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Establishing Procedures for Institutional Oversight of Stem Cell Research

Zettler, Patricia; Wolf, Leslie E. JD, MPH; Lo, Bernard MD

doi: 10.1097/
Research Issues

Academic health centers (AHCs), which are at the forefront of stem cell research, need to establish institutional stem cell research oversight committees (SCROs) to comply with 2005 National Academy of Sciences (NAS) recommendations and to establish public trust in this sensitive research. Institutional review boards (IRBs) typically lack the expertise and time to adequately review the specific ethical issues raised by stem cell research. To assure careful, timely, and coordinated review of the science and ethics of stem cell protocols, AHCs need to address many practical procedural issues, such as SCRO membership, quorum, conflicts of interest, and procedures for protocol review. The SCRO committee at the University of California San Francisco (UCSF), established in 2003, has developed detailed policies and procedures on these issues. The UCSF SCRO has broad scientific expertise and uses ad hoc reviewers to strengthen the review process. Studies receiving full SCRO review have three lead reviewers: a scientist, a reviewer with ethics expertise, and a public representative. Studies introducing human stem cells into nonhuman blastocysts receive full review, even if the stem cells are anonymized. Some protocols are eligible for expedited review. The SCRO neither replaces nor duplicates review by the IRB and institutional animal care and use committees. Other AHCs can draw on the UCSF experience when developing their own policies and procedures for stem cell research oversight.

Ms. Zettler is a first-year student at the Stanford Law School, Stanford, California.

Ms. Wolf is assistant adjunct professor of medicine, Program in Medical Ethics, and a member of the Human Gamete, Embryo and Stem Cell Committee, University of California, San Francisco, San Francisco, California.

Dr. Lo is professor of medicine, director, Program in Medical Ethics, and chair, Human Gamete, Embryo and Stem Cell Committee, University of California, San Francisco, San Francisco, California.

Correspondence should be addressed to Dr. Lo, 521 Parnassus Ave, Suite C-126, San Francisco, CA 94143-0903; telephone: (415) 476-5370; fax: (415) 476-5020; e-mail: (

© 2007 Association of American Medical Colleges