All research directed toward fetuses and pregnant women is first subjected to general limitations: (1) the necessary completion of appropriate animal studies; (2) minimal risk to the fetus in nontherapeutic research
; (3) separation of researchers from decisions regarding the timing or method of abortion or regarding the viability of the fetus ex utero; (4) no introduction of significant changes into the abortion procedure solely in the interests of research where such changes may cause greater than minimal risk to either the fetus or the pregnant woman; and (5) no inducements offered to abort for purposes of research.
For example, prior to the NHA, Van Wyk submitted that nontherapeutic research
with children should only be possible if it was classified as being observational in nature and did not pose more than a minor increase over minimal risk.
Smolin, Nontherapeutic Research
with Children: The Virtues and Vices of Legal Uncertainty, 33 CUMB.
The opinion, for example, notes that "there are conflicting views in respect to nontherapeutic research
, as to whether consent, even of a person capable of consenting, can justify a research protocol that is otherwise unjustifiable." (188) The court also quoted at length from a law review article that said:
The enforcement of morals: nontherapeutic research
on children: a reply to McCormick.
For nontherapeutic research
with greater than minimal risk both parents must give their permission if feasible (1).
In the literature on children as subjects of research, it rears its head in the idea that if parents enroll their children in nontherapeutic research
that poses more than minimal risk, then they are doing something wrong.
One author notes that "[s]ome ethics committees are prepared to consider sedation of healthy infants for nontherapeutic research
, but this is becoming more exceptional, and there is a move to develop tests which can be performed during natural sleep without the need for sedation." (20) However, in her view, "the use of sedation itself is neither 'ethical' nor 'unethical' and it should be considered in the context of the whole proposed study and as part of the benefit:risk equation." (21)
, which was created in the original 1965
As with the recommendations for assent, professional organizations (AAP, SAM, SPN) take the position that adolescent refusal to participate in research should be considered binding (even in instances of parental permission), especially in cases of nontherapeutic research
However, nine states forbid nontherapeutic research
on extra-uterine human embryos, (77) with Louisiana requiring that any embryo manipulation be undertaken for the purpose of bringing about the development of a new human life.
(6) Bioethicists generally reject nontherapeutic research
(7) done on human subjects.