Consent for Use of Human Reproductive Material and In Vitro Embryos Regulations (SOR/2007-137)

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 obtained 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 obtained for the purpose of 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 obtained for the purpose of 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 obtained for the purpose of 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) [Repealed, SOR/2019-195, s. 7]

13.1 Despite section 12 and subsection 13(1), if a person who makes use of an in vitro embryo cannot obtain the written consent of the donor for that use because the embryo was donated on the condition of anonymity, the person shall have instead, before making use of that embryo, a document signed by the person who originally obtained consent from the donor, attesting to the following:

• (a) that the donor provided a signed document stating that they had been informed, in writing, of the information set out in section 12 prior to consenting to the use of their embryo;

• (b) that the donor gave written consent to the use of their embryo for the purposes referred to in paragraph (c); and

• (c) the purposes indicated in the written consent of the donor.

• 13.2 (1) Before a person makes use of an in vitro embryo for a purpose mentioned in paragraph 13(1)(c), (d) or (e), the person shall have, for each of the persons whose human reproductive material was used to create the embryo,

  • (a) their written consent for that use, provided in accordance with section 4; or

  • (b) if the donation of material was made on the condition of anonymity, the document referred to in section 4.1 that attests to the consent for that use by that person.

• (2) Subsection (1) does not apply if the persons whose human reproductive material was used to create the embryo 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 obtained 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 obtained for the purpose of 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 obtained for the purpose of 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 obtained for the purpose of 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 using human reproductive material that is to be used 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 the consent provided under sections 3, 4 and 4.1 in respect of the use of their human reproductive material for the purpose of creating the embryo constitute, respectively, the document and the consent required under section 12, subsection 13(1) and section 13.1 with respect to the use of the embryo.

PART 4Records

15.1 A person who makes use of human reproductive material from a donor under Part 1 shall keep, for each use of that material, a record of all the documents required under that Part for a period of 10 years following the day on which that material is used.

15.2 A person who removes human reproductive material from a donor under Part 2 shall keep a record of all the documents required under that Part for a period of 10 years following the day on which that material is removed.

15.3 A person who makes use of an in vitro embryo under Part 3 shall keep a record of all the documents required under that Part for a period of 10 years following the day on which the embryo is used.

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, 13 and 13.2, 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.