It would also make sweeping changes in the California Institute for Regenerative Medicine (CIRM), which is down to its last $27 million. They range from expanding the scope of the agency to restructuring its governance.
This article is an initial attempt to summarize the measure’s more important changes. It does not capture all of the implications and alterations that could affect CIRM. Readers may see other sections of the initiative that are of interest. If so, please email the California Stem Cell Report at firstname.lastname@example.org.
- Expand the agency’s Alpha Clinic program and create “centers of excellence” to expand clinical trial locations based on geographic diversity.(p. 3) The measure prescribes specific criteria for decisions by the board.
- Require the board to establish and oversee affordability programs for CIRM-funded treatments.
- Create a new, 17-member affordability group (p. 5, p. 6, p. 20) to deal with a wide-range of affordability issues including development of financial models and funding of patient and caregiver expenses
- Require the agency to create new training and fellowship programs to help create a stem cell work force, including programs at the community and state college levels. (p. 4)
- Re-establish the “shared research laboratory” program to provide more training and equipment and to create lab access for neighboring institutions. (p. 5)
- Adds as criteria for selection of some board members “other vital research opportunities, therapy development, or therapy delivery,” “nursing” and “mental health” patient advocacy. Criteria for the board chairman would be expanded to include a “documented history” in “other vital research opportunity (sic) in therapy development and/or therapy delivery advocacy.”
- Allows for ouster of some board members with a half of a term left at the time of the passage of the measure when a new appointment is made. (p. 10)
- Makes more information confidential including “progress reports” currently filed publicly by applicants. (p. 12)
- Includes “applications” as confidential, although that is current practice. Currently the agency is excluded from some transparency requirements that apply to other state agencies. (p. 12)
- Caps the number of employees nominally at 70 but allows the addition of 15 agency employees to deal with affordability issues. Also allows the addition of “employees funded throuqh sources other than bond proceeds or the (state) General Fund." (p. 19)
- Enacts formulas that restrict the use of bond funds in various categories, including new clinical programs, affordability, buildings and research equipment. (p.23)
- Establishes new rules and limits on indirect, administrative costs in grant awards, an important consideration for recipient institutions. (p.24, p.27)