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Adopted by the WMA General Assembly, Pilanesberg,
South Africa, October 2006
Preamble
- Assisted reproductive technology encompasses a wide range
of techniques designed primarily to aid couples unable to conceive
without medical assistance. Since the birth of the first so-called
'test-tube baby' in 1978, more than 1.5 million children worldwide
have been born following IVF treatment.
- The term 'assisted reproductive technology' includes techniques
such as in-vitro fertilisation (IVF) and intra-cytoplasmic sperm
injection (ICSI). It can be defined as including all treatments
that include medical and scientific manipulation of human gametes
and embryos in order to produce a term pregnancy. Although some
legislatures have considered artificial insemination, whether
using donor semen or semen from the patient's partner, as different,
many of the issues about regulation in relation to obtaining,
storing, using and disposing of gametes and embryos are closely
interlinked. In this statement treatments such as artificial
insemination are excluded.
- Assisted reproductive technologies raise profound moral issues.
Views and beliefs about the moral status of the embryo, which
are central to much of the debate in this area, vary both within
and among countries. Assisted conception is also regulated differently
in various countries. Whilst consensus can be reached on some
issues, there remain fundamental differences of opinion that
cannot be resolved. This statement identifies areas of agreement
and also highlights those matters on which agreement cannot
be reached. Physicians faced with such situations should comply
with applicable laws and regulations as well as the ethical
requirements and professional standards established by their
National Medical Association and other appropriate organisations
in the community.
- Physicians involved in providing assisted reproductive technologies
should always consider their ethical responsibilities towards
any child who may be born as a result of the treatment. If there
is evidence that a future child would be exposed to serious
harm, treatment should not be provided.
- As with all other medical procedures, physicians also have
an ethical obligation to limit their practice to areas in which
they have relevant expertise and experience and to respect the
rights of patients. These rights include that of personal bodily
integrity and freedom from coercion. In practice this means
that valid or real consent is required as with other medical
procedures; the validity of such consent is dependent upon the
adequacy of the information offered to the patient and their
freedom to make a decision, including freedom from coercion
or other pressures to decide in a particular way.
- Assisted conception differs from the treatment of illness
in that the inability to become a parent without medical intervention
is not always regarded as an illness. While it may have profound
psychosocial, and thus medical, consequences, it is not in itself
life limiting. It is, however, a significant cause of major
psychological illness and its treatment is clearly medical.
- Obtaining informed consent from those considering undertaking
treatment must include consideration of the alternatives, including
accepting childlessness or pursuing adoption, the risks associated
with the various techniques, and the possibility of failure.
In many jurisdictions the process of obtaining consent must
follow a process of information giving and the offer of counselling
and might also include a formal assessment of the patient in
terms of the welfare of the potential child.
- Patients seeking assisted reproductive technologies are entitled
to the same level of confidentiality and privacy as for any
other medical treatment.
- Assisted reproductive technology always involves handling
and manipulation of human gametes and embryos. Different individuals
regard this with different levels of concern but there is general
agreement that these special concerns should be met by specific
safeguards to protect from abuse. In some jurisdictions all
centres handling such materials require a licence and must demonstrate
compliance with high normative standards.
Success of the techniques
- The success of different techniques may differ widely from
centre to centre. Physicians have an obligation to give realistic
information about success rates to potential patients. If their
success rates are widely different from the current norm they
should disclose this fact to patients. They also have an obligation
to consider the reasons for this as they might relate to poor
practice, and if so, to correct their deficiencies.
Multiple pregnancies
- Replacement of more than one embryo may raise the likelihood
of at least one embryo implanting. This is offset by the increased
risk, especially of premature labour, in multiple pregnancies.
The risk of twin pregnancies, while higher than that of singleton
pregnancies, is considered acceptable by most people. Practitioners
should follow professional guidance on the maximum number of
embryos to be transferred per treatment cycle. If multiple pregnancies
occur, selective termination might be considered on medical
grounds to increase the chances of the pregnancy proceeding
to term where this is compatible with the national law and code
of ethics.
Donation
- Some patients are unable to produce usable gametes. They
require ova or sperm from donors. Donation should follow counselling
and be carefully controlled to avoid abuses, including coercion
of potential donors. It is inappropriate to offer money or benefits
in kind (for example free or lower cost treatment cycles) to
encourage donation but donors may be reimbursed for reasonable
expenses.
- Where a child is born following donation, families should
be encouraged to be open with him/her about this, irrespective
of whether domestic law entitles the child to information about
the donor. Keeping secrets within families is difficult and
can be harmful to children if information about donor conception
is disclosed inadvertently and without appropriate support.
Pre-implantation Genetic Diagnosis (PGD)
- Pre-implantation genetic diagnosis (PGD) may be performed
on early embryos to search for the presence of genetic or chromosomal
abnormalities, especially those associated with severe illness
and very premature death and for other reasons, including identifying
those embryos most likely to implant successfully in women who
have had multiple spontaneous abortions. Embryos carrying the
abnormality are discarded; only embryos with apparently normal
genetic and chromosomal complements are implanted.
- Neither this powerful technique nor simpler means should
be used for trivial reasons such as sex selection for reasons
of gender preference. The WMA holds that physicians should only
be involved with sex selection where it is used to avoid a serious
sex-chromosome related condition such as Duchenne's Muscular
Dystrophy.
- PGD can also be combined with HLA matching to select embryos
on the basis that stem cells from the resulting child's umbilical
cord blood could be used to treat a seriously ill sibling. Views
on the acceptability of this practice vary and physicians should
follow national laws and local ethical and professional standards
if confronted with such requests.
Use of spare gametes and embryos and disposal of unused gametes
and embryos
- In most cases, assisted conception results in the production
of gametes and embryos that will not be used to treat those
from whom they are procured. Such so-called spare gametes and
embryos may be stored, cryo-preserved for future use, donated
to other patients or disposed of. One alternative to disposal,
in countries that permit embryo research, is donation to a research
facility. The available options must be explained clearly and
precisely to individuals before donations are made or retrievals
performed.
Surrogacy
- Where a woman is unable, for medical reasons, to carry a
child to term, surrogacy may be used to overcome childlessness,
unless prohibited by national law or the ethical rules of the
National Medical Association or other relevant organisation.
Where surrogacy is practised, great care must be taken to protect
the interests of all parties involved.
Research
- Physicians should promote the importance of research using
tissues obtained during assisted conception procedures. Because
of the special status of the material being used, research on
human gametes and especially on human embryos is, in many jurisdictions,
specifically regulated. Physicians have an ethical duty to comply
with such regulation and to help inform public debate and understanding
of the issues.
- Due to the special nature of human embryos, research should
be carefully controlled and should be limited to areas in which
the use of alternative materials will not provide an adequate
alternative.
- Views, and legislation, differ on whether embryos may be
created specifically for, or in the course of, research. Physicians
should act in accordance with national legislation and local
ethical advice.
Cell Nuclear Replacement
- The WMA opposes the use of cell nuclear replacement with
the aim of cloning human beings.
- Cell nuclear replacement may also be used to develop embryonic
stem cells for research and ultimately, it is hoped, for therapy
for many serious diseases. Views on the acceptability of such
research differ and physicians wishing to participate in such
research should ensure that they are acting in accordance with
national laws and local ethical guidance.
Recommendations
- Assisted reproductive technology is a dynamic, rapidly developing
field of medical practice. Developments should be subject to
careful ethical consideration alongside the scientific monitoring.
- Human gametes and embryos are accorded a special status.
Their use, including for research, donation to others and disposal,
should be carefully explained to potential donors and subject
to local regulation.
- Embryo research should only be carried out if local law and
ethical standards permit it and should be limited to areas where
the use of alternative materials or computer modelling does
not provide an adequate alternative.
- Physicians should follow professional guidance on the maximum
number of embryos to transfer in any treatment cycle.
- It is inappropriate to offer money or benefits in kind (for
example free or lower cost treatment cycles) to encourage donation
but donors may be reimbursed for reasonable expenses
- Families using donated embryos or gametes should be encouraged
and supported to be open with the child about this.
- Sex selection should only be carried out to avoid serious,
including life threatening, medical conditions.
- Physicians have an important role in ensuring that public
debate about the possibilities of assisted conception, and the
limits to be applied to its practice, is informed.
- Physicians should comply with national legislation and should
demonstrate compliance with high normative standards.
14.10.2006
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