Integrating Research into Clinical Practice (IRCP): Digestive Disease Center Innovation in Health Care Delivery Grant

Integrating Research into Clinical Practice (IRCP): Digestive Disease Center Innovation in Health Care Delivery Grant

Digestive Disease Center announces this request for application (RFA) in collaboration with the Clinical and Translational Science Institute of Southeast Wisconsin (CTSI) to promote integration of research into GI clinical practice. The fundamental goal of this RFA is to encourage development of new patient-centered models for delivery of Gastroenterological care. Applications are expected to be innovative, outcome driven and have the potential to measurably and meaningfully improve delivery of care to patients with digestive diseases in terms of clinical quality, patient experience, value and efficiency i.e. delivering higher quality care faster and more cost effectively. Applications are also expected to take full advantage of a multidisciplinary approach to develop the appropriate Research Product Lines (RPL) comprised of needed experts to develop the new model and test it against current practice.

3-4 applications will be selected for funding up to $70,000.

STATUS: CLOSED

  • MCW GCO Submission Deadline: 02/22/2016
  • CTSI Application Submission Deadline: 02/29/2016

Integrating Research into Clinical Practice (IRCP): Digestive Disease Center Innovation in Health Care Delivery Grant RFA
Key Dates

Key Dates

  • MCW GCO Submission Deadline: February 22, 2016
  • CTSI Application Submission Deadline: February 29, 2016, 11:59pm CDT
  • Peer-Review: February/March
  • Decision letters sent out: March 18, 2016
  • Funds Available for Awarded Project: April 1, 2016

Overview

Overview

Funds will be provided to proposals with strengths in the following areas:

  • Proposals that apply innovations to increase clinical efficiency and patient satisfaction.
  • Proposals that use innovative models such as a “one stop shop” to solve complex clinical problems.
  • Proposals with potential for broad, sustainable clinical impact.
  • Proposals that improve practice, decrease costs and are creative.
  • Proposals that are simple, discreet with an end point in one year.
  • Proposals with direct clinical outcomes and impact.

Additionally, this grant is intended to fund the formation of RPLs to solve important clinical problems. Therefore, the applications will be reviewed with a focus on:

  • Research Product, i.e., the clinical issue being resolved, the impact of solving this problem and feasibility of achieving this goal;
  • Members of the Research Product Line, i.e., qualified investigators working on the clinical research question;
  • Qualifications of the Research Product Line Leader (Principal investigator) to deploy each expertise and the ability of the team to operate effectively.

Research Product Lines are anticipated to incorporate the following principles in their operations – CollaborationTransformationFacilitation and Education. CTSI will provide a research project coach to each awarded product line to support the team in navigating this award.

Definitions

Research Product is defined as the outcome of investigation into a clinical problem. This outcome may include improved process, facilitated access, improved patient satisfaction, new diagnostic or therapeutic modalities; cheaper, faster and better diagnostic or treatment outcomes.

Research Product Line is defined as a team of investigators comprised of clinicians, patients, patient advocates, clinical staff and others with relevant complementary disciplines aiming to develop a well-defined research product. This team is envisioned to be inter- or trans-disciplinary and include those with the expertise necessary to deliver the research product. DDC and CTSI seek to encourage applicants to take advantage of available expertise in the continuum of care and related disciplines such as: nursing, social scientists, ethicists, biostatisticians, informatics specialists, human factors specialists, patients, patient advocates, industrial engineers and other members of clinical care delivery teams in developing the Research Product Line.

CTSI Support

  • All Applicants, whether funded or not, have the ability to receive assistance and support with grant writing, IRB pre-review, and IRB navigation from CTSI.
  • CTSI can assist with identifying potential interdisciplinary and inter-institutional collaborators for projects.

For more information, please contact the CSTI Pilot Translational and Clinical Studies Program Director—Ramona Tenorio, PhD at 414-955-2537, rtenorio@mcw.edu.

Eligibility

Eligibility

General Guidelines and Eligibility

  • Projects will be funded at a level of up to $70,000. Institutional and departmental cost sharing to supplement these funds is highly encouraged.
  • Project duration will be 12 months or less.*
  • All projects must have an MCW PI. This award allows for, but does not mandate, a multiple PI model. All PIs must have at a minimum 5% effort on project.
  • The MCW PI will have the additional expectation of managing the award through MCW Office of Grants and Contracts and through their department. The MCW PI will be responsible for all grant reporting and fiscal management, and will be the main contact for budget and reporting management.
  • PI(s) will be expected to comply with reporting and meeting requirements as a condition of receipt and continuation of funds.
  • All PIs and Investigators must be CTSI Members. To become a member, please complete the CTSI Membership Form.
  • All PIs must have full-time or full professional effort status to be eligible to serve as principal investigators (PIs). Adjunct and part-time faculty are not eligible to apply as a PI.
  • Applications that are inter-institutional** are highly encouraged to apply. Investigators that are interested in forming new collaborative relationships are encouraged to contact CTSI. We will assist you with identifying potential interdisciplinary and inter-institutional collaborators for these projects.
  • PI(s) may submit only one application in response to this RFA. PI(s) may receive awards for successive, but not concurrent or overlapping, proposals.
  • All personnel must be identified prior to the start date to replace any “to be named” positions proposed in the application.
  • Investigators are encouraged to submit regulatory applications (IRB/IACUC, etc.) at time of application. If applicable, proof of any Exempt Status must be provided.
  • Applicants are required to contact CTSI IRB Navigator, Keryl Jones: kjones@mcw.edu at the time of application to review IRB requirements.
  • Untenured junior faculty member PIs are encouraged to apply.

Budget Information

  • 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.
  • No “indirect costs” may be charged for any CTSI funding and no funds may be requested for purchase of laboratory or clinical equipment.
  • Faculty salaries are subject to the NIH salary cap.

* 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 Translational and Clinical Studies Program Director, Ramona Tenorio, PhD at 414-955-2537, prior to applying.

** Investigative team with members from more than one of the CTSI Partner institution (MCW, UWM, MU, MSOE, CHW, BRI, VA, FMLH).

Other Terms & Conditions

National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS) 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.

Review Criteria

Review Criteria

The Clinical and Translational Science Institute will convene a special review panel comprised of members with expertise in clinical science to manage the review process and assign reviewers. Each application will be reviewed by a minimum of 2 reviewers.

Overall Impact/Priority Score

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to lead to an improved delivery of healthcare through the development of a Research Product Line (RPL). Consideration of the following program specific review criteria should be given:

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. Research Product Line

  • Are the PIs, investigators, 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 the outcomes and impact of the Research Product effectively defined, planned, and measurable?
  • 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 all intended outcomes?
  • 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?

How to Apply

Submission Details

The online IRCP Application Form must be completed and received by February 29, 2016, 11:59pm CDT. Submissions by any other means will not be accepted.

Elements & Requirements of the Application

  • 2016 Integrating Research into Clinical Practice Application Form
  • Budget and Budget Justification Form (1 per partnering institution/agency)
  • NIH Biographical Sketch (all PIs and all Co-Investigators; limit 5 pages per individual)
  • Letter(s) of Support for project from PI(s) Department Chair or Clinical Supervisor
  • Letters of Support from each Co-Investigator to the PI(s)
  • MCW Faculty Cost Sharing Commitment Form (if applicable)

Additional Requirements by Institution

For MCW investigators or any application with an MCW collaborator, applications must be routed through the Office of Grants & Contracts (GCO) no later than 5 business days before the submission deadline in this RFA.

Different departments and institutions may have different deadlines for obtaining departmental approvals prior to receipt by the Office of Grants & Contracts.

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 CenterFroedtert HospitalMedical College of Wisconsin Childrens Hospital of WisconsinBloodCenter of WisconsinUniversity of Wisconsin - MilwaukeeMarquette UniversityMilwaukee School of Engineering