Synthetic Biology Parts, Devices and Applications

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394 18 Synthetic Biology: From Genetic Engineering 2.0 to Responsible Research and Innovation


The open access approach demonstrates not only the willingness of the free
flow of information among parts of the scientific community but also the
demands from the public to secure the common benefit from the public-funded
research. Thus making open access a reality is an important aspect to build the
framework of RRI. The challenges for open access are basically twofold: firstly
whether it will be sustainable and successfully picked up by “users” and secondly
the legal issues of some open source content that (might) overlap with the exist-
ing patents.

18.4.5 Ethics
Another key component for the RRI framework is ethics. The shared values
among the European society call for RRI to be built respecting fundamental
rights and the highest ethical standards [76]. As early as 2006, to stimulate the
develop of SB in Europe, the EC funded 18 SB projects through NEST Pathfinder,
aiming to stimulate advancements in science as well as to address ethical and
safety concerns [93]. Among these projects, SYNBIOSAFE was particularly dedi-
cated to study safety, ethical, and governance issues [94]. A number of other SB
ethics-related projects funded by the EC came followed by SYNBIOSAFE later
on. The EGE published their opinion article on SB [68]. Ethical issues raised by
SB were analyzed by the EGE, including biosafety, biosecurity, justice, and intel-
lectual property issues [68]. Twenty-six recommendations were proposed by
the  EGE in their opinion article regarding safety (environmental applications,
sustainable energy, and healthcare products), security, governance, intellectual
property (patent and justice), science and society aspects, and basic research.
A recent study from EC pointed out that there were gaps between research and
innovation systems and RRI regarding ethics. The research system failed to con-
sider the ethical and societal aspect sufficiently, and the innovation system often
failed to anticipate future societal needs. For both systems, the researchers were
often less aware of the ethical and societal impacts of their research activities
[65]. To integrate the ethical dimension into the research projects, the EU has
asked the researchers to address the ethical questions and questions of social
needs (if any) associated with their project in their grant applications and
research projects. To further integrate research responsibility into the research
projects, the expert group brought up an improved option other than the “busi-
ness as usual” option: more research funding should be allocated (€79 billion for
Horizon 2020 and €2.5 billion for COSME); and the researcher should reflect
both ethics and responsibility in their proposals [65]. This option will require
RRI to turn into the mainstream of the EU funding programs. The share of
trans-/interdisciplinary research should be increased. Furthermore, a special
funding should be set up dedicated to RRI research. The importance of ethical
consideration in research has been also emphasized a UK study [64]. The funder
BBSRC has placed a number of checks and balances to ensure the awareness of
the ethical and social issues raised by the funded projects. Examples for the
checks of ethical issues are ethical considerations on using animals in an experi-
ment and the potential for misuse/dual use of the knowledge obtained from the
projects.
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