Pilot Clinical and Translational Research Awards

Pilot Clinical and Translational Research Awards

The CTSI Pilot Translational and Clinical Studies Program is supported by the Advancing a Healthier Wisconsin Research and Education Program (AHW REP) and the National Institutes of Health (NIH).

For the 2018 cycle, the CTSI is set to fund 13 awards up to $50,000. These awards are intended to stimulate inter-institutional and interdisciplinary translational and clinical research among the CTSI partner institutions. By supporting collaboration, these awards will promote best practices in team science research.

Key Dates

  • RFA for 2018 Pilot cycle release date: June 1, 2017
  • Intent to Apply due: July 1, 2017
  • Full application due in MCW Grants & Contracts Office: August 25, 2017, 11:59 a.m. CDT
  • Application deadline: September 1, 2017, 5:00 p.m. CDT
  • Notification of award: December 1-15, 2017
  • Mandatory Orientation: January, 2018
  • Project Start Date: April 1, 2018

Overview

The fundamental goal of this RFA is to stimulate clinical and translational research among the institutions that comprise the CTSI of Southeast Wisconsin through meaningful collaboration and high quality team science. This award uses a multiple PI model 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:

  • Provide preliminary data for projects poised to be competitive for new extramural grant submissions;
  • Support new and promising clinical and translational projects across all disciplines, including special emphasis categories of community-engaged health disparities and underserved and special populations.
  • Model best practices in team science research;
  • Maximize scientific interactions between junior and senior investigators;
  • Stimulate collaborative research between bench and clinical investigators from similar research areas;
  • Foster interdisciplinary and inter-institutional collaborations;
  • Support research in novel technologies and/or novel approaches and 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

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

Applications will be reviewed and considered for funding based on the two NIH identified translational areas. The NIH provides the following definition:

‘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 must provide a T-level designation for the proposed research based on the CTSI translational continuum described below, based on NIH guidelines.

CTSI Pilot Award Program, Translational T-Level
  • T-0 proposals that are only T-0 are not eligible to apply. T-0 research can be described as:
    • Pre-clinical approaches designed to inform an investigator about a pathway, pathophysiology, or treatment approach. Examples include:
      • animal models of human disease, human blood or cell lines
      • development of questionnaires, computational models, and human physiological studies
    • “Bench” research which may or may not require approvals from human or animal use committees.
  • T-1 Translation to Humans
    • Studies with human participants that yield knowledge about human behavior, physiology, pathophysiology and the potential for intervention (i.e. diagnoses, therapies, etc.)
    • findings from basic research are tested for clinical effect and/or applicability. 3
  • T-2 Translation to Patients
    • test new interventions under controlled environments to form the basis for clinical application and evidence-based guidelines. 3
    • yields knowledge about the efficacy of the interventions in optimal settings. 3
  • T-3 Translation to Practice
    Pilot grants in this T level would provide preliminary evidence to compete for studies in the following areas, for example:

    • health services research & community-based participatory research (dissemination, communication, implementation research)
    • explore ways of applying recommendations or guidelines in general practice. 3
    • yields knowledge about how interventions work in real-world settings. 3
  • T-4 Translation to Communities/Population Health
    • Study factors and interventions that influence the health of populations. 3
    • results benefit society & improve global health in areas such as improving disease prevention and reducing medical costs.


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.
3 Source: Harvard Catalyst

Eligibility

  • Project proposals must be identified and will be reviewed according to Translational T-Level:

    • T-0 research proposals that are only T-0 are not eligible to apply
    • T1 – T4 as described above are eligible to apply
      • Proposals for T1-T2 studies will be reviewed and considered for funding together as a group.
      • Proposals for T3-T4 studies will be reviewed and considered for funding together as a group.
    • T5 – Research proposals that incorporate T5 (policy-level research) in addition to one of T1 through T4 are eligible to apply
  • Projects will be funded at a level of up to $50,000

  • Project duration will be 12 months

  • Principal Investigator; Investigator; Study Team Roles & Requirements

    • Note that for the purposes of this award and in the language of this RFA, the roles of Principal Investigator (PI) and Co-Principal Investigator (Co-PI) are equivalent. These are distinct and have different requirements from the roles of Investigator or Co-Investigator (Co-I).
    • PI Requirements
      • All projects must have an MCW PI.
      • All PIs must have a minimum of 5% effort and be fully vested in the project in both spirit and practice, and contribute actively on the project. It is possible – and encouraged – for PIs to seek institutional/department cost-sharing to support all or a portion of this or other effort, thereby leaving more funds available for other research expenses. In these cases, cost-sharing commitment documentation from the institution and/or department is required.
      • A letter of support from each PI’s department chair is required.
      • All PIs must have full-time or full professional effort status. Adjunct and part-time faculty are not eligible to apply as a PI.
      • This award allows for, but does not mandate, a multiple PI model. In cases where a project has multiple PIs one must be from MCW. The other PI may come from another CTSI partner institution (UWM, MU, MSOE, CHW, BRI, VA, FMLH). According to MCW corporate policy, the MCW PI will be primarily responsible for ensuring compliance with the scientific, safety, and ethical responsibilities of the grant award.
      • The MCW PI will have the additional expectation of managing the award through the MCW eBridge system and through her/his 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.
      • PIs are responsible for fulfilling reporting requirements as a condition of receipt and continuation of funds. Non-compliance of final and/or annual reporting could result in the rescinding of funds by CTSI.
      • All PIs must be CTSI Members. To become a member, please complete the CTSI Membership Form.
    • Inter-Institutional Requirement
      • Projects must be inter-institutional: the research team must include investigators from at least two of the five CTSI academic/research partner institutions (UWM, MU, MCW, MSOE, BCW) participating on a project.
      • Independent investigators from our clinical partners (VA, Froedtert, CHW) may meet the requirement only if they are not primarily employed by MCW. An example of this would be a CHW nurse researcher who is primarily employed at CHW.
      • Community partners or investigators from other academic institutions would be welcomed additions to projects as Co-PIs or Co-Is, but alone do not meet the inter-institutional requirement. Please note, only primary employment will be used in determining institutional affiliation.
      • Faculty from the MU/MCW joint department of biomedical engineering should use their employment platform to determine institutional affiliation. However, two faculty alone from this department will not fulfill the inter-institutional requirement.
      • All Investigators must be CTSI Members. To become a member, please complete the CTSI Membership Form.
      • Investigators that are interested in forming new collaborative relationships are encouraged to contact the CTSI Pilot Award Program Manager, Christine Zeller at 414-955-2524 or czeller@mcw.edu.
    • All personnel must be identified prior to the start date to replace any “to be named” positions proposed in the application.
    • Untenured junior faculty members and early-stage investigators are encouraged to apply.

Regulatory Requirements

  • Investigators must provide proof that all regulatory applications (IRB/IACUC, etc.) are in pre-submission or approved by time of application. If applicable, proof of any Exempt Status must be provided.
  • If your project involves human subject research, all study team members must obtain CITI training.
  • If your project involves FDA regulated research, all study team members must obtain training in Good Clinical Practice (GCP).
  • Clinical trials that utilize any Froedtert Hospital (FH) resources – medical records, staff, facilities, equipment, etc. – in one way or another, must be reviewed via the Office of Clinical Research and Innovative Care Compliance (OCRICC) to ensure that FH has the staff, equipment, and other resources to successfully support the trial. Visit the OCRICC website for a list of services that require OCRICC approval.
    • Submitting your project’s OCRICC application at the same time as the IRB submission will facilitate the FH administrative approval, and will typically follow notification of MCW/FH IRB approval within an average of 3 business days.
    • When applying for OCRICC approval for a CTSI pilot project, please add “CTSI PILOT” in the title of your OCRICC application. This will help to expedite the approval process.
  • Applicants are encouraged to contact CTSI IRB Navigator, Sonia Maldonado-Schmidt: smaldonado@mcw.edu and the MCW IRB office at MCWIRBReliance@mcw.edu at the time of application for assistance in managing IRB(s).

* 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 Christine Zeller at czeller@mcw.edu or 414-955-2524 prior to applying.

Budget Requirements

  • 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.
  • AHW REP funds cannot be used to supplant funds or resources that are available from other sources. However, matching funding and opportunities to leverage AHW funds to obtain other sources of financial support are encouraged.
  • No “indirect costs” may be charged. For more information on allowable expenses, please view the Advancing a Healthier Wisconsin Research and Education Program Award Administration Manual (PDF).
  • Faculty salaries are subject to the NIH salary cap (FY15 Executive Level II salary cap of $181,500).

Special Emphases

2018 Special Emphases

Community-Engaged Health Disparities Research and Under-served & Special Populations Research are special emphasis categories for 2018. Additional review weight will be applied to research in these respective areas.

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:

  • the clear potential to directly translate anticipated results into improved preventative health, diagnostics, therapeutics or health outcomes for our southeast Wisconsin community; and
  • the potential for proposed studies, when completed, to generate extramural funding.

Upon submission of an Intent to Apply you will be emailed a personalized link to proceed to a full application.

The CTSI Pilot Award Committee (PAC) will initially review all applications for technical feasibility and compliance with above requirements. CTSI PAC is comprised of members from partner institutions MCW, MSOE, UWM.

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

Projects are reviewed based on their selected Translational T-level. Specific review criteria for each Translational Track can be viewed in the documents below.

  • T-1 and T-2 Review Guide and Score Sheet
  • T-3 and T-4 Review Guide and Score Sheet
341 kBTranslational Track 1 Review Guide and Score Sheet 286 kBTranslational Track 2 Review Guide and Score Sheet
Terms & Conditions

National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS)
Terms and Conditions for CTSI Pilot Award Projects

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.
NCATS PRIOR APPROVAL FOR STUDIES INVOLVING HUMAN SUBJECTS

The CTSI must collect and submit to NIH NCATS 30 days prior to funding approval the following documentation, much of which is available from an IRB submission:

  • The complete clinical research protocol and consent document(s). If the clinical research protocol is considered an amendment to a parent protocol, include information explaining exactly what is being supported by NCATS pilot 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
  • Targeted Enrollment Table or Inclusion Data Record (IDR)
  • Data and Safety Monitoring Plan (DSMP) and Board (DSMB), if applicable.
  • Certification that the pilot awardee and any key personnel directly involved in the study have taken appropriate education in protection of human subjects.
STEM CELLS
  • 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. 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. For more information, view the NIH Guidelines on Human Stem Cell Research
HUMAN/ANIMAL SUBJECTS RESTRICTION
    • It is understood that no clinical research trainee 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.

    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 in the NIH Grants Policy Statement (PDF) for specific requirements and grantee responsibilities related to the protection of human subjects.

DATA SAFETY AND MONITORING OF CLINICAL TRIALS
  • Data Safety and Monitoring of Clinical Trials: In accordance with Part II, Chapter 4 in the NIH Grants Policy Statement (PDF) the grantee must submit a data and safety monitoring plan to the NCATS for review and approval.
CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE

CTSI seeks to promote the highest quality of human subjects research, therefore as part of the post award process, pilot projects that were ranked 4.5 or higher on the NIH Likert scale, will be analyzed for trends in deficiencies. The purpose of this analysis will result in generalizable knowledge, as required by NCATS, and be used for educational training opportunities to enhance translational science and investigator knowledge. Note, this quality improvement initiative will have no impact on the CTSI Pilot Review process. All information shared as educational material will be de-identified. For any questions or concerns, please contact the project lead, Amit Gode, MD, MCW CTO Director at agode@mcw.edu

How to Apply

How to Apply

Required Application Materials

(to be released June 1, 2017)

  1. 2018 CTSI Pilot Award Proposal Form
  2. Budget and Budget Justification Form (1 each per partnering institution/agency)
  3. MCW Faculty Cost Sharing Commitment Form (if applicable)
  4. NIH Biographical Sketch is required for all PIs; Co-PIs; Investigators; Co-Investigators (limit 5 pages per individual)
  5. AHW Goals Alignment Form
  6. AHW Non-Supplanting Attestation Form is required for each PI; Co-PI; Investigator; Co-Investigator
  7. Letter of Support for project from PI(s) Department Chair (if required by your institution)
  8. Letters of Support from each Co-Investigator to the PI(s)

All applications must be routed through eBridge and must be received by the MCW Grants & Contracts Office (GCO) no later than 5 business days before the submission deadline in this RFA. Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the GCO. Please note: indicate AHW-Research and Education Program as Primary Sponsor with CTSI as Secondary Sponsor.

The online Intent to Apply Form must be completed and submitted by July 1, 2017 5:00 p.m. CDT.

eBridge Funding Proposals must be submitted to the MCW Grants & Contracts Office (GCO) by August 25, 2017, 11:59 a.m. CDT

All applications must be received by CTSI on September 1, 2017, 5:00 p.m. CDT.

Additional Requirements by Institution

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 sub-awardees 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 sub-award 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 Sheku Kamara, Dean of Applied Research, 277-7416, kamara@msoe.edu

AHW REP and NIH Funding Acknowledgment: Important Reminder – Please acknowledge the AHW REP and NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement. Please see page 21 of AHW REP Award Administration Manual (PDF) for the Acknowledgement Policy.

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