Eligibility Criteria
Full-time early-stage investigators who hold primary appointments in Children’s Wisconsin Research Institute and have a faculty appointment from the Medical College of Wisconsin, University of Wisconsin-Milwaukee, Marquette University, and Milwaukee School of Engineering, with a professional doctoral degree or its equivalent (e.g., MD, PhD, DDS), US citizenship or permanent residency, and a documented commitment to clinical and translational research are eligible. Adjunct and part-time faculty are not eligible to apply since this award supports full-time research and clinical effort.
Ineligible individuals also include faculty who have had previous similar training awards, or who have served as Principal Investigator on any peer-reviewed research grants (NIH or other funding agencies) that are in excess of $100,000/year direct costs, or who are project leaders on sub-projects of a program project or center grant.
Candidates must demonstrate active participation in a Children’s Specialty Practice Unit (SPU). These include pediatric medical, surgical and diagnostic subspecialties; nursing, dental, and primary care.
Non-competitive letters of intent are mandatory and are being requested to identify potential reviewers and confirm eligibility. Only those applicants who do not meet entry criteria will be notified following LOI submission. Applicants must submit a letter of intent (1 page maximum) that briefly describes the proposed project scope of work and its goals, and how it specifically meets the eligibility criteria noted in this RFA.
Application
The application must address the following areas. A template with the required sections can be downloaded here.
Body of the Application – not to exceed 7 pages.
1. Specific Aims
The Specific Aims page is an abbreviated version of the grant proposal. This section should include an introductory paragraph with what is known and current gaps in knowledge. Include an explanation of how your proposed research can address the gap(s), goal(s), hypothesis, and rationale of the proposed project. The Specific Aims should address the identified need and be related to the overall project goals without being highly dependent on one another. (1 page)
2. Candidate
Provide a statement detailing your accomplishments to date, career goals and plans towards an independent academic career in clinical and translational research (C&TR). Provide background information relevant to your interest and experience in C&TR and indicate how the CTSI Mentored Research Career Development Program will help you achieve your future goals in C&TR. Include a description of your current professional activities/responsibilities in the institution and elsewhere and show how these will help ensure career progression to achieve independence as an investigator conducting C&TR.
Include a statement indicating your commitment to 75% effort to the Program and related career development activities.
(No more than 1 page)
- Exceptions may be made for surgeons or procedure-intensive specialties (see below).Accommodation for Certain Clinical Specialties
To remain consistent with NIH guidelines (see links below for additional detail), it is acknowledged that individuals in medical specialties that require significant clinical activity to maintain specialty clinical competency skills may be unable to devote the required minimum of 9 person months of effort (i.e., 75% of full-time professional effort). The KL2 award will allow certain clinical specialties (e.g., surgical and procedure-intensive specialties) to request less than the required 9 person months of effort for the specific purpose of maintaining specialty clinical competency skills. Applicants may request a minimum of 6 person 4 months (50%) of effort in the application. A clear justification for the reduced level of effort must be included.
3. Career Development and Mentoring Plan
Provide a description of your needs for career development, including activities and external enrichment experiences that may be beneficial to your success. The candidate and the mentor are jointly responsible for the preparation of the career development plan. Include a timeline for your career development with intermediate and final goals. The sponsor/mentor may form an advisory committee to assist with the development of the program of study or to monitor the candidate’s progress through the career development program. Indicate any prior completion or recent acceptance into any advanced didactic programs in C&TR or equivalent education and/or training. For e.g., indicate prior education/training or plans to participate in courses such as: data management, epidemiology, study design, hypothesis development, drug development, conflict of interest, responsible authorship, policies for handling misconduct, etc., as well as the legal and ethical issues associated with research on human subjects.
Required Training in Responsible Conduct of Research: Include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete.
(1-2 pages)
4. Research Plan
Describe your planned research while in the program, providing a vision of your research program. The research plan should represent a 2-year research program. The research strategy should include background and significance, innovation, research design and methods/approach, sample size/power, plan for statistical analysis, and a timeline. The candidate should consult with mentor(s) regarding the development of this section. Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects.
(3 pages)
5. Alignment
Describe how your research project has the potential to improve the way we prevent, diagnose or treat childhood diseases, or enhance childhood health and well-being, including management strategies for living with chronic disease. Please also describe your active participation in a Children’s Specialty Practice Unit (SPU).
(1/2 page)
Additional required Items not included in 7-page limit:
6. References
Include citations for all sources. (no page limit)
7. Biographical Sketch (NIH format) – applicant.
Please use the General Biographical Sketch Format Page** from the SF424 (R&R) Application and Electronic Submission Information page on the NIH website (updated by NIH 10/2021). (<5 pages)
**Biosketches submitted in an older format may result in the application being considered incomplete 5
8. Statements by Mentor and Collaborators
Mentors: The application must include a statement from the mentor(s) indicating; a) research qualifications and previous experience as a research supervisor; 2) mentoring plan describing the nature of the supervision and mentoring that will occur during the proposed award period; and 3) plan for transitioning the candidate from the mentored phase of their careers to the independent investigator phase during the project period of the award. The mentor must agree to provide annual evaluations of the candidate’s progress for the duration of the award. Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate.
Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided that clearly documents expertise in the proposed area(s) of consulting/collaboration.
Children’s SPU Leader: If mentors and collaborators do not include your SPU leader, also include a letter of support from your SPU leader describing your role in the SPU.
9. Institutional Commitment to Applicant’s Research Career Development (required)
Provide Letter(s) of Support from your Department Chair and Division Chief (if relevant) indicating acceptance of the terms of this award. Provide internal research support service center agreement, if applicable. Applicants from UWM, Marquette, and MSOE must also submit a Letter of Intent from their institution indicating their acceptance of terms of the award.
10. Detailed Budget and Budget Justification.
Recipients should budget for:
- Salary support is limited to $120,000, not including fringe (cost-share is required if 75% FTE exceeds this amount)
- Research-related costs (e.g., tuition and fees related to research development; supplies, equipment and technical personnel; statistical services)
- Travel funds of up to $2,500 per scholar per year (e.g., scientific meetings, training workshops)
Provide the salary and fringe benefits requested and a detailed description with justification of all equipment, supplies and research personnel that will be used to help achieve the career development and research objectives of this award. Please note that salary support for the mentors or administrative support personnel is not allowed. Funding cannot be used as “bridge funding” for lapsed grants from any extramural source and is intended to be used for new projects. Each recipient should budget salary support for 75% protected time for research and training (subject to the current NIH salary cap). This award will support up to $175,000 (direct costs) annually towards salaries, fringe benefits, research expenses, and travel for up to two years of supervised career development activities and mentored clinical and translational research.
Budget Form: NIH PHS 398 budget Form 4, Form 5, and detailed budget justification
Complete Form 4 for the first year in the program and include a detailed budget justification form. Form 5 should include the cumulative numbers from each category of Form 4 for year one and include the total budgeted amount for each category for year two of the award. If there is a significant change in a category from the previous year this change should be justified in the box at the bottom of Form 5. A significant change is defined as increase or decrease >25%. The budget template can be found here and within the application template.
11. Letters of Recommendation (3 required)
Three letters of reference should be submitted from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator in patient-oriented research. Please note that mentors may not submit a letter of reference. All letters of reference should be submitted by the applicant within the REDCap application form.
