Evidence of meeting #33 for Health in the 39th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was consent.
A recording is available from Parliament.
4:20 p.m.
Conservative
The Chair Conservative Rob Merrifield
Mr. Caulfield would like to answer as well.
Your time is up, but we'll allow Mr. Caulfield to answer.
4:20 p.m.
Professor, Health Law Institute, University of Alberta
I'd again like to endorse the idea that this consent should be as specific as possible. I agree with Professor Baylis on that point. But the question is on whether or not section 8 is the appropriate place to talk about the substance of consent.
I would like to read from the study, because Dr. Nisker's study has received a lot of attention here today. Let me read exactly what the conclusions were.
Of the 40 couples contacted, only 22 agreed to donate embryos to stem cell research. One couple no longer wished to donate embryos to research, so that was one explicit “no”. One package was returned as non-deliverable. There were no responses received from 16 couples, and we don't know what was behind those 16 couples.
Dr. Nisker does a good job of explaining why he thinks they can read some interpretation into those 16 couples, but I think you also need to be careful not to over-interpret the data. It's an interesting study.
4:20 p.m.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
Thanks, Mr. Chair.
Thank you to all the witnesses for coming today.
One observation is that we are here to talk about section 8 and section 8 alone. I'm getting the sense we may be drifting a little away from that.
A concern was raised by Ms. Gagnon, and I can assure you that the department is moving as fast as possible in a very difficult area.
It's the same as the concern you raised, Dr. Fry.
My first question is to Timothy. I understand the amendments to the CIHR guidelines were made to clarify that both non-frozen and frozen embryos could always be used in stem cell research provided that consent practices are followed. Are you satisfied this does not constitute a change in the consent provisions of the act?
4:25 p.m.
Professor, Health Law Institute, University of Alberta
As was also highlighted earlier, I think there's a very interesting conflict with the 2002 guidelines, which are explicitly referenced in the act. I believe it means the 2002 CIHR guidelines are the guidelines that are relevant to the legislation. It creates a very interesting legal dilemma because you have a set of guidelines that were created by a relatively ad hoc committee, which both Françoise and I sat on, and became incorporated into law without the knowledge that it was in fact what was going to happen.
In the document that we both participated in, we said it was a living document and that they may be changed in the future. Nevertheless, the legislation explicitly references 2002. If you move forward to the amendments that occurred, it clearly seemed to try to clarify that you can use fresh embryos.
I was not closely involved in the amendments, but they seem to be a clarification on the use of fresh embryos. Is it appropriate? Is that what you're asking me?
4:25 p.m.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
I want to get your view on the fact that there has not been any change to the consent provisions of the act as they constitute or reflect the CIHR guidelines.
4:25 p.m.
Professor, Department of Bioethics, Novel Tech Ethics, Dalhousie University
I think I can speak to that on two points. There were the 2002 guidelines that came out. The guidelines were updated in 2005. They were also updated in 2006. In 2006, they returned to some of the text of 2002 and explicitly acknowledged that it is because it is a 2002 guideline that it had been incorporated into legislation. So there is a recognition on their part that at least some of the changes they tried to introduce would not be consistent with what would be required legally. So there have been changes in both directions.
On the point you're making with respect to fresh and frozen, there is, in my view, now an inconsistency that has been introduced into the CIHR guidelines. They still require a reiterated consent, which doesn't make sense in the context of taking fresh embryos. I've also suggested that there's data from other countries suggesting that there is no obvious reason to do that, and I have other documentation here that shows it's actually harmful to women to have made this change. I'm actually disappointed in the change, but there is no course of law for it.
4:25 p.m.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
I'll have to take exception to the point.... It's my understanding, and that of the government, that CIHR has put systems in place to ensure that the research it funds meets the highest ethical standard, and certainly the 2002 stem cell guidelines, as they're commonly known, meet that high ethical standard. You're nodding your head, so I assume you agree with that.
4:25 p.m.
Professor, Department of Bioethics, Novel Tech Ethics, Dalhousie University
I'm in full agreement with the 2002 guidelines. I have problems with the changes that have been made since then, from an ethics point of view.
4:25 p.m.
Professor, Department of Bioethics, Novel Tech Ethics, Dalhousie University
But I'm in full agreement with the 2002 guidelines, and in fact I'm suggesting a return to that. I'm suggesting that it be clear with respect to that, that the assumption was that you would take cryopreserved embryos because all fresh embryos would either be transferred to a woman, because doing so would be in her best interest, or cryopreserved for her best interest.
4:25 p.m.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
That's from an ethics point of view, but the law and ethics are sometimes not consistent, and ethics depends on who you talk to, but the guidelines are—
4:25 p.m.
Professor, Department of Bioethics, Novel Tech Ethics, Dalhousie University
That's not the case with respect to the 2002 guidelines. With respect to the 2002 guidelines, which are referenced in the act, there is the presumption that you're using cryopreserved embryos. In 2005...which is not referenced in the act, there is an explicit statement that you can use fresh and frozen.
4:30 p.m.
Chair, Government Relations Committee, Canadian Fertility and Andrology Society
Excuse me. Can I just make a very quick point?
4:30 p.m.
Chair, Government Relations Committee, Canadian Fertility and Andrology Society
There are certain cases in which you may have embryos that are not good enough to freeze--in other words, they're not going to survive being frozen and thawed--but they are not going to transfer either. Therefore, the idea that it's in the best interest of the patient to either transfer the embryos or freeze them is not actually the case. Yes, we transfer the fresh ones--one or two or three or whatever--and freeze some if we can, but there are still going to be other embryos that would otherwise be destroyed.
4:30 p.m.
Conservative
December 12th, 2006 / 4:30 p.m.
NDP
Penny Priddy NDP Surrey North, BC
Thank you, Mr. Chair.
I want to go back to what you said was the original consent percentage. So it wasn't really that 45% of people did not change their mind; it was, if you will, that there was a non-return.
4:30 p.m.
NDP
Penny Priddy NDP Surrey North, BC
That was not my first understanding of it. Thank you.
Secondly, in the area of who should request consent--which does cause me some particular concern in terms of who actually requests consent--do you have a recommendation? It says here that members of the research team are.... One would suggest the members of the research team have a bias. That's fair enough. They're researchers. But would anybody want to comment on whether it should be some more neutral third party?
4:30 p.m.
Professor, Health Law Institute, University of Alberta
I think this is a very interesting question and again one that has immediate relevance. The interesting question is whether it falls under our section 8 analysis. Having said that, I'd be happy to offer an opinion.
I actually think the clinician who is uninvolved with the research may be an appropriate party. Certainly, legally, I think they're an appropriate party, because the consent will be obtained in a clinical setting over which the clinician has legal responsibility, whether that is for research or clinical activities. It's important to note that the clinician should not be the researcher in that sense.
The other reason a clinician might be a good person to play this role is that they have other obligations toward the patient. They have fiduciary obligations that exist for the exact purpose of dealing with potential conflicts of interest.
One could argue that in other research settings, be it cancer research or other clinical research settings, the potential conflicts may be even more profound. I'm not saying there aren't issues in those contexts, but in those situations, we let the clinician get consent. Some would argue that they're the appropriate person to get consent because they know the patient well and they have these other legal obligations.
4:30 p.m.
NDP
Penny Priddy NDP Surrey North, BC
I think I asked this question the last time, but I got an answer I didn't understand, so I'm going to try again. It may sound like a foolish question, but when there's a request made for organ transplants, or organ donation, if you will, is there any connection between that and...? In many circumstances, if people are dying, embryos would not be appropriate for donation, but in some cases they might be. Is there any connection between asking around organ donations and asking around embryos? Are they part of that?
4:30 p.m.
Professor, Department of Bioethics, Novel Tech Ethics, Dalhousie University
My understanding is that it's dealt with in part 2 of the regulations. The expectation there is that you would have similar kinds of expectations in terms of proper disclosure, full understanding of the rules with respect to withdrawal, and very clear mechanisms as to how the withdrawal would have had to take place prior to it being acted upon.