Scientific and Medical Accountability Standards Working Group

(a) Membership

Terms Used In California Health and Safety Code 125290.55

  • Facilities: means buildings, building leases, or capital equipment. See California Health and Safety Code 125292.10
  • Oversight: Committee review of the activities of a Federal agency or program.
  • 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

The Scientific and Medical Accountability Standards Working Group shall have 19 members as follows:

(1) Five ICOC members from the 10 groups that focus on disease-specific areas described in paragraphs (3), (4), and (5) of subdivision (a) of Section 125290.20 or from the members appointed pursuant to paragraph (6) of subdivision (a) of Section 125290.20.

(2) Nine scientists and clinicians nationally recognized in the field of pluripotent and progenitor cell research.

(3) Four medical ethicists.

(4) The Chairperson of the ICOC.

(b) Functions

The Scientific and Medical Accountability Standards Working Group shall have the following functions:

(1) To recommend to the ICOC scientific, medical, and ethical standards.

(2) To recommend to the ICOC standards for all medical, socioeconomic, and financial aspects of clinical trials and therapy delivery to patients, including, among others, standards for safe and ethical procedures for obtaining materials and cells for research and clinical efforts for the appropriate treatment of human subjects in medical research consistent with paragraph (2) of subdivision (b) of Section 125290.35, and to ensure compliance with patient privacy laws.

(3) To recommend to the ICOC modification of the standards described in paragraphs (1) and (2) as needed.

(4) To make recommendations to the ICOC on the oversight of funded research to ensure compliance with the standards described in paragraphs (1) and (2).

(5) To advise the ICOC, the Scientific and Medical Research Funding Working Group, and the Scientific and Medical Research Facilities Working Group, on an ongoing basis, on relevant ethical and regulatory issues.

(Amended November 3, 2020, by initiative Proposition 14, Sec. 15. Effective on December 16, 2020. Note: This section was added on Nov. 2, 2004, by initiative Prop. 71.)