Conclusions and recommendations
The Committee's detailed conclusions and recommendations are
as follows:

stem cell research

  (i)  Stem cells appear to have great therapeutic potential
for the treatment of many disorders that are both common and
serious and for the repair of damaged tissue.
  (ii)  Until recently most research on stem cells has
focussed on ES cells from animals and the derivation of ES
cell lines from them; cell lines from human ES cells have
the potential to provide a basis for a wide range of
therapies.

  (iii)  Recent research on adult stem cells, including stem
cells from the placenta and umbilical cord, also holds
promise of therapies; and research on them should be
strongly encouraged by funding bodies and the Government.

  (iv)  To ensure maximum medical benefit it is necessary to
keep both routes to therapy open at present since neither
alone is likely to meet all therapeutic needs.

  (v)  For the full therapeutic potential of stem cells,
both adult and ES, to be realised, fundamental research on
ES cells is necessary, particularly to understand the
processes of cell differentiation and dedifferentiation.

  (vi)  Future developments might eventually make further
research on ES cells unnecessary. This is unlikely in the
foreseeable future; in the meantime there is a strong
scientific and medical case for continued research on human
ES cells. (i-vi paragraph 3.22)

status of the early embryo

  (vii)  Whilst respecting the deeply held views of those
who regard any research involving the destruction of a human
embryo as wrong and having weighed the ethical arguments
carefully, the Committee is not persuaded, especially in the
context of the current law and social attitudes, that all
research on early human embryos should be prohibited
(paragraph 4.21).
  (viii)  Fourteen days should remain the limit for research
on early embryos. (paragraph 4.22)

  (ix)  Embryos should not be created specifically for
research purposes unless there is a demonstrable and
exceptional need which cannot be met by the use of surplus
embryos. (paragraph 4.28)

cell nuclear replacement and cloning

  (x)  Basic research is a necessary step to developing
treatments and facilitating the potential use of adult stem
cells and should be permitted under the Regulations in the
same way as more directly applied research to which it is
designed to lead, provided that it is subject to strict
regulation. (paragraph 5.4)
  (xi)  Although there is a clear distinction between an IVF
embryo and an embryo produced by CNR (or other methods) in
their method of production, the Committee does not see any
ethical difference in their use for research purposes up to
the 14 days limit. (paragraph 5.13)

  (xii)  Even if CNR is not itself used directly for many
stem cell-based therapies, there is still a powerful case
for its use, subject to strict regulation by the HFEA, as a
research tool to enable other cell-based therapies to be
developed. However, as with embryos created by IVF for
research, CNR embryos should not be created for research
purposes unless there is a demonstrable and exceptional need
which cannot be met by the use of surplus embryos.
(paragraph 5.14)

  (xiii)  If CNR is permitted in certain limited
circumstances, oocyte nucleus transfer should also be
allowed for research purposes. (paragraph 5.20)

  (xiv)  Given the high risk of abnormalities the scientific
objections to human reproductive cloning are currently
overwhelming. (paragraph 5.21)

  (xv)  There are further strong ethical objections in
addition to those based on the risk of abnormalities,
although not all the arguments deployed against reproductive
cloning are equally valid. The most powerful are the
unacceptability of experimenting on a human being and the
familial and child welfare considerations arising from the
ambiguity of the cloned child's relationships. (paragraph
5.21)

  (xvi)  The Committee unreservedly endorses the legislative
prohibition on reproductive cloning now contained in the
Human Reproductive Cloning Act 2001. (paragraph 5.21)

  (xvii)  The HFEA has an excellent record in ensuring that
IVF clinics comply with the law, and we are satisfied that
its regulatory powers, now reinforced by a specific
statutory prohibition, provide sufficient protection against
the development of CNR leading to reproductive cloning in
the United Kingdom. (paragraph 5.24)

  (xviii)  The Government should take an active part in any
move to negotiate an international ban on human reproductive
cloning. (paragraph 7.22)

legislation and regulation

  (xix)  At an appropriate time, perhaps towards the end of
the decade, the Government should undertake a further review
of scientific developments, particularly of the progress of
adult stem cell research and therapies, and of the
development of stem cell banks, with a view to determining
whether research on human embryos is still necessary.
(paragraph 8.4)

  (xx)  The Government should keep the funding of the HFEA
under review and ensure that its resources are commensurate
with its increased responsibilities. (paragraph 8.5)

  (xxi)  The HFEA and the Department of Health should
consider how a review of the outcomes of research licensed
under the Act might be undertaken and updated on a regular
basis (paragraph 8.6)

  (xxii)  The Department of Health should examine with the
HFEA the possibility of drawing up indicative guidance as to
what constitutes serious disease (paragraph 8.9)

  (xxiii)  When the Government bring forward legislation
they should consider making express provision for such basic
research as is necessary as a precursor for the development
of cell-based therapies (paragraph 8.15)

  (xxiv)  The separation of clinical and research roles
should be standard practice for donation of eggs or embryos.
The prohibition in the United Kingdom of payment to donors
for gametes has been an important element in preventing
undesirable commercialisation of this aspect of assisted
reproduction and should be strictly maintained (paragraph
8.21)

  (xxv)  The Department of Health should consider either
establishing a body similar to the Gene Therapy Advisory
Committee with oversight of clinical studies involving stem
cells, or extending the membership and remit of GTAC to
achieve the same ends. The Committee sees no other special
need at present for additional regulation of the use of stem
cells in the treatment of patients (paragraph 8.23)

  (xxvi)  The Department of Health's proposals to establish
a stem cell bank overseen by a steering committee,
responsible for the custody of stem cell lines, ensuring
their purity and provenance and monitoring their use, are
endorsed. As a condition of granting a research licence, the
HFEA should require that any ES cell line generated in the
United Kingdom in the course of that research is deposited
in the bank. Before granting any new licence to establish
human ES cell lines, the HFEA should satisfy itself that
there are no existing ES cell lines in the bank suitable for
the proposed research. (paragraph 8.29)


  (xxvii)  The HFEA should ensure that the implications
arising from the "immortality" of stem cell lines are fully
covered in obtaining informed consent from donors giving
embryos for the potential establishment of ES cell lines for
research. To prevent future restrictions in using ES cell
lines (and therefore minimise the need to generate new ES
cell lines) the HFEA should not permit ES cell lines be
generated from donated embryos unless informed consent
places no specific constraint on their future use. Where
parents wish to restrict the type of research which can be
undertaken, for example specifically for reproductive
purposes, the embryos donated should be used for purposes
other than the generation of ES cell lines. (paragraph 8.33)
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Bob Martone
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http://www.samlink.com/~bmartone

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