A federal agency has released guidelines on embryonic stem cell research, but private sector researchers will continue to operate without any rules until legislation is in place.
The guidelines, issued in March by the Canadian Institutes of Health Research (CIHR), take effect immediately. They call for creation of a national oversight committee to review all proposals for research involving embryonic stem cells and establishment of a uniform ethical code for all such publicly funded research. The committee is to include experts in stem cell biology and therapeutics and ethics and law, as well as members of the public. The CIHR does not have a mandate to create a framework for private sector research.
At present, Canada has no legislation governing either publicly or privately funded stem cell research.
“With no legislation, the situation here is very permissive,” said Dr. Françoise Baylis, one of the guidelines' authors and a member of CIHR's governing council. Baylis, an associate professor in bioethics and philosophy at Dalhousie University, said that legislation — not guidelines — is needed to address issues surrounding private sector research.
The guidelines, which expand upon preliminary rules created nearly 4 years ago, will permit human embryonic stem cell research:
· when pre-existing human embryonic stem cell lines are being used;
· when embryos were created for reproductive purposes but are no longer required for that purpose;
· when persons for whom the embryos were created have given free and informed consent for their use;
· when there are no commercial transactions involved in the creation and use of the embryos.
The guidelines will not permit funding for research leading to human cloning, reproductive and therapeutic cloning, research involving the creation of embryos strictly for research purposes, and research combining nonhuman stem cells with a human embryo or fetus, or human stem cells with a nonhuman embryo or fetus.
CIHR will also create a national registry of human embryonic stem cell lines generated in Canada; participation in it will be a prerequisite for CIHR funding.
The guidelines have received a mixed reaction. “Research with embryonic stem cells has no proven track record,” said Dr. John Shea, a radiologist who belongs to the Canadian Catholic Bioethics Institute and is a member of the Campaign Life Coalition, a national pro-life organization. “Funds should be directed to adult stem cell research.”
MP Paul Szabo, a member of the Commons Health Committee, said release of the guidelines is premature, since Health Minister Anne McLellan is to table a report in May based on draft legislation that the CIHR and Health Canada are formulating.
“My feeling is that there should be a moratorium on such research, both public and private, until there is legislation that Parliament has had a chance to look at,” said Szabo. “CIHR does not have the authority to make policy.”
However, organizations such as the Parkinson Society of Canada and the Canadian Cancer Society (CCS) have embraced the guidelines.
“We appreciate that the proposals for research will be centrally reviewed by an oversight committee,” said Julie White, CEO of the National Cancer Institute of Canada and the CCS.
“The whole point of research is to explore an area that seems to have so much potential. We will now be able to track proposals to distinguish between what knowledge we gain from adult stem cell research and what we would gain from embryonic stem cell research.”
Bonnie Brown, the MP who chairs the Commons Health Committee, said the guidelines might force the government to act more quickly to pass legislation on pluripotent (embryonic) stem cell research.
“The main thing is that CIHR not [devote money to] projects on embryonic stem cell research without a law on the books,” said Brown. — Louise Gagnon, Ottawa