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Helpful Hints for 
Independent Scientist Award (K02)

Revised: August 2006

These Helpful Hints were written to assist potential candidates who are planning to submit K02 applications to the National Heart, Lung, and Blood Institute (NHLBI). This document clarifies some of the NIH K02 program guidelines; it does not replace those guidelines. Candidates MUST follow the instructions in the NIH K02 Program Announcement (AKA guidelines) found at http://grants.nih.gov/grants/guide/pa-files/PA-00-020.html, and in the PHS Form 398, Section III, available at http://www.grants.nih.gov/grants/forms.htm.

Summary of the K02 Goal - The K02 is a salary only award which provides protected time for newly independent investigators so they will be able to expand their research commitment to at least a 75% effort. Newly independent scientists often have non-research obligations such as heavy teaching loads, clinical duties, committee assignments, service and administrative duties that prevent them from having a period of intensive research early in their independent research career. The salary from the K02 will allow investigators to be relieved of those other duties which provide a portion of their income, and allow them to focus on their research and career development.

Candidate - Eligibility:  At the time of the award, candidates must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence. Candidates must meet the U.S. citizenship requirements. Candidates must possess a doctoral degree (i.e., Ph.D., Ph.D./M.D., M.D., D.V.M., PharmD., or an equivalent degree). Candidates should be new investigators who have peer reviewed independent support at the time of the award of the K02. When in doubt about eligibility, candidates are strongly encouraged to contact the NHLBI program representative listed at the end of this document prior to preparation of an application.

Candidates must describe their short and long-term career objectives and explain how this award will contribute to them.

Candidates must clearly document that they have a relatively small amount of time dedicated to research and have a need for protected time which would allow them to focus on research and research related activities. Candidates who currently are devoting approximately 75% of their time to research projects are viewed as not needing protected time. Further, the K02 is not intended for investigators who already have full time available to conduct research, or who have publication records or considerable research support indicating that they are well established in their fields, or who have achieved tenure or its equivalent.

Career Development Plan - This section is an important part of a career award application and weighs significantly in the assignment of a priority score. Successful candidates have a documented career development plan, which may include didactic coursework and training in areas that would promote multidisciplinary skills, and their potential to make future contributions to their chosen field of research.

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).  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) that includes the coursework and the research projects is helpful, as are benchmarks and a schedule for evaluating progress.

Environment and Institutional Commitment - The letters from the 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 institution should provide statements concerning the protected time the candidate will receive (at least 75 % required), the duties from which they will be relieved, and the institutional commitment to enhancing the candidate's ability as a productive, independent investigator. 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.

Research Plan - The reviewers evaluate the research plan of an on-going independent project differently than they would a proposed expansion of an existing project or a new project. The NHLBI K02 is for newly independent investigators whose research is in the areas of cardiovascular, pulmonary, blood diseases or resources, transfusion medicine, or sleep disorders. Applications submitted to the NHLBI must be in one or more of these scientific areas. K02 applications will be accepted by the NHLBI if the scientific focus is in one of these areas even if the peer reviewed independent project is supported by another NIH institute or a non-NIH entity.  

1. Ongoing Research Project: The research in the peer reviewed independent project has previously been reviewed and will not be reviewed in depth as part of the K02 application. However, the description of ongoing research should include a description of its background and significance, specific aims, study design(s), methods, and related information necessary for the reviewers to understand the previously-funded research project. Applicants should clearly identify their peer reviewed project in their request for protected time.

2. Additional Research for the K02: The additional research can be either an expansion of one or more of the aims of the previously-funded research or a new project. Applicants should propose additional work beyond expansion of previously-funded research or new work. The reviewers will review the expanded or new research project in depth. The research plan must be as well documented as in an R01 application.  The relationship of the additional research to the original funded research should be described.  Candidates should explain new research hypotheses, new techniques to be employed and new data related to the original research.

Format for Letters - Letters submitted with an application must be addressed to the "NHLBI K02 Review Committee" and be written on institutional letterhead stationery. Revised applications must include new letters, since  letters submitted with previous applications are not retained by NIH.

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

The salary requested and awarded may not exceed $75,000 per year plus fringe benefits. Facilities and Administrative Costs are 8% of direct costs. The K02 has an award period of 3 to 5 years and is not renewable.

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 the NHLBI.

Research Support - The research support is that provided by the peer reviewed, independent research project (e.g., R01) and any other research projects that will be ongoing at the time of an award. It is important to list all the research projects that will be ongoing during the K02's project period. Each research support entry should include the inclusive dates of the project period, the percent effort, and the dollar amount of support.

Funds for Research Support - Because the K02 is a salary only award, it does not provide funds for research support. Salary support from a pre-existing NIH grant is relinquished prior to receiving a career award. Usually, the funds budgeted in the NIH grant (R01) for salary may not be re-budgeted. However, it may be possible to rebudget salary funds within an R01 to support the cost of research support (including tuition, fees, and books) with the prior approval of the NIH.

Documenting the Need for Protected Time - New investigators just starting their independent research often have a small percentage of their time allocated to their research-related endeavors. Institutions may require candidates to earn the remainder of their salary by assuming teaching assignments, by working on committees, by performing clinical duties, or by performing other duties that take new investigators away from their research. In order to demonstrate their need for protected research time, candidates must clearly outline the percentage of time devoted to their research project and the percentage of time devoted to other duties. The following points are suggested:

1. List all current duties and the percentage of time devoted to each.

2. Include a letter on institutional letterhead addressed to the "NHLBI K02 Review Committee" from the individual having the authority to protect a candidate's time, such as the Department Chair. The letter should state that, if the K02 is awarded, the candidate will be relieved of the duties requiring some specified percent effort and the candidate will have 75% (or more) protected time. The percentages should be consistent with those listed by the candidate.

3. Candidates must clearly document that the requested period of salary support and protected time will foster their career as a highly productive scientist.

Need For Independent Support At the Time of the Award - K02 applications may be submitted on the next receipt date after the submission of an R01 or concurrently with an R01 application for the same receipt date. However, applicants must have on-going peer reviewed support at the time of the award of a K02

A K02 may be awarded for three to five years. Therefore, enough time should remain on an on-going independently funded project so the K02 will provide support for at least two or more years concurrently with the independent support. If the K02 project period will exceed the project period of funded independent support, the candidate should provide information about proposed continuing research. Documentation of PENDING applications or proposed PENDING applications is recommended.

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 (see the Public Health Service policy on RCR at: http://ori.dhhs.gov/multimedia/acrobat/rcrpolicy.pdf). This document describes nine core instructional areas that comprise RCR: 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. 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.

Human Subjects - Prior to preparing an application, candidates should read the definition and clarification of Human Subjects in PHS 398 (rev. 5/01) sections IIIA. - Definition and IIIG. - Assurances and Certification.

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 revised PHS 398 (rev. 5/01) application kit (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 K02 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 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. 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://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Data and Safety Monitoring Plan - NIH has a new requirement for competing applications. Applications for  research projects that include clinical trials (i.e., biomedical or behavioral intervention studies) must contain a section entitled "Data and Safety Monitoring Plan".  See the PHS 398 (rev. 5/01) 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.

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) regarding inclusion of the additional material in the review. The NHLBI SRA for K02 applications is Roy White, Ph.D.  Dr. White may be reached at the Review Branch, Division of Extramural Affairs, NHLBI, by telephone at (301) 435-0287, or by e-mail at whiter@nhlbi.nih.gov.  Candidates intending to include color or detailed photographs in their applications should contact Dr. White, the Scientific Review Administrator, to arrange for them 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 candidates unreviewed. The PHS 398 preparation instructions contain detailed information on the standards.

Review Criteria - A panel of reviewers will judge the merit of applications by the review criteria stated in the NIH program announcement and by the following criteria:

Career Development Plan - Likelihood that an award will contribute substantially to continued scientific development, productivity, and independence of an applicant.

Research Plan - Quality of the proposed research plan and potential for strengthening an investigator's independence.

Scientific and technical merit of the research proposed for the augmented time provided by a K02 award.

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

Applicants should use both the NIH program announcement (http://grants.nih.gov/grants/guide/pa-files/PA-00-020.html) and the PHS form 398, "Additional Instructions to Preparing Individual Research Career Award Applications - the K Series" and the information in this Helpful Hints in completing their applications. Consultation with program staff, identified under "NHLBI Staff Contact," is also recommended before submitting an application.

Letter of Intent - Applicants are asked to submit a Letter of Intent at least one month before the announced receipt date to:

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

Application Procedures - Submit a signed, typewritten original of the application with Checklist and five signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710
BETHESDA, MARYLAND 20892-7710
(For express/courier service use Bethesda, Maryland 20817-7710)

One additional copy of the completed application should be sent to the Chief, Review Branch at the address listed under the Letter of Intent.

Application Receipt Dates: February 1, June 1, and October 1
Resubmission/Amended NHLBI K02 Career Development Award applications are to be submitted for the Standard NIH Receipt Dates,
which are included in the following notice: http://grants.nih.gov/grants/guide/notice-files/NOT-HL-06-133.html. This notice is effective immediately and supercedes earlier instructions and includes dates for submitting Letters of Intent.

NHLBI Staff Contact:

For further information regarding NHLBI K02 applications, please contact the NHLBI Program Official:

Traci Heath Mondoro, Ph.D.
Health Scientist Administrator
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive MSC 7950
Bethesda, Maryland 20892-7950 (for overnight delivery, insert Room 10182 and use zip code 20817)
Telephone: 301-435-0052
FAX: 301-480-1060
Email: mondorot@nhlbi.nih.gov

 

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