2017 NIH Mentored Career Development Program Award

2017 NIH Mentored Career Development Program Award

The overall goal of the Mentored Career Development Program award is to provide training opportunities for junior faculty working in clinical and translational research to become independent investigators. The proposed programs will focus on junior faculty with strong potential for careers in clinical and translational research.

Status

Open for applications
Application Deadline: 5/15/2017
Award(s) Available: 1

Each recipient should budget salary support for 75% protected time (subject to the FY14 Executive Level II ($181,500) NIH salary cap).  The CTSI will support up to $137,500 annually towards salaries, fringe benefits, research expenses, and travel (following AHW allowable and unallowable cost policy) for up to two 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 the Medical College of Wisconsin are eligible to apply to conduct mentored interdisciplinary research. Only faculty with full-time or full professional effort status at the Medical College of Wisconsin are eligible to serve as principal investigators (PI) for AHW REP funding. Adjunct and part-time faculty are not eligible to apply for AHW REP funding.

Curriculum design for each trainee is a joint undertaking involving the trainee, his/her mentors, and the 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, Mentored Career Development Program 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.

Clarification of Award

Clarification of Award

  • Salary Support: Each recipient should budget salary support for 75% protected time (subject to the FY14 Executive Level II ($181,500) NIH salary cap).  If additional support is required to assure 75% protected time, applicants are required to identify additional source(s) in budget; this could require leveraging departmental funds.
  • Research Expenses: up to $25,000
    • Examples of appropriate Research Expenses are: tuition and fees related to career development; supplies, equipment and technical personnel; statistical services
  • Travel: up to $2,500
    • Examples may include: scholar travel to scientific meetings and research training workshops

Key Dates

Key Dates

  • Application Submission Deadline: May 15, 2017
  • Award(s) Available: 1
  • Projects to Begin: July 1, 2017 *Requires NCATS Prior Approval

Program Requirements

Program Requirements

The candidate must name a primary sponsor/mentor, who, together with the applicant is responsible for the planning, directions, 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

Eligibility criteria include full time junior faculty from the Medical College of Wisconsin 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. Faculty with full-time or full professional effort status at the Medical College of Wisconsin are eligible to serve as principal investigators (PI) for AHW REP funding. Adjunct and part-time faculty are not eligible to apply for AHW REP funding.

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 Information

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 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 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 General Biographical Sketch Format Page from the SF424 (R&R) Application and Electronic Submission Information page on the NIH website (updated by NIH 01/2015).

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

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 01/2015).

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. Please note that salary support for the mentors or secretarial and administrative assistants is not allowed.

AHW funds can only be used for direct costs necessary to carry out the approved project. Follow the link for a copy of the AHW REP direct, indirect, and unallowable costs.

Funding cannot be used as “bridge funding” for lapsed grants from any extramural source and is intended to be used for new projects.

18 KBBudget Form
80 KBNIH allowable and unallowable costs

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 – 11), 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 Mentored Career Development Award Program 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 Mentored Career Development Award Program 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

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 eBridge Support for specific guidance to complete the eBridge funding proposal.

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.

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Terms and Conditions

National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS)
Terms and Conditions for Mentored Career Development Program Awards

RESTRICTION OF CLINICAL ACTIVITY BEYOND THE END OF PHASE IIA:

  • In accordance with section 479(b) of the Public Health Service Act (as amended by the Consolidated Appropriations Act, 2012, Public Law 112-74), NCATS is authorized to use fiscal year 2015 funds to provide infrastructure and resources for all phases of clinical trials research, but can only support clinical trials through the end of Phase IIA (with the exception of certain clinical trial activities involving treatment of a rare disease or condition). However, all phases of clinical trials may utilize infrastructure and resources provided through the CTSA.

PRIOR APPROVAL OF DELAYED ONSET RESEARCH INVOLVING HUMAN SUBJECTS

THE CTSI MUST COLLECT AND SUBMIT TO NCATS, 30 DAYS PRIOR TO FUNDING APPROVAL, THE FOLLOWING:

  • Name of the grantee, the name of the scholar who is conducting the research, and the scholar’s NIH Biosketch.
  • The complete clinical research protocol and consent document. If the clinical research protocol is considered an amendment to a parent protocol, include information explaining exactly what is being supported by NCATS scholar funding. If the entire parent protocol is included in the submission, that portion which is supported by NCATS funding should be clearly labeled as such.
  • If a clinical trial is proposed, product information, such as the clinical investigator brochure or package insert or description of the device shall be included. Documentation that an IND or IDE has been obtained or letter from FDA that the study is IND exempt or IDE has been waived.
  • Description of risk, protections, benefits and importance of the knowledge to be gained by research involving human subjects.
  • Inclusion Plans for Women, Minorities, and Children, if applicable
  • Targeted Enrollment Table or Inclusion Data Record (IDR), if applicable.
  • Data and Safety Monitoring Plan (DSMP) and Board (DSMB), if applicable.
  • Certification that the scholar and any Key Personnel directly involved in the study have taken appropriate education in protection of human subjects.

STEM CELLS

STEM CELLS – INFORMATION REQUIRED

  • No funds in this award may be used for any research involving human embryonic stem cells (hESCs) until the grantee has submitted to NIH information on the specific, approved hESC line(s) that will be used from the NIH Human Embryonic Stem Cell Registry: (http://grants.nih.gov/stem_cells/registry/current.htm).
  • While the Registry will include lines pending review; only those hESCs listed on the Registry as eligible for NIH funding may be used in this award. Information should be submitted from an Authorized Organizational Representative to the assigned Grants Management Specialist noted below.
  • The grantee may use only those hESCs that appear on the NIH Human Embryonic Stem Cell Registry as eligible for NIH funding and in accord with any restrictions placed on the use of those lines: (http://grants.nih.gov/stem_cells/registry/current.htm)
    • For more information on the requirements regarding use of Human Embryonic Stem Cell (hESC) lines, see: https://stemcells.nih.gov/.

HUMAN/ANIMAL SUBJECTS RESTRICTION

  • It is understood that no clinical research scholar or mentor will be permitted to work on any project involving live vertebrate animals or human subjects that has not been approved by the IACUC and/or IRB, as appropriate.
  • If any scholar undertakes a project which includes human subject research studies, these must conform to the NIH policies on the inclusion of women, minorities, and children in study populations.

HUMAN SUBJECTS

  • No funds may be drawn down from the payment system and no obligations may be made against Federal funds for research involving human subjects by any site engaged in such research for any period not covered by both an OHRP-approved Assurance and an IRB approval consistent with 45 CFR Part 46.
  • See ” Human Subjects Protections” Part II, Chapter 4 (http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf) for specific requirements and grantee responsibilities related to the protection of human subjects.

RESTRICTION: DATA SAFETY AND MONITORING OF CLINICAL TRIALS

281 kBDownload Terms and Conditions
Review Criteria

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?
2017 NIH Mentored Career Development Program Award
Support for the 2017 NIH Mentored Career Development Program Award is made possible by grants from the Department of Health and Human Services: National Institutes of Health: National Center for Advancing Translational Sciences: KL2TR001438 and UL1TR001436.

Publications arising from any research project receiving support from the CTSI should acknowledge support by stating “Support received by grants KL2TR001438 and UL1TR001436 and from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences”.

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.

PARTNERS

Zablocki VA Medical CenterMedical College of WisconsinMSOE