ITCR Collaborative Set-Aside Funds

Due Dates and Review Schedule

• Proposals are due by September 23, 2024 for review at the October 2024 meeting.
• Proposals are due by December 16, 2024 for review at the January 2025 meeting.
• Proposals are due by March 24, 2025 for review at the April 2025 meeting.
• Proposals are due by June 23, 2025 for review at the July 2025 meeting.

These dates will be updated as future meetings are scheduled.

Procedures for Preparing Set-Aside Proposals

Updated August 2024

Set-Aside Funds are funds dedicated for collaborative activities and correspond to 10 percent of the annual budget of each ITCR Cooperative Agreement, beginning in Year 2 of the award. This structure is intended to provide a novel and essential approach to advancing the utility and/or interoperability of ITCR-supported technologies.

For the purpose of this mechanism, a collaboration is defined as bringing together two or more distinct research groups towards a mutually-beneficial goal that will ultimately benefit the research community the informatics tool is intended to serve. 

Proposals for collaborative studies must be budgeted using the set-aside funds for the parent ITCR Cooperative Agreement award. The use of set-aside funds must be reviewed and recommended by the ITCR Steering Committee (see below) and approved by the NCI.

Release and Use of Set-Aside Funds

A Principal Investigator may only apply for the set-aside funds within his/her Cooperative Agreement award. Set-aside funds may only be used for collaborative projects that complement and expand the scope of the Cooperative Agreement award and abide by the terms and conditions section of the parent U01 or U24 award. These projects are meant to enhance the utility and/or interoperability of the ITCR-supported technology. The applications for the release of set-aside funds are reviewed by the SC at their quarterly meetings.

Collaborative projects could be:

• Between/among ITCR investigators
  • If multiple awards request release of their set aside funds for one multi-site collaborative project, each team must submit a proposal
• Between ITCR members and non-ITCR parties
• For the release of one year of set aside funds
• For the release of up to two years of set aside funds
  • Two-year projects are subject to annual approval by verifying success in annual progress reports (RPPRs)

Set-aside funds may be allocated as appropriate to support the collaborative project requirements. For example, they may be fully or partially sub-awarded to the collaborator or they may stay on the parent award. 

Application Requirements for Release of Set-Aside Funds

The proposal for use of Set-Aside Funds must follow the NIH Format, as used in PHS Form 398 (Set-Aside Funds Application). The proposal should be organized and submitted as follows:

1. Title Page (PHS Form page 1, signed by institution official), Project Summary and Performance Sites (PHS Form page 2), Biosketches of key researchers involved.
2. Budget (PHS Form page 4. Include page 5 if multi-year). Budget cannot exceed allocated set-aside funds for the project and must comply with NIH policies for allowable costs. 
3. Budget justification
4. Checklist Form page and resources as relevant
5. Specific Aims (optional, up to 1 page)
6. Research strategy (up to 6 pages)
   1. Include a description of how the proposed collaborative activity relates to the aims of the parent grant. Reviewers and members of the Steering Committee do not have access to the parent application, so the set-aside proposal should be clear on the scope of the parent project and how the collaborative project complements and is distinct from those activities.
   2. Address the review criteria defined below
   3. Include a timeline and milestone plan
7. Bibliography (optional, up to 1 page)
8. Letters of support, including letters of commitment from the collaborators

Electronic copies of the proposal, signed by an Authorized Institutional Official, should be submitted to the NCI Program Director (PD) assigned to the parent ITCR U01/U24 grant as well as to the ITCR Program Coordinator(s) (Juli Klemm at klemmj@mail.nih.gov) and the Executive Secretary of the Steering Committee (Kelly Crotty at kelly.crotty@nih.gov).

Set-Aside Proposal Review Process

ITCR Steering Committee Composition

The ITCR Steering Committee (SC) is established for the purpose of reviewing the collaborative set-aside proposals. The SC will be comprised of six ITCR PIs and the NCI Coordinator, for a total of seven members. The ITCR PI members are selected by NCI and serve a 1-year term, with half the committee turning over every six months. The selection of committee members will be based on a diverse representation of scientific expertise, seniority, and gender. The Chair of the SC, who will not be NCI staff, will rotate every meeting. An NCI Staff Member will serve as the Executive Secretary of the SC and will manage the operations of the committee. 

ITCR Steering Committee Meeting Schedule and Quorum

The ITCR Steering Committee will meet via teleconference on a quarterly basis (April, July, October, January). Meeting dates will be scheduled at the start of each year of service for a given group of SC members. Proposals will be due 1 month prior to the scheduled meeting date. Proposals not received by the deadline will be deferred to the next scheduled SC meeting.

At least five of the seven SC members must be in attendance for a regularly-scheduled meeting to proceed. If the Chair is unable to attend, they may delegate Chair responsibilities to another (non-NCI) member.

Reviewers of Set-Aside Proposals

The ITCR SC Executive Secretary, with input from the NCI Coordinator and the PD of the parent grant, will select two ITCR investigators outside of the steering committee to review the set-aside proposal. The identity of these reviewers will not be made known to the SC. Proposals will be sent out to the external reviewers and to the SC members at least three weeks before the review meeting. Written reviews from the external reviewers will be made available to the ITCR SC at least 24 hours prior to the review meeting.

Review Criteria

Investigators are encouraged to propose activities that enhance the utility, adoption, and/or interoperability of the informatics technology being supported through their ITCR award. These expansion activities are intended to further the impact of the technology that is the subject of the award. Review criteria for release of set-aside funds are based on the following considerations:

• Significance
  • Potential impact of the proposed project on cancer research
  • Impact of the collaboration on each collaborating unit
  • How the proposed work will enhance the goals of the parent ITCR project
  • How the proposed work fulfills the goals of ITCR to enhance the utility and/or interoperability of informatics tools and resources
• Innovation
  • The novelty or uniqueness of the collaboration and
  • How the collaboration will address unmet needs
• Approach
  • Whether the proposal has a well-reasoned and appropriate strategy to accomplish the aims of the project, including alternative strategies and plans for benchmarking and user testing, as appropriate
  • Whether the proposal has a sound and quantitative milestone plan
  • If the proposal has a realistic scope of work given the time and budget requested
  • The contributions of each collaborative unit are articulated and effective
• Collaborative Team
  • Whether the parties involved in the collaboration are appropriate for the project
  • The willingness of the investigators to collaborate and share information
  • Whether the project represents a mutually-beneficial collaboration

Steering Committee Review Meeting

At the beginning of the review of the application by the SC, the PD assigned to the parent award provides a summary of the collaborative project's objectives and approach followed by the major strengths and weaknesses identified by the reviewers. The collaborative project application is then open for discussion by the full SC. At the end of the discussion, the Chair seeks a motion from the SC members participating in the teleconference with one of the four recommendations: 

1. Approve As Written: The committee recommends approval of the collaborative project as written
2. Approve with Minor Modifications: Investigators are asked to address minor concerns and questions from the SC and return their proposal with modifications within 2 weeks. Modifications are reviewed by the Program Coordinator and PD of the parent grant for approval
3. Requires Modifications and Additional Review: Investigators are asked to address major concerns and questions and return their proposal with modifications within 3 weeks. Modifications are sent back to the reviewers. The reviewer feedback and the modified proposal are then re-evaluated by the SC and a new vote is taken via email unless the Chair deems it necessary to reconvene the committee
4. Disapprove: The committee does not recommend the proposed collaboration. The SC Executive Secretary will prepare a summary of feedback to be provided to the investigator outlining the reasons for this decision. The investigators must provide a new collaborative proposal for review at the next quarterly SC meeting

In the event of a tie (in the case when an even number of SC members is present), the Chair will serve as the tiebreaker.  If a SC member has a proposal for consideration that round, either as the PI or a collaborating partner, they will recuse themselves from review of that proposal (only). However, they will participate in the review of other proposals that round.

The SC Executive Secretary notifies investigators of the SC decision via email within 48 hours of the SC meeting. For applications requiring re-review by the SC, a vote will be taken within 1 week of receipt of the revised proposal.

The final SC recommendation is provided to the NCI Program Director for a final approval decision for the release of the restricted funds. The official release of the restricted funds is by the issuance of a revised notice of award.

Code of Conduct

Steering Committee members and external reviewers will be asked to adhere to a general code of conduct with the following principles:

• Confidentiality of reviews and review discussions
• While Conflict of Interest Rules associated with competitive funds do not apply here, SC members and reviewers are expected to conduct reviews in an impartial manner, maintaining focus on scientific rigor and impact

Appeals

If an investigator proposing a set-aside proposal disagrees with a Disapprove decision, they may submit a rebuttal of the comments to NCI. NCI ITCR program staff will review the rebuttal and determine whether to bring to the SC for reconsideration.

Change Control

Changes to the process outlined in this document may be proposed to NCI by the SC. Change requests will be reviewed by the ITCR Program Staff and if approved, the Policies and Procedures document will be updated and communicated to the ITCR investigators.