Transhuman Babies and Human Pariahs 199
of an experiment they result to be.139 Other critics go as far as stating that biomedical enhancement
objectifies children, making them nothing more than products of their parents’ whims.140
Regarding physical harms, commentators note the many unknown risks of genetic
engineering.141 Although genetic engineering is more sophisticated than ever before, the
technology is inherently risky in part because it cannot be tested safely.142 Also, knowledge of
human genetics, as advanced as it may be, is still in its infancy; it is still largely unknown how the
approximately 20,000 genes in the human genome work.143 To this point, one commentator noted:
“Evolution has been working toward optimizing the human genome for 3.85 billion years. Do we
really think that some small group of human genome thinkers could do better without all sorts of
unintended consequences?”144 Since the consequences of gene editing are largely unpredictable,
they are therefore potentially harmful.145
In addition to the absence of comprehensive federal laws regulating genetic engineering of
children and human embryos,146 the federal research regulations,147 which govern human
experimentation and have specific provisions meant to protect children148 and embryos,149 are
insufficient to address the concerns that arise as a result of genetic engineering technologies.150
General bioethical values will also not suffice. One of the fundamental concepts of bioethics and
medical research is to inform a research subject of the potential benefits and risks of the research
experiment,151 and to obtain the individual’s full informed consent.152 But in the designer baby
139 Id. at 147-48.
140 MEHLMAN, supra note 48, at 101. (The author refers to relevant comments made by philosopher Jürgen
Habermas and former Supreme Court Justice John Paul Stevens).
141 Lori Andrews, Genetics: Coitus Defunctus, 522 NATURE 36 (April 2016),
http://www.nature.com/nature/journal/v532/n7597/full/532035a.html (responding to Henry Greely’s claims that
what he calls “easy PGD” will replace sex as the usual manner of having children) See generally Greely, supra note
132. See also Skerret, supra note 25.
142 See Annas, Andrews & Isasi, supra note 13, at 158.
143 See Kelly Rae Chi, The Dark Side of The Human Genome, 538 NATURE 275 (Oct. 13, 2016),
144 Skerret, supra note 25.
145 Id. For example, geneticist and NIH Director, Francis Collins notes that, most of the changes imagined by
proponents of genetic enhancement are “complex multigene situations in which the environment plays critical
roles.” Id. Professor Gang Bao further notes that even sophisticated gene-editing techniques such as CRISPR can
edit genes in an unexpected, harmful manner. Id.
146 See supra note 48 and accompanying text.
147 45 C.F.R. §46.401, et seq. The federal research regulations govern human subjects research as undertaken by (1)
institutions which receive monetary support from the federal government or (2) those seeking to obtain FDA
approval. § 45 CFR 46.101-103, 111; 25 CFR § 50.1, et seq.
148 45 C.F.R. §46.401, et seq.
149 45 C.F.R. §46.116 (b) (1).
150 See 45 C.F.R. §46.401. See also Federal Policy for the Protection of Human Subjects, U.S. DEP’T OF HEALTH
AND HUM. SERV., https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/ (last visited May 12,
2017). The federal research regulations are general rules governing human subjects research in general. Id. See also
Skerret, supra note 25 and accompanying text.
151 45 C.F.R. §46.116 (a)(2).
152 Informed consent from a research subject requires that researchers provide the following information: (1)
information about the research, (2) description of possible risks, (3) disclosure of alternative treatments, (4) how
confidentiality will be maintained, (5) contact information for questions that may arise and (6) “a statement that
participation is voluntary.” 45 C.F.R. §116 (a). The principle of requiring informed consent derives from the
Nuremberg Code, which was conceived after the Nuremberg Trials to prevent the atrocious acts committed by Nazi
scientists from happening again. The Nuremberg Code, U.S. DEP’T OF HEALTH & HUM. SERV.,