Helpful Hints for Competitive Renewal of the
NHLBI Midcareer Investigator
Award in Patient-Oriented Research (K24)
Revised: December 2008These 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. 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. 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. Candidate - Candidates for competitive renewals must continue to meet the NIH eligibility requirements. Candidates applying for competitive renewal of their K24 must:
Information about the candidate's history of grant support, patient-oriented
research, publications, and mentoring record should be included in the
"Candidate's Background." 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. 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. 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. 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. 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". 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. 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. 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. Jackie Chia NHLBI Program Staff Contact - For further information regarding NHLBI K24 applications, please contact the NHLBI Program Official: Sandra Colombini Hatch, M.D. |
