Helpful Hints for
NHLBI Mentored Clinical Scientist
Development Award (K08)

Revised: February 2007

The following information is presented to applicants as advice and helpful hints for preparing K08 applications for submission to the National Heart, Lung, and Blood Institute (NHLBI). However, applicants MUST carefully follow the NIH K08 program guidelines at http://grants.nih.gov/grants/guide/pa-files/PA-06-512.html.

Candidate - Candidates must meet both the NIH and NHLBI eligibility criteria. Some candidates may have completed as little as 2 postgraduate years of clinical training with little research experience, whereas other candidates may have completed subspecialty training that included 2 years of postgraduate research training. A candidate's publications are an important component of an application, although a set number of publications is not specified. Though a range of previous research experience is accepted, a candidate with no publications would be seen as a poor candidate. Occasionally, candidates are seen as too senior in terms of research experience because of the number of publications they have authored in the area proposed for the K08 application. Candidates who may be perceived as too senior should clearly identify the new directions and techniques they will learn and consider requesting support of less than 5 years. Candidates with significant research experience in the proposed field of study should consider applying for independent research support (R01, etc.). The career development plan for senior candidates should justify the need for additional training and coursework or for an intensive research experience under the guidance of an established scientist. K08 candidates may not hold any other Federal or non-Federal equivalent salary award, such as the American Heart Association Scientist Development Grant.

Career Development Plan - This section is a major part of a career award application and weighs heavily 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 training experience for a candidate's progression toward an independent research career. Courses, though not required, are usually expected for candidates with limited research experience and should be completed in the earlier stages of the career development plan. Candidates should specify the courses to be taken, explain how they relate to career goals, and indicate whether they will be taken for credit or audit (for credit is preferred). A description of proposed seminars, journal clubs, and scientific conferences to be attended as well as interactions with other scientists should also be included. The career development plan should be "customized" for the candidate, rather than a generic plan that would be used for other comparable trainees. A timetable (graphic or text) that includes the coursework and the research project is helpful, as is a plan for evaluating progress. The number of years requested should be appropriate for the amount of research and training proposed.

Mentor - Candidates must identify a primary mentor who is an accomplished investigator in the proposed research area and has experience in developing independent investigators. The mentor must provide a statement of support, provide a plan for the development of the candidate, and provide guidance during preparation of the research project. A list or description of the mentor's prior trainees (from not more than the last 10 years) should be provided. The list or description should include their names, the dates of mentored training, the title of the research project, and the current positions. This information can be included in the bibliographic sketch or in the mentor's letter of support. It is not required that mentor(s) have NIH funding but this tends to weigh favorably in the review. A two-page bibliographic sketch of the mentor must be included, along with information describing their other support. Co-mentors are encouraged, but one person should be identified as having primary responsibility for a candidate's mentoring. Applications should also include information on the co-mentors' prior trainees, as well as bibliographic sketches and other support.

Environment and Institutional Commitment - The letters from the mentor and institution should provide specific details about the facilities and other resources that will be provided to the candidate. In addition, letters of commitment from the mentor and institution should provide statements concerning the protected time the candidate will receive (minimum of 75% required), and if applicable, the duties from which they will be relieved. Descriptions of the institution should be sufficiently detailed so that reviewers can determine if the environment is conducive to performing high quality research. These letters are carefully reviewed by the peer reviewers and carry substantial weight in the evaluation of an application.

Advisory Committee - The NHLBI strongly encourages K08 candidates to include an Advisory Committee composed of the candidate's mentor(s) and two or three other senior faculty members. If the candidate does not propose an Advisory Committee, she/he should document which individuals are available to cover all areas of expertise that are required for the research plan and career development. This Advisory Committee should meet with the candidate to develop the career development plan and research project prior to submission, review the plan after award, evaluate the awardee's progress, and provide guidance for scientific career development. Each Committee member should provide a biographical sketch, a letter of commitment to participate actively in advising the candidate, and a description of the method and frequency of interactions in the application. It is not required that all Committee members be at the candidate's institution, but if a member is at another institution, the method and frequency of planned interactions should be described. Peer reviewers usually find the lack of an Advisory Committee to be a weakness that negatively affects the priority score.

Research Plan - The reviewers will look for innovative approaches in the research, for proposals that are feasible and realistic, for the necessary expertise of the persons involved, and for clarity in the application. Candidates should clearly define the specific aims and explain the rationale and long- and short-term objectives. Candidates are strongly encouraged to submit preliminary data to demonstrate the feasibility of the project. Candidates should address potential pitfalls in the research proposal and present alternative approaches, including methods, sample size justifications, and plans for data analysis.

Format for Letters - Letters submitted with an application must be addressed to the "NHLBI K08 Review Committee" and be written on institutional letterhead stationery. Applications with fewer than three reference letters will be returned without review. These letters should be from individuals in addition to/other than those directly involved in the application (i.e., not from sponsors, cosponsors, and collaborators). Neither sponsor/mentor and sponsors of this application, nor collaborators, can be counted as a reference. Revised applications must include new letters of reference, since letters submitted with previous applications are not retained by NIH. See the PHS 398 instructions for more details on requirements for letters of reference.

Budget - The NHLBI K08 requires that recipients devote a minimum of 75% effort to the research plan supported by the career development award. The remaining 25% effort may be devoted to research and research-related activities such as teaching, patient care, or other research-related clinical 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 separately from the salary and are based on the salary requested. A maximum of $25,000 is allowed for Research and Development Support. If it is clear that the $25,000 will be insufficient to support the project, the candidate should explain what other financial resources will be available to cover the expenses.

Research Ethics: Research ethics training for NIH career award candidates consists of: training in the 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 includes an explicit statement that a candidate has taken the course, or will take it at a specific date. No award will be made if an application lacks this component. See the NIH website bioethics 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 all investigators submitting NIH grant applications for research involving human subjects to complete education in the protection of human research participants. An NIH Web page contains links to the NIH web-based tutorial and frequently asked questions at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Before the NIH can issue awards for research involving human subjects, candidates must provide a letter that includes the names of the key personnel who are responsible for the design and conduct of the study, the title of the education program completed by each named person, and a one sentence description of the program. The letter must be signed by an authorized institutional official.

If this requirement has been fulfilled for ongoing independent support, it need not be duplicated. However, if human subject use will be added, either by expansion of a current project or initiation of a new project, then this requirement must be satisfied and documented.

Women and Minority Inclusion in Clinical Research Policy - Candidates must list the expected number of human subjects, their gender, and the number of minority group members expected to be involved in the proposed research. The NIH requirements for the inclusion of women and minorities in study populations are detailed at: http://www.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html.
The NIH requirements for reporting race and ethnicity data are detailed at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.

In addition, the NHLBI expects participation of women and racial/ethnic minorities in study populations to reflect their representation in the U.S. population unless a compelling justification to the contrary is provided. Applications proposing research studies with human subjects that differ materially from this standard will not be funded. The PHS 398 application form (in PDF) contains a table for listing the targeted/planned enrollment of the study population (http://grants.nih.gov/grants/funding/phs398/enrollment.pdf). All K08 applications involving human subjects must include a completed table.

Inclusion of Children Policy - This 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 not to include them. This policy applies to all NIH conducted or supported research involving human 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. If children will be excluded from the research, the application must present an acceptable justification for the exclusion. 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 - 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 - Applications should be reviewed by an editor or proofreader and a trusted colleague. Poorly written applications are generally viewed as evidence of lack of attention to details and often receive a poor priority score.

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

NHLBI suggests that K08 applications include biographical sketches of the collaborators and consultants.

If, after submitting an application, candidates obtain additional preliminary data or publications relevant to the project, or they obtain additional grant support, they should contact the NHLBI Scientific Review Administrator (SRA) about submitting this additional material prior to the review. The NHLBI SRA for K08 applications is Rina Das, Ph.D. Dr. Das may be reached at the Review Branch, Division of Extramural Research Activities, NHLBI, by telephone at (301) 435-0297, or by email at dasr2@nhlbi.nih.gov. Candidates intending to include color or detailed photographs in their applications should contact Dr. Das, the Scientific Review Administrator, to arrange for them to be available to reviewers.

NHLBI requires documentation of the candidate's professional clinical licensure in the United States. This document may be placed after the candidate's biosketch.

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 candidates unreviewed. The PHS 398 preparation instructions contain detailed information on the standards.

Links 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/.

Link to the NHLBI Model K08 Application: http://www.nhlbi.nih.gov/funding/training/redbook/k08model.htm

Link to Documents Providing Advice on the Preparation of a Grant Application: http://grants.nih.gov/grants/grant_tips.htm

Application Procedures - Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service, non-USPS service)

Note that new and revised applications must include at least three sealed letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

Personal deliveries of applications are no longer permitted
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all five collated sets of the appendix material must be sent to:

Chief, Review Branch
Division of Extramural Research Activities, NHLBI
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924

Bethesda, MD 20817 (for express mail)

Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhblichiefreviewbranch@nhlbi.nih.gov

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 K08 applications, please contact the NHLBI Program Director: