2024 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 an 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 translational science and the development of innovative tools and methods to address barriers to translational and clinical research. Applications should adhere to the principles of translational science, particularly generalizability, creativity, cross-disciplinary teams, and promotion of efficiency in research (https://ncats.nih.gov/training-education/translational-science-principles).

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.

ELIGIBILITY

• Lead PI must be from MCW due to funding source restrictions.
• Proposals must be inter-institutional: the scientific team must include investigators (either mPI or co-I) from at least two different CTSI partner institutions: Versiti, Children’s Wisconsin, Froedtert, MCW, MSOE, MU, UWM, Milwaukee VA (Zablocki). Please note, this condition is based on the investigator’s institution of primary employment. Volunteer appointments do not qualify. The ‘institution of primary employment’ is the institution that pays greater than 50% of the investigator’s salary.
  • mPIs must have a primary affiliation with any of the eight CTSI partner institutions.
  • Community partners or investigators from other academic institutions would be welcome additions to projects as co-investigators, but alone do not meet the inter-institutional requirement.
  • While identification of full investigator team is preferred at the time of the Letter of Intent submission, at a minimum, the Lead PI and mPI/Co-investigator meeting the inter-institutional requirement need to be identified on the Letter of Intent submission by the listed deadline.
  • Applicants wishing assistance in identifying scientific team members from other CTSI partner institutions should contact Renee McCoy (rmccoy@mcw.edu) or Louann Sullivan (lmsullivan@mcw.edu) prior to the Intent to Apply deadline.
• All PIs/mPIs must meet eligibility requirements for PI status at their respective institution and 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 and co-investigators must have a minimum of 1% effort. The Lead MCW PI must 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 funding.
• The Lead MCW PI is responsible for fulfilling reporting requirements as a condition of receipt and continuation of funds. Non-compliance of quarterly, final and/or annual reporting could result in the rescission of funds by CTSI.
• All PIs/mPIs must be CTSI Members. To become a member, please complete the CTSI Membership Form.

APPLICATION

• Intent to Apply submissions will be accepted only via the REDCap “Intent to Apply” link provided at https://ctsi.mcw.edu/investigator/funding/.
  • This award mechanism is focused on methodologic developments in Biostatistics, Epidemiology, and Research Design (BERD) for clinical and translational research. This means that the proposal should propose the development of new approaches to data analysis or study design that can be generalized and used in a variety of settings, and not just the application of existing methods to a particular dataset or clinical problem.
  • 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).
• Applicants must provide verifiable proof that all regulatory applications (IRB/IACUC, etc.) are in at least pre-submission status. If applicable, proof of any non-human subjects designation or approved Public Data Set by the IRB must be provided. Please see MCW Designated Public Data Sets for more information, if needed.

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 award period.
• All salary support is subject to the current NIH salary cap at time of award. Current NIH salary cap is $212,100.
• 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 funding.
• 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. No “indirect costs” may be charged. 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 31, 2023, 5:00 P.M. CDT.

Once your Intent to Apply is reviewed and approved, you will be notified by November 10, 2023, that you can proceed with the full application and sent a link to the application form and required documents.

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 submit the online REDCap application form to CTSI by 5:00 p.m. on January 8, 2024. If your application is selected for funding, a funding proposal in eBridge will be initiated at that time.

1. 2024 Pilot – BERD Methodological Innovation Award Proposal Form (A LaTeX format of the Proposal Form will be available within the grant application.)
   191 KB2024 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. No indirect costs may be charged.
   161 KB2024 Pilot – Budget and Budget Justification Form
3. NIH Biosketchin the most current NIH format is required for all PIs, mPIs, Co-Investigators, and Other Significant Contributors. (limit 5 pages per individual). Biographical Sketch Format Page (non-fellowship) Template can be found at https://grants.nih.gov/grants/forms/biosketch.htm.
4. Letters of Support / Acknowledgement / Intent to Establish Consortium
   • From Co-Investigators to mPI(s)
     • A Letter of Support is required from each co-investigator to the PI/mPI(s) explaining her/his intention and commitment to this project.
     • Letters of Support should be addressed to all mPIs.
     • A Letter of Support is not required from a mPI to the PI.
   • From Division Chief or Department Chair to the project PI/mPI.
     • To acknowledge awareness and support of the project (including cost-sharing).
   • From other institutions – Letters of Intent to Establish Consortium
     • A Letter of Intent/Support to establish consortium 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.
267 KB2024 Instructions 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/.

Versiti investigators/collaborators: Please contact your designated point of contact early in the proposal process. These proposals will need to be processed through the Versiti Grants and Contracts office observing Versiti’s standard internal deadlines.

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. Please reach out to your respective IRB office at the time of application to plan your submission. If applicable, proof of any non-human subjects designation or approved Public Data Set by the IRB must be provided. Please see MCW Designated Public Data Sets for more information, if needed.
  • Please note that all applicable projects that receive recommendation for funding must provide proof that the IRB application/amendment has been submitted by April 15, 2024; 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 early in the process 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 MCW IRBReliance@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 protections.

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.

DATA MANAGEMENT SHARING POLICY

Applicants must agree to abide by NIH data management sharing policy.^1
1NIH 2023 Data Management Sharing Policy

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.

For questions, please contact Renee McCoy, Program Director I, CTSI Pilot Translational and Clinical Studies Program, at rmccoy@mcw.edu or Louann Sullivan at lmsullivan@mcw.edu.