May 2005 - Medical Research in Developing Countries
The revised Declaration
of Helsinki (DoH) that was adopted by the WMA General
Assembly in October 2000 contains several paragraphs that are
particularly relevant for medical research that is conducted in
developing, or low income, countries:
- Para. 19 - Medical research is only justified if there is
a reasonable likelihood that the populations in which the research
is carried out stand to benefit from the results of the research.
- Para. 29 - The benefits, risks, burdens and effectiveness
of a new method should be tested against those of the best current
prophylactic, diagnostic, and therapeutic methods. This does
not exclude the use of placebo, or no treatment, in studies
where no proven prophylactic, diagnostic, and therapeutic method
exists.
- Para. 30 - At the conclusion of the study, every patient entered
into the study should be assured of access to the best proven
prophylactic, diagnostic, and therapeutic methods identified
by the study.
These sections of the DoH subsequently generated considerable
controversy. The WMA attempted to resolve the controversy by adopting
notes of clarification on para. 29 (in 2002) and on para. 30 (in
2004). Other national and international organizations that deal
with the ethics of research on human subjects issued their own
reports and guidelines that are in some ways inconsistent with
the DoH.
In an attempt to find common ground on these divisive issues,
the U.K. Nuffield Council on Bioethics and the Medical Research
Council of South Africa hosted a workshop in Cape Town, South
Africa in February 2004. The report of the workshop, The
ethics of research related to healthcare in developing countries:
a follow-up Discussion Paper, includes four tables that
compare the requirements of the DoH with those of the Council
for International Organizations of Medical Sciences (CIOMS), the
Council of Europe, the European Union, the European Group on Ethics
in Science and New Technologies, and the Nuffield Council on Bioethics.
The specific topics compared are consent, standards of care, what
happens after the research is over, and ethical review. The report
does not attempt to resolve the differences in the guidance provided
by these organizations.
Another organization that deals with the ethics of medical research
in developing countries is The
Global Forum on Bioethics in Research. Its annual meeting
brings together ethicists, researchers and other interested individuals
to discuss a specific topic of concern to developing countries.
The 2004 Forum dealt with "Sharing the benefits from research
in developing countries: equity and intellectual property,"
and the theme of the 2005 Forum was "What happens when research
is over? Post trial obligations of researchers and sponsors."
Various initiatives are underway to build the capacity of developing
countries to conduct ethics review of proposed medical research,
including the following:
March 2005 - Cloning of Human Beings
The announcement of the cloning of Dolly the sheep in February
1997 generated enormous ongoing controversy about whether cloning
techniques can and should be applied to humans. A widespread consensus
soon developed against any attempts to reproduce a human individual
by the same or a similar technique as had produced Dolly (generally
known as 'reproductive cloning'). In 1997 the World Health Assembly
adopted a resolution that "cloning for the replication of
human individuals is ethically unacceptable and contrary to human
dignity and integrity." Later that year UNESCO's General
Conference adopted a Universal Declaration on the Human Genome
and Human Rights that includes the statement, "Practices
which are contrary to human dignity, such as reproductive cloning
of human beings, shall not be permitted." Many countries,
supported by national medical associations and scientific societies,
passed laws prohibiting reproductive cloning.
There has been much less consensus about the acceptability of
what has come to be known as 'therapeutic cloning' or 'cloning
for biomedical research', that is, the application of cloning
techniques to human tissues such as stem cells in order to determine
whether treatments for currently incurable diseases can thereby
be developed. Although there is some indication that adult stem
cells can be harvested and used for this purpose, it seems that
stem cells from human embryos are more suitable. However, experiments
on human embryos are widely, though by no means universally, considered
to be ethically objectionable.
In contrast to reproductive cloning, there has been considerable
variation in how international organizations, national governments
and medical and scientific associations have dealt with therapeutic
cloning, in particular, stem cell research using human embryos.
Some nations explicitly permit the practice, but under varied
conditions, others prohibit it, and still others have yet to decide.
In March 2005 the United Nations General Assembly adopted a Declaration
on Human Cloning calling on nations " to adopt all
measures necessary to prohibit all forms of human cloning inasmuch
as they are incompatible with human dignity and the protection
of human life." The vote on the resolution, 84 members in
favour, 34 against, and 37 abstentions, reflected the lack of
consensus on this issue, and several nations immediately announced
that they would continue to permit therapeutic cloning.
The World Medical Association reacted quickly to the announcement
of Dolly's cloning but was cautious in its response. In May 1997
the WMA Council adopted a resolution, subsequently endorsed by
the WMA Assembly, that "calls on doctors engaged in research
and other researchers to abstain voluntarily from participating
in the cloning of human beings until the scientific, ethical and
legal issues have been fully considered by doctors and scientists,
and any necessary controls put in place." The WMA Medical
Ethics Committee will review this resolution at its May 2005 meeting
together with the WMA Statement on Genetic Counseling and Engineering
and Declaration on the Human Genome Project.
National Medical Associations that have taken stands on this
issue include the following:
- American Medical Association - The
Ethics of Human Cloning: "Two potentially realistic
and possibly appropriate medical uses of human cloning are for
assisting individuals or couples to reproduce and for the generation
of tissues when the donor is not harmed or sacrificed. Given
the unresolved issues regarding cloning…, the medical profession
should forsake human cloning at this time and pursue alternative
approaches that raise fewer ethical concerns."
- Australian Medical Association - Human
Genetic Issues: "The cloning of human beings should
be prohibited. With approval by a human research ethics committee,
human genetic tissue can be used for processes involving cloning
techniques."
- British Medical Association - BMA
Position on Human 'Cloning' : On 'reproductive cloning',
"The BMA considers unacceptable the notion of cloning whole
humans and would not wish to see public policy develop in this
way." On 'therapeutic cloning', "The BMA supports
the use of carefully controlled research, including research
using human embryos where necessary for: the development of
tissue for transplantation; and the development of methods of
therapy for mitochondrial diseases. The BMA would also wish
to see the continuation of important basic research provided
this is strictly controlled and regularly monitored.
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