The vision is to organize and leverage clinical/translational research to improve patient health and health care. The mission of an ICRE is to integrate clinical and research faculty, community stakeholders and health system representatives in highly innovative and efficient units/Ensembles to get more treatments and interventions more quickly to more patients and our community.
Ensembles are groups that may be comprised of appropriate basic/clinical and translational investigators, clinicians, patients, patient advocacy groups, community stakeholders and health system experts to provide solutions to unmet health needs emanating from clinic, community and the laboratory. This design allows for identification of real unsolved patient care problems and provides the opportunity for the Ensemble members to develop a solution to these unmet shortcomings.
The goal of this Pilot/ICRE funding path is to foster the development of these Ensembles to collaboratively focus on advancing the health of our patients and community through clinical and translational research; thus, it is not required that all potential ICRE participants be present at the time of application. Once the appropriate Ensemble is formed, the research portion of the Pilot/ICRE Awards will support small, short-term feasibility studies addressing the identified unmet clinical need for the purpose of developing a strong, highly competitive proposal for our Translational and Clinical Pilot (TCP) Award or other comparable proposal.
The duration of the Pilot/ICRE Award is 12 months; this includes time for team development and for the conduct of research projects. The expected outcome of these research Ensembles should demonstrate a clear path leading to a clinical and translational research proposal submission to CTSI partner institutions or for extramural funding. A total of 4 to 5 awards are available for up to $35,000 each (funded using NIH dollars) and are intended to develop effective, integrated and interdependent teams with long-term collaborations.
** CTSI is supported by the National Institutes of Health, National Center for Advancing Translational Sciences. As such, CTSI is required to submit documentation based on IRB and/or IACUC approval for each applicable project. NCATS requires at least 30-days to review approval requests. To accommodate this requirement, Pilot/ICRE teams must allow time within the first few months of the award for any required regulatory, safety, or other ancillary committee approvals to be obtained and for the NCATS Prior-Approval request to be received. Timeliness is important to avoid delays that could affect the project timeline.
** No-cost extensions will NOT be allowed; all research expenses must be incurred by May 31, 2022.
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 the Co-Investigator (Co-I).
Proposals will not be permitted to use funding for the research project if any required regulatory, safety, or other ancillary committee approvals are not in place and submitted/approved by NCATS at the time the proposed research is to start. This includes IRB; IACUC; OCRICC; IBC (biosafety); etc.
Pilot/ICRE applications that include a(n):
MCW CoPI applications must be routed through MCW eBridge and must be received by the MCW GCO at least 5 business days before the CTSI submission deadline. Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the GCO. Once the eBridge Funding Proposal has been institutionally approved, the online application form must be completed and submitted via REDCap by the CTSI deadline.
MU CoPI (or co-investigators), applications may need to be registered via the routine Proposal Registration process with the Office of Research and Sponsored Programs (ORSP) prior to submission. Please contact an ORSP staff member (https://www.marquette.edu/research-sponsored-programs/) early in your application preparation process to ensure accurate compliance. Email: firstname.lastname@example.org.
UW-Milwaukee CoPI (or co-investigators), applications may 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/) early in your application preparation process to ensure accurate compliance. Email: email@example.com
MSOE CoPI (or co-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/.
The online 2021 Pilot/ICRE Application may be accessed by CTSI members through the form below and must be completed and submitted via REDCap by 5:00 pm CDT on February 1, 2021.
National Institutes Of Health (NIH) National Center For Advancing Translational Sciences (NCATS) Additional Terms And Conditions
When defining the research project portion of the application, it is important to note:
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 2020 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 2020 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.
CTSI is supported by the National Institutes of Health National Center for Advancing Translational Sciences (NCATS). As such, CTSI is required to submit documentation based on IRB and/or IACUC approval for each applicable research project. For any research project involving human and/or animal subject research, including human subjects’ data/specimens, the CTSI must collect and submit to NIH NCATS specific documentation, much of which is available from an IRB/IACUC submission. NCATS requires at least 30-days to review approval requests and prior approval must be received prior to starting any human and/or animal subject research. To accommodate this requirement, Pilot/ICRE teams will need to allow time within the first few months of the award for any required regulatory, safety, or other ancillary committee approvals to be obtained and for the NCATS Prior-Approval request to be received. Timeliness is important to avoid delays that could affect the research project timeline. For every applicable Pilot/ICRE proposal that receives a recommendation for funding, CTSI will request from the CoPI/Team Lead documentation for NCATS Prior Approval in accordance with federal requirements.
A limited list of the NCATS Prior Approval requirements is listed below. If a clinical trial is proposed as the Pilot/ICRE research project, multiple additional requirements apply.
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.
It is understood that no clinical research trainee or mentor will be permitted to work on any researchproject 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 in the NIH Grants Policy Statement (PDF) for specific requirements and grantee responsibilities related to the protection of human subjects.
This award reflects the NCATS’ acceptance of the certification that all key personnel have 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 research 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.
CTSI is supported by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS); as such, CTSI is required to submit reports to NIH NCATS. Awardees will be required to provide timely Pilot Interim Progress Reports documenting Ensemble development and the respective research project. In addition, awardees will be required to respond to annual surveys, i.e., The CTSI Pilot Award Annual Survey. These surveys will be sent to awardees after the completion of their CTSI Pilot/ICRE Award and are to be completed annually for at least 5 years and up to a period of 10 years.
Please help to ensure the future of clinical and translational research at the CTSI partner institutions. Cite the National Institutes of Health (NIH) CTSA award any time you use CTSI resources, services, and facilities, or refer to your CTSI-funded Pilot/ICRE Award in a presentation or publication using the following listed language (as available at CTSI CITEit):
The project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, Award Number UL1TR001436. The content is solely the responsibility of the author(s) and does not necessarily represent the official views of the NIH.