105 Mass. Reg. 960.004

Current through Register 1527, August 2, 2024
Section 960.004 - Definitions

The following terms as used in 105 CMR 960.000 shall have the following meanings, unless the context or subject matter clearly require a different interpretation:

Asexual, not initiated by the union of an oocyte and a sperm.

Donated to Research, when, in the absence of valuable consideration and after fulfillment of the requirements of informed consent, the person from whose cells the pre-implantation embryo has originated or will originate gives the pre-implantation embryo or cells to another person; provided, however, that the recipient shall use the extant or resultant pre-implantation embryo in biomedical research and shall not transfer the pre-implantation embryo beyond 14 days of development.

Embryo, an organism of the species homo-sapiens whether formed by fertilization, somatic cell nuclear transfer, parthenogenesis or other means.

Fertilization, the process whereby the male and female gametes unite to form an embryo. Gametes, a sperm or oocyte.

Human Reproductive Cloning, the asexual genetic replication of a human being by transferring a pre-implantation embryo that has been created by somatic cell nuclear transfer, parthenogenesis or by other asexual means into a uterus or uterine-like environment with the purpose of creating a human fetus or a human child.

Informed Consent, the written consent for the donation of gametes or embryos used for research conducted pursuant to this chapter which complies with the requirements of a duly appointed institutional review board, acting in accordance with 45 C.F.R. 46.116 and 45 C.F.R. 46.117, as may be amended from time to time. The written consent shall be in a language understandable to the donor or patient and shall include all reasonably foreseeable risks, discomforts or benefits of the procedure to the donor or patient.

In Vitro, in an artificial environment, referring to a process or reaction occurring therein, as in a test tube or culture medium.

In Vitro Fertilization, an assisted reproduction technique in which fertilization is accomplished outside of the human body.

Parthenogenesis, the development of an egg without fertilization.

Person, a natural person, corporation, association, partnership or other legal entity.

Pre-implantation Embryo, an embryo formed and maintained outside of the human body whether by in vitro fertilization, somatic cell nuclear transfer, parthenogenesis or other asexual means, which has not experienced more than 14 days of development; provided, however, that such length of time shall not include any interval in which such development has been suspended, such as through freezing.

Somatic cell, a nongamete cell obtained from a living or deceased human being.

Somatic cell nuclear transfer, the technique in which the nucleus of an oocyte is replaced with the nucleus of a somatic cell.

Valuable Consideration, any consideration beyond reimbursement for reasonable costs incurred in connection with the donation, removal, processing, disposal, preservation, quality control, storage, transplantation or implantation of gametes, embryonic or cadaveric tissue.

105 CMR 960.004