Helpful Hints for Competitive Renewal of the
NHLBI Midcareer Investigator
Award in Patient-Oriented Research (K24)

Revised: May 2008

These Helpful Hints were written to help current or past NHLBI K24 grantees who are planning to submit applications for competitive renewal to the National Heart, Lung, and Blood Institute (NHLBI). This document clarifies some of the NIH K24 program guidelines; it does not replace those guidelines. Candidates for a competitive renewal MUST follow the instructions in the National Institutes of Health (NIH) K24 Program Announcement found at http://grants1.nih.gov/grants/guide/pa-files/PA-08-151.html and in the PHS Form 398 (http://grants1.nih.gov/grants/funding/phs398/phs398.html), Part I, Section 7.

Requirement for "Patient-Oriented" Research - The K24 candidate must interact directly with the study participants, preferably in ongoing clinical activities. Candidates who propose to only analyze extant databases or biological specimens, see study participants briefly (e.g., for a blood draw), or design a patient questionnaire that will be administered by other medical support staff, are not conducting research that is eligible for this award. Epidemiologic, nutrition, behavioral and social science research are included in the spectrum of patient-oriented research supported by the K24 award as long as the candidate interacts directly with study participants. K24 candidates whose research is expanding to include translational or “back translational” (e.g., from bedside or clinic back to the lab) may propose these new areas as long as at least one aim of the competitive renewal application meets the criterion for patient-oriented research.

Budget - Career awards use the JUST IN TIME process, but do not use modular budgets.

The NHLBI requires that candidates devote between 25 and 50 % effort to the research and mentoring being supported by the K24 award. The remaining percent effort may be devoted to research and research-related activities such as teaching, patient care, or other administrative activities. The salary that may be requested and awarded is 25% to 50% of the recipient's institutional salary, exclusive of fringe benefits, up to the maximum allowable annual salary rate in effect at the time of award. For awards in 2008, the maximum allowable annual salary at 50 percent effort is $95,650. Fringe benefits are separate from the salary and are based on the salary requested. Facilities and Administrative Costs are 8% of the direct costs.

The NIH K24 Program Announcement contains additional information about salary supplementation.

Biographical Sketches - The following information on all current and pending patient-oriented research support must be listed in the "Biographical Sketch:" sources of funding; start and end dates; total amount of award; and role on grant. Candidates for a competitive renewal must have adequate funding for patient-oriented research in order to fulfill the research aims and to support junior faculty research activities.

Candidate - Candidates for competitive renewals must continue to meet the NIH eligibility requirements. Candidates applying for competitive renewal of their K24 must:

• Show a record of peer-reviewed Federal or private research grant funding as Principal Investigator (PI) or as a co-investigator/project leader with a significant role in a project on multi-project/collaborative grants during the initial K24 period of support (i.e., Type 1);
• Have independent peer-reviewed funding at the time of application;
• Have a record of publications in patient-oriented research, including publications with individuals they mentor during the initial K24 period of support;
• Demonstrate the continued need for intensive research to enhance their clinical research career, and for protected time to devote to mentoring activities; and
• Demonstrate successful mentorship of junior clinical researchers during the initial K24 period of support.

Information about the candidate's history of grant support, patient-oriented research, publications, and mentoring record should be included in the "Candidate's Background."

The candidate's immediate and long-term career objectives should be stated clearly and should serve as the basis for the proposed research and mentoring plan. The candidate should state how career objectives evolved during the initial K24 period of support, how that support helped the candidate achieve objectives listed in the initial K24 application, and how additional years of support are necessary to achieve the candidate’s current objectives.

Candidates without current or recent peer-reviewed funding are not eligible for a competitive renewal. Candidates with funding from industry alone are also not eligible.

Career Development Plan and the Mentoring Plan - This is an important section of the application and weighs heavily in assignment of the priority score. Candidates for a competitive renewal must submit a progress report on their career development accomplishments and their mentorship of junior faculty during the initial K24 period of support. This section should include: a list of the career development objectives from the initial K24 application and a description of the progress made toward each objective; and a list of the trainees showing their names, dates of mentored training, areas of research, and current positions. This information should be sufficiently detailed for reviewers to determine if the candidate successfully met career objectives and mentored junior faculty during the initial K24 period of support.

In addition, the career development plan should describe in detail how the candidate will identify, recruit, select, mentor, and train junior faculty in research; financially support their research; and evaluate their progress. The plan for a competitive renewal should be sufficiently detailed for reviewers to determine if the candidate will succeed at mentoring junior faculty and fellows during the next period of support.

Candidates must state how much funding will be available to support (from all sources listed in the Biosketch) the junior faculty's research endeavors.

Letters of Reference - Letters of reference and the Research Career Award Reference Report are not required for the K24.

Environment and Institutional Commitment - Letters from the institution should describe the facilities and other resources that are available to the candidate and the availability of junior investigators who can train with the candidate. Institutional letters of commitment should state the percent effort the candidate will have to conduct patient-oriented research and to mentor junior faculty; the duties from which the candidate will be released; and the institution's commitment to the candidate as an important investigator in its patient-oriented research program. Descriptions of the institutional environment should be sufficiently detailed so that reviewers can determine if it is conducive to performing high quality, patient-oriented research. The review group reads these letters and descriptions very carefully and uses them as an important criterion in assigning a priority score.

Letters should be addressed to the "NHLBI K24 Review Committee" and written on institutional letterhead stationery. Revised applications must include new letters.

Research Plan - The proposed research must be in scientific areas consistent with the mission of the NHLBI and relevant to the candidate's career objectives. Candidates should submit a progress report describing research conducted during the initial K24 period of support. PHS 398, Part I, Section 8.9.6. provides instructions for submitting a progress report in a competitive renewal application.

The Research Plan section should also include a description of the candidate’s ongoing patient-oriented research that will be pursued during the second K24 period of support. The research plan should include the background and significance, specific aims, study design(s) and methods and the potential effectiveness of the research plan in training new investigators. Innovative approaches and research likely to advance knowledge in a field are encouraged. New research, that has not been previously peer-reviewed or funded, is not required for competitive renewals.

If the candidate is conducting research that is funded by industry, this cannot comprise more than 50 percent of the research proposed in the K24 competitive renewal.

The candidate should avoid use of the passive voice in the research plan. It might give reviewers the impression that the candidate will not be interacting directly with study participants. The candidate should state explicitly what he/she will do, especially in those activities involving study participants.

Preliminary data should be provided to demonstrate feasibility. Plans for patient recruitment, sample size calculations, data analysis methods, availability of adequate resources, and timelines should be described in sufficient detail for reviewers to determine if the proposed research is feasible, realistic, and methodologically sound.The application should describe the informed consent process and form(s), and include copies of consent forms when possible.

Reviewers will also evaluate whether the research meets bioethical standards, gender and minority requirements, and NIH criteria for inclusion of children. Inadequate plans for inclusion and protection of human subjects will be considered a research design flaw by the review committee. The NIH K24 Program Announcement and the section on Human Subjects, below, cite URLs that link to documents with detailed information about the requirements for human subjects, including children, minorities and women.

Human Subjects - PHS 398 Part III, Section 3 - Contains the definition of Human Subjects as research participants, assurances and certification.

Required Education in the Protection of Human Research Participants - Before a K24 can be awarded, the PI must verify that each individual identified as a "key person" in the proposed research has or will satisfy this requirement. Key personnel include all individuals responsible for the design and conduct of the study. Prior to award, the PI must submit a letter that lists the names of key personnel, the title of the educational program completed by each named person, and a one sentence description of the program. This letter must be signed by an authorized institutional business official. The NIH will request this letter before an award is issued. The website (http://grants.nih.gov/grants/policy/hs_educ_faq.htm), contains links to the NIH frequently asked questions and additional information.

Women and Minority Inclusion in Clinical Research Policy - All K24 applications must include a table that shows the expected number of human subjects, their gender, and their racial/ethnic group (http://grants1.nih.gov/grants/funding/phs398/enrollment.pdf). The NIH requirements for inclusion of women and minorities in study populations are detailed in the following documents: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html (women and minorities), and http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html (reporting race and ethnicity data). The NHLBI expects the proportion of women and racial/ethnic minorities in study populations to reflect the proportion of women and racial/ethnic minorities in the U.S. population, unless a compelling justification to the contrary is provided.

Inclusion of Children Policy - NIH policy defines children as "individuals under the age of 21". Children must be included in all human subjects research conducted or supported by the NIH unless there are scientific or ethical reasons to justify their exclusion. This policy applies to all NIH conducted or supported research involving humans subjects, including research that is otherwise "exempt" in accordance with DHHS Regulations (45 CFR Part 46, Subpart D, Sections 401-409) - Federal Policy for the Protection of Human Subjects. In the research plan, the investigator should create a section titled "Participation of Children". The full instructions, including the list of allowable justifications for exclusion of children, are found at http://grants1.nih.gov/grants/guide/notice-files/not98-024.html.

Data and Safety Monitoring Plan - Applications that involve participation of human subjects in clinical research must include a plan for data safety and monitoring. For interventional studies, there are requirements for a Data Safety and Monitoring Board (DSMB) and for noninterventional, observational studies, there are requirements for an Observational Safety and Monitoring Board (OSMB) .

Miscellaneous - Applications should be reviewed by an editor or proofreader and trusted colleague. Poorly written applications can negatively affect the priority score.

Candidates should reread the program announcement and check that sufficient information is provided in the application for reviewers to evaluate all review criteria.

If, after submitting the application, candidates have additional preliminary data, relevant publications, or grant support, they should contact the NHLBI Scientific Review Official (SRO) about submitting this additional material prior to the review. The NHLBI SRO for K24 applications is Mark Roltsch, Ph.D. Contact Dr. Roltsch at the Review Branch, Division of Extramural Research Activities, NHLBI, telephone (301) 435-0287, or via email at roltschm@nhlbi.nih.gov. If the application includes color or detailed photographs, the candidate should contact Dr. Roltsch to arrange for these photographs to be available to reviewers.

Font Size - The Center for Scientific Review has standards for font size and spacing. Applications that do not adhere to the rules are being returned to the candidate unreviewed. The PHS 398 preparation instructions contain further information on the standards.

Link to NIH Application Forms, including the PHS 398 - http://grants.nih.gov/grants/forms.htm

Application Receipt Dates: February 12, June 12, and October 12 (New Applications)
March 12, July 12, and November 12 - renewal and resubmission applications. Letters of intent (LOI) are requested from applicants who are planning to submit resubmission applications. These LOIs should be submitted one month in advance of the resubmission receipt due date and emailed to the Chief, Review Branch, Division of Extramural Research Activities, NHLBI.

NHLBI Office of Grants Management Contact – For questions about financial or grants management matters, please contact the NHLBI Grants Management Official:

Howard W. Moore
Grants Management Specialist
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7165, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-5081
FAX: (301) 451-5462
Email: mooreh@nhlbi.nih.gov

NHLBI Program Staff Contact - For further information regarding NHLBI K24 applications, please contact the NHLBI Program Official:

Sandra Colombini Hatch, M.D.
Program Director
Division of Lung Diseases (responding for all NHLBI programmatic Divisions)
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Dr., MSC 7952
Bethesda, MD 20892-7952 (for overnight delivery, use zip code 20817)
Telephone: (301) 435-0222
FAX: (301) 480-3557
Email: hatchs@nhlbi.nih.gov