Clinical Trial (CLIN2) Awards

[Placeholder text from DISC4]

The applicant organization must be a California organization per CIRM’s definition. A “California Organization” is a for-profit or non-profit organization or is a California-domiciled wholly owned subsidiary of a non-California organization (any entity that does not qualify as a California Organization) that meets all of the following criteria:

• Employment and Payroll: Employs at least one W-2 employee; and more than 50% of its W-2 employees, whether part-time or full-time, who are paid in any manner (e.g., wage, salary, commission, equity), must be domiciled full-time in California and be required to file California state income taxes due to their employment with the organization.
• Management of Award Activities: The Principal Investigator (PI) must be physically located in California while overseeing all project activities.
• Intellectual Property Rights: In the case of a California-domiciled wholly owned subsidiary of a non-California organization, the subsidiary must retain exclusive rights to any intellectual property arising out of the CIRM-funded project as well as any pre-existing IP rights held by the parent organization.

The maximum duration of a DISC4 Award is four years, and the award will be capped at $13 million total costs inclusive of direct facilities and indirect costs. Additional funding of up to $1 million ($14 million total) may be requested IF matching funds of equivalent or greater value are provided, please refer to the PA for eligible matching fund contributions.

To be eligible, the proposed project must satisfy the following requirements:

• The proposed project must address knowledge gap(s) or research bottleneck(s) in the study of human diseases
• The proposal must include studies that employ human stem cells or genetic research as part of the central approach or hypothesis
• Strong justification must be provided for any proposed use of non-human models

The Core applicant team must be multi-institutional and include at least five CA-based investigators – one Principal Investigator and at least four Co-investigators. The broader team may include any number of additional Key Personnel – including collaborators, consultants, subcontractors, etc.

All Core Team members (Principal Investigators and designated Co-investigators) must be employed by California-based organizations. In addition, Principal Investigators and Co-Investigators must commit at least 15% (PI) or 10% (co-I) effort respectively to working on this project and all effort must be expended in California.

The broader team (which includes key personnel) must include at least one data project manager, at least one member with relevant clinical expertise, at least one member with industry/translational experience, and at least one member with relevant computational biology or bioinformatic expertise.

Non-CA-based investigators are not eligible to serve as PI or Co-I on DISC4 awards. However, DISC4 applicants are allowed to budget grant funds to support a non CA-based collaborator through a grant subcontract, provided the out-of-state organization does NOT retain the intellectual property or independent publication rights of any intellectual property (e.g., invention, technology, data) arising out of the CIRM-funded project.

In addition, collaborating non-CA investigators and organizations may contribute research activities to the overall project at no cost to the team (in-kind contribution). While non-CA investigators and organizations will not receive CIRM funds in this arrangement, the contributed research may qualify as matching funds, which would allow the applicant team to request additional CIRM funding. Applicants should refer to the section on “Matching funds” in the RFA or contact CIRM staff to learn more.

An investigator cannot be listed as a Principal Investigator on more than one application. An investigator may be included in the core team of up to two applications. For instance, a researcher may be listed as a co-investigator on two applications OR a Principal Investigator on one application and a co-investigator on a second application.

Programmatic questions regarding this award should be emailed to discovery@cirm.ca.gov with the subject line “CLIN2”. Specific questions related to budget and Grants Administration policies should be emailed to  grantsmanagement@cirm.ca.gov with the subject line “CLIN2”.