Issues in Oocyte Donation for Stem Cell Research

As described by Hwang et al. in this issue (1), somatic cell nuclear transfer (SCNT) to create human embryonic stem cell (hESC) lines represents a step towards realizing the promise of stem cell research. They have shown the generalizability and efficiency of the approach in creating 11 cell lines from the nuclei of skin cells of individuals with serious diseases or disabilities and the oocytes of donors. This work raises ethical and policy questions for hESC researchers. As hESC research proceeds internationally, these issues must be adequately addressed for public confidence to be maintained. We will discuss three issues here that particularly deserve attention: (i) ethical oversight of research collaborations between scientists working in countries with different standards, (ii) protection of oocyte donors, and (iii) avoidance of unrealistic expectations (therapeutic misconception). International Oversight The research described in Hwang et al. took place in South Korea. It was conducted with oversight and approval from Korean institutions required by South Korean law. However, one of the researchers is a U.S. scientist. No U.S. Federal funding was used, and the creation of human embryonic stem cells for research under these conditions is not prohibited in either country (2, 3). This scientist obtained Institutional Review Board (IRB) review from his university, in which the IRB determined that the research did not involve human subjects on the basis of the Federal definition of human subjects research. These regulations exempt research from full IRB review if samples cannot be traced back to their donors (4). If this had been a clinical trial, his institution in the United States would have been mandated also to provide full IRB oversight for the research. Full IRB review might have been warranted in this case, because at least one of the researchers must be able to ascertain the identity of the donor from the clinician’s encoded information if family members were to receive priority for future hESC transplants, in compliance with the Korean Network for Organ Sharing