.
Candidates may not be current or former principal investigators on NCI K01 grants (Temin Award), NCI K07 grants or NIH K08 grants, NIH Research Project Grants (R01, R29) or subproject leaders on Program Project Grants (P01) and Center Grants (P50), or non-NIH equivalents to these grants/awards. Candidates also may not be current or former principal investigators on NIH K23 grants, NCI K22 grants, or non-NIH equivalent grants/awards. However, clinician candidates appointed to K12 grants are encouraged to apply for these grants/awards.
NOTE: Please use this Program Announcement until further notice.
PAR-06-449 PAUL CALABRESI AWARD FOR CLINICAL ONCOLOGY (K12)
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NCI Special Notes
This is an NCI-specific program announcement. For all of the policies governing
this award mechanism, refer to the Program Announcement:
PAR-06-449 PAUL CALABRESI AWARD FOR CLINICAL ONCOLOGY (K12).
Under the NIH
Data Sharing Policy, grantees are expected to engage in a timely
release of final data sets that have been generated with NIH support for use by
other researchers, provide a Data Sharing Plan that will achieve this
objective, OR state why data sharing is not possible or appropriate. No Data
Sharing Plan is required for the K12 mechanism because it supports a training,
rather than, a research grant. It supports salaries and other ancillary costs
for individual trainees, but it does not provide support for the generation of
research data, directly. With regard to the data generated by trainees working
in research environments funded by NIH research grants, it is the
responsibility of the institutions that are awarded these research grants to
share the data and provide acceptable Data Sharing Plans to the NIH as part of
the research application.
Summary Information on Program (We have created suggested tabular formats for
your convenience. "Click on"
TABLES (Word for Windows) or TABLES (Adobe for
Acrobat Files), which ever you prefer to download this information.
The National Cancer Institute (NCI) Paul Calabresi Career Development Award for Clinical Oncology (K12) must be in compliance with all NIH/NCI policies pertaining to the use of human subjects. These policies apply to all research involving human subjects, not just clinical trials. The K12 is a training and career development grant in which candidate positions are filled at the discretion of the institution and assignment of candidate positions is generally not known at the time of application or at the time of an award. Due to this uncertainty, the word "Indefinite" should be placed in the box for IRB review date on the face page of the application and the applicant institution must provide in the submitted grant application a Special Statement on Human Subjects Research.
The complete Special Institutional Statement Regarding Human Subjects Research Under K12 Support may be accessed by clicking
K12 Special Institutional Statement Regarding Human Subjects Research.
Inquiries are encouraged, and the opportunity to clarify any issues or questions is welcome. Inquiries should be sent to:
Dr. Dorkina Myrick
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7019
Rockville, MD 20852 (overnight mail)
Bethesda, MD 20892-8346 (regular mail)
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: myrickd@mail.nih.gov
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Funded K12 Grants
| Grant # | PI Name | Project Title | Org Name |
| 5K12CA087718-08 | Albertini, Mark R. | Clinical Academic Oncologist Training Program | UNIVERSITY OF WISCONSIN MADISON |
| 5K12CA088084-08 | BAST, ROBERT C | Paul Calabresi Clinical Oncology Award | UNIVERSITY OF TEXAS MD ANDERSON CAN CTR |
| 5K12CA076930-09 | BERNSTEIN, IRWIN D | Career Development in Pediatric and Medical Oncology | FRED HUTCHINSON CANCER RESEARCH CENTER |
| 2K12CA087723-06 | CHABNER, BRUCE | Clinical Research Career Development Program | MASSACHUSETTS GENERAL HOSPITAL |
| 5K12CA001709-14 | Donehower, Ross C | Clinical Oncology Research Career Development Program | JOHNS HOPKINS UNIVERSITY |
| 5K12CA076905-10 | ECONOMOU, JAMES S. | UCLA Clinical Scientist Training in Cancer Gene Medicine | UNIVERSITY OF CALIFORNIA LOS ANGELES |
| 5K12CA001727-15 | FIGLIN, ROBERT | Oncology Research Career Development Program | CITY OF HOPE/BECKMAN RESEARCH INSTITUTE |
| 5K12CA076917-10 | GERSON, STANTON L | Clinical Oncology Research Career Development Program | CASE WESTERN RESERVE UNIVERSITY |
| 5K12CA076931-10 | Gewirtz, Alan M | CELLULAR/MOLECULAR BIOLOGICS IN CLINICAL CANCER RESEARCH | UNIVERSITY OF PENNSYLVANIA |
| 1K12CA120780-01A1 | Goldberg, Richard M | UNC Oncology Clinical Translational Research Training Program | UNIVERSITY OF NORTH CAROLINA CHAPEL HILL |
| 5K12CA090625-07 | HANDE, KENNETH R | Vanderbilt Clinical Oncology Research Career Development Program | VANDERBILT UNIVERSITY |
| 5K12CA090628-07 | HARTMANN, LYNN C | Paul Calabresi Program in Clinical-Translational Research at Mayo Clinic | MAYO CLINIC COLL OF MEDICINE, ROCHESTER |
| 2K12CA086913-06A2 | KANE, MADELEINE A | Paul Calabresis Award in Clinical Oncology Research | UNIVERSITY OF COLORADO DENVER/HSC AURORA |
| 5K12CA100639-04 | LYERLY, HERBERT KIM | Clinical Oncology Research Career Development Program | DUKE UNIVERSITY |
| 5K12CA090354-07 | MARTUZA, ROBERT L | Training Program in Nervous System Tumors | MASSACHUSETTS GENERAL HOSPITAL |
| 2K12CA090433-06 | Poplack, David G | Pediatric Clinical Oncology Research Training Program | BAYLOR COLLEGE OF MEDICINE |
| 5K12CA120121-02 | SCHWARTZ, GARY K | MSKCC Clinical Oncology Research Career Development Program | SLOAN-KETTERING INSTITUTE FOR CANCER RES |
| 5K12CA087989-05 | Zuckerman, Kenneth S | CLINICAL SCHOLARS IN ONCOLOGY | UNIVERSITY OF SOUTH FLORIDA |
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Submitting an Application
In submitting an application for the K12 Award, the applicant must use the
PHS 398 Form (Revised 9/2004), and should download the instructions and
the Research Career Development Award form files. Refer to Section III of the
instructions, "Preparing an Individual CDA Application", and follow the
modified instructions provided in the
K12 Program Announcement. It is suggested that you print, if possible,
the pages of PHS
398 Form (Revised 9/2004) and carefully review all pages, especially
the section titled "NOTABLE CHANGES MADE TO PHS 398. This section contains
information to facilitate the completion of your application.
The
PHS 398 Form (Revised 9/2004) is also available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, Office of Extramural Research, NIH, Phone (301)
435-0714, Fax (301) 480-0525, E-mail: GrantsInfo@nih.gov.
Because the instructions in the
PHS 398 Form do not fully apply to the special needs of the K12 Award,
follow the modified instructions that are detailed in the
K12 Program Announcement.
For sample tables to use in your application, please contact the
NCI Staff Contacts.
| Receipt Date: Letter of Intent (LOI)
|
Receipt Date: New Application
|
Receipt Date: Competing Continuation, Supplement and Amended Application |
Initial Review |
Council Review |
Earliest Possible Start Date * |
May 12
(an LOI is not required, but is encouraged) |
June 12 |
July 12 |
October/November |
January/February |
April |
If the application receipt date falls on a weekend, the application must be postmarked by the application receipt date and received at the Center for Scientific Review (CSR) by the following Monday.
If the application receipt date falls on a holiday, (but not on a weekend), the application must be postmarked by the application receipt date and received at CSR by the following day.
* Start dates are determined by the availability of NCI funds and may not occur until well after the earliest possible start date.
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Peer Review Process
Upon receipt, competing applications will be reviewed both by the Center for
Scientific Review (CSR) and the National Cancer Institute (NCI) for
completeness and for conformance to all eligibility requirements and special
provisions and requirements. Incomplete applications will be returned to the
applicant without further consideration.
Those applications judged to be complete and eligible will be evaluated,
according to the review criteria listed in the Program Announcement by a peer
review group convened by the Division of Extramural Activities of the NCI. A
second level of review will be conducted by the National Cancer Advisory Board
that will ensure that the application meets the broad program needs and
priorities of the NCI and the National Cancer Program before an award can be
made.
For review criteria for the K12 grant mechanism, see the REVIEW CRITERIA
section of the Program Announcement:
PAR-06-449 PAUL CALABRESI AWARD FOR CLINICAL ONCOLOGY (K12).
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Frequently Asked Questions
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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NCI Staff Contacts
For additional information regarding policies and/or guidance in preparing an
application for the K12 Award, contact: Dr. Dorkina Myrick
Program Director
Phone: (301) 496-8580
Fax: (301) 402-4472
E-mail: myrickd@mail.nih.gov
For information regarding fiscal and/or budget issues, contact: Grants
Administration Branch
Phone: (301) 496-7208
Fax: (301) 496-8601
For information regarding review issues, contact: Referral Officer
Division of Extramural Activities
Phone: (301) 594-1403
Fax: (301) 402-0275
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