Informed consent and federal funding for stem cell research.

A review of the consent forms signed by those who donated embryos for the NIH-approved embryonic stem cell lines reveals several problems, providing ethical as well as scientific reasons to overturn the Bush administration's restrictions on federal funding for stem cell research. ********** President Bush's compromise policy on human embryonic stem cell research, announced on August 9, 2001, provides federal funding for the research. However, it restricts the funding to research on cell lines derived before the announcement from embryos left over from infertility treatment and donated with informed consent. This policy would, said Bush, allow "us to explore the promise and potential of stem cell research without crossing a fundamental moral line, by providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life." The National Institutes of Health now has a registry of twenty-one lines that are eligible for funding and available for distribution. Despite the indisputable utility of the NIH lines, several scientific obstacles stand in the way of exploring the full potential of human embryonic stem cell research--often known as hESC research--so long as federal funding is restricted to lines derived prior to August 9, 2001. Because there are only twenty-one of these lines, they represent a narrow range of genetic diversity. Also, they were grown on mouse cells, which contaminate other cells with animal products capable of eliciting an immune response from humans, (1) and they were grown in poorly defined media conditions using dated protocols that make the cells difficult to thaw and grow in culture. (2) Substantial progress has been made on these problems with hESC lines established after Bush's announcement, but because of his policy, these lines may not be used in federally funded research. (3) Such progress has made Bush's policy increasingly unsatisfactory for exploring the tremendous potential of hESC research and has fueled widespread criticism from the scientific community and from such high-level government officials as Elias Zerhouni, director of the NIH, and Story Landis, director of the NIH's National Institute of Neurological Disorders and the person responsible for implementing Bush's policy. (4) What has not been appreciated, however, is that an examination of the consent forms under which the NIH lines were derived reveals a parallel ethical argument for expanding federal funding. In the course of establishing the registry, the NIH collected samples of the consent forms used with the donors of the embryos from which the NIH lines were derived. I obtained copies of these forms from the NIH through a Freedom of Information Act request. A review of the consent forms reveals several problems that have not been acknowledged by the NIH or the National Academy of Sciences, despite their oversight and guidance in this area. Some forms make explicit commitments to donors that preclude redistribution of the cells or that limit acceptable research. Some fail to inform donors about the nature of stem cell research, the option to refuse donation without jeopardizing medical care, or the possibility that donors' biological materials might be transplanted into embryonic or fetal animals to create animal-human chimeras. These problems provide ethical reasons not to perform several kinds of important research with the NIH lines. But given the importance of this research, they also provide ethical reasons for allowing research with new lines to receive federal funding. The Importance of Informed Consent The importance of informed consent, specifically in the context of embryo donation, has long been recognized: * The NIH Human Embryo Research Panel concluded in 1994 that embryos could be used for research only if the donors had provided informed consent for such use. The panel found that the consent process must provide specific information about the nature and purpose of the research, as well as any facts that a reasonable individual would consider relevant to the donation decision. …