California Health and Safety Code 125290.60 – Scientific and Medical Research Funding Working …
Scientific and Medical Research Funding Working Group
(a) Membership
Terms Used In California Health and Safety Code 125290.60
- Grant: means a grant, loan, or guarantee. See California Health and Safety Code 125292.10
- Grantee: means a recipient of a grant from the institute. See California Health and Safety Code 125292.10
- Institute: means the California Institute for Regenerative Medicine. See California Health and Safety Code 125292.10
- Interim standards: means temporary standards that perform the same function as "emergency regulations" under the Administrative Procedure Act (Government Code, Title 2, Division 3, Part 1, Chapter 3. See California Health and Safety Code 125292.10
- Oversight: Committee review of the activities of a Federal agency or program.
- Quorum: means at least 65 percent of the members who are eligible to vote. See California Health and Safety Code 125292.10
- Quorum: The number of legislators that must be present to do business.
- Research funding: includes interdisciplinary scientific and medical funding for all stages of research, including, but not limited to, stem cell discovery research, early development, translational research, therapy development, and the development of treatments through clinical trials, including, without limitation, the reimbursement of patient-qualified costs for research participants and their caregivers pursuant to paragraph (4) of subdivision (b) of Section 125290. See California Health and Safety Code 125292.10
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
- Vital research opportunity: means scientific and medical research and technologies, including, but not limited to, genetics, personalized medicine, and aging as a pathology, and/or any stem cell research not actually funded by the institute under paragraph (3) of subdivision (c) of Section 125290. See California Health and Safety Code 125292.10
The Scientific and Medical Research Funding Working Group shall have at least 23 members as follows:
(1) Seven ICOC members from the 12 disease advocacy group members described in paragraphs (3), (4), and (5) of subdivision (a) of Section 125290.20 or from the members described in paragraph (6) of subdivision (a) of Section 125290.20.
(2) At least 15 scientists nationally recognized in the field of stem cell research or other vital research opportunities, 15 of whom shall be designated to serve on each expert review panel.
(3) The Chairperson of the ICOC.
(b) Functions
The Scientific and Medical Research Funding Working Group shall perform the following functions:
(1) Recommend to the ICOC interim and final criteria, standards, and requirements for considering funding applications and for awarding research grants and loans.
(2) Recommend to the ICOC standards for the scientific and medical oversight of awards.
(3) Recommend to the ICOC any modifications of the criteria, standards, and requirements described in paragraphs (1) and (2) above as needed.
(4) Review grant and loan applications based on the criteria, requirements, and standards adopted by the ICOC and make recommendations to the ICOC for the award of research, therapy development, clinical trial, and therapy delivery grants and loans.
(5) Conduct expert peer review and progress oversight reviews of grantees to ensure compliance with the terms of the award, and report to the ICOC any recommendations for subsequent action.
(6) Recommend to the ICOC standards for the evaluation of grantees to ensure that they comply with all applicable requirements. Such standards shall mandate periodic reporting by grantees and shall authorize the Scientific and Medical Research Funding Working Group to audit a grantee and forward any recommendations for action to the ICOC.
(7) Recommend its first grant awards within 60 days of the issuance of the interim standards.
(c) Recommendations for Awards
Award recommendations shall be based upon a competitive evaluation as follows:
An expert peer review panel shall consist of both scientists and patient advocates. There shall be 15 scientists on each expert peer review panel. Only the scientist members of the Scientific and Medical Research Funding Working Group shall score grant and loan award applications for scientific merit. Such scoring shall be based on scientific merit in three separate classifications-research, therapy development, and clinical trials, on criteria including the following:
(1) A demonstrated record of achievement in the areas of pluripotent stem cell and progenitor cell biology and medicine, or in other vital research opportunities.
(2) The quality of the research proposal, the potential for achieving significant research, or clinical results, the timetable for realizing such significant results, the importance of the research objectives, and the innovativeness of the proposed research.
(3) In order to ensure that institute funding does not duplicate or supplant existing funding, a high priority shall be placed on funding pluripotent stem cell and progenitor cell research that cannot, or is unlikely to, receive timely or sufficient federal funding, unencumbered by limitations that would impede the research. In this regard, other research categories funded by the National Institutes of Health shall not be funded by the institute, unless such research funding is not timely or sufficient.
(4) Notwithstanding paragraph (3), other scientific and medical research and technologies and/or any stem cell research proposal not actually funded by the institute under paragraph (3) may be funded by the institute if at least two-thirds of a quorum of the members of the Scientific and Medical Research Funding Working Group recommend to the ICOC, or if a majority of a quorum of the members of the ICOC determine, that such a research proposal is a vital research opportunity.
(Amended November 3, 2020, by initiative Proposition 14, Sec. 16. Effective on December 16, 2020. Note: This section was added on Nov. 2, 2004, by initiative Prop. 71.)