The CTSI Translational and Clinical Studies Program Traditional Pilot Awards are supported by the Advancing a Healthier Wisconsin Research and Education Program (AHW REP) and the National Institutes of Health (NIH).
The total available funding CTSI is offering for the 2020 cycle is $50,000 each for up to 12 meritorious projects. Due to the importance of supporting research to address the opioid epidemic in alignment with the NIH HEAL Initiative, the CTSI has set aside funding for up to 3 meritorious opioid-related pilot studies for the 2020 cycle. This does not preclude the funding of additional pilot proposals that are opioid-related and demonstrate merit.
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.
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.
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 all members of clinical health care delivery teams.
Research in these areas is not a requirement for the award; however, additional review weight will be applied to these studies as being in alignment with a focus of the CTSI.
The Clinical and Translational Science Institute of Southeast Wisconsin announced in 2018 a special emphasis category for pilot funding focused on factors contributing to opioid misuse and abuse and strategies to address the opioid epidemic.
Proposals should describe a clear link to future funding opportunities, such as specific NIH program announcements or other federal or private funding opportunities (e.g., NIDA, CDC).
Applications in this area may include but are not limited to:
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 ofthe Co-Investigator (Co-I).
Due to the requirement of the funding source for the Traditional Pilot Awards, only MCW faculty can be PIs. An MCW PI can submit more than one application but only one project can be funded, with one exception. The CTSI allows for a multiple PI model such that the Co-PI can be from a partner institution. Therefore, a second award to an MCW PI will be considered if the following are clearly explicated and justified:
The online Intent to Apply Form may be accessed by CTSI members through the form below and must be completed and submitted via REDCap by 5:00 pm CDT on June 1, 2019.
Each Intent to Apply submission that has been received by deadline will be reviewed. In cases where the submissions meet eligibility criteria and receive approval from the Committee, a personalized email containing a link to the full application will be sent to the submitting PI.
Letters of Support / Intent
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 August 1, 2019. If your application is selected for funding, a funding proposal will be initiated at that time.
For Marquette University (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. 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, firstname.lastname@example.org.
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:
Each Intent to Apply that has been received by deadline will be reviewed. In cases where the submissions meet eligibility criteria and receive approval from the Committee, a personalized email containing a link to the full application will be sent to the submitting PI.
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), and University of Wisconsin-Milwaukee (UWM).
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.
The 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 Guide Notice NOT-OD-14-073 and NOT-OD-15-106.
Projects will be reviewed based on their selected Translational T-level according to specific review criteria for each T-level grouping: T-1 and T2 will be grouped and reviewed together and T-3 and T-4 will be grouped and reviewed together.
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), NCATS is authorized to use fiscal year 2018 funds to provide infrastructure and resources for all phases of clinical trials research, but can only support clinical trials through the end of Phase IIB (with the exception of certain clinical trial activities involving treatment of a rare disease or condition; consult NCATS program staff for additional information). Therefore, unless specifically authorized via Revised Notice of Award, with attendant specific Terms of Award, no clinical trial activity beyond phase IIB using fiscal year 2018 funds may be supported by this grant through the pilot project, K or T programs. However, all phases of clinical trials may utilize infrastructure and resources provided through the CTSA.
For every applicable pilot project that receives a recommendation for funding (scheduled to be sent mid-November), CTSI will request from the PIs documentation for NCATS Prior Approval in accordance with federal requirements. The following conditions must then be met:
In order to accommodate this time restriction, CTSI requires that all IRB applications be submitted to each respective IRB by December 1, 2019. If the complete IRB application has not been submitted by December 1, 2019 the recommendation for funding may be rescinded.
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 email@example.com.
Page last modified: July 3, 2019 @ 3:53 pm CDT