2021 CTSI Pilot/Integrated Clinical and Research Ensemble (ICRE) Award

Co-Principal Investigator & Study Team Roles

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).

• Inter-institutional collaboration among CTSI academic/research partner institutions is required. This requirement includes:
  • A Core Team made up of CoPIs from at least two different CTSI partner institutions:
  • Children’s Wisconsin, Froedtert Hospital, Marquette University, Medical College of Wisconsin, Milwaukee School of Engineering, UW-Milwaukee, Versiti, and Zablocki VA Medical Center.
  • CoPIs must have a primary affiliation with any of these eight CTSI partner institutions. For joint affiliations and appointments, the institution of primary employment will be the determining factor.
• Pilot/ICREs require that an Ensemble designate one CoPI per Ensemble as the Contact CoPI/Team Lead. This individual will be responsible for all grant and fiscal compliance and management, as well as related reporting requirements ensuring compliance with the scientific, safety, and ethical responsibilities of the grant award.
• All CoPIs must meet all eligibility requirements for PI status at their respective institution.
• All Ensemble CoPIs must be CTSI Members. To become a member, please complete the CTSI Membership Form.
• Coinvestigators from CTSI partner institution, the community, or from academic institutions outside the CTSI would be welcome additions.

Regulatory Requirements

• Because inter-institutional collaboration is a requirement of the Pilot/ICREs, any research projects that require IRB approval, will need to work with the respective IRB to complete an Investigator Reliance Request to determine appropriate IRB and obtain Deferral notice from respective IRBs.
• Human/Animal Subjects Research projects need to have IRB/IACUC approval. If applicable, proof of any Exempt or Non-Human Subjects Research Status must be provided.
• Research conducted at Froedtert Hospital will need OCCRIC approval.

IMPORTANT NOTE:
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.

Budget Requirements

• Proposals will be funded at a level of up to $35,000. Institutional and departmental cost sharing to supplement these funds is highly encouraged.
• Pilot/ICREs must be completed within a maximum of 12-months.
  • No-cost extensions will NOT be allowed for Pilot/ICRE awards/subawards; all research expenses must be incurred by May 31, 2022.
• A general budget will be submitted with the Pilot/ICRE application; however, a budget in NIH format will be required and approvals obtained prior to the research study commencing.
• Funds may be used toward team building and strengthening collaborations as well as for the research project expenses.
• No “indirect costs” may be charged for any CTSI Pilot funding.
• No funds may be requested for general purchase of laboratory or clinical equipment greater than or equal to $3,000.
• A minimum of 5% effort is required for the Contact CoPI/Team Lead and is to appropriately reflect effort.
  • All salary support is subject to the NIH parent award annual salary cap of $197,300. Institutional and departmental cost sharing to supplement these funds is highly encouraged.

Additional Requirements by Institution

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.

• an eBridge Funding Proposal (FP) must be submitted to MCW Grants & Contracts Office (GCO) no later than: January 25, 2021 @ 11:59 a.m. CDT; and
• once the FP has been institutionally approved, the completed application must be submitted via REDCap to CTSI by: February 1, 2021 @ 5:00 p.m. CDT

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: ude.etteuqram@gnitcartnoctnarg.

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: ude.mwu@stcartnoc-pso-ro

MSOE CoPI (or co-investigators), please contact Sheku Kamara, Dean of Applied Research (ude.eosm@aramak), and fill the Early Notification Form at https://www.msoe.edu/faculty-staff/grant-policies-procedures/early-notification-form/.

How to Apply

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.

Application Materials

1. Complete all fields within application
2. Download and complete the 2021 CTSI Pilot-ICRE Award Proposal Narrative Form then upload this to the application.
   29 KB2021 CTSI Pilot-ICRE Award Proposal Narrative Form
   Reminder: an initial Pilot/ICRE proposed budget is required. A detailed research project summary, complete budgets in NIH format (one form per partnering institution/agency), and appropriate regulatory and NCATS approvals will be required before the research project can be initiated.
3. Upload current NIH Biosketches for each CoPI (in current NIH format) as a single MS Word document or PDF.
4. Upload Letter of Support for proposal from the Department Chair(s) for each CoPI as a single MS Word document or PDF.

Terms & Conditions

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:

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), 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.

NCATS Prior Approval For Studies Involving Human Or Animal Subjects

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.

• Responses to NCATS Prior Approval Survey and Addendum at least 45-days prior to the human or animal subject research start date.
• Conditions or focus of study; Subject eligibility criteria
• The complete clinical research protocol and consent document(s).
• Inclusion Plans for Women, Minorities, and Children
• Recruitment Retention Plan; Recruitment status; Study Timeline
• Inclusion Enrollment Report
• Description of risk, protections, benefits and importance of the knowledge to be gained by research involving human subjects.
• Data and Safety Monitoring Plan or Board (DSMB), as applicable.
• Overall Structure of the Study Team (brief overview of the organizational/administrative structure and function of the study team, particularly the administrative sites, data coordinating sites, enrollment/participating sites, and any separate laboratory or testing centers)
• IRB approval documentation / IRB Exemption Determination (if applicable) and related Exemption Justification / IRB approved consent, assent, parental permission, or waivers
• NIH Biosketches for all investigators, other significant contributors (OSC), and key personnel (in current format: https://grants.nih.gov/grants/forms/biosketch.htm)
• Certification that the pilot awardee, OSC, and any key personnel directly involved in the study have taken appropriate education in protection of human and/or animal subjects.

Stem Cells

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

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.

Human Subjects Education Certification Requirement

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.

Clinical & Translational Science Institute

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.

Funding Acknowledgment

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.