Betwixt and between human stem cell guidelines and legislation.

Introduction On March 4, 2002, the Canadian Institutes of Health Research released its guidelines Human Pluripotent Stem Cell Research: Guidelinesfor CIHR-Funded Research. (1) The CIHR is Canada's major federal funding agency for health research and the new research guidelines (in tandem with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2) set out the conditions under which CIHR will fund human stem cell The stem cell guidelines also carefully outline those types of research that are not eligible for CIHR funding. In very general terms, research to derive and study human stem cell lines from embryos, fetal tissue, amniotic fluid, the umbilical cord, placenta, and other body tissues (either from persons or cadavers) is eligible for CIHR funding. Research not eligible for CIHR funding includes research involving the creation of human embryos for research purposes, the use of somatic cell nuclear transfer to develop stem cell lines, the mixing of human or non-human stem cells wit h a human embryo or fetus, and the mixing of human stem cells with a non-human embryo or fetus. Two months later, on May 9, 2002, the federal government released Bill C-56, An Act respecting assisted human reproduction. (3) The proposed legislation and regulatory framework is the government's most recent attempt to regulate various aspects of infertility treatment. Since many of the new reproductive technologies involve the creation and manipulation of in vitro human embryos, the bill necessarily includes a number of provisions that apply directly to embryo These provisions overlap with some of the CIHR guidelines for stem cell Among these provisions is the requirement that embryo research only be permitted on in vitro embryos discarded by infertility clinics, and only when the licensing Agency is satisfied that the use is necessary for the purpose of the proposed research. (4) Some believe these proposed legislative requirements are a significant barrier to promising embryo research, while others believe this limit to be morally required. More recently, on September 16, 2002 Parliament was prorogued. With the prorogation of Parliament, all bills on the Order Paper (i.e., bills under consideration that have not received Royal Assent) are considered dead. (5) This included Bill C-56. Significantly, this is not the first time the federal government has tried to introduce comprehensive legislation on assisted human reproduction only to have the bill die on the Order Paper. In 1996, the government introduced Bill C47, the Human Reproductive and Genetic Technologies Act. (6) This bill also died on the Order Paper in the spring of 1997 when a federal election was called before the legislative process was complete. Fortunately, however, Bill C-S6 has not shared the same fate as Bill C-47. On October 9, 2002, Bill C-S6 was introduced in the House of Commons and reinstated at the same stage in the legislative process, as prior to prorogation. (7) The reinstatement of the bill reflects the fact that much has changed since 1997 when the previous bill died . For many it is now imperative that some kind of regulatory framework for infertility treatment and human embryo research be put in place. Among the significant changes that have occurred since the original bill on reproductive technologies died on the Order Paper is the growing interest in stem cell research, on the part of both scientists and the general public. In November 1998, there were three dramatic announcements of successful privately-funded research in the United States on the derivation of human stem cells. James Thomson and colleagues announced that they had isolated human embryonic stem cells from embryos remaining after infertility treatment. (8) John Gearhart and colleagues announced that they had isolated human embryonic germ cells using aborted fetal tissue. (9) And finally, Advanced Cell Technology disclosed that it had created a hybrid embryo by fusing human nuclei with enucleated cow oocytes, and that cells resembling human embryonic stem cells had been isolated. …

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