Helpful Hints for
NHLBI Mentored Patient-Oriented Research Career
Development Award (K23)

Revised: February 2007

These Helpful Hints were written to help K23 candidates who are planning to submit applications to the National Heart, Lung, and Blood Institute (NHLBI). This document clarifies some of the K23 program guidelines; it does not replace those guidelines. Candidates MUST follow the instructions in the National Institutes of Health (NIH) K23 program guidelines found at http://grants.nih.gov/grants/guide/pa-files/PA-05-143.html, and PHS Form 398 (http://grants1.nih.gov/grants/funding/phs398/phs398.html), Section III. As a reference in developing a K23 application, the NHLBI has identified two model K23 applications, which are located at the following URL: http://www.nhlbi.nih.gov/funding/training/redbook/k23models.htm.

Requirement for "Patient-Oriented" Research - The K23 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 K23 award as long as the candidate interacts directly with study participants.

If the project does not include direct interaction with study participants, consider applying instead for the NIH Mentored Clinical Scientist Development Award (K08), see http://grants.nih.gov/grants/guide/pa-files/PA-06-512.html.

Candidate - Candidates must have a clinical doctoral degree or its equivalent and have completed clinical training, including specialty and, if applicable, subspecialty training, prior to receiving an award. Candidates must be U.S. citizens or must have obtained permanent residency in order to receive an award.

The NHLBI accepts applications from individuals holding a Ph.D. in non-clinical disciplines who are performing patient-oriented research.

Candidate's publications are an important component of the application, although there is no required minimum number of publications. Although previous research experience may be limited, an applicant with no publications may be judged as a weak candidate. Likewise, a candidate may be seen as too senior if the candidate is well published in the area proposed for the K23 application. Such candidates should identify clearly the new directions and techniques they will learn and consider requesting less than 5 years of support or consider applying instead for independent research support (R01). The career development plan for more senior candidates should justify the need for additional training and coursework or for an intensive research experience under the guidance of an established scientist.

Career Development Plan - This section is an important part of a career award application and weighs significantly in the assignment of a priority score. Candidates should describe how the proposed research project, coursework and other training experiences will provide the best possible avenue for attainment of independence as a patient-oriented researcher.

Candidates should specify the courses they will take, explain how they relate to career goals, and indicate whether they will be taken for credit or audited (for credit is preferred). They must demonstrate that they have received or will participate in training in data management, epidemiology, study design, hypothesis development, drug development, etc., as well as legal and ethical issues associated with research on human subjects. A description of proposed seminars, journal clubs, and scientific conferences to be attended as well as opportunities for interactions with other scientists should also be included. The career development plan should be "customized" for the candidate, based on clearly stated career goals and past experience. The number of years requested should be appropriate for the amount of research and training proposed. A timetable (graphic or text) which includes the coursework and the research project is helpful, as are benchmarks and a schedule for evaluating progress.

Mentor - Candidates must identify a primary mentor who is an accomplished investigator in the proposed research area and has experience in developing independent investigators specifically in patient-oriented research. The mentor must provide a statement of support, a development plan for the candidate, and a schedule of planned interactions with the candidate. It is also important that the mentor provide guidance during preparation of the application.

A list or description of the mentor's prior trainees including trainees' names, dates of mentored training, type of research, and current positions should be provided. This information can be placed in the bibliographic sketch or in the mentor's letter of support. The reviewers will want to see a successful track record of mentoring other trainees at the same level as the candidate. If the mentor does not have a track record, then consideration should be given to including a co-mentor with such experience.

Other Support pages for the mentor(s) must be included. Mentor(s) are not required to have NIH funding, but this tends to weigh favorably in the review. A bibliographic sketch of the mentor(s) must be included. Co-mentors with complementary expertise are encouraged, but one person should be identified as having primary responsibility for the candidate's mentoring. Applications should also include information on the co-mentor's prior trainees, as well as bibliographic sketches and Other Support. If mentors are not located in the same department or institution as the candidate, specific details should be provided on the expected frequency and type of their interactions.

Environment and Institutional Commitment - Letters from the mentor and institution should describe the facilities and other resources that are available to the candidate. Letters of commitment from the mentor and institution should provide statements assuring that the candidate will be able to devote a minimum of 75% effort to research. Candidates should be aware that reviewers often look for a current or committed (not contingent on receipt of award) faculty appointment as evidence of institutional commitment. These letters are carefully reviewed by the peer reviewers and carry substantial weight in the evaluation of an application.

Advisory Committee - The NHLBI suggests (but does not require) K23 candidates to include an Advisory Committee composed of the candidate's mentor(s) and two or three other senior faculty members. Each advisor should provide a biographical sketch, a letter of participation, and description of the method and frequency of interactions. It is not required that all advisors be at the candidate's institution, but for those at another institution, the method and frequency of planned interactions should be described.

Format for Letters - Letters submitted with an application should be addressed to the "NHLBI K23 Review Committee" and be written on institutional letterhead stationery. Revised applications must include new letters. See the PHS 398 instructions for more details on requirements for reference letters.

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

The NHLBI requires that K23 recipients devote a minimum of 75% effort to research and research-related activities. The salary that may be requested and awarded for a career development award can be 100% of the recipient's institutional salary, exclusive of fringe benefits, up to the $75,000 maximum allowed by the program. Fringe benefits are requested separate from the salary and are based on the salary requested.

Below are several examples of calculations that illustrate the salary policy described above:

* the examples use a fringe benefit rate of 26% for illustrative purposes only; candidates need to check with their university to determine the correct rate to use in their application.

Generally, the NHLBI will provide up to $30,000 per year for Research and Development Support. In exceptional cases, candidates may request up to $50,000 per year, when the need for such higher costs is well documented and strongly justified. The Budget Justification page should be used for this purpose. For expensive studies, the application must describe how the costs in excess of the K23 provisions will be covered.

Other Salary Support - NIH policy permits supplementation of salary from non-Federal funds. Supplementation from other Federal funds is not permitted unless explicitly authorized by both the program from which the funds are derived and by the NHLBI.

Career award applicants receiving salary support from a preexisting NIH grant must relinquish that salary support prior to receiving their career award. Funds that become available in the preexisting NIH grant as a result of the individual's career award salary support may not be used for any other purpose without prior NIH approval.

In the latter years of a career award, awardees are encouraged to apply for independent research funding (such as R01 grants) including salary support. Award recipients in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a Principal Investigator or subproject Director of the research grant. Details on this concurrent support policy are located at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Research Plan - Reviewers expect the proposed research to be clearly described and feasible and the investigators involved to have the necessary expertise. Candidates should provide rationale for the study, state the hypothesis, clearly define the specific aims and explain the short- and long-term objectives. Methods, sample size justifications, and plans for data analysis should also be provided. Candidates are strongly encouraged to submit preliminary data to demonstrate the feasibility of the research plan, address potential pitfalls in the research proposal and present alternative approaches. 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 documents cited in the URLs below provide further advice and information on writing the research plan, including the requirements relating to ethics, human subjects, and inclusion of children.

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.

Research Ethics - There are two requirements for ethics training: responsible conduct of research; and education in the protection of human subjects. The latter is addressed in the section that follows on Human Subjects.

Training in the Responsible Conduct of Research (RCR): Candidates must describe plans to receive instruction in the responsible conduct of research. Plans for RCR training must be described in a single paragraph that addresses the proposed subject matter, format, frequency and duration of instruction and include an explicit statement that a candidate has taken the course, or will take it at a specified date. No award will be made if an application lacks this component. See the NIH bioethics website for resources and information on this topic at http://www.nih.gov/sigs/bioethics/researchethics.html. Candidates are encouraged to consider instruction in the following areas: data acquisition, management, sharing, and ownership; mentor/trainee relationships; publication practices and responsible authorship; peer review; collaborative science; human subjects; research involving animals; research misconduct; and conflict of interest and commitment.

Human Subjects - Prior to preparing an application, candidates should read the definition and clarification of Human Subjects in PHS 398, Part II.

Required Education in the Protection of Human Research Participants: As of October 1, 2000, the NIH requires that all investigators submitting NIH grant applications for research involving human subjects complete education on the protection of human research participants. The website (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html), contains links to the NIH web-based tutorial and frequently-asked-questions.

K23 applicants 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. Candidates 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.

Women and Minority Inclusion in Clinical Research Policy - All K23 applications must include a table that shows the expected number of human subjects, their gender, and their racial/ethic group (http://grants.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://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html (women and minorities) and http://grants.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 US 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 Sections 101(b) and 401(b) of 45 CFR 46 - 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://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Data and Safety Monitoring Plan - If the research project will include a clinical trial (i.e., biomedical or behavioral intervention studies), the application must contain a section entitled "Data and Safety Monitoring Plan". See the PHS 398 for details.

Miscellaneous - Be sure to use the "Additional Instructions for Preparing Individual Research Career Award (RCA) Applications - "K Series" in the PHS 398 when preparing the application. These instructions include helpful information and advice on preparing a career award application and explain the additional requirements for such applications.

Mentors and advisors should carefully review the entire application. Candidates should allow sufficient time in the preparation process for advisors to give adequate input and review revisions. 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 Administrator (SRA) about submitting this additional material prior to the review. The NHLBI SRA for K23 applications is Mark Roltsch, Ph.D. Contact Dr. Roltsch at the Review Branch, Division of Extramural Research Activities, NHLBI, telephone (301) 435-0287, or email at roltschm@nhlbi.nih.gov. If the application will include 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 applicant 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
Note: NIH is in the process of converting to SF424 (Research and Related [R&R]) forms and electronic submission through Grants.gov. Information on this plan (SF424) and on registering for electronic submission is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html. Updates regarding the transition process are at http://era.nih.gov/ElectronicReceipt/.

Application Receipt Dates: February 12, June 12, and October 12 - new applications;
March 12, July 12, and November 12 - resubmission applications. Letters of intent (LOI) are requested from applicants who are planning to submit resubmission applications. The LOIs should be submitted one month in advance of the resubmission receipt due date to:

Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Two Rockledge Centre
Room 7214, MSC 7924
Bethesda , MD 20892-7924
Bethesda, MD 20817(for express mail)
Telephone: (301) 435-0270 FAX: (301) 480-0730
Email: Chief, Review Branch  

Additional information on application receipt dates is located in the notice, "Change in Standing Receipt Dates for NIH/AHRQ/NIOSH Beginning in January 2007," http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-001.html. The new receipt dates are effective as of January 2007 and will apply to both paper and electronic applications.

NHLBI Staff Contact - For further information regarding NHLBI K23 applications, please contact the following individual:

Ms. Ann Rothgeb
National Heart, Lung, and Blood Institute
National Institutes of Health
Two Rockledge Center, Room 10158
6701 Rockledge Drive, MSC 7952
Bethesda, MD 20892-7952
Telephone: (301) 435-0202
FAX: (301) 480-3557
E-mail:Rothgeba@mail.nih.gov