Funded K05 Grants

Submitting an Application

Peer Review Process

Frequently Asked Questions

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

NCI Staff Contacts

Introduction

The purpose of the NCI Established Investigator Award in Cancer Prevention, Control, Behavioral and Population Sciences Research (K05) is to provide established investigators protected time to devote to research and to act as mentors for young investigators. The target candidates are outstanding, established scientists who have demonstrated a sustained, high level of productivity, research accomplishments, and contributions to cancer prevention, control and population sciences research, and who can demonstrate the need to sustain an intensive research focus that will enhance the progress of their own research and provide them greater opportunity to serve as mentors to new scientists. The award provides salary support and other costs for up to five years and can be renewed for an additional 5-year period.

Candidates must be established cancer scientists with a strong track record of publications and successful competition for cancer research support. They must have peer-reviewed, independent research support at the time of and during the entire duration of the award, must have a record of supervising junior researchers, and must commit up to 50 percent (minimum of 25 percent) to research specifically relevant to this award.

At the time of the award, candidates must be citizens or noncitizen 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 (1-151 or 1-551), or other legal verification of such status. Individuals on temporary or student visas are not eligible for this award.

The K05 award supports salary (up to the current Federal salary rate limit plus commensurate fringe benefits for up to 50 percent effort), research development support (up to $25,000 per year) for tuition, fees and books, research expenses, statistical services and travel to research meetings, and ancillary personnel costs (mentors, secretaries, and administrative assistants), and facilities and administrative costs (reimbursed at 8 percent).

UPDATE: The K05 salary is now capped for competing awards issued after January 1, 2009 at $100,000 per year for a 50% effort (6 person-months) commitment. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-CA-09-022.html for further salary details.

Program Announcement

New Electronic PA required for February 12, 2009 Grant Submission: PA-09-088 ESTABLISHED INVESTIGATOR AWARD IN CANCER PREVENTION & CONTROL (K05) ¹

This replaces PAR-05-145 ESTABLISHED INVESTIGATOR AWARD IN CANCER PREVENTION, CONTROL, BEHAVIORAL, AND POPULATION SCIENCES (K05) ²

The K05-NCI Cancer Prevention, Control, and Population Sciences Established Investigator Award is for investigators with a Ph.D., M.D., or other research or professional degree who have an established record of independent, peer-reviewed Federal or private research support in cancer prevention, control, or behavioral or population sciences. In addition, candidates must demonstrate a need for KO5 support in order to provide them with protected time for research and for mentoring junior investigators. The award provides support for up to five years of salary for the recipient for levels of effort between 23% and 50%. The award may be renewed one time. The actual salary provided under the award is based on the candidate's full-time, 12-month institutional salary and the level of effort requested, up to the maximum legislated salary rate in effect at the time of award. The award also provides up to $25,000 annually for research development support.

See the NCI Funded Research Portfolio ³ for a current list of K05 awards.

Applications are to be submitted using the PHS 398 Form (Revised 11/2007) ⁴, following the instructions in Section III, "Preparing an Individual CDA Application". It is suggested that you print, if possible, the pages of PHS 398 Form (Revised 11/2007) ⁴ 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.

Important Note:

Because the instructions in the PHS 398 Form (Revised 11/2007) ⁴ are for 'mentored' awards, and do not entirely apply to the K05 award, please also refer to the APPLICATION PROCEDURES section of the Program Announcement: PAR-05-145 ESTABLISHED INVESTIGATOR AWARD IN CANCER PREVENTION, CONTROL, BEHAVIORAL, AND POPULATION SCIENCES (K05) ².

The PHS 398 Form (Revised 9/2004) ⁴ 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.

Application Receipt Dates and Review Schedule

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.

Upon receipt, applications will be reviewed by the Center for Scientific Review (CSR) and the National Cancer Institute (NCI) for completeness and conformance to all eligibility 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 Subcommittee G ⁵ convened by the Division of Extramural Activities of the NCI. Applications will receive a second level review by the National Cancer Advisory Board (NCAB) to determine if the application meets the broad program needs and priorities of the NCI and the National Cancer Program.

For review criteria for the K05 grant mechanism, see the Review Criteria ⁶ section of the Program Announcement.

Policy-Related

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 ⁷).

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.

Application Process/Review Related

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 11/2007) ⁴ 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 11/2007) ⁴ 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 11/2007) ⁴ application and follow the instructions in the Vertebrate Animals section of the instructions for preparing a PHS 398 Form (Revised 11/2007) ⁴ 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 11/2007) ⁴ 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.

Policy/Post Award

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.

For additional information regarding policies and/or guidance in preparing an application for the K05 Award, contact:

Dr. Shannon M. Lemrow
Program Director
Telephone: (301) 496-8580
Fax: (301) 480-1744
E-mail: lemrows@mail.nih.gov

For information regarding fiscal and/or budget issues, contact:

Grants Administration Branch
Phone: (301) 496-3179
Fax: (301) 496-8601

For information regarding review issues, contact:

Referral Officer
Division of Extramural Activities
Phone: (301) 594-1403
Fax: (301) 402-0275