Assisted Human Reproduction (Section 8 Consent) Regulations

Link to law: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2007-137/FullText.html

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Assisted Human Reproduction (Section 8 Consent) Regulations

SOR/2007-137ASSISTED HUMAN REPRODUCTION ACT
Registration 2007-06-14
Assisted Human Reproduction (Section 8 Consent) Regulations
P.C. 2007-958 2007-06-14Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 65(1) of the Assisted Human Reproduction ActFootnote a, hereby makes the annexed Assisted Human Reproduction (Section 8 Consent) Regulations.
Return to footnote aS.C. 2004, c. 2Interpretation

1 (1) The following definitions apply in these Regulations.

Act
Act means the Assisted Human Reproduction Act. (Loi)
common-law partner
common-law partner, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship at the relevant time, having so cohabited for a period of at least one year. (conjoint de fait)
third party

third party means

(a) in relation to human reproductive material,

(i) an individual who is not the donor of the human reproductive material or the spouse or common-law partner of that donor, or
(ii) a couple in respect of whom neither spouse or common-law partner is the donor of the human reproductive material; and

(b) in relation to an in vitro embryo,

(i) an individual who is not the donor of the in vitro embryo under subsection 10(1), or
(ii) a couple who is not the donor of the in vitro embryo under subsection 10(1). (tiers)

(2) In these Regulations, the term spouse does not include a person who, at the relevant time, lives separate and apart from the person to whom they are married because of the breakdown of their marriage.
(3) For the purpose of these Regulations, the written consent of a donor must be signed by the donor and attested by a witness.

PART 1 Consent Given Under Subsection 8(1) of the Act

2 This Part applies in respect of a consent given under subsection 8(1) of the Act to make use of human reproductive material for the purpose of creating an embryo.

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

(a) subject to paragraph (b), the human reproductive material will be used in accordance with the donor’s consent to create an embryo for one or more of the following purposes, namely,

(i) the donor’s own reproductive use,
(ii) following the donor’s death, the reproductive use of the person who is, at the time of the donor’s death, the donor’s spouse or common-law partner,
(iii) the reproductive use of a third party,
(iv) improving assisted reproduction procedures, or
(v) providing instruction in assisted reproduction procedures;

(b) if the human reproductive material is to be removed from the donor’s body after the donor’s death, the material will be used in accordance with the donor’s consent to create an embryo for one or more of the following purposes, namely,

(i) the reproductive use of the person who is, at the time of the donor’s death, the donor’s spouse or common-law partner,
(ii) improving assisted reproduction procedures, or
(iii) providing instruction in assisted reproduction procedures;

(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

(i) in the case of human reproductive material to be used to create an embryo for a purpose mentioned in paragraph (a) or (b), other than subparagraph (a)(iii), before the material is used, and
(ii) in the case of human reproductive material to be used to create an embryo for the purpose mentioned in subparagraph (a)(iii), before the third party acknowledges in writing that the material has been designated for their reproductive use;

(e) 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;
(f) if the human reproductive material is used to create in vitro embryos for a third party’s reproductive use and there are in vitro embryos in excess of the third party’s reproductive needs, the excess in vitro embryos will be used in accordance with the third party’s consent and, if the use is providing instruction in assisted reproduction procedures, improving assisted reproduction procedures or other research, the consent of the donor in accordance with section 4;
(g) if the human reproductive material is used to create in vitro embryos for the reproductive use of the person who, at the time of the donor’s death, is the donor’s spouse or common-law partner and there are in vitro embryos in excess of the spouse or common-law partner’s reproductive needs, the excess in vitro embryos will be used in accordance with the spouse or common-law partner’s consent and, if the use is providing instruction in assisted reproduction procedures, improving assisted reproduction procedures or other research, the consent of the donor in accordance with section 4;
(h) if the human reproductive material is used to create in vitro embryos for the reproductive use of a third party who is a couple, along with human reproductive material from an individual who is a spouse or common law partner in the couple, the use of the in vitro embryos will be subject to the consent of that individual alone if, prior to the use of the in vitro embryos, the individual is no longer a spouse or common-law partner in the couple; and
(i) if the donor consents to the human reproductive material being used to create an in vitro embryo for the purpose of providing instruction in assisted reproduction procedures or improving assisted reproduction procedures, no additional consent from the donor is required to permit the use of the embryo for that purpose.

4 (1) Before a person makes use of human reproductive material for the purpose of creating an embryo, the person shall have the written consent of the donor of the material stating that the material may be used for one or more of the following purposes:

(a) the donor’s own reproductive use;
(b) following the donor’s death, the reproductive use of the person who is, at the time of the donor’s death, the donor’s spouse or common-law partner;
(c) the reproductive use of a third party;
(d) improving assisted reproduction procedures; or
(e) providing instruction in assisted reproduction procedures.

(2) A donor’s consent stating that the donor’s human reproductive material may be used for a purpose mentioned in paragraph (1)(b) or (c) shall also state whether any in vitro embryos that are not required for that purpose may be used for providing instruction in assisted reproduction procedures, improving assisted reproduction procedures or other research.

5 (1) If a donor wishes to withdraw their consent, the withdrawal must be in writing.

(2) 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

(a) in the case of human reproductive material to be used to create an embryo for a purpose mentioned in paragraph 4(1)(a), (b), (d) or (e), before the material is used; and
(b) in the case of human reproductive material to be used to create an embryo for the purpose mentioned in paragraph 4(1)(c), before the third party acknowledges in writing that the material has been designated for their reproductive use.

PART 2 Consent Given Under Subsection 8(2) of the Act

6 This Part applies in respect of a consent given under subsection 8(2) of the Act to remove human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo.

7 Before a person removes human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo, the person shall have a document signed by the donor stating that, before consenting to the removal, the donor was informed in writing that

(a) the human reproductive material will be removed in accordance with the donor’s consent to create an embryo for one or more of the following purposes, namely,

(i) the reproductive use of the person who is, at the time of the donor’s death, the donor’s spouse or common-law partner,
(ii) improving assisted reproduction procedures, or
(iii) providing instruction in assisted reproduction procedures;

(b) if the donor wishes to withdraw their consent, the withdrawal must be in writing;
(c) the withdrawal is effective only if the person who intends to remove the human reproductive material is notified in writing of the withdrawal before the removal of the material; and
(d) human reproductive material removed from the donor cannot be used for a purpose mentioned in paragraph (a) unless the person who intends to make use of the material has the donor’s written consent under Part 1 respecting the use of the material.

8 Before a person removes human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo, the person shall have the donor’s written consent respecting the removal of the material and the donor’s written consent under Part 1 respecting the use of the material.

9 (1) If a donor wishes to withdraw their consent respecting the removal of human reproductive material after their death, the withdrawal must be in writing.
(2) The withdrawal is effective only if the person who intends to remove the human reproductive material is notified in writing of the withdrawal before the removal of the material.

PART 3 Consent Given Under Subsection 8(3) of the Act

10 (1) Subject to section 15, in this Part, donor means the following individual or individuals for whose reproductive use an in vitro embryo is created:

(a) the individual who has no spouse or common-law partner at the time the in vitro embryo is created, regardless of the source of the human reproductive material used to create the embryo; or
(b) subject to subsection (3), the couple who are spouses or common-law partners at the time the in vitro embryo is created, regardless of the source of the human reproductive material used to create the embryo.

(2) If the donor is a couple, the consent of each spouse or common-law partner must be compatible in order for the consent of the donor to comply with the requirements of this Part.
(3) In the case of an in vitro embryo created using human reproductive material from only one of the individuals in the couple that was the donor of the embryo at the time it was created, that individual becomes the donor of the embryo under paragraph (1)(a) if, before the use of the embryo, the individual is no longer a spouse or common-law partner in the couple.

11 This Part applies in respect of a consent given under subsection 8(3) of the Act to make use of an in vitro embryo.

12 Before a person makes use of an in vitro embryo, the person shall have a document signed by the donor of the embryo stating that, before consenting to the use of the embryo, the donor was informed in writing that

(a) the in vitro embryo will be used in accordance with the donor’s consent for one or more of the following purposes, namely,

(i) the donor’s own reproductive use,
(ii) the reproductive use of a third party,
(iii) improving assisted reproduction procedures,
(iv) providing instruction in assisted reproduction procedures, or
(v) a specific research project, the goal of which is stated in the consent;

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

(c) the withdrawal is effective only if the person who intends to make use of the in vitro embryo is notified in writing of the withdrawal

(i) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(i), before the use of the embryo,
(ii) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(ii), before the third party acknowledges in writing that the embryo has been designated for their reproductive use,

(iii) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(iii), before the later of the following occurrences, namely,

(A) the person acknowledges in writing that the in vitro embryo has been designated for improving assisted reproduction procedures, and
(B) the beginning of the process of thawing the in vitro embryo for the purpose of improving assisted reproduction procedures,

(iv) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(iv), before the later of the following occurrences, namely,

(A) the person acknowledges in writing that the in vitro embryo has been designated for providing instruction in assisted reproduction procedures, and
(B) the beginning of the process of thawing the in vitro embryo for the purpose of providing instruction in assisted reproduction procedures, and

(v) in the case of an in vitro embryo to be used for the purpose mentioned in subparagraph (a)(v), before the latest of the following occurrences, namely,

(A) the person acknowledges in writing that the in vitro embryo has been designated for research,
(B) the beginning of the process of thawing the in vitro embryo for the purpose of research, and
(C) the creation of a stem cell line using the in vitro embryo.

13 (1) Before a person makes use of an in vitro embryo, the person shall have the written consent of the donor of the embryo stating that the embryo may be used for one or more of the following purposes:

(a) the donor’s own reproductive use;
(b) the reproductive use of a third party;
(c) improving assisted reproduction procedures;
(d) providing instruction in assisted reproduction procedures; or
(e) a specific research project, the goal of which is stated in the consent.

(2) Before a person makes use of an in vitro embryo for a purpose mentioned in paragraph (1)(c), (d) or (e), the person must also have the written consent, in accordance with section 4, of the persons whose human reproductive material was used to create the embryo, unless those persons have already consented to that use as the donor of the embryo.

14 (1) If a donor wishes to withdraw their consent, the withdrawal must be in writing.

(2) The withdrawal is effective only if the person who intends to make use of the in vitro embryo is notified in writing of the withdrawal

(a) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(a), before the use of the embryo;
(b) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(b), before the third party acknowledges in writing that the embryo has been designated for their reproductive use;

(c) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(c), before the later of the following occurrences, namely,

(i) the person acknowledges in writing that the in vitro embryo has been designated for improving assisted reproduction procedures, and
(ii) the beginning of the process of thawing the in vitro embryo for the purpose of improving assisted reproduction procedures;

(d) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(d), before the later of the following occurrences, namely,

(i) the person acknowledges in writing that the in vitro embryo has been designated for providing instruction in assisted reproduction procedures, and
(ii) the beginning of the process of thawing the in vitro embryo for the purpose of providing instruction in assisted reproduction procedures; and

(e) in the case of an in vitro embryo to be used for the purpose mentioned in paragraph 13(1)(e), before the latest of the following occurrences, namely,

(i) the person acknowledges in writing that the in vitro embryo has been designated for research,
(ii) the beginning of the process of thawing the in vitro embryo for the purpose of research, and
(iii) the creation of a stem cell line using the in vitro embryo.

(3) If the donor is a couple, the consent of the donor may be withdrawn by either spouse or common-law partner.

15 For the purpose of sections 12 to 14, in the case of an in vitro embryo created for a purpose mentioned in paragraph 4(1)(d) or (e), the persons whose reproductive material was used to create the embryo are the donor of the embryo and the document and consent provided by them under sections 3 and 4 in respect of the use of their human reproductive material for the purpose of creating the embryo constitute, respectively, the document and consent required under section 12 and subsection 13(1) with respect to the use of the embryo.

Transitional

16 (1) Despite sections 3 and 4, in the case of human reproductive material obtained before the coming into force of these Regulations, a person may make use of the human reproductive material to create an embryo for a purpose mentioned in any of paragraphs 4(1)(b) to (e) if the person has the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that the human reproductive material may be used for that purpose.

(2) Despite sections 12 and 13, in the case of an in vitro embryo created before the coming into force of these Regulations, a person may make use of the embryo for

(a) the purpose mentioned in paragraph 13(1)(b) if the person has the written consent of the donor of the embryo, dated before the coming into force of these Regulations, stating that the embryo may be used for that purpose;

(b) a purpose mentioned in paragraph 13(1)(c) or (d) if the person has

(i) in the case of the embryo having been created for that purpose, the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that their human reproductive material may be used to create an in vitro embryo for that purpose, or

(ii) in the case of the embryo having been created for another purpose but not required for the purpose for which it was created,

(A) the written consent of the donor of the embryo, dated before the coming into force of these Regulations, stating that the embryo may be used for the purpose mentioned in paragraph 13(1)(c) or (d), as the case may be, and
(B) the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that if the embryo is not required for the purpose for which it was created, it may be used for the purpose of providing instruction in assisted reproduction procedures or improving assisted reproduction procedures, as the case may be, unless those persons have already consented to that use as the donor of the embryo;

(c) the purpose mentioned in paragraph 13(1)(e), if the person has

(i) the written consent of the donor of the embryo, dated before the coming into force of these Regulations, stating that the embryo may be used for that purpose, and
(ii) the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that if the embryo is not required for the purpose for which it was created, it may be used for research, unless those persons have already consented to that use as the donor of the embryo.

(3) Despite sections 3 and 4, in the case of an in vitro embryo created after the coming into force of these Regulations using human reproductive material obtained before the coming into force of these Regulations, a person may make use of the embryo for a purpose mentioned in paragraph 13(1)(c), (d) or (e) if

(a) the requirements of sections 12 and 13 are satisfied; and
(b) the person has the written consent of the persons whose human reproductive material was used to create the embryo, dated before the coming into force of these Regulations, stating that if the embryo is not required for the purpose for which it was created, it may be used for the purpose of providing instruction in assisted reproduction procedures, improving assisted reproduction procedures or other research, as the case may be, unless those persons have already consented to that use as the donor of the embryo.

Coming into Force

17 These Regulations come into force on December 1, 2007.