Human Stem Cell Research Policy
Date: February 15, 2007
From: Beth Burnside, Vice Chancellor for Research
To: Deans, Directors, Department Chairs, Senior Administrative Officers
Subject: New Human Stem Cell Research Policy
In order to ensure that all U.C. Berkeley research involving the use or derivation of human stem cells is conducted with the highest ethical and scientific standards, and in compliance with all applicable government regulations, U.C. policies, and the requirements of extramural sponsors, the Vice Chancellor for Research announces the adoption of a new campus policy for the review and approval of human stem cell research. The policy can be found at:
The increased interest in human embryonic stem cell (hESC) research among the public, as well as within the scientific community, has been accompanied by concern and debate about the appropriate ethical standards that ought to govern the conduct of such research. Sensitive to this concern, as well as to the scientific promise and challenges associated with hESC, the National Academies initiated a project to develop guidelines for hESC research "in order to advance science in a responsible fashion." The publication Guidelines for Human Embryonic Stem Cell Research (2005) was the first product of this project. This report and the guidelines it contained called on institutions within which hESC is conducted to adopt regulatory requirements and to create oversight bodies for their implementation. In the words of the National Academies Committee on Guidelines for Human Embryonic Stem Cell Research:
"...Because of the complexity and novelty of many of the issues involved in hES cell research, the committee believes that all research institutions conducting hES cell research should create special review bodies to oversee this emerging field of research. Such committees will be responsible for ensuring that all applicable regulatory requirements are met and that hES cell research is conducted in accordance with the guidelines set forth in this report."
In California, the California Institute for Regenerative Medicine (CIRM), created to direct and administer the research funds that become available as a result of Proposition 71, adopted the National Academies' Guidelines as interim regulations for its grant awards. Building on the NAS guidelines, CIRM subsequently developed its own Medical and Ethical Standards (MES) Regulations. These mandate that all investigators who receive CIRM funds adhere to its MES and require all institutions in which CIRM funded research is conducted to establish a Stem Cell Research Oversight (SCRO) committee. The legislature of the State of California has expanded the role of institutional oversight bodies by passing legislation (SB1260) that amends California's Health and Safety Code so as to require review and approval by a SCRO committee of all stem cell research, adult as well as embryonic.
If Berkeley investigators are to participate in the growing stem cell research field it is clear that the campus needs regulations that will set standards for the conduct of campus stem cell research. Since most of Berkeley's stem cell research will wholly, or in part, be funded by CIRM our campus regulations need to conform closely to CIRM's Ethical and Medical Standards. For that reason, the newly adopted campus policy governing stem cell research follows the 2005 NAS guidelines and adheres closely to the ethical standards issued by CIRM in 2006. To view the policy click on the following link:
source: 2/15/2007 CALmessages: New Human Stem Cell Research Policy