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REVIEW DRAFT: CIRM Guidelines for Reducing Risk in Oocyte Donation for Stem Cell Research

CIRM is committed to ensuring the safe conduct of funded research. As part of this effort, CIRM commissioned the Institute of Medicine and the National Research Council to form the Committee on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research in September 2006. The committee organized a workshop and prepared a summary of the current state of knowledge of the medical risks of human oocyte donation for stem cell research.

One conclusion from the workshop is that the medical risk to oocyte donors of ovarian hyperstimulation syndrome (OHSS) and other acute health outcomes can be mitigated through a combination of strategies including:

• Identifying and excluding from research donation, those women most at risk;
• For those women who do undergo ovarian stimulation, individualizing stimulation and retrieval protocols; and
• Once the process is initiated to provide careful monitoring.

Based on the workshop report, CIRM commission a group of expert consultants from outside of California with clinical experience with assisted reproductive technologies (ART) to develop recommendations to reduce medical risk in donors providing oocytes exclusively for research. The advisors were charged with providing recommendations for how the following methods can be applied to reduce donor medical risks:

• Screening strategies for excluding from research donation, women at increased risk;
• Clinical strategies for individualizing stimulation protocols;
• Systems for monitoring donors to modify the stimulation protocol or cancel retrieval.

The recommendations can be obtained by following this link. [CIRM Guidelines for Oocyte Donation for Stem Cell Research]

The guidelines are intended to provide institutional review boards and research oversight committees with a set of criteria to evaluate clinical protocols. CIRM is seeking comment on the utility and feasibility of these guidelines from the research and reproductive health community. In additional to any general comments you may have, we are interested in your comments regarding:

• The utility of the guidelines for reviewing studies proposing to obtain oocytes for research;
• The consistency of the guidelines with current clinical protocols and standards of care;
• General feasibility considerations with the draft guidelines?

Please direct comments to Dr. Geoffrey Lomax glomax@cirm.ca.gov

Please provide comments by May 23, 2008.