Can a donor withdraw consent?

Word games

The fine print on withdrawing consent has changed. We weren't consulted.

In October 2018 new regulations were proposed for Canada's Assisted Human Reproduction Act (AHRA). Most watchers had an eye on the biggies — reimbursement of third parties and processing and handling of gametes. The language in the proposals (which are formally published in Gazette I) was scrutinized, consultations (however inadequate) were held, then the final wording (formally published in Gazette II) was fixed.

Unnoticed by many was the fact that a few words changed in the regulations on consent. (The "consent regs" were the only regulations of the AHRA that had ever been in force.) Some of the changes didn't appear in the proposals at all and so faced no real public consultation. 

Alana Cattapan, an assistant professor at the University of Waterloo, who has written several papers about consent in assisted reproduction, did notice. The original wording suggested she could withdraw her consent up until the time the material had been "designated" for someone else; the proposed wording in Gazette I changed that to "obtained." But in final wording an entirely new clause was inserted, which was so clumsily written that it's hard to know for certain what it means. Cattapan admits that even she isn't entirely sure she knows. "Do they? Does anyone?" 

"What I'm concerned about is the way the current regulations read as if the second that eggs are removed from a donor's body, she can no longer withdraw her consent," says Cattapan. 

Below, I place the various wordings in succession. First, the original wording. Then, the proposed wording (Gazette I). Then, the revised and final wording (Gazette II). Alterations are in bold. Then follows my brief lay translation. Finally, a possible interpretation. See what you think.

The original wording:

3 Before a person makes use of human reproductive material for the purpose of creating an embryo, the person shall have a document signed by the donor of the material stating that, before consenting to the use of the material, the donor was informed in writing that

(c) if the donor wishes to withdraw their consent, the withdrawal must be in writing;

(d) the withdrawal is effective only if the person who intends to make use of the human reproductive material is notified in writing of the withdrawal

(ii) in the case of human reproductive material to be used to create an embryo for the purpose mentioned in subparagraph (a)(iii) [third party use], before the third party acknowledges in writing that the material has been designated for their reproductive use;

The proposed wording in Gazette I:

3 Before a person makes use of human reproductive material for the purpose of creating an embryo, the person shall have a document signed by the donor of the material stating that, before consenting to the use of the material, the donor was informed in writing that

(c) if the donor wishes to withdraw their consent, the withdrawal must be in writing;

(d) the withdrawal is effective only if the person who intends to make use of the human reproductive material is notified in writing of the withdrawal

(ii) in the case of human reproductive material to be used to create an embryo for the purpose mentioned in subparagraph (a)(iii) [third party use], before the third party acknowledges in writing that the material has been obtained for their reproductive use;

The final wording in Gazette II: 

3 Before a person makes use of human reproductive material for the purpose of creating an embryo, the person shall have a document signed by the donor of the material stating that, before consenting to the use of the material, the donor was informed in writing that

(c) if the donor wishes to withdraw their consent, the withdrawal must be in writing;

(d) the withdrawal is effective only if the person who intends to make use of the human reproductive material is notified in writing of the withdrawal

(ii) in the case of human reproductive material to be used to create an embryo for the purpose mentioned in subparagraph (a)(iii) [third party use],

  • (A) before the third party acknowledges in writing that the material has been obtained for their reproductive use, or

  • (B) if the material to be used has not yet been removed or collected but the third party has acknowledged in writing that the material is to be obtained for their reproductive use, before the removal or collection;

My lay translation:

If donors want to change their mind about donating, they have to do it in writing (and the IPs have to receive that written notice) either before they have given written consent or before the eggs or sperm have been removed from their body. 

A reasonable interpretation: 

Donors can't really withdraw their consent.

If they haven't given written consent, then there's nothing to withdraw.

If they haven't given their gametes yet, there's nothing to withdraw consent over — the gametes will simply remain in their bodies and they won't give them.

If they change their minds after signing a consent, and after having the gametes removed from their bodies, but before an embryo is created, they have no way to withdraw their consent.

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What this could mean, in practical terms, is that if an egg donor comes out of sedation in a clinic and has second thoughts, it's too late to reconsider. 

Cindy Wasser, a Toronto fertility lawyer, says that interpretation is likely correct. When the eggs are still in her body, the charter of rights and freedoms protects her right not to have them removed, even if she signed a consent to do so. But "...once out of the barn," says Wasser, "the gametes are now property and they signed an informed consent to donate their property. Section 7 of the Charter may not apply here because the property is no longer part of the body we get to control." 

Wasser says the changes may have been made in part to deal with the difference between donating to a specific person or couple and donating through a bank for use someday in the future.  

Cattapan notes that Health Canada's regulatory impact analysis statement says the government made the changes in order to better align with industry practices. The document says: "A few respondents commented that the timing of a donor's withdrawal of consent in the proposed regulations are not consistent with industry practice as it does not recognize that consent forms for in vitro fertilization (IVF) are signed prior to the IVF cycle. They noted that the proposed regulations would have required the recipients to return to the clinic to sign an additional form after the ova are obtained but before the IVE [embryo] is created [note: was that not true of the original regulations too? or does the revised word "obtained" change something?]; otherwise the Regulations would allow the donor to withdraw their consent at any time following donation. Returning to the clinic to sign another form could be burdensome for those who do not live in close proximity to the clinic. [note: or is this equally about the burden on the clinic to obtain further consents?] Health Canada notes this and has corrected the Regulations to take into account current clinical practices."

Cattapan says this new clause should have been considered more carefully by all stakeholders. "Health Canada's job is not to conform to clinical practice," she says, "it is to create best practice." 

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original regs

proposed regs

revised regs

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