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  • PART I ADMINISTRATION OF THE GOVERNMENT
  • TITLE XVI PUBLIC HEALTH
  • CHAPTER 111L BIOTECHNOLOGY
  • Section 2 Definitions

Section 2. As used in this chapter the following words shall have the following meanings unless the context clearly requires otherwise:—

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

“Commissioner”, the commissioner of public health.

“Council”, the biomedical research advisory council.

“Department”, the department of public health.

“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 to a uterus or uterine-like environment or nurture 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.

“Employee”, an individual who performs services for and under the control and direction of an employer for wages or other remuneration.

“Fertilization”, the process whereby the male and female gametes unite to form an embryo.

“Gametes”, a sperm or oocyte.

“Human adult stem cell”, an undifferentiated cell found in a differentiated tissue that can renew itself and differentiate to yield specialized cell types.

“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.

“Institution”, a corporation, association, partnership, nonprofit organization or other legal entity which conducts research authorized by this chapter.

“Institutional Review Board”, a board that has a minimum of 5 members who meet regularly to review research applying the standards of 45 CFR Part 46 or 21 CFR Parts 50 and 56, as may be amended from time to time.

“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.

“Manager”, an individual to whom an institution conducting research pursuant to this chapter has given the authority to direct and control the work performance of the affected employee and who has authority to take corrective action regarding a violation of a law, rule, regulation, activity or policy.

“Parthenogenesis”, the development of an egg without fertilization.

“Parthenote”, the product of egg development without fertilization.

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

“Placental cells”, cells obtained from the placenta.

“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.

“Public body”, (a) the United States Congress, a state legislature, including the general court, or a popularly elected local government body, or a member or employee thereof; (b) a federal, state or local judiciary, or a member or employee thereof, or a grand or petit jury; (c) a federal, state or local regulatory, administrative or public agency or authority or instrumentality thereof; (d) a federal, state or local law enforcement agency, prosecutorial office or police or peace officer; or (e) a division, board, bureau, office, committee or commission of any of the public bodies described in clauses (a) to (d), inclusive.

“Public institutional review board”, a board established pursuant to subsection (a) of section 6 that has a minimum of 5 members who meet regularly to review research applying the standards of 45 CFR Part 46 or 21 CFR Parts 50 and 56, as may be amended from time to time.

“Retaliatory action”, the unlawful discharge, suspension, demotion, harassment, denial of promotion, layoff or other adverse action taken against an employee affecting the terms and conditions of employment.

“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.

“Umbilical cord cells”, cells derived from an umbilical cord.

“Uterine-like environment”, a replicate of the uterus used for the purpose of sustaining an embryo through birth and creating a human being.

“Uterus”, a uterus or fallopian tube.

“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 cadeveric tissue.