NCI Special Notes

Funded K24 Grants

Submitting an Application

Peer Review Process

Frequently Asked Questions

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

NCI Staff Contacts

Introduction

The Midcareer Investigator Award in Patient-Oriented Research (K24) is designed to provide clinicians protected time for patient-oriented research and to act as mentors for beginning clinical investigators. For the purposes of this award patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials, and; 4) the development of new technologies. Studies falling under Exemption 4 for human subjects research are not included in this definition.

Applicants must have a health-professional doctoral degree or its equivalent. Such degrees include but are not limited to the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral degree in nursing. (Individuals with Ph.D. degrees are eligible for this award if the degree is in a clinical field and they usually perform clinical duties. This may include clinical psychologists, clinical geneticists, speech and language pathologists.) Applicants must be citizens of the United States, or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (1-151 or 1-551) or some other verification of legal admission as a permanent resident at the time of the award. Individuals on temporary visas are not eligible for this award.

Applicants should be at the Associate Professor level, or are functioning at that rank in an academic setting or equivalent non-academic setting. They must have independent peer-reviewed support in patient - oriented research at the time of the application for this program, and must have an established record of independent, peer-reviewed patient-oriented research grant funding and record of publications.

Applicants must be able to commit up to 50 percent effort (at least 25 percent) to this award. The remainder of time may be devoted to other clinical, teaching, or research pursuits consistent with the objectives of the award.

The K24 award provides support in the form of salary, ancillary personnel support (e.g., secretarial and administrative assistance), and up to $50,000 for research development, for expenses such as supplies/equipment, technical support for the investigator and his/her mentored clinical investigators, and travel to meetings.

UPDATE: The K24 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-09-037 Midcareer Investigator Award in Patient-Oriented Research (K24) ¹

This replaces PA-08-151 Midcareer Investigator Award in Patient-Oriented Research (K24) ²

NCI Special Notes

Special NCI Eligibility Requirements

1. Under MECHANISM OF SUPPORT, the NIH K24 Program Announcement states " ….since this PA requires that the applicant have a track record of research support, independent or otherwise, current and past research support must be documented in the application as a part of the research support section of the biosketch." The NCI interprets this to mean that all applicants must have independent research support in patient-oriented research as either NIH awards or awards equivalent to NIH peer-reviewed support. This would not include support from industry. Additionally, applicants must be identified as the PI at the time of submission/review of the application for this research support. This interpretation will be used as a basis for accepting applications for peer review and will be used by the peer reviewers in the evaluation of applications.

2. The NIH K24 Program Announcement also states under SPECIAL REQUIREMENTS that " Candidates are expected to continue to hold independent peer-reviewed support during the period of this award. Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the K24 award." The NCI interprets this to mean that candidates must hold independent patient-oriented research support as defined above in Item 1 for the duration of the award. However, it is the policy of the NCI that should recipients of this award lose their independent research support, they will be given up to one-year to regain it before the NCI takes any action to terminate the K24 grant.

The K24-Mid-Career Investigator Award in Patient-Oriented Research is primarily intended for individuals with a health professional degree or equivalent or with a clinical Ph.D. degree who are at the Associate Professor level or function at that rank in an academic setting or equivalent non-academic setting. Candidates must have an established record of independent, peer-reviewed Federal or private research grant funding in patient-oriented research (POR) and be able to demonstrate a need for protected time to devote to POR as well as act as research mentors, primarily for clinical residents, clinical fellows, and/or junior clinical faculty. The award provides one-time renewable support for up to five years of salary for levels of effort between 25% and 50%. The actual salary provided by 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 $50,000 annually for research development costs.

See the NCI Funded Research Portfolio ³ for a current list of K24 awards.

In submitting an application for the K24 Award, the applicant must use the PHS 398 Form (Revised 11/2007) ⁴, 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. 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.

The PHS 398 Form (Revised 11/2007) 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, 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. 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 K24 grant mechanism, see the REVIEW CRITERIA section of the Program Announcement: PA-08-151 MIDCAREER INVESTIGATOR AWARD IN PATIENT-ORIENTED RESEARCH (K24) ².

Policy-Related

1. 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 K24?
   The NCI has a special policy that applies to the independent, patient-oriented research support required for the K24 award. All candidates must have independent research support in patient-oriented research as either NIH awards or awards equivalent to NIH peer-reviewed support. Industry support does not fulfill this requirement. For general eligibility criteria for the K24 grant mechanism, see the Program Announcement: PA-04-107 MIDCAREER INVESTIGATOR AWARD IN PATIENT-ORIENTED RESEARCH (K24) ⁶.

2. Should I apply for a K24 award if I have just completed a 5-year individual mentored career development award and have independent research support?
   If you are just starting in an independent research career, you are not likely to have sufficient experience to mentor junior investigators. Also, your application is not likely to meet the intent of the K24 award and, if this is obvious, it could be returned to you by NCI staff without review. Without a strong track record of independent research and mentoring, it is unlikely that your application would receive an enthusiastic peer review and be competitive for funding.

3. I am a 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 considered as a single project R01 grant or as a multi-project Program Project Grant or 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 on a U01, which is similar to a P01 subproject and 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 have an established record of independently funded research, but do not have a track record in mentoring. Should I apply for a K24 award at this time?
   No. Eligibility criteria for this award state "Candidates must have a track record of mentoring junior investigators." The best course to take is to develop a mentoring track record and then apply.

5. As part of the mentoring component of the K24, am I allowed to mentor individuals at another institution?
   This could be done, but the arrangements would have to be very carefully worked out to ensure that the trainee can function off-site and benefit from your funded research environment.

Application Process/Review Related

6. Since human subjects are to be involved in my K24 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 approval.

   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 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.

   Without the proper information on Gender and Minority Inclusion, 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.

7. I am planning to submit a K24 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?
   You should wait until you move to the new institution before submitting an application. Moving the application from one institution to another would require a statement from the new institution guaranteeing your protected time. If reviewers know you are going to move, this would complicate their evaluation of the application.

8. How strong must the statement of institutional commitment be with regard to the percent effort that will be protected during K24 support?
   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.

9. Where do I send my K24 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.

10. 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.

11. If I receive additional independent support prior to the review of my K24 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 you 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

12. What happens if I am not able to maintain independent research support during the tenure of the award?
    The NCI K24 requires that you have independent, patient-oriented research at the time of the award that meets its special policy requirements (see the K24 Program Announcement ⁶). If you lose this support, you will have one year to regain it. Otherwise, your K24 grant will be terminated. Without stable support you can neither expand nor refine your own research or provide a suitable funded environment for training new clinical scientists in patient-oriented research.

13. Can a K24 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 for 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.

14. If I have a K24 award and I 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 K24 Award, contact:

Dr. Susan Lim
Program Director
Phone: (301) 496-8580
Fax: (301) 480-1744
E-mail: lims@mail.nih.gov ⁸

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