Canadian Institutes of Health Research sets guidelines for stem cell research

Provinces and charities expected to follow suit

Canada appears to be steering towards a middle ground on the inflammatory issue of embryonic stem cell (ESC) research with the high-profile release of guidelines by an ad hoc working group of the Canadian Institutes of Health Research (CIHR). The decision to stake out research territory between the highly restrictive US position and the more liberal regulatory environment of the UK comes as the federal government prepares to introduce legislation on the issue, expected as early as this spring.

If the legislation maintains the scope and tone of the CIHR guidelines, Canada’s status as a favoured locale for conducting ESC research could be greatly enhanced. Many in the research community have long predicted that a more liberal attitude in Canada could attract US researchers and eventually financing to Canada , as ESC research matures to the point where products and therapies are generated..

As of March 4th — the day the guidelines were released) — CIHR-funded researchers are now permitted to conduct research on ESC lines taken from embryos, fetal tissue, amniotic fluid, the umbilical cord, placenta and other body tissues. That falls short of the UK positions, which allows the creation of human embryos specifically for deriving stem cells.

It’s estimated that Canadian funding for stem cell research totals $15 million from all sources, including $3-5 million a year from CIHR. The guidelines do not cover privately funded research, although the provinces and Canadian charitable organizations are expected to support them. Little if any private sector ESC research is currently conducted in Canada.

In addition to spelling out the types of research CIHR will fund, the working group also called for CIHR to:

• immediately establish a National Stem Cell Oversight Committee;

• create a national registry of human embryonic stem cell lines;

• establish a working group to examine scientific and ethical issues relating to inter-specific chimeras (organisms containing genetically different tissues);

• regularly review guidelines to broaden or narrow the scope of permitted research;

• Revise the document — Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans — in conjunction with other granting agencies to clarify guidelines for human stem cell research.

The working group also has recommendations for Health Canada, including the creation of a National Research Ethics Review Committee that would eventually supercede the CIHR National Stem Cell Oversight Committee.

APPROPRIATE RESPONSE

CIHR president Dr Alan Bernstein says the middle ground taken by the working group is appropriate at this stage in time, adding that the guidelines have been designed to be fluid. He hopes that the pending legislation will be broad in nature, allowing the guidelines to be modified if and when required.

“We should not watch the world go by in this area. It’s important to position Canada to be in the game subject to conditions. The guidelines will be reviewed on a regular basis in light of changing scientific and public opinion. It’s much harder to change the law,” says Bernstein. “We’re (releasing guidelines) because stem cells hold tremendous promise and that’s why these guidelines are in place. The guidelines and the process that led up to them are a model for the world.”

In addition to ESC research directly funded by CIHR, the Networks of Centres of Excellence program is funding the Stem Cell Network. It began operations in 2000 with funding of $21.1 million between FY00-01 and FY04-05. Several national charities provide funding to specific researchers although the exact amount is unknown.

FLEXIBILITY REQUIRED

The guidelines generated unprecedented publicity for CIHR and the working group’s stand on ESC research, with opinion ranging from extremely negative to enthusiastically positive. Bernstein stresses that, contrary to accusations of some quarters, the guidelines do not loosen the ability to conduct ESC research. They actually imposes restrictions. Prior to their release, the only marker guiding publicly funded Canadian research was the Tri-Council Policy Statement, which did not explicitly mention stem cells or therapeutic cloning. While there was obvious need to update research guidelines, Bernstein stresses that it is not the role of the CIHR or the working group to create policy. He contends that broad, overarching legislation that provides flexibility in interpretation is the most logical route.

“These guidelines are extremely consistent with the draft legislation. In fact the stem cell legislation is based on our guidelines and its principles,” he says. “From the CIHR perspective, we were charged by Parliament to be proactive.”

It’s a view shared by Tim Caufield, a member of the working group and a professor with the Univ of Alberta Health Law Institute. Caufield says that the legislation when passed should avoid criminalizing aspects of ESC research currently prohibited from receiving CIHR funding.

“It would be absurd to make therapeutic cloning a criminal offense because criminal prohibition will inevitably become outdated,” he says, adding that he favours a regulatory scheme similar to the UK model. “I would like to see a regulatory body that licenses researchers and they must comply with the rules to get funding. But it must also be flexible enough to respond to changes in science.”

Caufield says the mandate of the working group was prescribed and did not revisit issues such as the moral status of the embryo. He acknowledges that the new guidelines are relatively conservative, but they set out clear parameters for research and the process required to receive funding.

“As a law professor, I’d say that it’s quite a conservative document, and appropriately so given the nature of the debate right now,” he says. “My fear is that the government might take the guidelines and make its restrictions into criminal prohibition. That would be a mistake.”

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