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2014 Mentored Career Development Award Program (KL2)

2014 Mentored Career Development Award Program (KL2)

The Clinical and Translational Science Institute is pleased to announce an open competition for a Mentored Clinical and Translational Research Award.

Overview

The overall goal of the KL2 award is to provide training opportunities for junior faculty working in clinical and translational research to become independent investigators. The proposed program will focus on junior faculty with strong potential for careers in clinical and translational research. The program provides 75% protected time, salary and benefits up to $140,000, and up to $25,000 in research support per year for up to three years of supervised career development activities and mentored clinical and translational research. Departments may be asked to leverage funds for their selected faculty. Applicants must justify the need for a period of mentored research experience and provide a convincing case that the proposed period of support and career development plan will substantially enhance their careers as independent investigators in clinical and translational research.

Full-time junior faculty from CTSI partnering institutions are eligible to apply (Froedtert Hospital, Zablocki VA Medical Center, BloodCenter of Wisconsin, Children’s Hospital of Wisconsin, Milwaukee School of Engineering, Medical College of Wisconsin, University of Wisconsin-Milwaukee, and Marquette University) to conduct mentored, interdisciplinary research.

Curriculum design for each trainee is a joint undertaking involving the trainee, his/her mentors, and the KL2 program director. The individually tailored curriculum will be based on an assessment of the unique needs and the articulated learning goals and objectives of the scholar, and a performance and evaluation plan for the scholar. Training activities may involve participation in CTSI’s Clinical Scholars’ Program, coursework, including a leadership training course, structured interactions with the Translational Research Units and with the leadership of the institutions’ multidisciplinary centers, and the opportunity to participate in a multidisciplinary research project under the guidance of a mentor.

Relatively early, KL2 scholars will be expected to focus on their own mentored research project and the development of a major grant proposal. During the training period, awardees have opportunities to attend national meetings that can enhance their career and provide networking opportunities, and to participate on institutional research-related committees, such as IRBs, Translational Research Units Scientific Review Committees and others.

Key Dates
  • Application Period: October 1, 2013 – January 31, 2014
  • Institutional Submission Deadline: January 24, 2014
  • Application Deadline to CTSI: January 31, 2014
  • Application Review: February, 2014
  • Award Notification: March 15, 2014
  • Official Start Date: April 1, 2014

Program Requirements

The candidate must name a primary sponsor/mentor, who, together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators in clinical and translational research. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. The candidate and mentor must describe a career development program with an emphasis on clinical and translational research that maximizes the use of relevant research, and educational resources, and qualified faculty as mentors in clinical and translational research.

Eligibility Criteria

Eligibility criteria include full time faculty from the CTSI partner institutions 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.

Ineligible individuals include faculty who have had previous similar training awards, or who have served as Principal Investigator of 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.

Application

The application must address the following areas:

1. Candidate

Describe the candidate’s commitment to an academic career in clinical and translational research. Include a description of all of the candidate’s professional responsibilities in the institution and elsewhere and show their relation to the proposed activities on the career development award.

  • Discuss prior training and how it relates to the objectives and long-term career plans of the candidate.
  • Discuss the candidate’s research efforts to this point in his/her research career, including any publications, prior research interests and experience.
  • Provide evidence of the candidate’s potential to develop into an independent investigator.
  • Include a statement that the candidate will commit 75% effort to the clinical and translational program and related career development activities. Exceptions can be made for surgeons or procedure-intensive specialties.
  • The department chair must agree and provide a statement in the application documenting that this 75% percent of time will be protected.

2. Career Development Plan

The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. 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.

  • Describe a systematic plan that:
    1. Shows a logical progression from prior research and training experiences to the training and research experiences that will occur during the KL2 award period and then to independent investigator status;
    2. Justifies the need for further career development to become an independent investigator; and
    3. Utilizes the relevant research and educational resources of the institution.
  • Describe a training and research plan that is tailored to the individual career development needs and goals of the candidate.
    The candidate must demonstrate that he/she has received training or will participate in courses such as: data management, epidemiology, study design, hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects.
  • Describe the professional responsibilities/activities, including other research projects, beyond the required 75% effort commitment to the KL2 award.
    Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator conducting patient-oriented research.

3. Training in Responsible Conduct of Research

The applications must 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. Candidates should consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Document prior instruction in, and propose plans to receive, instruction in the responsible conduct of research in terms of subject matter and duration of instruction.

4. Research Plan

A sound research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided.The research plan should be organized under the following sections:

  • Specific Aims
  • Background and Significance
  • Progress Report/Preliminary Studies
  • Research Design and Methods

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.

Note: There is an 8 page limit for items 1 – 4.

5. Literature Cited

6. Biographical sketch (NIH format) – applicant.

Please use the format located on the NIH website.

7. Biographical sketch (NIH format) – primary mentor.

Please use the format located on the NIH website.

8. Statements by mentor and collaborators

Mentor(s)
  • The application must include a statement from the mentor(s) providing:
    1. Information on their research qualifications and previous experience as a research supervisor
    2. A mentoring plan describing the nature of the supervision and mentoring that will occur during the proposed award period
    3. A 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.

9. Institutional commitment to applicant’s research career development

Letters of support from their Department Chair and Division Chief (if relevant) indicating their acceptance of the terms of this award are required. Candidates who will use the resources within the Translational Research Units during the course of their award should include a copy of their agreement.

10. Budget and budget justification

Provide the salary and fringe benefits requested and a detailed description with justification for all equipment, supplies and research personnel that will be used to help achieve the career development and research objectives of this award (up to $25,000). Please note that salary support for the mentors or secretarial and administrative assistants is not allowed.

KL2 Budget Form

In addition, three letters of reference are 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. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three recommendations. All letters of reference should be submitted directly through the Letter Submission form.

How to Prepare Your Application

All of the above items (1 – 10), with the exception of the letters of reference, must be submitted electronically to the CTSI as a single PDF file or Word Document (.doc or .docx) through the KL2 Application form. You will need to be logged into the site with your CTSI credentials to access this form.

All letters of reference must be submitted through the Letter Submission form. Please note that the person(s) submitting letters for you does not need to log into the site to access this form. It is open for anyone to use.

Submission Process

Applications must be submitted electronically to the CTSI office for administrative approval via the KL2 Application form. The font used in the application should be no smaller than 11 pt., and the margins should be at least .5”.

Institutional Submission

For MU investigators, the application must be registered via the routine Proposal Registration process with the Office of Research and Sponsored Programs prior to submission. This process is required for proposals in which MU is the prime applicant and those for which MU is the collaborating applicant receiving funds. Remember that Marquette requires that a signed institutional letter of intent is in hand from all subawardees or collaborating institutions who will be receiving funds (i.e. MCW, UWM, MSOE, etc.) from a grant in which MU is the prime applicant prior to submission. Please contact an ORSP staff member early in your application preparation process as we can assist with forms, budget formulation, proofreading, securing subaward letters of intent, etc.

For UWM investigators, full applications must be routed using the WISPER system and approved by the Office of Sponsored Programs prior to submission to MCW. UWM applicants with new collaborators must process the sub-award within the MCW timeline.

For MSOE investigators, please contact Tom Bray, Dean of Applied Research, 277-7416 or bray@msoe.edu.

For MCW investigators, the application must be submitted through eBridge and be received by the Office of Grants & Contracts (GCO) no later than 5 business days before the submission deadline to CTSI. Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the Office of Grants & Contracts. Please consult the reference document below for specific guidance to complete the eBridge funding proposal.

eBridge Instructions

eBridge Funding Proposal SmartForms:

1. Page A – Investigator Information

  • Question 1.0, Short Title – Please include the indicator “CTSI KL2” somewhere in the short title.
  • Question 6.0, Other MCW Personnel – Select “Yes”

2. Page B – Additional Personnel

  • Question 1.0, Other MCW Senior/Key Personnel – Identify Project Mentor here.

3. Page C – General Project Information

  • Question 3.0, Type of Program,– Select “Training”
  • Question 8.0, Type of Organization – Select “Internal”
  • Question 9.0, Type of Internal Organization Select – “Advancing a Healthier Wisconsin.”
  • Question 13.0, Centers/Institutes – Select “Clinical & Translational Science Institute (CTSI).” Note that other selections may be made in this question as well.

4. Page I – Sponsor Information

  • Question 1.0, Primary Sponsor – Select “Advancing a Healthier Wisconsin”

5. Page R – Other Project Information Attachments

  • Question 9.0, Sponsor Application – Upload your completed KL2 Application here. Please create a PDF file of the full application to upload.
eBridge Budget SmartForms:

6. 1. Page T – Budget General

  • Question 10.0, F&A Rate – Default selection will be ‘0%.’
  • Question 11.0, F&A Base – Default selection will be ‘None.’

All other Funding Proposal and Budget pages should be completed as appropriate.

If you have any questions about how to use the eBridge system, please call the eBridge Help Desk at (414) 456-8476, or email the Help Desk at Help-eBridge@mcw.edu.

Award Review Criteria

Overall Impact

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

  • Does the candidate have the potential to develop as an independent and productive researcher focusing on patient-oriented research?
  • Is the candidate’s academic, clinical, and (if relevant) research record of high quality?
  • Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator focusing on patient-oriented research?
  • Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

Career Development Plan/Career Goals & Objectives

  • What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence?
  • Is the candidate’s prior training and research experience appropriate for this award?
  • Are the goals and scope of the plan when considered in the context of prior training/research experience and the stated training and research objectives, appropriate?
  • Are the content and duration of the proposed didactic research activities during the proposed award period clearly stated and appropriate?
  • Are there adequate plans for evaluating the candidate’s research and career development progress?

Research Plan

  • Are the proposed research question, design, and methodology of significant scientific and technical merit?
  • Is the research plan relevant to the candidate’s research career objectives focusing on patient-oriented research?
  • Is the plan for developing/enhancing the candidate’s research skills appropriate and adequate?
  • If applicable, are there adequate plans for data and safety monitoring of clinical trials?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

  • Are the qualifications of the mentor(s) in the area of the proposed patient-oriented research appropriate?
  • Do the mentor(s) adequately address the above review criteria including the candidate’s potential and his/her strengths and areas needing improvement?
  • Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
  • Is the mentor’s description of the elements of the research career development activities, including formal course work adequate?
  • Is there evidence of the mentor’s, consultant’s, collaborator’s previous experience in fostering the development of independent investigators?
  • Is there evidence of previous research productivity and peer-reviewed support focusing on patient-oriented research?
  • Is active/pending support for the proposed research project appropriate and adequate?
  • Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?

Environment & Institutional Commitment to the Candidate

  • Is there clear commitment of the sponsoring institution to ensure that a minimum of 75% of the candidate’s effort will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
  • Is the institutional commitment to the career development of the candidate appropriately strong?
  • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
  • Is the environment for scientific and professional development of the candidate of high quality?
  • Is there assurance that the institution intends the candidate to be an integral part of its research program?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points:

  1. proposed use of the animals, and species, strains, ages, sex, and numbers to be used;
  2. justifications for the use of animals and for the appropriateness of the species and numbers proposed;
  3. adequacy of veterinary care;
  4. procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and
  5. methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Related Links

 
NIH Funding Acknowledgment: Important Reminder - Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.
Zablocki VA Medical CenterFroedtert HospitalMedical College of Wisconsin Childrens Hospital of WisconsinBloodCenter of WisconsinUniversity of Wisconsin - MilwaukeeMarquette UniversityMilwaukee School of Engineering