Scientific and Medical Accountability Standards Working Group An Update from January 30th Meeting

LOS ANGELES, CA – Yesterday the Scientific and Medical Accountability Standards Working Group (“Standards Working Group”), chaired by Sherry Lansing and Bernard Lo, M.D., met in Los Angeles to finalize their recommendations for the Independent Citizens’ Oversight Committee (ICOC) on the medical, ethical, and scientific standards governing stem cell research funded by the California Institute for Regenerative Medicine (CIRM).

The Standards Working Group made the following additional recommendations for the current Draft CIRM Regulations:

  • To adopt a broad definition of “covered stem cell lines” to ensure that human stem cells derived from any source are subject to strict ethical standards. Guidelines for Human Embryonic Stem Cell Research, published by the National Academies, only covered embryonic stem cell lines.
  • To create a single “gold” standard intended to ensure that all cell lines used by CIRM-funded researchers are derived according to the highest ethical standards. This revised standard has the practical implication of guaranteeing that all cell lines used by CIRM-funded researchers are derived without payment to egg donors.
  • To add that research institutions ensure that oocyte donors do not have to pay for any immediate and short-term complications for oocyte retrieval. The National Academies’ guidelines make no mention of this issue.
  • To strengthen existing regulations to make clear that it is not acceptable to provide payments for eggs (beyond reimbursement for expenses) used in CIRM-funded research under any circumstances.
  • To reaffirm that the Draft CIRM Regulations go above and beyond state regulations and federal guidelines for assuring that potential eggs donors are fully informed of their decision and the research. Institutional review committees are required to approve a process for determining whether prospective donors have understood the essential aspects of the research, including but not limited to how eggs will be used and the medical risks associated with participation.

Background: The Standards Working Group makes recommendations to the 29-member ICOC that governs the CIRM on scientific, medical and ethical standards pertaining to stem cell research the institute funds. After five public meetings and three public sessions to solicit public comments from across the state, the Standards Working Group is expected to finalize the Draft CIRM Regulations today and submit them to the ICOC to consider on Friday, February 10 at Stanford.

CIRM Contact:  Nicole Pagano
  (415) 396-9100

 

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