REPORT OF THE COMMITTEE Wednesday, February 14, 2007

The Standing Senate Committee on Social Affairs, Science and Technology

has the honour to table its

NINTH REPORT


 

Your Committee, to which was referred proposed Regulations under Section 8 of the Assisted Human Reproduction Act has, in obedience to its order of reference of Wednesday, December 6, 2007, examined the said proposed Regulations, and reports as follows:

 

BACKGROUND

The Assisted Human Reproduction Act, which received Royal Assent in March 2004, is atypical with respect to the regulation-making process as there is parliamentary oversight of the Governor-in-Council’s regulation-making power.  Section 66 of the Act requires the Minister of Health to lay all proposed regulations before each House of Parliament, and allows for Committees of both Houses to review the proposed regulations and report their findings within a specified timeframe.  Section 66 also indicates that, although the Minister is not obligated to incorporate a recommendation of the committee, he is required to provide a statement of rationale for not incorporating a recommendation.  That is, subsection 66 (4) reads;

The Minister shall take into account any report of the committee of either House.  If a regulation does not incorporate a recommendation of the committee of either House, the Minister shall lay before that House a statement of the reasons for not incorporating it.

The Committee held one meeting on these proposed regulations and heard from officials from the Assisted Human Reproduction Implementation Office as well as a bioethicist.

 

 

COMMITTEE’S CONCLUSIONS

After reviewing the proposed Regulations, Your Committee is not recommending any changes but is concerned that three inter-related issues could be better addressed.  These are: the timing of consent to the research use of embryos; the timing of the withdrawal of consent, and; the research use of fresh, viable embryos.

The Committee heard that these issues are of concern as they may not be handled in the Regulations in a way that is in the best interests of women.  It considered specific revisions to the proposed regulations that were submitted to them to address these concerns.  However, members suggested that submitted revisions might result in unintended interpretation.  The Committee therefore concluded that a more in-depth review is necessary.  As such, Your Committee recommends that;

 

The Minister undertake to study the proposed revisions as put forth in the appended document and make appropriate adjustments to the proposed Regulations to address these concerns.

Respectfully submitted,

Art Eggleton, P.C.
Chair


 

APPENDIX TO THE NINTH REPORT OF THE STANDING SENATE COMMITTEE ON SOCIAL AFFAIRS, SCIENCE AND TECHNOLOGY

 

Françoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy, Dalhousie University   www.noveltechethics.ca

 

Presentation to the Standing Senate Committee on Social Affairs, Science and Technology on the Draft Consent regulations for the Assisted Human Reproduction Act, Ottawa, January 31, 2007

 

Opening Remarks  

Regulations pursuant to the AHR Act[i] should be passed as soon as possible. It has been nearly three years since the AHR Act received Royal Assent and as yet there are no regulations in place.  It is important not to further delay the realization of the objectives of the Act (most notably, the protection of women and others directly affected by the use and development of assisted human reproductive technologies). 

I have three main concerns with the draft consent regulations:  the timing of consent to the research use of embryos; the timing of withdrawal; and the research use of viable, healthy, fresh embryos.

 

Summary of Recommendations re: Draft Consent Regulations 

Amend s.13 by adding the following subsection:  

“13(3) Consent to a specific research project must be requested at the time of anticipated research use.” 

Throughout the regulations, search and replace “the material has been designated for XXX” to “the material designated for XXX has been received” 

Throughout the regulations, search and replace “the embryo has been designated for XXX” to “the embryo designated for XXX has been received” 

Revise s.3 (e) to read as follows: 

“the number of in vitro embryos created with the human reproductive material may be in excess of the immediate reproductive needs of the individual or couple for whom they were created. Such embryos may be: (i) cryopreserved for later reproductive use; (ii) destroyed; or (iii) if they ‘unsuitable for transfer’ (for morphological, biological, or genetic reasons), used for research purposes.”

 

Revise 12(c) (v) (C) to read as follows: 

the creation of a stem cell line using the thawed in vitro embryo (or fresh embryo ‘unsuitable for transfer’ (for morphological, biological, or genetic reasons).”

 

Reasons for the Recommendations 

1. Timing for consent 

Amend s.13 by adding the following subsection:  

“13(3) Consent to a specific research project must be requested at the time of anticipated research use.” 

Under the AHR Act, the consent regulations must be consistent with 2002 CIHR Guidelines.  [s.3 and s.40 (3.1); See Appendix B] The 2002 CIHR Guidelines clearly require reiterated consent proximate to the time of use (i.e., “At the time when the embryos are to be used for research to derive and study ES cells (and other human cells or cell lines of a pluripotent nature), consent of the embryo providers must be reiterated”). [7.2.2]  The regulations require that consent from embryo donors be consent to “a specific research project”. [s.13(1)(e)]  It might be thought that consent to a specific research project would result in consent proximate to the time of research use, but this is not necessarily so.  A “project” can mean a plan, strategy, scheme, proposal, or undertaking.  Clearly a plan for use could be described to someone and the actual use might not occur until years later.  One could therefore consent to a plan without the consent being proximate to the time of use.  This would be inconsistent with the 2002 CIHR Guidelines and, hence, the AHR Act.  Therefore, the regulations need to be very explicit and clear with respect to the timing of consent and this can be achieved through the addition recommended above. 

Another reason to make this suggested addition is that, by ensuring that consent is proximate to the time of actual research use, the quality of the consent will be greater – it will be easier to give full disclosure of the nature, goals, and objectives of the research.

 

2. Timing for withdrawal 

Throughout the regulations, search and replace “the material has been designated for XXX” to “the material designated for XXX has been received” 

Throughout the regulations, search and replace “the embryo has been designated for XXX” to “the embryo designated for XXX has been received” 

The regulations seek to balance the competing needs and interests of the donors of human reproductive material, embryo donors, third parties, clinician scientists, and researchers.  This explains and justifies limits on the right to withdraw.  

According to the regulations any withdrawal must be in writing and must be before another person (e.g., researcher) acknowledges in writing that the human reproductive material or in vitro embryo has been designated for his or her use.  This limit is premature.  For example, with this limit, many years might pass between the time at which a researcher might acknowledge in writing that a human embryo has been designated for his/her research use and the time when the embryo is actually used.  In the intervening years, changes in circumstances of profound moral significance for the embryo donors could have occurred such that they would like to withdraw their consent to the embryo being used for research.  Therefore, at the very least, the regulations should be amended so that the right to withdraw extends to the point at which another person (e.g., researcher) acknowledges in writing the receipt of designated human reproductive material or in vitro embryo. 

This concern would be further alleviated by the proposed amendment to s.13.

 

3. Use of fresh embryos for research 

Revise s.3 (e) to read as follows: 

“the number of in vitro embryos created with the human reproductive material may be in excess of the immediate reproductive needs of the individual or couple for whom they were created. Such embryos may be: (i) cryopreserved for later reproductive use; (ii) destroyed; or (iii) if they ‘unsuitable for transfer’ (for morphological, biological, or genetic reasons), used for research purposes.”

 

Revise 12(c) (v) (C) to read as follows: 

the creation of a stem cell line using the thawed in vitro embryo (or fresh embryo ‘unsuitable for transfer’ for morphological, biological, or genetic reasons.”

There is considerable debate about the permissibility of research involving viable, healthy, fresh embryos.  Unfortunately, the AHR Act did not address this issue directly and so we are left with a lack of clarity.  The regulations should be used to clarify the legal position of research involving fresh embryos.  It is clear that the drafters of the AHR Act wanted the consent regulations to be consistent with the 2002 CIHR Guidelines.  It is also clear that the spirit (if not the letter) of the 2002 CIHR Guidelines was permissive in relation to the research use of frozen but not fresh embryos.  The regulations should therefore be revised to make it clear that research involving frozen embryos as well as fresh embryos ‘unsuitable for transfer’ (for morphological, biological or genetic reasons) is permissible, but that research involving suitable for transfer is not. 

I would also note here that a number of arguments can be, and have been, made persuasively in support of the claim that the research use of fresh embryos (except where unsuitable for transfer for morphological, biological, and genetic reasons) is morally indefensible.


 

Appendix A:

Detailed Commentary on Recommendations 

1. Timing of Consent to the Research Use of Embryos

The regulations stipulate that consent from donors of human reproductive material (where the material is originally donated for the reproductive use of the donor’s spouse or common-law partner or a third party) is a general consent to “other research” [s.4 (1) (b) or (c)]. Consent from embryo donors is a consent to “a specific research project” [s.13 (1) (e)] 

The regulations do not stipulate that consent from embryo donors to a specific research project must be obtained at the time of anticipated research use, nor do the regulations require a reaffirmation of any initial, earlier consent or authorization.  

This does not appear to be consistent with “the provisions of the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research in March, 2002”, as required by law (AHR Act s. 3) [See Appendix B] 

7.2.1 Embryos no longer wanted for reproductive purposes may be donated to another couple, used for research (including research to derive and study human ES cells), or discarded. These options should be discussed with the gamete providers (and the embryo providers if these are different individuals), and a decision regarding the eventual disposition of unwanted embryos should be made prior to the collection of gametes and the creation of embryos for reproductive purposes. (CIHR 2002 Guidelines[ii])

7.2.2 At the time when the embryos are to be used for research to derive and study ES cells (and other human cells or cell lines of a pluripotent nature), consent of the embryo providers must be reiterated. This requirement affirms the right to withdraw and is necessary because of the possible lengthy delay between the time at which the original consent is given and the time at which the embryos are utilized for research purposes. A renewal of the consent provided by the gamete providers (if the gamete providers are not the same individuals as the embryo providers), is not required provided that appropriate consent for the unrestricted research use of the embryos was given at the time of gamete donation. (CIHR 2002 Guidelines) (italics added)

The intent of the 2002 CIHR Guidelines was to promote decision-making regarding the future disposition of excess embryo prior to the collection of gametes and the creation of embryos. As regards embryo research, this consent would not be acted upon until such time as the potential donors could be provided with information about a specific embryo research project, at which time their initial general consent/authorization would need to be reiterated in order for their embryos to be eligible for research use. 

Arguably s. 7.2.1 of the 2002 CIHR Guidelines is inconsistent with the legal prohibition on creating “an in vitro embryo for any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures.” Thus, it is not surprising that the regulations do not require consent to the future research of embryos prior to the creation of embryos.   

What is surprising, however, is the failure to require a reiterated consent at the time of anticipated research use, as per 7.2.2. This potentially introduces a serious problem for the research use of frozen embryos “because of the possible lengthy delay between the time at which the original consent is given and the time at which the embryos are utilized for research purposes.”  

Much depends on the interpretation of “specific” in the phrase “a specific research project.”  If a high degree of specificity is required (i.e., more than information about a specific area of research such as infertility research, or research on PGD, or stem cell research), then de facto it may only be possible to request a consent to embryo research at the time of anticipated research use. Clarity on this point is lacking.

 

RECOMMENDATIONS:  

Amend s.13 by adding the following subsection: 

”13 (3) Consent to a specific research project must be requested at the time of anticipated research use.

 

2. Research Use of Fresh Embryos 

The research use of embryos should be limited to frozen-thawed embryos or fresh embryos not suitable for transfer for morphological, biological or genetic reasons.[iii]  It is in the medical interest of women and couples who are infertile and who use IVF in the hope of building a family to freeze all of their viable, healthy embryos. Donating viable, healthy, fresh embryos created for reproductive purposes to research can harm women because if there are further IVF attempts, having donated these embryos to research can: i) decrease the chance of pregnancy and childbearing; ii) increase the psychological stress experienced as a result of IVF; iii) increase the number of risky or painful procedures; iv) increase the social disruption that IVF causes; and v) increase the financial burden of infertility treatment.

Evidence suggests that decision-making regarding the future disposition of embryos is complicated and influenced by experiences during fertility treatment.[iv]  Indeed, in 2001, Klock et al reported that 88% of couples who initially decided to donate their frozen embryos to research changed their mind.[v] More recently, in a 2006 survey of one Canadian IVF clinic, Nisker et al reported that only 55% of couples who had designated their frozen embryos for donation to research were willing to consent to a specific embryo research project when provided with the opportunity to do so.[vi]  Thus, many IVF patients who initially consent to the future donation of excess frozen embryos to research (consent provided prior to the creation of  in vitro embryos) change their mind once they are no longer in active treatment and no longer potentially influenced by what their physicians want.[vii]

This evidence should give us pause in relation to some of the key elements of informed consent, namely disclosure and voluntariness. Here it is worth noting that the Ethics Committee of the American Society for Reproductive Medicine holds that:

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.[viii]

For the record, the 2005 CIHR Guidelines changed the original presumption that non-transferred embryos typically would be cryopreserved for later reproductive use and instead explicitly endorsed the research use of fresh embryos. This change was made despite evidence documenting the fact that it was easier to derive human embryonic stem cells from frozen-thawed embryos than fresh embryos.[ix]

The draft consent regulations only address the issue of research involving fresh versus frozen embryos indirectly in the discussion of withdrawal.  More clarity is needed on this contentious issue.  Consistent with the intent of the 2002 CIHR Guidelines, embryo research should involve the use of frozen-thawed embryos.  As well, it could be ethically defensible to allow the research use of fresh embryos not suitable for transfer for morphological, biological or genetic reasons.

 

RECOMMENDATIONS:  

Revise 3 (e) to read as follows: 

“the number of in vitro embryos created with the human reproductive material may be in excess of the immediate reproductive needs of the individual or couple for whom they were created. Such embryos may be: (i) cryopreserved for later reproductive use; (ii) destroyed: or (iii) if they are ‘unsuitable for transfer’ (for morphological, biological, or genetic reasons), used for research.”

 

Revise 12(c) (v) (C) to read as follows: 

the creation of a stem cell line using the thawed in vitro embryo (or fresh embryo ‘unsuitable for transfer’ (for morphological, biological, or genetic reasons)”


 

Appendix B:

Relevant Excerpts of AHR Act 

The AHR Act defines consent as follows:

s. 3 ‘‘consent’’ means fully informed and freely given consent that is given in accordance with the applicable law governing consent and that conforms to the provisions of the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research in March, 2002, as detailed in the Regulations.

 

Furthermore, in its administrative section, the AHR Act requires that:  

s. 40 (3.1) The Agency shall not issue a licence under subsection (1) for embryonic stem cell research unless it has received the written consent of the original gamete providers and the embryo provider in accordance with the Human Pluripotent Stem Cell Research Guidelines released by the Canadian Institutes of Health Research in March, 2002, as specified in the regulations. 

While the Human Pluripotent Stem Cell Research: Guidelines for CIHR Funded Research (hereafter the 2002 CIHR Guidelines) have twice been amended (in 2005 and 2006), these amendments have no legal force given the specificity of the reference to consent requirements of the 2002 CIHR Guidelines in the AHR Act.[x]

[i]Assisted Human Reproduction Act, S.C. 2004, c.2.

[ii] Canadian Institutes of Health Research, Human Pluripotent Stem Cell Research: Guidelines for CIHR-funded Research, (March 2002), online: <http://www.cihr-irsc.gc.ca/e/1487.html>.

[iii] Nisker J, White A. “The CMA Code of Ethics and the Donation of Fresh Embryos from Stem Cell Research” (2005) 173:6 CMAJ 621; Baylis F. McInnes C. Warning: Women at Risk: Embryonic and Fetal Stem Cell Research in Canada. McGill Health Law Publication (forthcoming March 2007); McLeod C, Baylis F. Women Donating Fresh Embryos to Stem Cell Research: In Whose Interests? Journal of Applied Ethics (in review).

[iv] Nachtigall, RD, Becker G, Friese C., et al “Parents’ Conceptualization of Their Frozen Embryos Complicates the Disposition Decision” (2005) 84:2  Fertil Steril 431.  See also, McMahon CA, Gibson F, Coehn L et al “Mothers Conceiving through in Vitro Fertiltization: Siblings, Setbacks, and Embryo Dilemmas after Five Years” (2000) 10:3 Reprod Technol, 131.

[v] Klock SC, Sheinin S, Kazer RR. “The Disposition of Unused Frozen Embryos” [Letter] (2001) 345 N Engl J Med, 69.

[vi] Nisker, J., White, A., Tekpetey, F., Feyles, V. “Development and investigation of a free and informed choice process for embryo donation to stem cell research in Canada,” Journal of Obstetrics and Gynaecology Canada, (2006) 28, 10: 903-908.

[vii] McLeod C, Baylis F. Women Donating Fresh Embryos to Stem Cell Research: In Whose Interests? Journal of Applied Ethics (in review); and McLeod C, Baylis F. The Ethics of Asking IVF Patients to Donate Fresh Embryos to Stem Cell Research. Canadian Fertility and Andrology Meeting, Ottawa, November 2006.

[viii] Ethics Committee of the American Society for Reproductive Medicine. “Donating Spare Embryos for Embryonic Stem-Cell Research” (2002) 78:5, Fertil Steril 957 at 959 (reviewed January 2004).

[ix] Sjogren, A., Hardarson, T., Andersson, K., Caisander, G., Lundquist, M., Wikland, M., Semb, H., Hamberger, L. (2004) ‘Human blastocysts for the development of embryonic stem cells,’ Reproductive Biomedecine Online, 9, 3: 326-9.

[x] Applying principles of statutory interpretation, the definition of “consent” in s. 3 of the Act is exhaustive: see Pierre-André Côté, The Interpretation of Legislation in Canada, 3d ed. (Scarborough: Thomson Canada Limited, 2000) 62:  “A first reading is usually sufficient to indicate whether a definition is exhaustive or not: if introduced by the word “means” it is deemed to be exhaustive.”  In this case, the definition of consent in s. 3 starts with the deeming word “means”.   At 61, Côté says, “An exhaustive definition purports to encompass all possible meanings of a term.”  In this case, only the 2002 CIHR Guidelines are encompassed in the definition as a possible meaning in relation to consent.


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