Research ethics and stem cells

F ew areas of scientific inquiry have received the amount of attention from politicians, the media and the ethics community that research involving human stem cells has received. A large part of this attention, particularly in the early days of the field, was focused as much on the controversial nature of the research as on its scientific promise. The primary cause of controversy remains the use and destruction of human embryos to derive stem cells or create human embryonic stem cell (hESC) lines, which is considered by some constituencies to be morally problematic. A common policy response to these issues has been to subject stem cell research to heightened or additional ethics reviews and oversights. Internationally, many jurisdictions have established specific legislation, ethical guidelines and oversight bodies to govern stem cell and related embryo research (Box 1). In Canada, for example, research that involves human embryonic stem cell (hESC) lines or the engraftment of human induced pluripotent stem cells (hiPSCs) or their derivatives into humans or animals for purposes other than testing teratoma formation, which is conducted at institutions that receive federal funds, must comply with guidelines that were specifically created to govern human pluripotent stem cell (hPSC) research. Protocols are subject to approval by a national research oversight body—the Canadian Institutes of Health Research (CIHR)’s Stem Cell Oversight Committee (SCOC)—which was created in 2002 for the purpose of implementing the guidelines. SCOC’s oversight functions are in addition to established research ethics reviews, which are handled by institutional research ethics boards (REBs) and animal care committees. This framework, commonly referred to as ‘dual review’, was partly intended to ensure that research protocols in this complex and controversial area conformed to specific policy requirements that include informed consent for embryo donation and hPSC provenance and prohibitions on reproductive cloning, the creation of chimeras and human germ-line modification. Canada is not the only nation that has adopted some form of dual review for stem cell research. A similar practice exists in India, where institutions are required to establish special oversight committees—the so-called Institutional Committees for Stem Cell Research (IC-SCR)—for basic science and clinical research in this field. A variety of approaches to heightened review and oversight have been adopted in other jurisdictions, including a requirement to obtain a specific license for certain types of embryo and stem cell research in countries including Germany, the United Kingdom and Australia. In Australia, the Embryo Research Licensing Committee at the National Health and Medical Research Council (NHMRC) issues licenses for research involving human embryos and monitors compliance with the legislation. ...................................................... “This regulatory oversight specific to stem cell research was, no doubt, warranted in the early years, given the degree of social controversy.” ......................................................