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CTSI Pilot Translational & Clinical Studies Program Methodological Innovation Award RFA

CTSI Pilot Translational and Clinical Studies Program (PTCS) Methodological Innovation Award Request for Applications

The CTSI of Southeast WI Pilot Translational and Clinical Studies Program (PTCS) is pleased to announce a new opportunity for a Biostatistics, Epidemiology, and Research Design (BERD) Methodological Innovation Award, and requests applications for funding to support development of methodological research. The purpose of this award is to promote innovative tools and methods to address barriers to translational and clinical research.

The actual topics of methodologic research will include developing novel methodologic strategies to more efficiently analyze “big data” related to clinical and translational research. Translational research takes scientific discoveries developed in the laboratory, in the clinic or in the community and transforms them into new treatments and approaches that improve the health outcomes of the population. Cost- and comparative-effectiveness of prevention and treatment strategies is also an important part of translational science.

Traditional approaches to collecting clinical trial data (e.g., patient recruitment) yield only moderate sample sizes due to cost prohibition. The recent availability of “big data” sets has brought an enormous opportunity to improve the effectiveness of translational science, including precision medicine.

Through this grant mechanism for funding, we anticipate development of novel methods to improve the efficiency and feasibility of biostatistical and computational methodology for clinical and translational research.

The proposed projects may include but are not limited to the following:

  • modeling complex high-dimensional data,
  • integrating data from clinical trials and observational studies to optimize analysis efficiency,
  • designing trials which can address multiple questions,
  • properly accounting for inference on a large number of scientific questions and hypotheses,

In addition to being methodological, proposals should clearly demonstrate future applied benefits to at least one of the three BERD components: Biostatistics, Epidemiology, and Research Design.

The duration of the Award is 12 months. Under this mechanism, up to 2 awards for meritorious proposals will be selected for up to $25,000 each.

KEY DATES

  • Intent to Apply due: October 29, 2021 @ 11:59 p.m. CDT
  • Application Deadline via REDCap: December 15, 2021 @ 5:00 p.m. CDT
  • Notifications of recommendation for award: March 8, 2022
  • IRB Submission Deadline: March 15, 2022*
  • Pilot-BERD start date: May 1, 2022**
  • Pilot-BERD end date: April 30, 2023***

*Applications must meet the respective institution’s grant/research office notification requirements.
**Funding will not be released until all regulatory approvals are in place.
***No-cost extensions will NOT be allowed; all research expenses must be incurred by April 30, 2023.

ELIGIBILITY

  • Lead PI must be from MCW due to funding source restrictions.
  • mPIs must have a primary affiliation with any of the eight CTSI partner institutions: Children’s Wisconsin, Froedtert Hospital, Marquette University, Medical College of Wisconsin, Milwaukee School of Engineering, UW-Milwaukee, Versiti, and Zablocki VA Medical
    • Inter-institutional collaboration among CTSI Partner Institutions is not a requirement of this RFA but is highly encouraged at the mPI or co-investigator level. (See Reviewer Instructions under “How to Apply” regarding evaluation and scoring related to collaboration.)
  • All PIs/mPIs must meet eligibility requirements for PI status at their respective
  • All PIs/mPIs must have full-time or full professional effort status. Adjunct and part-time faculty are not eligible to apply as a PI/mPI.
  • All PIs/mPIs 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 encouraged that PIs/mPIs seek institutional/department cost-sharing to support all or a portion of personnel effort, thereby leaving more funds available for other research expenses. Note: cost-sharing commitment documentation is not required at the time of application and is only required for projects which have received recommendation for
  • The Lead PI is 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 rescission of funds by
  • All PIs/mPIs must be CTSI Members. To become a member, please complete the CTSI MembershipForm.

APPLICATION

  • Intent to Apply submissions will be accepted only via the REDCap “Intent to Apply” link below.
    • Each Intent to Apply that has been received by the deadline will be reviewed. For those that meet eligibility criteria and are approved, the submitting MCW PI will be notified and sent a direct link to the “Grant Application”.
  • Grant applications will undergo a scientific review by individual reviewers with appropriate subject area expertise, and highly ranked proposals will be further discussed by a committee comprised of the BERD Review Committee and Pilot Award Committee (i.e., biostatisticians, epidemiologists, and stakeholders as determined by the content of proposals).

BUDGET REQUIREMENTS

  • Projects will be funded at a level of up to $25,000.
  • Project duration will be 12 months (no extensions are permitted).
  • All funds must be EXPENDED within the 12-month
  • All salary support is subject to the current NIH salary cap at time of award. Current NIH salary cap is $199,300.
  • Effort must be specified for all personnel, even when cost-sharing. Indicate any cost-sharing within the budget justification and within a Letter of Support; cost-sharing commitment forms are no longer required at the time of application and need only be provided from MCW departments upon notification of recommendation for
  • One budget form is required for each CTSI partner institution providing personnel effort on the study that is not considered consultative or fee-for-service. Consultant and/or service fees sourced from another institution or agency such as Children’s Wisconsin or Froedtert Hospital can be included on the MCW budget and need not be paid via a subcontract. Use the appropriate budget template provided within the application.

HOW TO APPLY

FIRST STEP: THE ONLINE  INTENT TO APPLY FORM MUST BE COMPLETED AND SUBMITTED BY October 29, 2021, 11:59 P.M. CDT.

REQUIRED APPLICATION MATERIALS

Once the Intent to Apply Form is reviewed and approved, applicants will be sent a link to an online application form which must be submitted along with the following documents (templates are available below).

Grant applications for this award are not required to be submitted in eBridge. Instead of starting a funding proposal in eBridge, please simply submit the online REDCap application form to CTSI by 5:00 p.m. on December 15, 2021. If your application is selected for funding, a funding proposal in eBridge will be initiated at that time.

  1. 2022 Pilot – BERD Methodological Innovation Award Proposal Form
    52 KB2022 Pilot – BERD Methodological Innovation Award Proposal Form
  2. Budget and Budget Justification Forms, one form is required for each partner institution providing personnel effort on the project that is not considered consultative or fee-for-service. Cost-shared effort should be identified on the budgets.
    36 KBBudget and Budget Justification-Form
  3. NIH Biosketch in the most current NIH format is required for all PIs, Co-Investigators, and Other Significant Contributors. (limit 5 pages per individual)
    28 KBNIH Biosketch Exp 02-28-2023
  4. Letters of Support / Intent / Acknowledgement
    • From Co-Investigators to mPI(s)
      • A Letter of Support is required from each co-investigator to the mPI(s) explaining her/his intention and commitment to this project.
      • Letters of Support should be addressed to allmPIs.
      • A Letter of Support is not requiredfrom a mPI to the other PI(s).
    • From Division Chief or Department Chair to the project mPI(s).
      • To acknowledge the resources are available for the mPI(s) (including cost-sharing).
    • From other institutions – Letters of Intent
      • A Letter of Intent/Support is required from any non-MCW institution indicating a willingness to negotiate a project-specific subaward and validation that the institution is on-board with the project and is aware of the effort commitments being made.

For Your Reference, please see the Instructions for Completing Reviews for CTSI Pilot-BERD Proposals.

157 KBInstructions for Completing Reviews for CTSI Pilot-BERD Proposals

ADDITIONAL REQUIREMENTS BY INSTITUTION

For Marquette University (MU) investigators involved in a grant application, please contact the Proposal Planning and Development team in the Office of Research and Sponsored Programs (ORSP) early in the proposal development process. You can reach ORSP through your normal contacts or at orspppd@marquette.edu. Following contact with ORSP, next steps and the process for internal routing and approvals will be determined. ORSP can assist with forms, budget formulation, proofreading, securing sub-award letters of intent, etc. ORSP involvement is essential in making sure your application has received any necessary approvals prior to submission. If you are unaffiliated with MU and would like to collaborate with a Marquette investigator, please contact the Proposal Planning and Development team within ORSP at orspppd@marquette.edu or if the collaborator has been identified, they can contact ORSP.

UW-Milwaukee investigators: applications will need to be routed using the WISPER system and approved by the Office of Sponsored Programs (OSP) prior to submission. Please contact an OSP staff member (https://uwm.edu/officeofresearch/contact/#pre-award) early in your application preparation process to ensure accurate compliance. Email: grant-notice@uwm.edu.

MSOE investigators, please contact Sheku Kamara, Dean of Applied Research (kamara@msoe.edu), and fill the Early Notification Form at https://www.msoe.edu/faculty-staff/grant-policies-procedures/early-notification-form/.

REGULATORY REQUIREMENTS

  • If applicable, researchers must obtain full regulatory approvals for the identified research We anticipate that many proposals will involve research that is Not human (or animal) subject research; therefore, IRB/IACUC regulatory requirements may not be applicable.
    • PIs must provide verifiable proof that all regulatory applications (IRB/IACUC, etc.) are in at least pre-submission. If applicable, proof of any exempt status must be provided.
    • Please note that all applicable projects that receive recommendation for funding must provide proof that the IRB application/amendment has been submitted by March 15, 2022; this is a firm deadline. This requirement is to accommodate necessary timelines for receiving notice of award and funding.
    • Applicants are encouraged to contact CTSI IRB Navigator, Charlotte Klis for assistance with any IRB-related issues: cklis@mcw.edu.
    • *“NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.” (https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm)
      • Please reach out to your respective IRB Reliance office at the time of application if needed. Please note that if you request that the MCW IRB serve as single IRB for a project, and if your project requires IRB oversight for sites outside of the Milwaukee area CTSI partner institutions, there may be a fee associated with this service. Additionally, please be aware that IRB reliance is a process that can take some time as all sites must ensure that they understand the project, are willing to rely or accept IRB oversight, ensure their local requirements have been satisfied, and agree with the terms of the reliance. Each site may have their own unique reliance documentation system. MCW IRB Reliance can be reached at MCWIRBReliance@mcw.edu.
    • Clinical research and clinical trials that utilize any Froedtert Hospital (FH) resources – medical records, staff, facilities, equipment, etc. – 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 study. Visit the OCRICC website for a list of services that require OCRICC approval. To help expedite OCRICC approval:
      • Submit your project’s OCRICC application at a minimum at the same time as your IRB submission. Note: OCRICC application requires ALL project documents. This supports OCRICC’s timely and efficient operational and financial feasibility review. A project submitted without all required documents is placed On Hold.
      • Add “CTSI PILOT” in the title of your OCRICC application
      • Notify OCRICC when you receive IRB approval
  • It is understood that no clinical research study member 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 (NIH Grants Policy Statement) for specific requirements and grantee responsibilities related to the protection of human subjects.
  • If your project involves human subject research, all study team members must obtain CITI training or equivalent training in human research

TERMS & CONDITIONS

Although not directly funded with National Institutes of Health (NIH) dollars, CTSI follows NIH National Center for Advancing Translational Sciences (NCATS) and Medical College of Wisconsin (MCW) Terms and Conditions for all CTSI Pilot Award Projects.

Applications with projects that include a new clinical trial with prospective enrollment of patients are not allowed.

CLINICAL & TRANSLATIONAL SCIENCE INSTITUTE (CTSI) RESOURCES FOR APPLICANTS

CTSI provides access to numerous CTSI resources and services. These include but are not limited to the MCW Clinical Trials Office (CTO), Adult, Pediatric, Community/Mobile, and Zablocki VA/Geriatric Translational Research Units (TRU), REDCap Secure Data Collection & Storage, as well as research support services in Biomedical Informatics, and Biostatistics / Epidemiology Research Design (BERD).Please see our website for resources available to our investigators and applicants.

REPORTING

As an NIH supported program, the CTSI is required to collect benchmark, annual progress, and long-term outcomes reports of all Pilot awarded projects. Timely progress and reporting of the funded research project is a requirement of the award.

The CTSI BERD-Pilot Awards are funded by the Medical College of Wisconsin (MCW). All applications and awarded projects must follow respective processes including but not limited to reporting requirements.

FUNDING ACKNOWLEDGMENT

Important Reminder – Please acknowledge the National Institutes of Health (NIH) CTSA award when publishing or presenting any outcomes resulting from your study by including the CTSI Funding Acknowledgement.

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

Children's Hospital of WisconsinMarquette UniversityMSOEUWMVersitiVA Medical Center