The CTSI Translational and Clinical Studies Program Traditional Pilot Awards are supported by the Medical College of Wisconsin and the National Institutes of Health (NIH).
Up to 5 meritorious projects will be awarded at up to $50,000 each for the 2023 Traditional Pilot cycle, which will include at least one meritorious scoring proposal with the special emphasis of Underrepresented Minority Populations.
Team Science: These awards are intended to stimulate inter-institutional and interdisciplinary/multidisciplinary clinical and translational research among the CTSI partner institutions. In supporting such collaboration, these Pilot awards promote and support best practices in team science research.1
1For more information on team science, see: Collaboration and team science: From theory to practice; Making virtual teams work: Ten basic principles; Team science learning module from Northwestern University
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 on 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.
**Funding will not be released until all regulatory approvals are in place.
*** All funds must be EXPENDED within the 12-month award period. No extensions are permitted.
ABOUT THE CTSI PILOT TRANSLATIONAL AND CLINICAL STUDIES PROGRAM (PTCS)
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, we strive to improve health outcomes by creating new, bidirectional flows of information between our biomedical research enterprise and the community we serve.
GOALS OF THIS FUNDING OPPORTUNITY
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 investigator model to encourage inter-institutional and interdisciplinary collaboration between clinical and basic biomedical scientists, social scientists, ethicists, engineers, biostatisticians, informatics specialists, and other members of the clinical health care delivery team with the appropriate training and expertise to make a substantive scientific contribution to the study.
FUNDS WILL BE PROVIDED TO:
This CTSI Pilot Translational and Clinical Studies Program (PTCS) funds clinical and translational research according to the NIH definitions described below:
The NIH definition of clinical research1 has three parts:
Applications will be reviewed and considered for funding based on NIH-identified translational areas.
Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes.
Applications must provide a T-level designation for the proposed research according to the CTSI translational continuum described below, based on NIH guidelines. Applications for this funding mechanism must be in a T1-T53 translational area. T0 proposals are not eligible. Preference will be given to meritorious T3-T5 proposals.
Proposals that are only T-0 research – Basic Biomedical Science or Discovery (Goal: To understand the human condition and environment as it exists) are not eligible to apply.
Funds will be set aside for at least one meritorious scoring proposal with the special emphasis of Underrepresented Minority Populations.
Underrepresented Minority Populations as defined by the NIH4:
Note that in the language of this RFA, the roles of Principal Investigator (PI) and multiple-Principal Investigator (mPI) are equivalent. For the Traditional Pilot Awards, only CTSI partner institution faculty meeting their institution’s requirements to serve as PI can be listed as PIs or mPIs. These are distinct and have different requirements from the roles of the Co-Investigator (Co-I).
An MCW PI can submit more than one application but only one project can be funded, with one exception. A second award to an MCW PI will be considered if the following are clearly explicated and justified:
For questions, please contact the CTSI Pilot Award Program manager, Renee McCoy, at firstname.lastname@example.org.
To help expedite OCRICC approval:
FIRST STEP: THE ONLINE INTENT TO APPLY FORM MUST BE COMPLETED AND SUBMITTED BY June 1, 2022, 5:00 P.M. CDT.
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 at 2023 Traditional Pilot Awards).
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 grant application to CTSI by 5:00 p.m. on September 1, 2022.
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 email@example.com. 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 firstname.lastname@example.org 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: email@example.com
MSOE investigators, please contact Sheku Kamara, Dean of Applied Research (firstname.lastname@example.org), 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.
Each Intent to Apply that has been received by deadline will be reviewed; for those that meet eligibility criteria and are approved, the submitting MCW PI will be notified and sent a personalized link to proceed with the full application.
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 that must be met for funding of any proposal include:
CTSI and 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 Marquette University (MU), Medical College of Wisconsin (MCW), Milwaukee School of Engineering (MSOE), University of Wisconsin-Milwaukee (UWM), and Versiti Blood Research Institute (Versiti).
All applications will undergo peer-review. To assist you in developing a strong proposal, specific review criteria will be available within the online application form for your reference.
CTSI participates in a national CTSA External Reviewer Exchange Consortium (CEREC) to improve fairness in the scientific review process and better match applicants with feedback from experts in their respective fields. Applications for this cycle may be reviewed externally through our association with CEREC and we require that you acknowledge within the online application form that your proposal may undergo external review.
Maintaining confidentiality throughout the peer review process is essential to allow for the candid exchange of scientific opinions and evaluations; and to protect trade secrets, commercial or financial information, and information that is privileged or confidential. Similar to the NIH peer review process, the CTSI is committed to protect the integrity of and to maintain confidentiality in peer review. See NOT-OD-18-115.
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.
RESTRICTION OF CLINICAL ACTIVITY BEYOND THE END OF PHASE IIB
In accordance with section 479(b) of the Public Health Service Act (as amended by the Consolidated Appropriations Act, 2012, Public Law 112-74 and by the 21st Century Cures Act, 2016, Public Law 114-255), no clinical trial activity beyond phase IIB may be supported by this grant through this Pilot award.
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.
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
(NIH Grants Policy Statement) for specific requirements and grantee responsibilities related to the protection of human subjects.
HUMAN SUBJECTS EDUCATION CERTIFICATION REQUIREMENT
completed education on the protection of human subjects, in accordance with NIH policy,
Required Education in the Protection of Human Research Participants. Any individual involved in the design and conduct of the study that is not included in the certification must satisfy this requirement prior to participating in the project. Failure to comply can result in the suspension and/or termination of this award, withholding of support of the continuation award, audit disallowances, and/or other appropriate action.
Demographic Data Collection
Similar to NIH requirements, recipients/offerors must submit data on participant age at enrollment in progress reports. Investigators planning to conduct research involving human subjects should design their studies in such a way that de-identified individual-level participant data on sex/gender, race, ethnicity, and age at enrollment may be provided in progress reports. Age at enrollment may be reported in units ranging from hours to years. Recipients/offerors are responsible for ensuring informed consent documents allow submission of de-identified individual-level data on participant sex/gender, race, ethnicity, and age at enrollment.
CLINICAL AND 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.
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 Traditional 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.
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.
Questions? Please contact Renee McCoy, CTSI Pilot Award Program manager at email@example.com.