Translational Methods Pilot Grant

CCTSI Pilot Grant Award Cycle

Your Notice of Selection (NOS), sent in late May or early June, lists the requirements you must complete before receiving award funds. The anticipated start date is August 1. All awards end July 31 next year, and no-cost extensions are not permitted.

Before your award begins

Complete the requirements in your NOS promptly to avoid delays in receiving funds. Update CCTSI administration on your progress.

Set up your award funds

CCTSI Pilot Grants are internal awards. CU Anschutz and CU Denver principal investigators (PIs) do not need Office of Grants and Contracts routing approval before receiving an award. PIs at CCTSI Partnering Institutions may need internal review. Contact your department's financial administrator for guidance.

CCTSI establishes the primary spending account at the PI's and/or co-PI's institution. Your Notice of Award (NOA) includes the speedtype and spending-account information. Your department's financial administrator can arrange purchase orders, vendor payments, and MSA/GO accounts at CHCO, as needed. If your award is funded by the CCTSI NIH grant, the CCTSI will add the appropriate indirect costs (F&A) to your budget.

Obtain required approvals

You are responsible for obtaining all required regulatory approvals. CCTSI releases award funds only after receiving documentation of the institutional and/or federal approvals listed in your NOS. Depending on your project and institution, these may include NCATS, COMIRB, CSU IRB, IACUC, Biosafety, IBC, Children's Hospital Research Institute (CHRI), or other relevant approvals.

Projects supported through the CCTSI NIH grant by the National Center for Advancing Translational Sciences (NCATS) must also be reported to NIH. Your NOS will state whether NCATS Prior-Approval is required. CCTSI administration will help collect the required documents and report to NCATS on your behalf. All institutional IRB and IACUC documentation must include the awarded CCTSI Pilot Grant project title.

Projects using CTRC resources require Scientific Advisory and Review Committee (SARC) approval. These resources include inpatient and outpatient research facilities, clinical research nursing support, nutrition research support, the exercise research laboratory, ancillary funds, and CTRC Core Lab support.

Only Phase I and Phase IIA clinical trials are eligible for support. Phase IIB, III, and IV trials are not supported.

NIH regulations for human fetal tissue research and human stem cell and pluripotent stem cell research apply to CCTSI Pilot Grants. Funded projects involving these types of research must also be reviewed by the institutional scientific ethics committee. Refer to your institutional review board (IRB) to discuss the review process.

Protect intellectual property

Public disclosure, in writing or verbally, may affect your ability to protect and commercialize an invention. If you are not familiar with standard protocols for protecting potential intellectual property, the CCTSI strongly encourages you to consult the CU Anschutz Innovations Office at 303-724-0221 or [email protected]  after receiving your NOS. Patents arising from funded projects must acknowledge CCTSI support. Follow the CCTSI grant acknowledgment instructions which can be found on the CCTSI website ( https://cctsi.cuanschutz.edu/resources/grant-language ).

During your award

Complete your project within the original one-year active award period whenever possible. The award ends July 31, and “no-cost extensions” are not permitted.

Use funds for approved project expenses

Use award funds only for direct costs related to the specific aims in your application. Retain documentation of all expenses to support any project-related audit requests.

Unallowable expenses include, but are not limited to:

• International entities
• Publication costs
• Equipment costing $5,000 or more
• Computers and telecommunications
• Food and furniture
• Administrative support and office expenses unrelated to the project
• Professional dues, fees, and memberships
• Expenses supporting future grant applications
• Training costs, unless specifically required to carry out the proposed investigations
• Indirect costs (unless your project is funded by CCTSI NIH funds in which case the CCTSI will add the appropriate amount of indirect costs to your funded budget.

Awards cannot support research conducted outside the United States. Proposals using data or samples (pro bono) previously collected internationally through other means may be considered if the CCTSI-funded work is conducted at CU Anschutz or a CCTSI Partner Institution.

Salary support for PIs and personnel from CCTSI Affiliated Institutions is allowed in proportion to their effort, subject to NIH salary cap restrictions.

Submit your April progress report

CCTSI includes all funded pilot projects in its annual report to NIH. In April, you will be asked to submit a brief online Mid-Project Progress Report with:

• Statement of progress to-date
• The anticipated end date for research activities
• Publications, patents, other research outputs, and follow-on funding arising from the project
• Respond promptly to requests for reporting information.

Close out your project and spending accounts

The award ends July 31. Closeout has two parts:

• Project closeout: Submit the brief online Closeout Report summarizing research results, publications, patents, other research outputs, and follow-on funding. Respond promptly to reporting requests.
• Financial closeout: Post all financial transactions within 30 days after the project end date. CCTSI coordinates closure of the primary spending account at the PI's and/or co-PI's institution, including inactivating speedtypes. Your department's financial administrator may also need to close purchase orders, vendor arrangements, and MSA/GO accounts at CHCO.

After your award ends

Provide annual updates for Five years

The CCTSI Evaluation Core will contact PIs and/or co-PIs annually for five years after the award closes. Respond promptly with updates on publications, patents, other research outputs, and follow-on funding arising from the project.

Acknowledge CCTSI support

Follow the CCTSI grant acknowledgment instructions for publications, patents, and other research outputs arising from the project, both during and after the award.

CCTSI Pilot Grant Review Criteria

Reviewers with relevant expertise evaluate eligible applications for scientific merit and alignment with the CCTSI mission. Funding recommendations go to the CCTSI Executive Committee for approval; Committee decisions are final. All applicants receive brief written feedback on their application's strengths and weaknesses after selection notifications.

Review factors and scoring

Reviewers use the NIH 9-point scoring system and the 3-Factor Review System. All three factors inform the overall impact score. Factors 1 and 2 also receive separate scores from 1 to 9. The overall score cannot be better than Factor 1 score. Factor 3 receives a rating of "Appropriate" or "Additional Expertise Needed."

Factor 1 Importance of the research

Should the research be done? Scored 1-9.

• Does the project offer an innovative approach to advancing translational science?
• Could the findings meaningfully improve health or advance scientific progress?
• Does the project address a significant translational science roadblock?

Factor 2 Rigor and feasibility

Can the research be done well? Scored 1-9.

• Are the methods and study design appropriate and well justified?
• Can the project be completed within the pilot funding period?
• Does the application identify potential challenges and strategies to address them?

Factor 3 Expertise and resources

Are there gaps in expertise or resources? Rated "Appropriate" or "Additional Expertise Needed."

• Does the team have the expertise needed to complete the project?
• Are institutional resources, core facilities, and the research environment adequate?

Additional considerations

Applicants should also describe:

• Dissemination: How results will be shared with other investigators or institutions.
• Expected products: Anticipated publications, presentations, patents, or other outputs.
• Future funding: Plans to pursue additional funding based on pilot results.

An application which does not address/ describe a translational science roadblock (evaluated in Factor 1) will not be recommended for funding

Funding

How many awards are available?

The number of awards varies each year based on available institutional and federal funding, usually at least 16 awards are granted each cycle across all 4 categories (CO-/ CMH-/ TM-/CE)

What percentage of applications receive funding?

The overall funding rate for each CCTSI Pilot Grant Program ranges from 19-27%, similar to NIH funding rates.

Eligibility and collaboration

Can I participate in more than one application?

You may serve in a key role on only one application per funding cycle across the Colorado Pilot (CO-Pilot), Child and Maternal Health (CMH-Pilot), and Community Engagement (CE-Pilot) programs.

CO-Pilot and CMH-Pilot applicants may also apply to the Translational Methods (TM-Pilot) program during the same cycle. You may participate in non-key roles, such as consultant or graduate student, on any number of applications. See the Request for Applications (RFA) for definitions of key roles.

Can I collaborate with investigators outside CCTSI Partner Institutions?

Yes. Investigators outside CCTSI Partner Institutions may collaborate with an eligible investigator at a CCTSI Partnering Institution who serves as PI. Investigators outside CCTSI Partner Institutions cannot serve as PI. TM-Pilot awards cannot fund expenses at non-CCTSI Partnering Institutions. Please pay special attention to the budget restrictions described in the RFA’s for application proposing to fund personnel or activities as non-CCTSI Partner Institutions.

Can I apply if I previously applied for or received a CCTSI Pilot Grant?

Yes. Previous applicants and awardees may apply. Renewals and follow-on funding for previously funded CCTSI projects are not allowed. An unfunded application from an earlier cycle may be resubmitted as a new application.

Can students, residents, fellows, or other trainees apply?

Undergraduate and graduate students are encouraged to participate in non-key roles. Postdoctoral and clinical fellows, as well as residents, can be PIs on CO- and CMH-Mentored Pilot applications. See the PI Eligibility by Academic Rank Table.

How do I check or obtain CCTSI membership?

Everyone serving in a key role must be a CCTSI member when applying. Check your membership status or sign up for free on the CCTSI Membership webpage.

Preparing and submitting an application

How can I strengthen my application?

Follow the RFA instructions and use the resources under "Information and Resources" on the Pilot Grant Program webpage:

• Application Checklist
• PI Eligibility by Academic Rank Table
• Budget Template

Attend an informational call to clarify requirements (one is mandatory)

Can I see previously funded applications?

CCTSI cannot distribute previous awardees' applications. You may contact past awardees directly to request advice or ask whether they are willing to share information.

Can I change or withdraw my Intent to Apply form?

Choose "Save and Return Later" to continue editing before submission. Once you select "Submit," you cannot edit the form.

You may submit additional Intent to Apply forms (LOIs) before the 5 p.m. Mountain Time deadline. Minor changes to the information provided may be made on the full application. You do not need to notify CCTSI if you decide not to proceed.

Can I change or withdraw my application?

Choose "Save and Return Later" to continue editing before submission. Once you select "Submit," you cannot edit the application. To withdraw a submitted application, email Kristen House. ([email protected])

Are biosketches and letters of support required?

Biosketches are required for everyone serving in a key role, please use the new NIH SciENcv format. Letters of support, including letters from outside consultants, are strongly encouraged.

What institutional reviews are required before I apply?

For any proposal involving a CSU investigator, complete the institutional proposal review process before applying. This includes review by the CSU PI's department research administrator and the Office of Sponsored Programs (OSP) research administrator. Submit a signed proposal transmission letter from CSU OSP with your application. Contact Jessica Hunter at [email protected] for details.

For any proposal involving a CU Boulder investigator, that investigator must contact their assigned Proposal Analyst in the Office of Contracts and Grants (OCG) before applying by completing the Proposal Submission Request form. Submit a signed proposal transmission letter from OCG with your application.

Budgets and allowable expenses

Can my budget include graduate research assistant effort?

Yes. Include percent effort in the proposal budget. Graduate Research Assistants should be paid at least the graduate school minimum rate, which is posted annually on the graduate school webpage.

Can I include Core fees in the budget?

Yes, the use of institutional Core and Shared Resources is highly encouraged. Since an individual Core might provide services and research support for multiple CCTSI applications, it is recommended to include their fee-for-services into the budget, rather than include the Core member salaries as key-personnel.

Should I include fringe benefits in my budget?

Include only direct costs, up to the award amount listed in the RFA. Fringe benefits are direct costs and the projected amounts that will be paid along with the associated salary support should be included in your budget.

Should I include indirect costs in my budget?

No. Your proposed budget should include only direct costs. CCTSI pays the appropriate indirect costs (F&A) for awards to external recipients funded with CCTSI federal grant dollars. CCTSI does not pay F&A for awards to external recipients funded with internal CCTSI institutional funds. If your award is ultimately funded using CCTSI NIH funds, the appropriate F&A costs will be added to your budget.

Regulatory approvals

How will I know whether NCATS Prior-Approval is required?

Your Notice of Selection (NOS) will state whether your project requires federal approval through NCATS Prior-Approval. If required, CCTSI administration will help collect the current required documents and report to NCATS on your behalf. Award funds cannot be spent until all NCATS Prior-Approval requirements are met. Email Kristen House ([email protected]) for details.

What documents are needed for human-subjects research?

Required documentation generally depends on the institutional review board's (IRB's) determination of risk to participants. 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.

All institutional IRB documentation must include the awarded CCTSI Pilot Grant project title. Alternatively, NCATS may accept a signed IRB letter linking the funded project title to an existing approved protocol or amendment.

What documents are needed for vertebrate animal research?

Required documents typically include:

• A formally signed IACUC approval notice
• A Vertebrate Animal Section narrative
• A checklist of items to address in the narrative

All institutional IACUC documentation must include the awarded CCTSI Pilot Grant project title. Alternatively, NCATS may accept a signed IACUC letter linking the funded project title to an existing approved protocol or amendment.