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Title: Section 52-8.8 - Informed consent

Effective Date

11/01/2000

52-8.8 Informed consent.

(a) Reproductive tissue banks shall obtain written informed consent from the donor for participation in the donation program, after the director or a designee has provided information to the donor on the procedures for collection, storage and use of semen, oocytes or embryos, and the risks of any drugs, surgical procedures and/or anesthesia administered. The informed consent shall include:

(1) a statement that the donor has been informed that his or her name and address will be kept on file by the reproductive tissue bank, and advised of the restrictions on release of donor-identifying information specified in section 52-8.9 of this Subpart;

(2) authorization for performance of genetic and infectious disease marker testing, consistent with statutory requirements for genetic testing;

(3) notification of all currently known ways in which the donor's reproductive tissue and resulting embryos may be used. If the reproductive tissue bank accepts reproductive tissue with restrictions on the manner in which embryos created may be used, the consent also shall include a statement that the reproductive tissue bank has informed the donor that it will make a good faith effort to ensure that the donor's restrictions are respected, but that it cannot guarantee that the recipients of the reproductive tissue will abide by the donor's restrictions;

(4) authorization for disclosure of the donor's medical history information to potential recipients and their physicians, consistent with statutory requirements for the disclosure of genetic and other medical information;

(5) an explanation of the oocyte donor's extent of responsibility for any costs of any medical complications associated with oocyte donation; and

(6) a statement that the reproductive tissue donor has the right to withdraw his/her consent to donation up until such time that a specific recipient has begun an assisted reproduction cycle in reliance on the availability of tissue from that donor.

(b) Reproductive tissue banks shall obtain written informed consent from the client-depositor for participation in the semen, oocyte or embryo storage program, after the director or a designee has provided information to the client-depositor on the procedures for collection/storage and retrieval of semen, oocytes or embryos, and the risks of any drugs, surgical procedures and/or anesthesia administered, as well as procedures for payment for semen, oocyte or embryo storage. The informed consent shall include the male client-depositor's specific instructions for disposition of frozen semen upon his death. The reproductive tissue bank shall maintain and adhere to written procedures for ensuring that the client-depositor's instructions are followed.

(c) The insemination/implantation site shall obtain written informed consent from the recipient for receipt of donated reproductive tissue, after a physician has explained the risks and benefits of the procedure, made available details of the medical history of the donor or donors, and, if applicable, notified the recipient that reproductive tissue bank records are required to be kept for the periods of time specified in section 52-8.9(a) of this Subpart and that the outcome of the procedure is required to be reported to the reproductive tissue bank.

Volume

VOLUME A-1 (Title 10)

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