Translational & Clinical Studies Program Pilot Start-up Awards

Translational & Clinical Studies Program Pilot Start-up Awards

Start-up projects are small, short-term feasibility studies for the purpose of developing a strong, highly competitive proposal for our traditional pilot award. The duration of the award is 6 months, with projects ending March 31, 2018 – in time for the traditional pilot application due several months later.

Key Dates

  • Request for Applications release date: June 15, 2017
  • Application due in MCW Grants & Contracts Office (GCO):
    July 25, 2017, 11:59 a.m. CDT (for projects with an MCW PI or Co-PI)
  • Application deadline: August 1, 2017, 5:00 p.m. CDT
  • Regulatory approvals, if applicable: August 15, 2017*
  • Notifications of Award: early September, 2017
  • Project start date: October 1, 2017
  • Project end date: March 31, 2018 **

* Proposal will not be considered for funding if any required regulatory, safety, or other ancillary committee approvals are not in place by this date. This includes IRB; IACUC; OCRICC; IBC (biosafety); etc.
** No-cost extensions will not be allowed; all research expenses must be incurred by March 31, 2018.

Request for Applications: Two awards are available for up to $12,000 each for a six-month project period

The CTSI Translational and Clinical Studies Program Start-up Awards are supported by the National Institutes of Health (NIH).

These funds may be used to:

  • Gather preliminary/feasibility research data
  • Validate a research method or approach
  • Conduct exploratory analysis
  • Data mining to identify potential hypotheses
  • Build community and/or academic collaborations (e.g. meeting costs; facility charges; travel costs)
  • Determine recruitment feasibility
  • Develop or test survey instruments and other measures
  • Explore methods for data collection
  • On a case by case basis, funds may also be used for strategic training (e.g. specific methods or technical skills)

Project Examples

  • To administer a battery of instruments to a small test sample of subjects to determine subject burden: time for completing, problem items, and sequence of measures.
  • To conduct complex cohort identification of cancer patients using the CTSI Clinical Data Warehouse (i2b2).
  • To conduct statistical power analysis to determine feasibility and assist in the development of a viable study.
  • To conduct preliminary surveys in a community to gauge interest in engaging in Community-based Participatory Research (CBPR)
  • To support meeting costs for convening community groups to explore partnering on a CBPR project.
  • To establish reliability and/or validity of a measurement tool in the population of interest.

APPLICATION INSTRUCTIONS
Requirements

PI and Study Team Requirements

  • All PI(s) and Investigators must be CTSI Members. To become a member, please complete the CTSI Membership Form.
  • Investigative teams from all of our CTSI consortium partners (MCW, UWM, MU, MSOE, CHW, BCW, VA, Froedtert Hospital) are encouraged to apply. Note: While inter-institutional collaboration among CTSI academic/research partner institutions is not required for this award, it is a requirement of the CTSI Traditional Pilot Award. Therefore, proposals for the Start-up which do not involve inter-institutional collaboration must include plans to establish these partnerships for the upcoming traditional pilot project.
  • This award allows for, but does not mandate, a multiple PI model. In cases where a project has multiple PI(s) and one is from MCW, the MCW PI must submit the proposal through the MCW Grants and Contracts Office (GCO) eBridge system.
  • All PI(s) must have full-time or full professional effort status at their primary academic institution to be eligible to serve as a Principal Investigator (PI). Adjunct and part-time faculty are not eligible to apply as a PI.
  • PI(s) are responsible for all grant reporting and fiscal management, and will be the main contact for budget and reporting management. PI(s) will be primarily responsible for ensuring compliance with the scientific, safety, and ethical responsibilities of the grant award.
  • PI(s) will be expected to comply with reporting requirements as a condition of receipt and continuation of funds. Non-compliance of final and/or annual reporting could result in the rescinding of funds by CTSI.
  • Community partners or investigators from other academic institutions would be welcome additions to study teams as Co-PI or Co-Investigator.
  • All personnel must be identified prior to the start date to replace any “to be named” positions proposed in the application.

Regulatory Requirements

  • Human Subjects Research projects need to have IRB approval by August 15, 2017 – no exceptions. If applicable, proof of any Exempt Status must be provided. Applicants are encouraged to contact CTSI IRB Navigator, Sonia Maldonado-Schmidt: smaldonado@mcw.edu or the appropriate IRB manager at their institution.
  • Research conducted at Froedtert Hospital will need OCCRIC approval by August 15, 2017 – no exceptions.
  • Animal Research projects need to have IACUC (or equivalent) approval by August 15, 2017 – no exceptions.

IMPORTANT NOTE: Proposals will not be considered for funding if any required regulatory, safety, or other ancillary committee approvals are not in place by August 15, 2017. This includes IRB; IACUC; OCRICC; IBC (biosafety); etc.

Email all final approvals to Christine Zeller by 5:00 p.m. August 15, 2017.

Budget Requirements

  • Projects will be funded at a level of up to $12,000. Institutional and departmental cost sharing to supplement these funds is highly encouraged.
  • Projects must be completed in a maximum of 6 months.
  • No-cost extensions will not be allowed; all research expenses must be incurred by March 31, 2018.
  • No “indirect costs” may be charged for any CTSI funding. Because the source of these funds is the NIH, you will need to request an F&A override in eBridge (please see specific eBridge instructions below).
  • No funds may be requested for general purchase of laboratory or clinical equipment greater than or equal to $3,000.
  • Faculty salaries are subject to the NIH salary cap ($187,000/year).

If you have any questions about whether your start-up project qualifies for funds, or have a question about a budget item, please contact: Christine Zeller, CTSI Pilot Award Program Manager at czeller@mcw.edu or 414-955-2524.

Additional Requirements by Institution

All projects with an MCW PI must be routed through MCW eBridge and must be received by the MCW GCO no later than 5 business days before the CTSI submission deadline (see key dates above). Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the GCO.

For MU 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 early in your application preparation process to ensure accurate compliance.

For UWM 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 early in your application preparation process to ensure accurate compliance.

For MSOE investigators, please contact Sheku Kamara, Dean of Applied Research, 414-277-7416, kamara@msoe.edu

How to Apply

All projects with an MCW PI must be routed through MCW eBridge and must be received by the MCW GCO no later than 5 business days before the CTSI submission deadline (see key dates above). Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the GCO.

eBridge Instructions for Funding Proposal SmartForm for CTSI Pilot Start-up Award

  • Investigator Information
    • Question 2.0 Title – please add “CTSI Start-up” at the beginning of your project title.
  • General Proposal Information
    • Question 3.0 Type of Program – select “Research”
    • Question 5.0 Sponsor – select “NIH Advancing Translational Sciences”
    • Question 6.0 Type of Organization – select “Federal”
    • Question 6.1 Is the proposal being submitted to the NIH for one of the following funding mechanisms? – select “No”
    • Question 6.2 Select the Funding Mechanism… – select “UL1 – Linked Specialized Center Cooperative Agreement”
    • Question 10.0 Centers/Institutes – select “Clinical & Translational Science Institute (CTSI)”
  • Proposal Attachments
    • Question 2.1 Sponsor Application – upload your completed CTSI Pilot proposal form and any additional required documents (see REQUIRED DOCUMENTS section below for details). Please create a single PDF file of the full application to upload.
  • Budget
    • Please request an F&A override within eBridge as no indirect costs are applicable to this award.

The CTSI application process involves completing an online form via REDCap where you will also be required to upload the following completed documents (in addition to proof of any applicable regulatory submissions or approvals):

  • 2017 CTSI Pilot Start-up Award Proposal Form
  • Budget and Budget Justification Form (1 per partnering institution/agency)
    NOTE: If cost-sharing, please indicate this within your application on the budget justification and/or within a Letter of Support; cost-sharing commitment forms are no longer required at the time of application and need only be provided from MCW departments during the Just-in-Time period prior to receipt of award.
  • NIH Biographical Sketch (all PIs, limit 5 pages per individual)
  • Letter of Support for project from the Department Chair(s) for each PI; Co-PI (if required by your institution)

Terms & Conditions
National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS) Prior Approval for Studies Involving Human Subjects

For any project involving human subjects research, including human subjects data/specimens, 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:

  • The complete clinical research protocol and consent document(s). If the clinical research protocol is considered an amendment to a parent protocol, include information explaining exactly what is being supported by NCATS pilot funding. If the entire parent protocol is included in the submission, that portion which is supported by NCATS funding should be clearly labeled as such.
  • If a clinical trial is proposed, product information, such as the clinical investigator brochure or package insert or description of the device shall be included. Documentation that an IND or IDE has been obtained or letter from FDA that the study is IND exempt or IDE has been waived.
  • Description of risk, protections, benefits and importance of the knowledge to be gained by research involving human subjects.
  • Inclusion Plans for Women, Minorities, and Children
  • Targeted Enrollment Table or Inclusion Data Record (IDR)
  • Data and Safety Monitoring Plan (DSMP) and Board (DSMB), if applicable.
  • Certification that the pilot awardee and any key personnel directly involved in the study have taken appropriate education in protection of human subjects.
Funding Acknowledgment

Please help to ensure the future of clinical and translational research at the Medical College of Wisconsin and 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 study in a presentation or publication using the following language:

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.

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

PARTNERS

Zablocki VA Medical CenterMedical College of WisconsinMSOE