Translational Methods Pilot Grant

Pre-Award

All requirements to activate the pilot grant award are outlined in the Notice of Selection (NOS) letter sent in late February. Investigators may avoid delays in receiving award funds by executing all pre-award requirements (i.e. regulatory approvals) in a timely manner. Principal Investigators should report monthly during the pre-award period to CCTSI administration regarding progress toward completion of all pre-award requirements.

Routing Award Funds

CCTSI Pilot Grant Program awards are considered internal awards, so CU-Denver PIs are not required to obtain approval from the Office of Grants and Contracts (“Routing”) prior to receiving a CCTSI Pilot Grant award. However, PIs from CCTSI Affiliated Institutions may be required to complete an internal review process at their organization prior to receiving a CCTSI Pilot Grant award (notably CU-Boulder). Contact your department’s financial administrator for details.

CCTSI will set up the primary award spending account at the PI and/or Co-PI’s institution. Speedtypes and spending account number(s) are included in the Notice of Award (NOA). The financial administrator in the PI’s home department can further route funds to purchase orders, vendors, MSA/GO accounts at CHCO, etc. Indirect costs (F&A) are added to the award by CCTSI only under very specific circumstances.

Regulatory Approvals

Award funds are distributed only after CCTSI has received documentation of required institutional and/or federal regulatory approval noted in the Notice of Selection (NOS). This may include, but is not limited to: NCATS, COMIRB, CSU IRB, IACUC, Biosafety, IBC, Children’s Hospital Research Institute (CHRI), and/or other regulatory groups relevant to the proposal and institution where the research will take place. It is the PI’s responsibility to obtain all regulatory approvals.

Pilot projects that are funded through the CCTSI by the National Center for Advancing Translational Sciences (NCATS) must also be reported to the NIH. PIs will be notified in their Notice of Selection letter if federal approval (called “NCATS Prior-Approval”) is required or not. CCTSI administration will assist you with collecting the required documents and reporting to NCATS on your behalf. Note: NCATS requires ALL institutional IRB/ICACUC documentation to indicate the name of the CCTSI Pilot Grant awarded project title.

If a project will use CTRC resources, PIs must obtain Scientific Advisory and Review Committee (SARC) approval. CTRC resources include inpatient/outpatient research facilities, clinical research nursing support, nutrition research support, exercise research laboratory, ancillary funds; and CTRC Core Lab support.

Any clinical trials proposed in Pilot applications are restricted to Phase I or Phase IIA. Phase IIB, Phase III or Phase IV clinical trials will not be supported.

All NIH regulations related to human fetal tissue research and human stem cell and pluripotent stem cell research flow down to CCTSI Pilot Grant Award projects. If funded, projects involving these types of research must undergo review by the institutional scientific ethics committee. Please email Alison Lakin to discuss the institutional review process.

Protecting Intellectual Property and Products

Public disclosure, either in text or verbal form, may result in a lost opportunity to protect and commercialize your invention. All Principal Investigators must connect with the CU Innovations Office (303-724-0221) for a consultation prior to receiving funds. In the event that a patent does arise from a funded project, it is imperative that CCTSI support is acknowledged (click “Cite Our CTSA Grant” for language).

Active Award

Award funds are distributed only after CCTSI has received documentation of required institutional and/or federal regulatory approval noted in the Notice of Selection (NOS). The active award period ends April 30, regardless of start date. PIs are strongly encouraged to complete their projects within the original one-year active award period. No-Cost-Extensions (NCEs) are granted on a very limited basis for extraordinary circumstances and may not be allowed on all programs.

Project Expenditures

PIs must spend awards on direct costs related to achievement of specific aims outlined in the Pilot Grant project application. PIs must retain sufficient documentation of all expenses to justify any audit requests made of the CCTSI specific to the project.

Unallowable expenses include (but are not limited to): international entities, computers, telecommunications, food, furniture, administrative support, non-project specific office expenses, professional society dues/fees, and research conducted outside the United States. However, proposals that use data or samples collected at international sites through other means may be considered for funding of the portion of the work conducted locally at CCTSI Affiliated Institutions. While salary support commensurate with percent effort is allowed for PI and personnel from CCTSI Affiliated Institutions, this is subject to NIH salary cap restrictions.

Project Progress Monitoring

The CCTSI, as a component of its ongoing NIH support, is required to submit a detailed annual progress report that includes all funded pilot projects. In January of each year, PIs will be asked to submit an online Mid-Project Progress Report. This brief report includes anticipated end-date for research activities, details on publications, patents, and tangibles, and follow-on funding arising from the CCTSI funded project. Prompt cooperation in providing the required information is expected.

Closeout Procedure

The active award period ends on April 30, and the Pilot Grant award is closed out in two parts: project closeout and financial closeout.

The CCTSI funded portion of the project is closed out when the PI submits a brief online Closeout Report. This report includes a summary of the research results, publications, patents, and tangibles, and follow-on funding arising from the CCTSI funded project. Prompt cooperation in providing the required information is expected.

All financial transactions must be posted within 30 days of the end date of the project. CCTSI will coordinate the primary spending account closeout for each award at the PI and/or Co-PI’s institution, including inactivating speedtypes. The financial administrator in the PI’s home department may further close out purchase orders, vendors, MSA/GO accounts at CHCO, etc.

Post-Award

Ongoing Reporting Requirements

The CCTSI Evaluation Core will contact PIs and/or Co-PIs annually for three years following the close of the award to collect updates on publications, patents, tangibles, and follow-on funding arising from CCTSI funded projects. Prompt cooperation in providing the required information is expected.

Citing CCTSI Funding

Please refer to the How to Cite our CCTSI Grant for all publications, patents, or other tangible outcomes from this project during and after project completion.

• Please refer to the Rank Eligibility Table for information about your eligibility to apply for awards.

Eligibility

• The Principal Investigator, the co-Principal Investigator, and all co-Investigator(s) all must hold Instructor level (or above) appointments with a one of The Affiliated Institutions of CCTSI.
• All individuals in Key Roles must be CCTSI Members at the time of application. Verify membership status and/or sign up for free membership via the CCTSI Membership webpage.
• Investigators from non-CCTSI Affiliate Institutions may participate in Non-Key Roles only (no salary support).
• Graduate, undergraduate, postdoctoral students, and PRAs are encouraged to participate in Non-Key Roles. Salary support for individuals in Non-Key roles, who are also employed by CCTSI Affiliated Institutions, may be included in the budget.
• Individuals from a broad representation of backgrounds are urged to apply, as the CCTSI intends to contribute to the creation of a research workforce that is representative of the U.S. population.
• Unfunded applications from a prior cycle may be resubmitted as a new application.

Exclusions/Restrictions

• Projects, which are focused on validation of an existing technology, will not be accepted.
• Investigators applying for TM-Pilot funding are also eligible to concurrently apply for funding from any other CCTSI Pilot Grant Program, including CO-Pilot, CMH-Pilot, and CE-Pilot.
• Awardees from the most recent funding cycle are ineligible to apply for the current cycle.  Past CCTSI awardees who are currently funded under a No-Cost-Extension (NCE) are ineligible to apply for the current cycle in the same program. Renewals or follow-on funding to any prior CCTSI funded project are not allowed. 
• If you are involved in a Key Role on an application in this cycle, you may not participate in the Review Panel for the same award category.
• CCTSI Pilot awards may not be used to support research conducted outside the United States.
• Any clinical trials proposed in CCTSI Pilot applications are restricted to Phase I or Phase IIA. 

Affiliate home organizations may require applicants to complete an internal review process prior to submission.  Applicants should check with their institutional grants or sponsored projects office to ascertain if their institution has pre-submission requirements for programs related to non-federal internally funded seed grant programs.  Any awarded projects that have not met these requirements prior to submission will not be activated until all such affiliate institutional requirements are met.

For CU Anschutz and CU Denver Investigators

Applications do not require official pre-award review (routing) through the CU Denver Office of Grants and Contracts (OGC) prior to submission.

For CSU Investigators

CSU investigators must complete the institutional proposal review process prior to submission, which includes review by the CVMBS college office and Office of Sponsored Programs Research Administrator, Julie Harvey. A signed proposal transmission letter from the CSU Office of Sponsored Programs (OSP) is required to be submitted with the Pilot Award application. Please contact Aimee Oke for details.

For CU-Boulder Investigators

You are required to complete an internal review process prior to receiving an award, but no prior approval for applying is required.

Regulatory Requirements

Regulatory approvals are not required at the time of application. All approvals/exemptions from appropriate review bodies or regulatory groups must be provided by the PI prior to the release of funds. This includes, but is not limited to: COMIRB, IACUC, Biosafety, IBC, Children’s Hospital Research Institute (CHRI), CSU IRB, and/or other regulatory groups relevant to the proposal and applicant’s institution.

Human Subject Research / Vertebrate Animal Research Projects

If a funded proposal involves human subject research (HSR) and/or vertebrate animal research (VAR), The PI must provide an institutionally approved IRB protocol prior to the start of funding. Some funded HSR/VAR projects will require additional documentation for the NCATS Prior-Approval process; the CCTSI Pilot Grant Program Coordinator, Debra Szuster, will work with awardees on a case-by-case basis to submit required documentation. Applicants are strongly encouraged to demonstrate capacity to obtain regulatory approvals as soon as possible upon notification of selection for award.

CTRC Projects

PIs are required to obtain Scientific Advisory and Review Committee (SARC) approval for all projects using CTRC resources (inpatient/outpatient research facilities, clinical research nursing support, nutrition research support, exercise research laboratory, and CTRC Core Lab support).

Technology Transfer Office (TTO)

Public disclosure, either in text or verbal form, may result in a lost opportunity to protect and commercialize your invention.  All Principal Investigators of all funded CCTSI Pilot Grant Awards must connect with the CU Innovations Office (303-724-0221) for a consultation prior to receiving funds.

Each award is for up to $20,000 (direct costs) for one year. Indirect costs are assessed internally by CCTSI and do not need to be included in your budget proposal, with the exception of proposals submitted by Colorado State University. CSU proposals should include Indirect costs at their federally negotiated rate. This will be in addition to the $20,000 direct cost budget. All funds are distributed to CCTSI Affiliated Institutions only, so there is no requirement for a cost-share budget review on TM-Pilot applications. Unallowable expenses include (but are not limited to): international entities, computers, telecommunications, food, furniture, administrative support, non-project specific office expenses, and professional society dues/fees. While salary support commensurate with percent effort is allowed for PI and personnel from CCTSI Affiliated Institutions, this is subject to NIH salary cap restrictions.

Intent to Apply Form (LOI)

• The mandatory Intent to Apply Form (LOI) collects minimal information and must be submitted online. A formal letter is not required. Submission by any other means will not be accepted.
• The Intent to Apply Form (LOI) is not binding, and information may be revised by applicants during the application process.

Application Form

• All applicants who submit an Intent to Apply are eligible to submit an application - this program does not utilize an invitation process
• Submission of the online Application Form will generate a confirmation email sent to the Principal Investigator’s email. If you do not receive this email within minutes of submitting your Application Form, contact Kristen House.

Review Process

Peer Reviewers with appropriate expertise will evaluate eligible applications with a specific emphasis on research that furthers the CCTSI mission. All Review Panel Study Sections are chaired by CCTSI Pilot Program Director(s) or Chair(s), and funding recommendations are presented to the CCTSI Executive Committee for approval.  All Executive Committee decisions are final.  Short informative critiques of application strengths and weaknesses are provided to all applicants after Notice of Selection for Awards are announced.

The six areas that are scored for each application include:

Innovation: Is the proposal innovative and novel in developing new technologies/assays/models? Are the proposed technologies presently not available to CCTSI members? Will the novel technologies enhance science and potential NIH proposals in the future?

Approach/Scientific Merit: Will the proposed study design achieve the aims of developing a new method or technology? What is the likelihood of success given the experiments/proposal as outlined? How feasible is the proposed one-year time frame to successfully develop the proposed technology? Are alternative approaches presented? Are there explicit plans for development of future funding for the project, whether from the NIH, foundations, or commercial sources?

Significance (especially to the CCTSI mission): Can the new method or technology be generalized and translated to other scientific settings/ applications?  Are the technologies translational in their nature? Will the results further our understanding, diagnosis, prevention, and/or treatment of human disease?

Investigators: Do the investigators have the necessary expertise and capacity to complete the proposed research? is all necessary technological expertise present?

Environment: Does the research environment improve the likelihood that the proposed research can be completed and have an impact? Does the proposal consider use of CCTSI resources, including Study Design, Biostatistics, CTRCs, Core laboratories, Bionutrition core, etc?

Responsiveness to the CCTSI Educational Mission: Does the proposal explain how the technology will be disseminated among the CCTSI members (giving workshops, collaborating with Shared Resources)? Are students and fellows are involved in the project?

Available Funding

How many awards will be made in each category?
The number of awards varies each year with the availability of institutional and federal funding each year.

What percent of applications receive awards? What is the funding rate?
The overall funding rate for each of the CCTSI Pilot Grant Programs ranges from 19-27%, similar to NIH funding rates.

Eligibility and Exclusions/Restrictions

Can you apply for, or participate in, more than one proposal or program?
Individuals may be listed in a Key Role on only one application per funding cycle across the Colorado Pilot (CO-Pilot) Grant Program, the Child and Maternal Health (CMH-Pilot) Grant Program, and the Community Engagement CE-Pilot) Grant Program. CO-Pilot and CMH-Pilot applicants may concurrently apply for funding from the TM-Pilot program. Individuals may be listed non-Key Roles (consultant, graduate student, etc.) on any number of applications. Key Roles are defined in the RFA.

Can you collaborate with someone outside of the CCTSI Affiliate Institutions (non-affiliate collaborator)?
Investigators from non-CCTSI Affiliated Institutions are ineligible to be Principal Investigators on Pilot Grant Program awards, but they are encouraged to collaborate with an eligible investigator from a CCTSI Affiliated Institution who could serve as PI on an application. Note: The Translational Methods (TM-Pilot) Grant Program does not allow any award funds to be spent at non-CCTSI Affiliated Institutions.

Can you apply if you previously applied for or received, a CCTSI Pilot Grant Program award?
Individuals who are currently funded through an active CCTSI Pilot Grant Award, including a No Cost Extension, may not apply as a PI, co-PI, co-Investigator, or in a role with salary support. Mentors who are not receiving salary support may be included as Primary Mentor (or Co-Mentor) on multiple applications. Renewals or follow-on funding to any prior CCTSI funded project are not allowed. Unfunded applications from a prior cycle may be resubmitted as a new application.

Are students, residents, or other post-graduate trainees eligible to apply?
Graduate and undergraduate students, trainees, residents, and fellows are encouraged to be included in Non-Key roles to help fulfil the CCTSI educational mission. However, they cannot be listed as Principal Investigators or co-Principal Investigators on the grant. Refer to the PI Eligibility by Academic Rank table.

How do you apply or check for CCTSI Membership?
All individuals in Key Roles must be CCTSI Members at the time of application. Verify membership status and/or sign up for free membership via the CCTSI Membership webpage.

Application Process

What is the most important thing you can do to have a competitive application?
Following the directions explicitly stated in the RFA will help demonstrate your competency in gathering, organizing, and communicating information. These qualities generally reflect your level of preparedness to receive awards. Utilize the application guidance posted on the Pilot Grant Program webpage under “Information and Resources,” which include the Application Checklist, PI Eligibility by Academic Rank Table, and Budget Template. Participate in the Informational Calls to ask for clarification.

Can you view the applications from previous awards?
The CCTSI cannot distribute applications form previous awardees. However, applicants may contact past awardees directly to ask for advice or sharing information. Past awardees are listed on the webpage of each Pilot Grant Program.

How many awards will be made in each category?
The number of awards varies each year with the availability of institutional and federal funding each year.

Can you change or withdraw your Intent to Apply Form (LOI)?
The online submission system allows applicants to “Submit” or “Save and Return Later.” Changes cannot be made after clicking “Submit.” You may submit any number of Intent to Apply Forms prior to the 5 pm MT deadline. Minor changes to the information provided on the Intent to Apply Form (LOI) may be made on the Application Form. You do not need to notify CCTSI if you wish to withdraw your Intent to Apply Form.

Can you change or withdraw your Application Form?
The online submission system allows applicants to “Submit” or “Save and Return Later.” Changes cannot be made after clicking “Submit.” Email Kristen House to withdraw a “Submitted” Application Form.

Are Biosketches and Letters of Support required?
Biosketches are required for all individuals in Key Roles. Letters of Support from other sources, including outside consultants, are strongly encouraged. For all Colorado State University investigators, a signed proposal transmission letter from the CSU Office of Sponsored Programs (OSP) is required to be submitted with the Application Form. Email Jessica Hunter for detail on obtaining the CSU OSP Letter of Transmission.

Application Budget and Expenses

Do you need to complete a Cost-Share Budget Review prior to application?
Cost-share budgets are required when a substantial and meaningful portion of the study design, data collection, intervention delivery, or analysis is conducted by an investigator who is based at an organization not on the list of CCTSI Affiliated Institutions. CCTSI expects that organization to make a financial contribution to the project since they are seriously vested in the project outcome. Fee-for-service (chart review, etc.) does not require a cost-share. Note: Community Engagement (CE-Pilot) Grant Program applicants are not subject to a cost-share budget, and Translational Methods (TM-Pilot) Grant Program does not allow any award funds to be spent at non-CCTSI Affiliated Institutions, so cost-share does not apply. Email Kristen House to schedule a brief phone call no less than two weeks prior to the application deadline or if you are unsure you need a cost-share budget.

Can the budget include a percent effort for a Graduate Research Assistant (GRA)?
Include percent effort in the proposal budget. Graduate Research Associates should be paid at the graduate school minimum rate (or higher), posted each year on the graduate school web page.

Should you include fringe benefits or indirect costs (F&A) in the proposed budget?
The proposed budget should only include direct costs, up to the full amount of the award noted in the RFA. Fringe benefits are considered direct costs, but CCTSI does not require you to include fringe benefits in your proposed budget. The CCTSI will pay the appropriate F&A on projects awarded to external recipients that are funded with CCTSI Federal grant dollars. The CCTSI does not pay F&A on projects awarded to external recipients that are funded with internal CCTSI institutional funds.

Regulatory Approvals

How do I know if my project requires NCATS Prior-Approval?
PIs will be notified in their Notice of Selection letter if federal approval (called “NCATS Prior-Approval”) is required, or not.

If my human subject research requires NCATS Prior-Approval, what documents do I need to provide?
If your proposal is funded, CCTSI administration will assist you with collecting the current required documents and report to NCATS on your behalf. The specific type of documentation is typically based on the formal IRB-determined level of risk to humans involved in a project. NCATS requires institutional IRB documentation with a determination of Not vertebrate animal research, Exempt (Category 1-9) from Federal Regulations, No More Than Minimal Risk, Greater Than Minimal Risk, or Clinical Trial. NCATS requires ALL institutional IRB documentation to indicate the name of the CCTSI Pilot Grant awarded project title. (Alternatively, NCATS may accept a signed letter from the institutional IRB linking the CCTSI funded title to an existing approved protocol or amendment). CCTSI pilot grant award funds can be spent only after all NCATS Prior-Approval requirements have been met. Email Kristen House for details.

If my human subject research requires NCATS Prior-Approval, what documents do I need to provide?
If your proposal is funded, CCTSI administration will assist you with collecting the current required documents and report to NCATS on your behalf. These documents typically include a formally signed IACUC approval notice, a narrative called the “Vertebrate Animal Section,” and checklist of items to be addressed in the narrative. NCATS requires ALL institutional ICACUC documentation to indicate the name of the CCTSI Pilot Grant awarded project title. (Alternatively, NCATS may accept a signed letter from the institutional IACUC linking the CCTSI funded title to an existing approved protocol or amendment). CCTSI pilot grant award funds can be spent only after all NCATS Prior-Approval requirements have been met. Email Kristen House for details.

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