Health Committee on Dec. 12th, 2006

[The Chair, Conservative, Rob Merrifield]

I call the meeting to order.

I want to thank the witnesses for coming and testifying before the committee. This is actually a reacquaintance of some old, familiar faces, and I understand you're probably getting together at the back of the room talking about this issue. We spent three years on it. It seems like four lifetimes, three years.

I certainly appreciate you coming back as we deliberate about the section 8 regulations we have before the committee right now. We do have some questions on that, and I'm sure you have some input that would help the committee as we take a look at these.

We have with us, from the University of Alberta, Timothy Caulfield; from Dalhousie University, Françoise Baylis; from the Society of Obstetricians and Gynecologists of Canada, Dr. André Lalonde; and from the Canadian Fertility and Andrology Society, William Buckett. It's good to have you here. Thank you for coming.

We'll start with Mr. Caulfield. The floor is yours.

[Timothy Caulfield, Professor, Health Law Institute, University of Alberta]

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.

[The Chair, Conservative, Rob Merrifield]

Thank you. I think you've stimulated a number of them. We'll get to them as soon as we're through the testimony.

Françoise Baylis, the floor is yours.

[Dr. Françoise Baylis, Professor, Department of Bioethics, Novel Tech Ethics, Dalhousie University]

I'd like to thank you for having invited me. It is a great pleasure to be here with you today. I hope to have the opportunity to come back when you will study other parts of this legislation.

I will make my presentation in English. However, I drafted a text that is available in French and in English. Moreover, I am ready to answer your questions in either French or English.

I do have a text that's available to you. I will not be following it tightly. There's much more there than I could possibly read in the time that's available to me. I want to highlight a couple of the points, but I thought it might be helpful for you at a later stage to go back to see that.

In the context of the issue of consent, I would like to suggest that there are a number of pivotal questions one needs to attend to, and from my perspective they are questions about who should consent on the basis of what information, when should this consent be requested and by whom, and what should be the limit on the right to withdraw. I'm going to speak very briefly to each of those, and as I said, we'd be happy to answer questions later.

With respect to who should consent, I'd like to say that it's very clear, both in the legislation and the regulations, that attention has been paid to the importance of ensuring that both the donors of the human reproductive material, the gamete providers, are consenting, as are the embryo donors. They may or may not be the same persons as when donor gametes are used, and I think the regulations pay good attention to that, something that ought not to be changed. Some people might argue that this consent process is complex by virtue of the many people who might have to be involved, but I think it's the right thing to do.

Having said that, I do think that for me, as somebody who is reading both the bill and the regulations, I would say that I found it surprising not to have a clear definition of the donor of human reproductive material and the donor of human embryos in section 1 on “Interpretation”. Now, to be fair, the definition of a donor of human reproductive material can be found in the bill, and possibly from a legal point of view you don't repeat that, but the bill does explicitly say that it is the regulations that will define who the donors of embryos are. The regulations do in fact do that, but they do that in section 10, rather than in section 1, which is the set of definitions that are set out at the beginning.

The reason I think this is important is that one of the terms that is defined is the term “third party”, and “third party” refers to the embryo donor. We don't know who the embryo donor is until section 10, much later in the regulations. So it's a small point, but I think there would be value in being clear about those terms in the definitions section, and then throughout, never to use the term “donor” alone, but rather to be clear about which donor we are speaking about at which time.

My second point is, I think in the regulations, at least for someone like me who's been following this relatively closely, it's quite clear who the donors can be when we're speaking of the embryo donor: they're the persons for whom an embryo has specifically been created. I do think, however, that there are two possible scenarios where there might be a misunderstanding in terms of its actual application in the real world, and I wonder whether there's room for some precision here.

As I said, it's clear the donors are the persons for whom the embryos have been created. However, I think it's conceivable that one could imagine a clinician-scientist who is using human reproductive material to create embryos in accordance with the legislation for one of the legitimate purposes, who, after having used that material perhaps for educational purposes, now actually has an embryo and is thinking that they could become an embryo donor rather than having to discard this material. As I said, I think the regulations are clear on this from a strict point of view. I think there needs to be a fair bit of education to understand that.

The other point where I think this comes into play, where again you may see the clinician or the IVF clinic thinking they could be a donor, is in the context of frozen embryos for whom the clinic has lost contact with the couple. We have a number of embryos in storage currently in that kind of situation. Is it possible that the IVF clinician or the clinic might see themselves, then, as legitimate donors of those embryos rather than having to discard them? I think there's room for some precision there.

The second point I'd like to speak to very briefly is what information should be disclosed to those from whom consent is requested. I think something very positive and innovative has been done with the regulations. They have asked for written documentation confirming disclosure with respect to the purposes for which the embryos would be created or the material would be taken, and also disclosure with respect to the rules for withdrawal, and that is separate from the consent document. That's an innovation that I think is well warranted and important.

The only caution I offer in my remarks is that one not unwittingly perhaps contribute to the mistaken perception that those are the only two required elements of disclosure. Disclosure is far more complicated than those two aspects, and I just worry that one might think that's all that is needed to be disclosed prior to moving on to the consent stage. Again, I applaud that move. I think it's an important set of documentation to ensure that there really is informed consent.

The third point is, when should consent be requested? This is the point that I probably feel most strongly about, and if you will permit, in order that I don't make a mistake, I will actually read that one part of the presentation.

I say here:

Issues of critical importance with consent to the research use of in vitro embryos are: i) the timing of the original consent; and ii) the need to reaffirm the original consent at the time of anticipated research use (owing to long delays).

This is a key aspect of the 2002 CIHR guidelines, which are incorporated into the legislation. They were introduced specifically to give positive effect to the right to withdraw. This does not appear to be reflected in the draft consent regulations.

Recently, debate has centred on the research use of fresh versus frozen-thawed embryos. In discussing the withdrawal of consent, the draft consent regulations foresee the future research use of cryopreserved embryos. Therefore, there are repeated references to the beginning of the process of thawing--this is in regulations 12 and 14--but further clarity is required on this point.

My colleagues and I have argued that the research use of embryos should be limited to frozen-thawed embryos or fresh embryos not suitable for transfer. This is because donating healthy, fresh embryos created for reproductive purposes to research is not in women's self-interest. If there are further IVF attempts, donating fresh embryos to research can, one, decrease the chance of pregnancy and childbearing; two, increase the psychological stress experienced as a result of IVF; three, increase the number of risky or painful procedures; four, increase the social disruption that IVF causes; and five, increase the financial burden of infertility treatment. Moreover, donating fresh embryos to research is not in women's other regarding interests.

The important point here is that in 2005 the CIHR guidelines were changed. The original presumption was that non-transferred healthy embryos typically would be cryopreserved for later reproductive use. Instead, the guidelines explicitly endorsed the research use of fresh embryos. This change was made despite evidence documenting the fact that it is easier to derive human embryonic stem cells from frozen-thawed embryos than from fresh embryos.

In the 2002 CIHR guidelines--and this is important because it is the 2002 guidelines that are incorporated into the act--it was understood that if embryos were truly being created for reproductive purposes, as required by the act, then typically, embryos not transferred in an initial cycle would be cryopreserved for such future use. Therefore, embryos available for research would be cryopreserved embryos.

Here I want to quote to you from the Ethics Committee of the American Society for Reproductive Medicine:

Using only frozen embryos for research ensures that time passes between the creation of embryos for conception and their donation for research. Still, it is reasonable to expect questions eventually to arise about the donation of fresh but supernumerary embryos. Donation of fresh embryos raises the possibility that a physician might induce a patient to allow insemination of extra eggs so that they may be donated for research. Moreover, this increases the chance that decisions will be made quickly and later regretted by couples. Without evidence that fresh embryos are significantly preferable to frozen embryos for ES cell use, it is appropriate to use only spare embryos that have been frozen.

The draft consent regulations address the issue of research involving fresh versus frozen embryos only indirectly in the discussion of withdrawal. More clarity is needed on this contentious issue. Consistent with the 2002 CIHR guidelines, embryo research should involve the use of frozen-thawed embryos. The draft consent regulations should also require a reiterated consent at the time of anticipated research use owing to anticipated long delays between the time of original consent and research use.

Below there--and I'll leave that for you to look at later--I've just made some suggested rewording that would be consistent with the recommendation.

I'll move very quickly and briefly to my last two points on who should request the consent. I find that the consent regulations are silent on this matter and that it would be helpful for there to be some direction, largely because there's the potential for conflict of interest between the perspective of the clinician and the perspective of the research scientist.

Finally, I would like to turn to the point already addressed by Mr. Caulfield: what should be the limits on the right to withdraw? Unlike Mr. Caulfield, I actually am pleased with the section on withdrawal with respect to embryo research, or items 12(c)(v)(A), (B), and (C). In here it says very clearly that in fact one can withdraw up until “the latest of the following occurrences”. And the latest of those occurrences is, in here, “the creation of a stem cell line”.

That does mean that up until the point at which the stem cell line has been created, the person who has provided the embryos or the reproductive material retains the right to withdraw. I do think it would be very difficult to make the claim that one could withdraw one's gametes or one's embryos once they don't exist any more by virtue of the fact that a stem cell line has been created.

That said, I am pleased with the withdrawal requirements with respect to research. I actually do find them to be problematic with respect to the use of third parties for reproductive purposes. Very briefly, the regulations there require that up until the point at which the person provides a written statement to the effect that the materials have been designated to them, the donor loses the right to withdraw.

My recommendation or suggestion is that this is far too early in the process. The right to withdraw needs to be protected to a later stage in that process. At the very least, it ought to be protected until such time as the materials have been received, later than the point at which they may have been designated.

The example I provide here is of a woman who may be willing to donate her eggs to a sibling. She couldn't withdraw this if she had already accepted a written document saying they had been designated to her sibling. That to me seems deeply problematic in the context of the material perhaps not even being in existence.

The last point I would like to make is that there's very little data available about the incidence of withdrawal from embryo research. However, what data there is suggests that with time and distance from IVF clinics, many women do not act on their original consent to donate excess in vitro embryos to research. This is a significant empirical finding that underlines the importance of providing women and couples with time to reflect on the options before the disposition of embryos.

Klock et al. reported that 88% of couples who initially decided to donate their frozen embryos to research changed their minds. More recently, in a 2006 survey here in Canada at one of the IVF clinics, Nisker et al. reported that 45% of couples who had specifically designated their frozen embryos for donation to research changed their minds.

My point is that people need the time to make the decision, and they need to reiterate that consent. If they don't, that's the time at which they're telling you, with that distance from their infertility treatment, that they really don't want to participate in that research. I think it's absolutely important that we protect that right to withdraw.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much. You've created even more questions.

Let's carry on with our next witness.

Dr. Lalonde, the floor is yours.

[Dr. André Lalonde, Executive Vice-President, Society of Obstetricians and Gynaecologists of Canada]

Thank you very much.

This presentation will be brief. I represent obstetricians, gynecologists, and family physicians in Canada. Our members are responsible for the care of the majority of pregnant women in Canada.

The Society of Obstetricians and Gynaecologists of Canada, or SOGC, is committed to promoting free and informed choice. We consider that consent and the right to withdraw consent should be the operative principle at all times and in all issues of gamete and embryo donation.

The SOGC endorses the requirement for two written documents in relation to the consent process. The first document should be a disclosure document attesting to the fact that there was full disclosure about the current options for the use of human reproductive material and human in vitro embryos. It should also include the rules for withdrawal of consent. A second document should be a consent document used to record consent, setting out the specific consent of individuals involved.

The SOGC is of the view that the withdrawal of consent must always be possible and believes the donors of human reproductive material should be allowed to change their minds, including where a third party acknowledges in writing that the material has been designated for their reproductive use.

The SOGC is concerned that there is a possibility that donors will be unable to withdraw their consent. General principles of consent to treatment require that physicians recognize that withdrawal of consent is a legitimate request at any time. No physician would force the woman to continue with ovarian stimulation. The SOGC believes clinicians should honour a woman's choice to withdraw her consent and should not ignore her revocation of consent.

In this document we do not comment on the debate around fresh and frozen embryos, as we believe this issue will probably come up in another part of the regulations. We feel that today is specific to consent.

In conclusion, the SOGC continues to support the Assisted Human Reproduction Agency of Canada as well as the Assisted Human Reproduction Act. The SOGC remains in agreement with the proposed regulations.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much. We'll move on to Dr. Buckett for his presentation.

[Dr. William Buckett, Chair, Government Relations Committee, Canadian Fertility and Andrology Society]

Thank you.

I'd like to thank the committee for inviting me here. I'm speaking on behalf of the Canadian Fertility and Andrology Society. The CFAS provides the leadership, we believe, in reproductive health. We include physicians and laboratory staff, nurses, psychologists, and counsellors, as well as patients, patient support groups, and so on. Therefore, we represent the stakeholders who are the providers of infertility care, as well as the recipients of infertility care.

With regard to the current proposed regulations, without reiterating what Dr. Lalonde, Dr. Caulfield, and Dr. Baylis have all said already, we broadly agree with the proposals. We feel that they reflect current best practice in IV centres and ART centres in Canada at the moment, and therefore, with the exception of some concerns about the language of what is actually written, we tend to support these.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Just for the committee's information, Ms. Françoise Baylis has to be out of here by five o'clock, so if we have questions for her, we would want to do that as soon as possible. Also, at the end of the committee, we'd like to go in camera for some quick business on childhood obesity.

With that, we have Ms. Fry for ten minutes.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Thank you.

I just want to ask one question. Does anyone, and can anyone, answer why choosing the members on this board is taking such a long time? I understand there is a meeting happening in Vancouver very soon and you don't have members of the board ready for the meeting. So perhaps someone has some answers for that.

Secondly, on the issue of reiterated consent, while in theory I agree with it, how practical is that? If a couple had years ago given their consent, and then, as you say, later on they decided not to bother, they adopted some kids, and they don't even want to be involved in this anymore, they may actually say, “No, I don't care, throw it away, I don't want to reiterate my consent”, because they've moved away and they've moved on, and they don't want to be reminded of that time. So while I understand your theory behind it, what are the practical ramifications of that reiterated consent that could occur a long time after?

[Dr. Françoise Baylis]

I think that's an excellent question, and Dr. Nisker and a number of his colleagues at the University of Western Ontario have in fact done a study. I referenced that. It's reference 14. It was published this year, in 2006. It involves a scenario whereby, in conjunction with their research group, they sent questionnaires out and letters explaining that this was a research project. They wanted to know if these people were still willing to have the embryos they had previously said could be used for research purposes.... I don't have all the numbers in my head for you, but what I can say is that 55% of those who responded said, “Yes, we really stand by the consent that we've given you, and it's fine, go ahead, use those embryos for research.” Forty-five percent said, “No, we've changed our mind. We don't want you to do that.”

So does it require an effort on the part of the clinic? Absolutely. Is it important in terms of making sure that people are not subtly, and I do mean subtly, coerced into saying yes? I think that's important, because IVF is a very emotional endeavour for people who participate. In that context, it's clear that there is lots of documentation about the psychology of this. People are trying to please their clinicians. They are dependent on their clinicians for access to treatment, and they do say yes when, with sober reflection or no longer being in the program, at least 45% are willing to change their mind.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Did the 45% who said they would change their mind, or who changed their mind, give you the reasons for changing their mind, and did they understand what would happen to the frozen embryos if they have changed their mind, that it would be discarded, destroyed, etc.?

[Dr. Françoise Baylis]

Yes. There were very detailed documents. I was not part of that research, but I did see drafts of those documents and they were quite detailed in terms of explaining the consequences of the different decisions. It was in fact to find out whether this is doable, and if so, what kind of response rate you would get. This is a clinic that has a number of embryos in storage because they've not been using them for teaching or research purposes in other contexts. It is doable, and it's recent Canadian data.

[The Chair, Conservative, Rob Merrifield]

Professor Caulfield.

[Timothy Caulfield]

That is obviously an excellent question. I actually have the study before me and would be happy to leave it with the committee. It's a valuable study, done by Jeff Nisker and his colleagues. I do want to clarify what it was: 45% was a non-response. So we don't know what they would have said. It was kind of like a survey. Still, I think Professor Baylis's points are important.

In some respects, you answered your own question by saying that people move on in their life. Their perspectives may change. That, in many respects, is the very reason you need to go back and reconsent.

I think, really, if you look at other ethics contexts, it's standard practice to reconsent in these kinds of situations, whether it's biobanking or other kinds of clinical research. So I think it can only increase trust and increase certainty in the consent process.

[The Chair, Conservative, Rob Merrifield]

Go ahead, Dr. Lalonde.

[Dr. André Lalonde]

I tend to put, as we say in French, a bémol on this issue, because, as he said, 40% of the people could not be reached. When people move from province to province, etc., we know that in relation to cervical cancer and other issues, it's nearly impossible to reach them. If we put this into the law, it is going to add to the cost of IVF, and at what difficulty? How are physicians going to reach somebody who moved eight years ago?

I have some questions on that. I think the regulations, as they are, are better; it's a more general regulation.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Thank you.

[The Chair, Conservative, Rob Merrifield]

Madame Gagnon is next.

[Christiane Gagnon, Bloc, Québec, QC]

Thank you for having studied this issue, Ms. Baylis, Mr. Lalonde, Mr. Caulfield and Mr. Buckett.

I would like to ask Ms. Baylis a question, but you may all share your thoughts on the subject with us.

Do you not think it would be easier, rather than analyzing one regulation in isolation, like section 8, to consider all of the regulations together? You say that in section 8, the user is not defined clearly enough. We would have to take a more comprehensive look at it. Why are we only studying section 8 today? The associated regulations do not give us a general view of the intentions. If the rationale is not clearly set out in section 8, would it not have been preferable to study all of the regulations together?

[Dr. Françoise Baylis]

Everyone would like to have an overview, but several of us are still aware of the fact that there have already been long delays. From what I understand, those working on the drafting of the regulations must do so as quickly as possible. If we had to wait until everything was ready before moving forward, we would have to wait for years and years to come.

I understand very well what you are saying, and in theory, I agree. However, for practical reasons, we cannot wait. We really must move forward and make sure that we are respecting the intentions expressed by Parliament when the law was enacted in 2004.

[Dr. André Lalonde]

I agree with Ms. Baylis and I would add that if the agency had really been launched and the people appointed who should have been, much more progress would have been accomplished in these areas. The people from the Department of Health have done a lot of consultation with the associations, ethics groups, etc. These documents are the subject of a broad consultation. The methodology is good.

On the other hand, to answer Ms. Fry, I would say that it is rather urgent that the agency be able to start its work.

[Christiane Gagnon, Bloc, Québec, QC]

If I understood clearly what you said, Ms. Baylis, a high percentage of people withdraw their consent as far as gametes or embryos for research are concerned. I would like to understand what their motivations are.

I can understand that this exercise involves a great deal of emotion and that people do not necessarily have the same perception before as after. Would one of the reasons why people withdraw their consent perhaps be that the context from which they gave it and the context in which they withdraw it are not the same, and that furthermore, that consent has become the subject of discussions? According to the clinician or doctor, is a rather moral approach not taken? We know that not everyone agrees on research involving embryos. Is it possible that the clinician's personality has an influence on these events?

[Dr. Françoise Baylis]

I think that everything you just said is quite correct. It depends on the people concerned, whether it be the two partners in the couple, the clinicians, or yet again on the spirit of the times. The scientific possibilities have changed, and permission is no longer granted for the research. We're talking about stem cells and we want to say yes to the research. It can work both ways. All we know—and this is very well documented—is that over time, people change their minds as to what the definition of an embryo is. At the outset, perhaps it was considered as tissue, perhaps later on, it is perceived as an unborn child, in a frozen state, which could be the brother or little sister of the child that is already born. Perhaps there are other factors that are taken into account, but what we know very well is that people change their minds, and the problem is that when you get the first consent, when the period of treatment is just beginning, it is highly unlikely that the couple can be told what the goal of the research will be.

One of the comments I make in my brief is that it is not enough to talk about research in general, because the participant may want to help advance research on infertility, and will agree that their embryos be used for such research or even for stem cells. But if told that the objective is to do research on abortion, participants may very well decide that they do not want their embryos to serve for that type of research. Therefore, very often, it is the objective of the research that will determine whether the person will support the project or not. If we look at the current guidelines on research involving humans, not only embryos, it states very clearly that the person must understand the goal of the research before granting his or her consent.

In this context, participants cannot give their consent unless they agree with the project, accept the goals of the project ,and donate their embryos. That is why I am emphasizing the fact that when the first consent is given, where research is concerned, the information available is insufficient. Whereas in the other cases, if the intention is to donate the embryos to another couple, the person understands what that means, she understands the objective. Things are different where research is concerned. That must be specified, in my opinion.

[Christiane Gagnon, Bloc, Québec, QC]

But how could we specify that?