SUBJECT:

Human Stem Cell Research

In November 2004, California voters approved Proposition 71, thereby granting $3 billion to support human embryonic stem cell (hESC) research and launching the California Institute for Regenerative Medicine (CIRM) as the entity responsible for awarding and monitoring the funding.

Since then, the campus has been engaged in a variety of planning activities under the auspices of the Stem Cell Oversight Work Group, which is advisory to the VC Research. The Work Group, co-chaired by Dr. Judith Swain and VC John Woods, was established to identify issues associated with UCSD human stem cell research, and recommend and facilitate the effective management of such research. In addition to training challenges and ethical concerns that will apply to both federal and non-federal projects, federal policy precludes/limits the use of federal resources (facilities, equipment, funding) for any research using embryonic material that is not on the NIH Human Embryonic Stem Cell Registry. Therefore, there are a variety of complex issues that still need to be resolved. In the interim, extreme care must be exercised to assure that federal resources are segregated appropriately.

The Work Group is also providing input to the current effort by the UC Office of the President to develop a UC policy for human stem cell research. This policy will be based on the principles that UC must ensure compliance with existing State and federal regulations, UC policies, and CIRM guidance. At the same time, the policy must be structured to facilitate seamless science. Recommendations issued by the National Academy of Science and the Institute of Medicine are also being considered.

An important element in our hESC research administration program is the establishment of an Embryonic Stem Cell Research Oversight (ESCRO) Committee. This body is also advisory to the Vice Chancellor-Research, and is co-chaired by Dr. Jeffrey Chang and Dr. Michael Kalichman. The Committee has responsibility for the oversight of issues related to the derivation and research use of human stem cell lines. We anticipate that the ESCRO Committee will work collaboratively with other UCSD offices, including the campus human subjects Independent Review Board (IRB), to assure that all projects that involve the use of human embryonic cells, human embryonic stem cells, human embryonic germ cells, nuclear transfer from a human cell into any germ cell, and human adult stem cells receive appropriate approvals and monitoring.

Until further guidelines are issued, all projects involving the above must be submitted for review and approval to the ESCRO Committee, regardless of whether the research material is de-identified, commercially purchased, available through the NIH Human Embryonic Stem Cell Registry, or available from other sources. More specific campus procedural guidelines will be issued shortly. In the interim, if you have questions about a project involving the above, please call Sara Burke (x25764) or email Dr. Kalichman at mkalichman@ucsd.edu.

Richard Attiyeh Vice Chancellor for Research