21- The need for independent peer review and approval of research protocols by
research ethics boards or research ethics committees, including ongoing moni-
toring of the research - The need for observing professional codes of conduct; clinical, safety, technical,
and quality assurance standards; as well as protecting and promoting scientifi c
integrity generally (e.g., by complying with standards relevant to quality, deriva-
tion, and maintenance of cell lines) - The need for risk-benefi t assessments
- The non-commercialization of human tissues
- The need to consider issues of social and distributive justice and benefi cence
(acknowledged in the need to improve and protect health and ensure equitable
access to research and the benefi ts resulting from research)
1.5.3 Issues of Difference
Issues on which regulatory and policy approaches vary more clearly are the following:
1 The creation of human embryos for stem cell research.
2 The legal and moral status of the human embryo.
3 Creation of embryos via somatic cell nuclear transfer (SCNT).
4 The derivation of stem cell lines from excess IVF embryos.
5 Intellectual property issues (e.g., variance in legal approaches regarding the pat-
enting of human embryonic stem cells across jurisdictions, notably between
Europe, the USA, and Japan) (Mathews et al. 2013 ). Despite broad agreement on
the principles referred to in Sect. 5.2 above, jurisdictional variation is evident
with regard to a range of activities, such as requirements for research funding,
research governance mechanisms, ethics review processes, quality assurance, and
access to stem cell material and data (Caulfi eld et al. 2009a , b ). There are also
disparities with regard to donor eligibility requirements and the suitability of
stem cell lines for use in clinical trials and subsequent commercialization (Feigal
et al. 2014 ). The legal regulation of human tissue (governing the procurement,
use, and disposal of human tissue) and tissue establishments across jurisdictions
is also diverse. Harmonization attempts are furthermore hampered by ambiguity
and uncertainty with regard to regulatory discrepancies, such as stem cell product
classifi cation (e.g., novel stem cell products may exhibit characteristics which
could label these as either or both medicines and medical devices).
The promotion of ethical and responsible stem cell research requires a delicate
balance between minimizing overregulation, while still at the same time ensuring
adequate protection of research subjects (Isasi and Knoppers 2011 ). In this regard,
the recommendations of the Hinxton Group ( 2010 ) regarding data and material
sharing, as well as intellectual property issues, should be noted. The Group recom-
mends the establishment of a centralized and comprehensive hub for accessing
global stem cell registry and stem cell patent information, as well as incentives for
data and materials sharing globally.
1 Stem Cell Therapy: Accepted Therapies, Managing the Hope of Society...