206 Children’s Legal Rights Journal [Vol. 37:2 2017]
The problem with relying on institutional oversight as a solution to issues arising from
experimentation with genetic engineering technologies is worth explaining in greater detail.
Research as an institution is currently plagued with issues relating to institutional oversight. 202
Researchers203and Institutional Review Boards (IRBs)—the bodies in charge of overseeing the
ethics of human experimentation and the safety of human subjects204—are subject to conflicts of
interest as it relates to their research, thus placing research subjects in danger. 205 Moreover,
oversight institutions have shown disregard for the well-being of vulnerable populations such as
children, and have even allowed researchers to perform harmful experiments on children without
the children’s or the parent’s full informed consent.206
For example, in the infamous case of Grimes v. Kennedy Krieger Institute, a research
institution associated with Johns Hopkins University exposed families with children to various
levels of lead in homes to test the effectiveness of lead abatement procedures. 207 The researchers
knew that the children subjects would accumulate lead in their blood. 208 The researchers, however,
did not disclose this to the parents. 209 As the court noted, “it can be argued that the researchers
intended that the children be the canaries in the mines, but never clearly told the parents.” 210 Also,
the IRB in charge of reviewing the study protocol, “apparently saw nothing wrong with the search
protocols that anticipated the possible accumulation of lead in the blood of otherwise healthy
children.” 211 Grimes, as well as the infamous case of the gene therapy-caused death of Jesse
Gelsinger212 evidence that reliance on oversight alone to protect research subjects is an insufficient
To conclude, to be effective, proposals in must aim to achieve first-step solutions to
regulating genetic engineering technologies, which are neither too broad in the philosophical
sense, nor too narrow in the legal and practical sense. Crucially, proposals must take into
consideration existing laws and precedent which can serve as a scaffold to regulatory or
jurisprudential development and facilitate a solution which would not require a significant revamp
liberty, share traits with humans—such as experiencing trauma and mental suffering—which would arguably entitle
them to limited “personhood” protections. See Lee Hall & Anthony Jon Waters, From Property to Person: The Case
of Evelyn Hart, 11 SETON HALL CONST. L.J. 1, 19-28 (2000).
202 Ezekiel J. Emanuel, Trudo Lemmens, & Carl Elliot, Should Society Allow Research Ethics Boards to Be Run
As For-Profit Enterprises?, 3 PLOS MEDICINE 941, 941 (2006); Heidi Ledford, Death in Gene Therapy
Trial Raises Questions About Private IRBs, 25 NAT. BIOTECHNOLOGY 1067, 1067 (2007).
203 Emanuel et al., supra note 202. See also Wilson, infra note 212, at 295-96, 307-10.
204 IRBs are in charge of: (1) reviewing and approving research subject to the federal research regulations, and (2)
requiring investigators to obtain informed consent from subjects. 45 C.F.R § 46.109 (2005).
205 See supra note 202 and accompanying sources.
206 Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807 (Md. 2001).
208 Id. at 38.
212 Robin Fretwell Willson, The Death of Jesse Gelsinger: New Evidence of the Influence of Money and Prestige in
Human Research, 36 AM. J. L. & MED. 295 (2010). Gelsinger suffered from a liver deficiency of genetic origin, and
enrolled in a gene therapy trial. Id. at 298. There were many irregularities in the research protocol which researchers
ignored, and it was later discovered that one of the researchers, Dr. James Wilson, had a financial stake in a
company which would profit from the research. Id. at 295. Furthermore, the informed consent form that Gelsinger
signed did not contain information about the death of monkeys during experiments as a result of the therapy. Id. at