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 2019 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 2019 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.
*CTSI is supported by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS). As such, CTSI is required to submit documentation based on IRB approval for each applicable pilot project that has been recommended for funding. NCATS requires IRB approval and all related documentation at least 30 days before the project start date. To accommodate this timeline, IRB must be submitted no later than December 1, 2018 or the recommendation for funding may be withdrawn.
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.
The NIH definition of clinical research has three parts:
Applications will be reviewed and considered for funding based on NIH-identified translational areas:
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
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.
Proposals for T1-T2 studies will be grouped and reviewed together; likewise proposals for T3-T4 studies will be grouped and reviewed together.
PLEASE NOTE: It is important to propose a project which is feasible within the given timeframe and budget of the pilot award. Pilot studies are by definition smaller in nature than those involving Phase II, III, and IV Clinical Trials, and would only provide preliminary evidence for these larger studies. In these cases, and especially for T-3 and T-4 studies, when determining the T-Level of your pilot project, use the descriptions below as a reference for the type of larger study your pilot project would directly support.
3 Source: Harvard Catalyst
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).
An individual may submit more than one proposal within a cycle as long as the studies’ aims and objectives are distinct; however, an individual may not hold more than one traditional pilot award per cycle in the role of PI or Co-PI. The role of PI/Co-PI must remain as originally submitted.
First, our Intent to Apply Form must be submitted via REDCap by June 1, 2018 @ 5:00 p.m. CDT
The Intent to Apply will be reviewed to determine if the proposed project meets eligibility requirements. If approved, applicants will be notified via email that includes a link to a personalized online application form.
The next step will be to prepare application materials for submission which include the following:
All applications must first be submitted via an eBridge Funding Proposal (FP) by the MCW PI to the MCW Grants & Contracts Office (GCO) for institutional approval by July 25, 2018 @ 11:59 a.m. CDT.
Once the FP has been institutionally approved, i.e. moved to the state of Pending Sponsor Decision, the online REDCap application form must be completed and submitted with all required documentation to CTSI by August 1, 2018 @ 5:00 p.m. CDT.
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, 414-277-7416, 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; those that meet eligibility criteria will be approved, at which point the submitting PI will be notified and sent a personalized link to proceed with the 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 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, an in-person panel review, and a post-panel 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.
National Institutes of Health (NIH) 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
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, 2018. If the complete IRB application has not been submitted by December 1, 2018 the recommendation for funding may be rescinded.
The current version of the CHECKLIST for NCATS PRIOR APPROVAL (PDF) provides a reference for the types of documents that will be required, but please note this version is subject to change. CTSI has developed a REDCap repository into which PIs will upload documents and which includes the most up-to-date version of the checklist along with detailed instructions and templates to facilitate this process.
HUMAN/ANIMAL SUBJECTS RESTRICTION
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 email@example.com
AHW REP and NIH Funding Acknowledgment: Important Reminder – Please acknowledge the AHW REP and NIH when publishing or presenting any outcomes resulting from your study by including the CTSI Funding Acknowledgement. Please also refer to page 21 of AHW REP Award Administration Manual (PDF) for the AHW Acknowledgement Policy.
The current version of the CHECKLIST for NCATS PRIOR APPROVAL (PDF) provides a reference for the types of documents that will be required, but please note this version is subject to change. CTSI has developed a REDCap repository into which PIs will upload documents and which includes the most up-to-date version of the checklist along with detailed instructions and templates to facilitate this process.397 KBCTSI PILOT NCATS PRIOR APPROVAL CHECKLIST