Thank you very much for this invitation to come and speak today. This is a topic I have great interest in and have had the opportunity to examine for some time. Also, it's nice to see that we're to the regulation stage.
My comments are brief. In general, I support the regulations and applaud the emphasis on autonomy and the goal of ensuring that patients' interests are protected. This is something that's noted throughout much of the Health Canada documentation and the other documentation that has supported this legislation and the regulations.
My comments are rather narrow, focusing on part 3, which is the research section, and explore the implications of limiting the right to withdraw. More broadly, this analysis is meant to serve as sort of an example to inform the question of whether the rationales for the regulations are sufficient and clear enough to justify varying from well-established consent norms.
The requirement to obtain informed consent in both the clinical and research setting, as everyone here knows, has existed for virtually decades, and it flows, in part, from a post-World War II emphasis on autonomy and human rights. I think this tremendously strong consent norm is informed by research ethics policies here in Canada and internationally, provincial legislation, and the common law, including negligence and fiduciary law.
The regulations really, in many ways, add little of substance to the standard of disclosure. We're not here to talk about in section 8 regulations, really, the standard of disclosure, but they do, however, help to create, at least in some areas, a clear national standard that must be met by all. They also provide the agency with the ability to monitor consent practices, which I view as a good thing, and they create a degree of certainty about consent responsibilities and rights of the various potential donors and third parties.
To be fair, not all agree with how those rights have been assigned, but nevertheless the fact that they are creating certainty is valuable.
One can question whether the creation of this unique consent regime is justified in this context, and some commentators have questioned this. In other words, are there unique risks and social issues that require the creation of this framework? Is the possibility of a lack of conformity to existing norms especially high in this context, particularly when you compare it to other areas of clinical research practice? As noted on page 4 of the government's background material, there's really little empirical evidence to support the contention that existing norms would not be complied with.
Having said that, on a practical level and subject to the comments I'm about to make, I don't think this unique framework and the policy issues around the creation of a unique framework are major policy concerns. For the most part, the consent regulations should help to enhance a culture of consent, which can only be viewed as a good thing. Moreover, the social controversies that have surrounded this entire area, and the tremendous importance of maintaining public trust in this area, would seem to support some form of adoption of these regulations. This has again been noted by several commentators.
The long-term legitimacy of the regulations would benefit from some more explicit clarity as to why a unique regulatory regime is required in this area, and I think that's doable. The rationales for the approach should be clearly articulated and reconciled with existing consent and research ethics norms. I'd like to give one example of what I mean by that, and it's in the area of the right to withdraw.
One of the most fundamental consent and research ethics principles is that patients and research participants retain the right to withdraw their consent at any time. The right to withdraw is rarely qualified in guidelines and extends to identifiable health information and linkable tissue removed from the body. We see this again articulated in numerous research ethics guidelines by the Supreme Court of Canada, etc.
Consent to research is not a binding contract. Research participants retain the right to change their minds without repercussion, regardless of what they agreed to at the start of the research project. It stands as a basic tenet of research ethics. It has been articulated in numerous documents, such as the Declaration of Helsinki. The proposed regulations before us significantly limit the right to withdraw to when a researcher acknowledges in writing that the embryo has been designated for research.
From the perspective of the researcher and for the purposes of administrative efficiency, it makes sense to limit withdrawal. It would be tremendously disruptive to have consent withdrawn from research after it has commenced. But as a general rule, the goals of research and administrative efficiency do not supercede individual rights. In fact, it's rare to find that happening anywhere in research ethics policy. That point has been enshrined in national and international policy statements throughout the world. I can give you various examples, but article 5 of the Declaration of Helsinki is one that's often cited to support that contention. In analogous situations, such as in biobanking projects where people donate genetic material, most guidelines explicitly support an ongoing right to withdraw at any time. A good example of that is the big U.K. biobank project.
If emerging stem cell policies are to deviate from this well-established tradition--and to be fair, almost all guidelines around the world deviate--particularly in regulations supported by legislation, then the special circumstances warranting such deviation must be shown to exist. In the context of stem cell research, there are reasons why this right might be viewed as particularly important. The research remains controversial, and I think it's going to forever remain somewhat controversial. It involves highly contested and strongly held moral positions, and in such an environment, ensuring donor wishes are respected seems especially important.
In addition, consent will be obtained in a clinical setting where donors are involved in sensitive medical procedures. With the passage of time and distance from the clinical encounter, donors' opinions may change. We've seen this, and some research supports that this may happen. In addition, one of the most important points is that stem cell lines are capable of revealing health information about donors. The stem cell line created from an embryo can be viewed as an extension of the donor's health record--DNA from the gamete donors or the embryo donors--something that patients clearly retain the right to control traditionally.
I encourage the standing committee to explore the justifications for the position on the right to withdraw and use this as a springboard to perhaps explore some of the other presumptions underlying the regulations. This exploration should start with the presumption that research participants retain the right to withdraw, and any variation from this norm should be as minimal as possible. I would be happy in the question period to explore some of the options I've been thinking about.
There are many other issues you could use. You could do a similar analysis severing the rights of individuals who donate to third parties. If you were a gamete donor and you donated an embryo to a third party, you would no longer have any interest in controlling that embryo and its disposition. That embryo might in fact create linkable cell lines that had the donor's DNA.
The issue of using a blanket consent in this context could also be seen as somewhat controversial as well as the requirement for written withdrawal. I think there are sound justifications that could support all those positions, but they need to be more clearly articulated.
In closing, I would like to set out where I receive my funding. I think it's important for the standing committee to know that I do research in this area. My research is supported by the Stem Cell Network, the Alberta Heritage Foundation for Medical Research, the CIHR, and several other NCEs, such as AFMNet and AllerGen. I also receive funding from Genome Canada.
I would like to thank you for this opportunity, and I look forward to your questions.