Section 24-9A-1 - Definitions.

24-9A-1. Definitions.

As used in the Maternal, Fetal and Infant Experimentation Act:  

A.     "viability" means that stage of fetal development when the unborn child is potentially able to live outside the mother's womb, albeit with artificial aid;  

B.     "conception" means the fertilization of the ovum of a human female by the sperm of a human male;  

C.     "health" means physical or mental health;   

D.     "clinical research" means any biomedical or behavioral research involving human subjects, including the unborn, conducted according to a formal procedure.  The term is to be construed liberally to embrace research concerning all physiological processes in human beings and includes research involving human in vitro fertilization, but shall not include diagnostic testing, treatment, therapy or related procedures conducted by formal protocols deemed necessary for the care of the particular patient upon whom such activity is performed and shall not include human in vitro fertilization performed to treat infertility; provided that this procedure shall include provisions to ensure that each living fertilized ovum, zygote or embryo is implanted in a human female recipient, and no physician may stipulate that a woman must abort in the event the pregnancy should produce a child with a disability.  Provided that emergency medical procedures necessary to preserve the life or health of the mother or the fetus shall not be considered to be clinical research;  

E.     "subject at risk", "subject" or "at risk" means any person who may be exposed to the likelihood of injury, including physical or psychological injury, as a consequence of participation as a subject in: 

(1)     any research, development or related activity that departs from the application of those established and accepted methods deemed necessary to meet the person's needs; 

(2)     controlled research studies necessary to establish accepted methods designed to meet the person's needs; or 

(3)     research activity that poses a significant risk to the subject;  

F.     "significant risk" means an activity that is likely to cause disfigurement or loss or impairment of the function of any member or organ;  

G.     "fetus" means the product of conception from the time of conception until the expulsion or extraction of the fetus or the opening of the uterine cavity, but shall not include the placenta, extraembryonic membranes, umbilical cord, extraembryonic fluids and their resident cell types and cultured cells;  

H.     "live-born infant" means an offspring of a person that exhibits heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles or pulsation of the umbilical cord if still attached to the infant ex utero; provided the Maternal, Fetal and Infant Experimentation Act does not apply to a fetus or infant absent the characteristics set forth in this subsection;  

I.     "infant" means an offspring of a human being from the time it is born until the end of its first chronological year;  

J.     "born" means the time the head or any other part of the body of the fetus emerges from the vagina or the time the uterine cavity is opened during a caesarean section or hysterotomy; and  

K.     "in vitro fertilization" means any fertilization of human ova that occurs outside the body of a female, either through admixture of donor human sperm and ova or by any other means.