Helpful Hints for
NHLBI Mentored Patient-Oriented Research Career
Development Award (K23)
Revised: December 2008These 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 Announcement. As a reference in developing a K23 application, the NHLBI has identified two model K23 applications. 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). 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. 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 -Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF 424 R&R Application Guide for Research Career Awards (Instructions, Part 7.3, http://grants.nih.gov/grants/funding/424/index.htm). 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. 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. 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. Human Subjects - The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the "Human Subjects Sections" of the PHS 398 Research Plan component of the SF 424 (R&R), part I, 5.5. Required Education in the Protection of Human Research Participants: 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-08-054.html. 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 - The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the "Human Subjects Sections" of the PHS 398 Research Plan component of the SF 424 (R&R) part I, 5.5. 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.
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". Miscellaneous - 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. 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. Link to NIH Application Forms, including the SF 424 (R&R) Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R) Application Guide. The SF 424 (R&R) Application Guide for NIH and Other PHS Agencies, now includes Part 1.7 Supplemental Instructions to the SF 424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" series). Note in particular that the "Candidate" and "Research Plan" (sections A-D) combined may not exceed 25 pages. Please note that this new Application Guide is to be used with all Adobe application packages, including those for the K programs. Application Receipt Dates: February 12, June 12,
and October 12 - new applications; Ms. Ann Rothgeb |
