Research Issues Establishing Procedures for Institutional Oversight of Stem Cell Research Patricia Zettler, Leslie E. Wolf, JD, MPH, and Bernard Lo, MD Abstract 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. Acad Med. 2007; 82:6–10. Human stem cell (hSC) research has the potential to answer fundamental scientific questions regarding human development and the pathogenesis of disease and to develop new treatments for degenerative diseases such as Alzheimer disease, Parkinson disease, and diabetes. Because such research also raises ethical concerns, 1–7 careful oversight is needed to ensure that it is carried out according to strict ethical and scientific standards. Academic health centers (AHCs), which are at the forefront of this innovative research, need to convene new institutional panels to review and oversee hSC research. Guidelines for Stem Cell Research National Academy of Sciences guidelines In May 2005, a National Academy of Sciences (NAS) report, Guidelines for Human Embryonic Stem Cell Research, recommended that research institutions establish embryonic stem cell research oversight committees (ESCROs) to “ensure that inappropriate research is not conducted and that controversial research is well justified and subject to appropriate oversight.” 8 Because this report was carried out and peer reviewed under the auspices of the NAS, its recommendations are likely to be widely adopted. The NAS recognized that human embryonic stem cell (hES) research presents complex and novel ethical issues that are beyond the scope of existing institutional review boards (IRBs) and institutional animal care and use committees (IACUCs). Donors of embryos and gametes for stem cell research must be protected. Some hSC research may not require IRB review but may still raise ethical concerns. Federal regulations governing human subjects research do not require IRBs to review research with existing hSC lines that are not linked to personally identifiable information. 9 However, it is ethically important for researchers and research institutions using stem cell lines derived at other institutions to verify that these lines were derived with IRB approval, free and informed consent, and minimization of risks. Furthermore, IRBs typically lack the expertise and time to review the specific ethical issues raised by stem cell research. The special status of the human embryo requires justification of the “scientific rationale for the need to generate new [embryonic stem cell] lines” and the “basis for the number of blastocysts and oocytes needed.” 8 Additional oversight also is necessary because “the implantation of human embryonic stem cells or human brain cells into nonhuman animals” 8 raises ethical concerns that human characteristics might be transmitted into nonhuman animals. 4 This blurring of lines between humans and other animals “may threaten to undermine human dignity.” 8 Studies to implant human cells into animals require IACUC review. However, because IACUCs are charged only with animal use and welfare, they are unlikely to address the issue of blurring of species lines. California state guidelines In 2004, California voters approved $3 billion for hSC research in the state for 10 years, making the state the largest funder of hSC research in the United States. The California Institute for Regenerative Medicine (CIRM), the state agency that will administer this funding, will require institutions receiving its grants to establish a stem cell research oversight committee (SCRO). 10 In adopting the term “SCRO,” CIRM omitted “embryo” from the NAS name for the oversight committee because 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: (bernie@medicine.ucsf.edu). Academic Medicine, Vol. 82, No. 1 / January 2007 6