Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 960.000 - Biotechnology › Section 960.004 - Definitions

Current through Register 1525, July 5, 2024
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.