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 – 2014

Key Dates

  • Pre-Application Submission Deadline: June 1, 2013, 11:59pm CDT
  • Application Invitations Emailed to Applicants: June 14, 2013
  • Application Submission Deadline: August 1, 2013, 11:59pm CDT
  • CTSI Peer-Review: September/October, 2013
  • CTSI Executive Committee Review: November, 2013
  • Funds Available for Awarded Projects: April 1, 2014

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, with special emphasis support for yearly request categories. 2014 special request categories are “Genomics” and “Community/Comparative Effectiveness”;
  2. Maximize scientific interactions of junior investigators with senior mentors;
  3. Stimulate collaborative research between bench and clinical investigators within similar thematic areas;
  4. Foster interdisciplinary and inter-institutional collaborations;
  5. Support research in novel technologies and their applications to clinical practice and community health

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 grant program funds clinical and translation 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 NIH categories of translational research:

Type 1 translational research is the process of applying discoveries generated in preclinical laboratory research to experimental studies in animal and human participants. Examples of Type 1 research include preclinical, human physiology, first in human, proof of concept and phase I clinical studies.

Type 2 translational research translates findings from efficacy studies into clinical application and evidence-based guidelines in controlled environments. Examples include clinical studies with human subjects, such as phase II and phase III clinical trials.

Type 3 translational research establishes how evidence-based health strategies work in real-world community settings. Examples of Type 3 translational research includes phase IV clinical trials, community-based participatory research, comparative effectiveness research and practice-based research.

Type 4 translational research involves the application of validated, health practices from communities to their impact on human populations. Population-level outcome studies and social determinants of health are examples of Type 4 translational research.


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.

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:

  • 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 commitment from department chair is required).
  • Project duration will be 12 months or less.*
  • Principal investigators 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.***
  • Any Principal Investigator may submit only one application in response to this RFA. Principal Investigators may receive awards for successive, but not concurrent or overlapping, proposals.
  • 5% minimum effort for Principal Investigator. 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.
  • If applying as an untenured junior faculty member, the PI will be required to submit a mentoring plan if their proposal is funded.
  • Principal Investigators will be expected to comply with reporting and meeting requirements as a condition of receipt of funds.


* This program has and 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 Ramona Tenorio, Pilot Program Manager, 414-955-2537, prior to applying.

** CTSI funding is provided by NIH, with major funding for this program being provided by the Advancing a Healthier Wisconsin (AHW) Research and Education Program. Only applications with an MCW PI will be eligible for AHW Research and Education Program funds. MCW faculty with full-time or full professional effort status are eligible to be the PI on an AHW Research and Education Program 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 Research and Education Program funded CTSI Pilot Awards will need to complete a non-supplanting Attestation form. CTSI Pilot Awards funded by the AHW Research and Education Program 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.

2014 Special Emphases

Research projects in the areas of Genomics and Community/Comparative Effectiveness are a specific focus for 2014. These projects should specifically address clinical and translational research in one of these areas. Funding has been made available for these types of meritorious projects as a result of the successful 2012 CTSI-sponsored Workshops “Community Engagement in Research-Comparative Effectiveness Research” and “Genetics and Personalized Medicine: Analysis and Clinical Implementation”.

Traineeship Projects are intended to obtain preliminary data for use in extramural applications to support interdisciplinary clinical and translational research. These include the research projects of CTSI translational tract graduate students. The amount of support will be up to $50,000 and the Trainee’s mentor must be the P.I. on the proposal.

Novel Technologies focus on the development of new and innovative technical resources. Projects that involve design and development of novel technologies which are accessible and efficient to monitor health or deliver care in real-time are highly encouraged to apply. Up to $25,000 will be available to fund 2 novel technology projects. The 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, if successfully completed, to generate extramural funding.

Specific Criteria

  1. Significance
    • What is the likelihood that the objectives outlined in the proposal will be achieved?
    • If the aims of the project are achieved, how will clinical practice be improved?
    • How will successful completion of the aims change the concepts, methods, technologies, treatments, services or preventative interventions that drive this field?
  2. Investigator(s)
    •  Are the PD/PIs, collaborators and other researchers well suited to the project?
    • Do the investigators have complementary and integrated expertise; is their leadership approach, governance and organizational structure appropriate for the project?
  3. Innovation
    • Does the application challenge and seek to shift current clinical practice paradigms by utilizing a refinement, improvement or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions?
  4. Approach
    • Are the overall strategies, methodologies, and analyses well-reasoned and appropriate for developing the research product as proposed?
    • Is the approach thoughtfully conceived and carefully planned?
    • Are potential problems, alternative strategies, and benchmarks for success presented?
    • If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed?
  5. Environment
    • Will the clinical environment in which the work will be done contribute to the probability of success?
    • Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?
    • Will the project benefit from unique features of the clinical environment, patient populations, or collaborative arrangements?
  6. Feasibility
    • Is the pilot project a discrete, well defined project that realistically can be completed in one year or less and requires limited levels of funding to obtain pilot data?
    • If the project requires complex regulatory approvals or agreements (examples include: complex IRB submissions, NIDA, FDA, including IND and IDE applications) or pharmacological agreements (e.g. clinical trial agreements, material transfer agreements), is there a well stated plan that would make it possible for the project to receive approvals and participate in a timely manner?

 
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