CTSI
CTSI
Pilot and Collaborative Clinical and Translational Research Grants

Pilot and Collaborative Clinical and Translational Research Grants

The CTSI Pilot and Collaborative Clinical and Translational Research Grants Program is supported by Advancing a Healthier Wisconsin (AHW) and the National Institutes of Health (NIH). These awards are intended to stimulate inter- and trans-disciplinary translational and clinical research within and among the CTSI partner institutions.

Request for Applications – 2015

Key Dates

  • Letter of Intent to Apply (Required): June 2, 2014, 11:59pm CDT
  • Application Invitations Emailed to Applicants: Mid June, 2014
  • Application Submission Deadline: August 29, 2014, 11:59pm CDT
  • CTSI Peer-Review: September/October, 2014
  • CTSI Executive Committee Review: November, 2014
  • Funds Available for Awarded Projects: April 1, 2015

Overview

Summary: The fundamental goal of this RFA is to stimulate clinical and translational research among the institutions that comprise the CTSI of Southeast Wisconsin. It seeks to encourage inter-institutional and interdisciplinary collaboration between clinical and basic biomedical scientists, social scientists, ethicists, engineers, biostatisticians, informatics specialists, and all members of clinical health care delivery teams.

Funds will be provided to:
  1. Support new and promising clinical and translational projects across all disciplines, including annual special emphasis categories. 2015 special emphasis categories are “Child Health” and “Community Health Outcomes Research”;
  2. Maximize scientific interactions of junior investigators with senior mentors;
  3. Stimulate collaborative research between bench and clinical investigators within similar research areas;
  4. Foster interdisciplinary and inter-institutional collaborations;
  5. Support research in novel technologies and their applications to clinical practice and community health;
  6. Support projects that will provide preliminary data for new extramural grant submissions.

This program is designed to advocate, facilitate, and foster the continuum of research from bench to bedside, and from bedside to community practice. In a sense, translational research focuses on discovery and the application of scientific findings into a real-world setting. It is the goal of the CTSI to diminish the barriers between institutions and disciplines, while encouraging novel approaches to solving complex health related problems. Ultimately, our goal is to improve health outcomes by creating new, bidirectional flows of information between our biomedical research enterprise and the community we serve

Definitions

This pilot award program funds clinical and translational research, defined as follows:

Clinical Research

The NIH defines clinical research in three parts:

  1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
  2. Epidemiologic and behavioral studies
  3. Outcomes research and health services research 1
Translational Research

The NIH defines translational research as: ‘Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.2

Applications should address one of the four T-levels on the CTSI Translational Continuum, based on NIH guidelines.

CTSI Pilot Award Program, Translational Track 1

T-1 Translation to Humans – Clinical Insights: Goal is to identify and analyze the effects of an intervention or relationship on the human condition or environment. The effect of an intervention, the effect of a relationship. Studies with human participants that yield knowledge about human behavior, physiology, pathophysiology and the potential for intervention (i.e. diagnoses, therapies, etc.).

T-2 Translation to Patients – Practice Implications: Goal is to identify and analyze the optimal effects of an intervention or relationship on the human condition or environment. The optimal effect of an intervention, or the optimal effect of a relationship. Both Phase 2 & 3 clinical trials.

CTSI Pilot Award Program, Translational Track 2

T-3 Translation to Practice – Goal is to incorporate into practice the optimal intervention or relationship. Phase 4 clinical trials – focus on post-marketing analysis. Includes health services research & community-based participatory research (dissemination, communication, implementation research).

T-4 Translation to Communities – Goal is to provide communities with the optimal intervention or relationship. Studies focusing on disease prevention through life-style and behavioral modifications. Documents “real-world” health outcomes of population health practices associated with improved disease prevention and reduced medical costs. Results in true benefit to society.

498 kBView the CTSI Translational Continuum


1 Glossary of Terms for Human Subjects Protection and Inclusion Issues, based on the 1997 Report of the NIH Director’s Panel on Clinical Research.
2 National Institutes of Health. RFA-RM-07-007: Institutional Clinical and Translational Science Award (U54) Mar2007.
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Eligibility

All clinical and translational pilot grant applications will be peer reviewed and the number of grants awarded will depend solely on the quality of the applications. Pilot projects are intended to lead to future major research and should conform to the following requirements:

  • Project proposals are identified and reviewed on one of two Translational Tracks; Translational Track 1 projects incorporate either T-1 to T-2 on the CTSI Translational Continuum, and Translational Track 2 projects incorporate either T-3 to T-4 on the CTSI Translational Continuum. Applicants must select the CTSI Pilot Award Program Transitional Track that best describes their research.
  • Projects will be funded at a level of up to a total of $50,000. Institutional and departmental cost sharing to supplement these funds is highly encouraged (Letter of support department chair is required).
  • Project duration will be 12 months or less.*
  • Principal Investigators (PIs) may be from any of the CTSI partnering institutions**.
  • Applications must be inter-institutional (investigative team with members from more than one of the partner institutions) and interdisciplinary.*** Investigators that are interested in forming new collaborative relationships are encouraged to contact the CTSI Pilot Award Program Manager, Ramona Tenorio, PhD at 414-955-2537, rtenorio@mcw.edu
  • PI may submit only one application in response to this RFA. PI may receive awards for successive, but not concurrent or overlapping, proposals.
  • PI must have 5% minimum effort. Support of faculty salaries are permitted up to a maximum of 15% effort (utilizing NIH maximum salary limits when appropriate).
  • No “indirect costs” may be charged for any CTSI funding and no funds may be requested for purchase of laboratory or clinical equipment.
  • If a previously submitted proposal has not received funding, a revised application may be submitted only once and must include a detailed response to concerns raised in the review of the original application.
  • Funding under this RFA cannot be used as “bridge funding” for lapsed grants from any extramural source and is intended to be used for new projects.
  • All personnel must be identified prior to the start date to replace any “to be named” positions proposed in the application.
  • CTSI funds cannot be used to supplant funds or resources that are available from other sources. Use of CTSI funds to supplement other financial resources is permitted with clear justification. Matching funding and opportunities to leverage CTSI funds to obtain other sources of financial support are specifically encouraged.
  • Investigators are encouraged to submit IRB and/or IACUC applications when they submit their proposals to the CTSI, to minimize delays in initiating funded projects.
  • Untenured junior faculty member PIs are encouraged to apply. If funded, untenured junior faculty member PIs will be required to participate in CTSI’s Mentoring Program.
  • PIs will be expected to comply with reporting and meeting requirements as a condition of receipt of funds.


* This program has an accelerated nature and only a 12 month funding period. If your project requires working with federal agencies such as NIDA, FDA (e.g., IND, IDE applications) or pharmacological agreements (e.g., clinical trial agreements, material transfer agreements), you must contact the CTSI Pilot Award Program Manager, Ramona Tenorio, PhD at 414-955-2537, prior to applying.

** CTSI funding is provided by NIH, with major funding for this program being provided by the CTSI’s AHW Research and Education Program (AHW REP) Award, entitled, “Advancing New Discoveries in Translational Research through the Collaborative and Pilot Studies Program.” Only applications with an MCW PI will be eligible for AHW REP funds. MCW faculty with full-time or full professional effort status are eligible to be the PI on an AHW REP funded CTSI Pilot Award, adjunct and part-time faculty are not eligible. Projects/budgets may need to be altered to meet these requirements. PI and Co-PIs applying for AHW REP funded CTSI Pilot Awards will need to complete a Non-Supplanting Attestation form. CTSI Pilot Awards funded by the AHW REP are required to demonstrate alignment with the AHW 5 year plan priorities and the State Health Plan.

*** Institutional affiliation is determined as follows: Primary institutional appointment as Faculty* at one of the four academic partners (MCW, UWM, MU, MSOE). Primary institutional appointment as research scientist (or other similar title) at a partner institution (CHW, BRI, VA, FMLH) and able to submit proposals as principal investigator from that institution. *Included research scientists who have principal investigator designation in some academic institution.

2015 Special Emphases

Child Health, and Community Health Outcomes Research are a special emphasis for 2015. Additional review weighs will be applied to research in one of these areas.

Novel Approaches and Technologies focus on the development of new and innovative technical resources. Projects that involve design and development of novel approaches or technologies which are accessible and efficient to monitor health or deliver care in real-time are highly encouraged to apply. Additional review weighs will be applied to research incorporating novel approaches or technologies. Selected proposals are intended to increase the efficiency and/or rigor of multidisciplinary clinical and translational research.

Review Criteria

To ensure that the results of scientific research will be used to directly benefit human health, proposals in all disciplines relevant to biomedical investigation will be considered for funding. Criteria for funding of any proposal include: 1) the clear potential to directly translate anticipated results into improved preventative health, diagnostics, therapeutics or health outcomes for our southeast Wisconsin community; and 2) the potential for proposed studies, when completed, to generate extramural funding.

An Intent to Apply Form will be reviewed for each intended application by the Pilot and Collaborative Clinical and Translational Research Program (PCCTRP). Projects meeting Intent to Apply Form standards will be send an email to proceed to full application.

The PCCTRP Committee will initially review all applications for technical feasibility and compliance with above requirements. The PCCTRP committee is comprised of at least one member from each of the partner institutions (MCW, MSOE, MU, and UWM), to ensure equitable representation of all the partner institutions within the CTSI.

All applications will go through a preliminary review, and in-person panel review, and a post-panel review.

Projects are reviewed based on their selected CTSI Pilot Award Program Translational Track. Specific review criteria for each Translational Track can be viewed in the documents below.
953 kBTranslational Track 1 Review Guide and Score Sheet 948 kBTranslational Track 2 Review Guide and Score Sheet

How to Apply

Submission Details

The online Intent to Apply Form must be completed and received June 2, 2014, 11:59pm CDT.

All applications must be received for CTSI administrative approval by August 29, 2014 – 11:59pm CDT. Submissions by any other means will not be accepted.

Elements & Requirements of the Application

  1. 2015 CTSI Pilot Award Worksheet
  2. Budget and Budget Justification Form (1 per participating institution)
  3. NIH Biographical Sketch (PI and all key personnel; limit 4 pages per individual)
    View Instructions
  4. CTSI Project Schedule and Project Readiness Templates
  5. CTSI AHW Goals Alignment Form
  6. AHW Non-Supplanting Attestation Form (1 per investigator)
  7. MCW Faculty Cost Sharing Commitment Form (if applicable)
  8. Letter of Support for project from PI Department Chair
  9. Letters of Collaboration from each Co-Investigator to PI
Download the Required Files

Please download and complete all of the documents prior to completing full application.
26 kB1) 2015 CTSI Pilot Award Worksheet 98 kB2) Budget and Budget Justification Form 41 kB3) NIH Biographical Sketch Template 7 MB4) CTSI Project Schedule and Project Readiness Templates 19 kB5) CTSI AHW Goals Alignment Form 32 kB6) AHW Non-Supplanting Attestation Form 43 kB7) MCW Faculty Cost Sharing Commitment Form

Additional Requirements by Institution

For MCW investigators or any application with an MCW collaborator, the application must be routed through eBridge and must be received by the Office of Grants & Contracts (GCO) no later than 5 business days before the submission deadline. Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the Office of Grants & Contracts.
110 kBFurther Instructions for MCW Investigators


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. Letters of intent do not require a WISPER record.

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

 
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