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Banking Initiative (ISCBI 2015 ) coordinated by the UK Stem Cell Bank, the
ISSCR’s Registry of Provenance of Human Embryonic Stem Cell Lines (Registry
of Provenance of Human Embryonic Stem Cell Lines 2013 ), the International Stem
Cell Registry (UMASS 2015 ) (ISCR 2015 ), and the European Human Pluripotent
Stem Cell Registry (hESCreg 2015 ).
Reference is often made to the need for harmonized legal or ethical standards,
without a clear understanding of the concept and objectives of harmonization.
Harmonization, which strives to achieve compatibility, is often confused with stan-
dardization, which is aimed at unifi cation. Harmonization may assist with produc-
ing consensus guidelines, or alternatively, with converging different regulatory
approaches. In this regard, harmonization has resulted, among others, in informal
cooperation agreements; common technical, safety, and quality standards and
requirements; as well as mutual recognition agreements (MRAs). Some of the broad
goals of harmonization include: (1) promoting and safeguarding global public
health, (2) promoting and facilitating the availability of safe and effective products,
(3) promoting the development of more effective product standards, and (4) mini-
mizing inconsistent standards. Harmonization in the fi eld of cellular therapy, in
addition to that of stem cell research, is equally important, as cell therapy as an
emerging product class poses diffi cult regulatory challenges, different regulatory
frameworks do not display the same level of maturity, and experience in reviewing
marketing applications for cell therapy globally is limited. Harmonization of techni-
cal requirements will be an important tool for strengthening the safe and effective
use of cell therapy products.
The scope of this chapter does not permit an exhaustive discussion of harmoniza-
tion efforts in this fi eld. The focus will instead be on some of the key efforts, includ-
ing the most signifi cant trends that have emerged from these harmonization
activities.
1.5.2 Consensus Principles
From existing guideline documents and codes of conduct relating to stem cell
research and therapy, referred to above, consensus exists with regard to the follow-
ing principles:
- The prohibition of reproductive cloning
- The prohibition of gene-editing research in human embryos (ISSCR 2015 )
- Respect for human autonomy (expressed, e.g., in the provision of free and
informed consent by research participants, gamete or tissue donors, and patients) - Respect for human dignity, inviolability of the human person, privacy, and con-
fi dentiality (expressed, e.g., in prohibitions relating to research on embryos
beyond 14 days after fertilization; measures aimed at the protection of donor
identity and the traceability of cell lines) - The prevention of confl icts of interest (e.g., by separating informed consent for
research donation from clinical treatment)
W.M. Botes et al.