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).
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 PI 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.
Community-Engaged Health Disparities Research and Under-served & Special Populations Research are special emphasis categories for 2018. 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. Examples include:
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).
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 (links to downloadable files are provided just below this list):
All applications must be routed through eBridge and must be received by the MCW Grants & Contracts Office (GCO) no later than 5 business days before the submission deadline in this RFA. Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the GCO.
eBridge Funding Proposals must be submitted to the MCW Grants & Contracts Office (GCO) by August 25, 2017, 11:59 a.m. CDT
All applications must be received by CTSI by September 1, 2017, 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, 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:
Upon submission of an Intent to Apply you will be emailed a personalized link to proceed to a 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.
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.
The CTSI must collect and submit to NIH NCATS 30 days prior to funding approval the following documentation, much of which is available from an IRB submission:
Data Safety and Monitoring of Clinical Trials: In accordance with Part II, Chapter 4 in the NIH Grants Policy Statement (PDF) the grantee must submit a data and safety monitoring plan to the NCATS for review and approval.
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 papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement. Please see page 21 of AHW REP Award Administration Manual (PDF) for the Acknowledgement Policy.
The following documents will help investigators who are required to submit documentation for NCATS Prior Approval for human subject research.