Biomedical Engineering Reference
In-Depth Information
Japan and the restrictive legislation in Germany (Rugg-Gunn et al.,
2009). The creation of embryos via cloning is banned, but the use of
non-animal oocytes in stem cell research more generally is allowed
in Canada (Rugg-Gunn et al., 2009). Yet the deliberate creation of
embryos for research purposes only is a criminal offence with a
significant penalty attached (Rugg-Gunn et al., 2009). Like elsewhere
around the world, these regulations developed out of parliamentary
debates that determined that embryos have a special moral status
that is deserving of legal protection (Rugg-Gunn et al., 2009).
The impact of these differing regulatory regimes on the progress
of science has been somewhat contested. Some observers argue that
restrictive limitations are directly responsible for some senior
scientists relocating to countries where they can conduct their
research more freely (De Trizio and Brennan, 2004). Another claim
is that young scientists are put off moving into this field of research
by the limitations imposed on research (Wolinsky, 2009). There is
some evidence too that governments are deliberately using these
disparities to attract researchers with targeted funding programmes
and new facilities (De Trizio and Brennan, 2004; Waldby, 2009;
Salter et al., 2006; Salter et al., 2007). There is also some indication
that restrictions on the conduct of research have resulted in lower
scientific output overall (Levine, 2008).
5.2
Current clinical trials
Moral and ethical considerations aside, there still remain a number
of concerns over the safety and efficacy of human embryonic stem
cell research. The three FDA clinical trials currently underway in the
US are being closely watched, with more trials expected to follow in
the near future. The studies currently being undertaken are under
intense scrutiny as they will have a significant impact on the future
of hESC if they do not show good outcomes. Like the Jesse Gelsinger
case in gene therapy (see below), any adverse consequences resulting
from the current trials could see a substantial decline in commercial
and political interest in continuing with this line of research.
