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Tuesday, April 14, 2015
The trouble with international ethics guidelines
In nearly regular intervals arguments flare up among
bioethicists as well as political activists about the substantive guidance
proffered in international ethics guidance documents such as the World Medical
Association’s (WMA’s) Declaration of Helsinki or the Council for International
Organisation of Medical Sciences’ (CIOMS’) research ethics guidance documents.
Who doesn’t recall the arguments about standards of care in clinical trials
undertaken in developing countries, or the post-trial benefits debate?
Monographs, anthologies, as well as an endless stream of graduate student theses
focused on particular aspects of these debates. There is nothing wrong with these
efforts. As someone who spends significant amounts of time vetting other
people’s content, as a journal editor, academic supervisor and external
examiner of graduate students’ theses I have read a lot of content dedicated to
these debates over the years.
What has always struck me as strange is that virtually nobody
seems to question the relevance of these documents. They are usually taken as
authoritative statements, not dissimilar to consensus statements clinicians
might publish in medical journals. And yet, it is far from clear that anyone
should accept these declarations and guidelines as relevant documents of that
Take the WMA’s Declaration of Helsinki as a case in point: it is interesting in
so far as it has been one of the most bitterly fought over international
research ethics guidance documents just a few years ago. It is still being
revised in fairly frequent intervals, alas the old battle axes in this dispute have
by and large moved on to other issues. There is little professional interest in
substantive changes to what once were highly sensitive provisions in the
At least the WMA has some claim to represent the world’s
doctors. Still, the Declaration offers no justifications for its guidance, so
it is unclear why anyone who undertakes biomedical research and isn’t a medical
doctor should bother about it. It is also doubtful that the national medical
associations debated in any meaningful way proposed revisions to the
Declaration and instructed their delegates to the WMA’s General Assembly to
vote in particular ways that actually represent the views of the members of
these national associations. You might also wonder why a local GP’s views and
vote ought to matter a great deal in matters research ethics in the first
place. CIOMS remains a fairly smallish operator with even less of a claim to
represent meaningfully people involved in biomedical research.
Its initial claim to fame was that it put itself forward to interpret the WMA
Declaration of Helsinki. Once that – kind of - established its legitimacy this
interpretation morphed into its own guidance document. At least CIOMS has a
habit of trying to justify its guidance, as opposed to engaging merely in ex
cathedra declarations like the WMA is wont to do.
The situation doesn’t get any better when one looks at
international institutions such as the World Health Organisation (WHO). While
undoubtedly United Nations insiders are clued in with regard to the status of
myriad WHO documents, the wider public, and indeed policy makers outside the
corridors of WHO offices, almost certainly do not. A case in point: After
spectacularly failing in its response to the Ebola outbreaks WHO engaged in
what can best be described as wild activism to show that it is doing something. It issued eventually an
ethical guidance document that declared that it is OK to use unregistered
experimental interventions on Ebola virus disease patients.
The authors of this document, celebrated as they were as experts on the subject
matter, had mostly never published a word on either Ebola virus disease or,
indeed, on the difficult subject of emergency access to experimental drugs in
case of patients with catastrophic illnesses. The latter topic has been a
matter of intense debate over the last few decades in bioethics. I should know,
I have been involved in these debates. The WHO’s experts may have been nice
people interested in this topic, who were known somehow to WHO people in charge of inviting someone ‘expert’, alas very few of their experts had any
demonstrable expertise when they willingly pontificated publicly on WHO
letterhead on this subject matter. Much like CIOMS, the authors of this
guidance document ought to be commended for having made the effort to provide
justifications for their recommendations.
The results of the WHO meeting were eventually reported the
world all over as the WHO ‘approving’ the use of experimental drugs in patients
with Ebola virus disease.
It turns out that the WHO has no jurisdiction to approve anything of that sort,
and, equally as importantly, WHO never actually did approve what it was
reported to have approved. The WHO documents produced by the people it invited
to pontificate on this subject, state actually in small print that they merely reflect
the views of the people who wrote them down, and that they are not the official
view of WHO. Their views, in other words, ought to carry no more weight than
the views of any other groups of academics who hang out together at conferences
and draft papers in their spare time. This hasn’t stopped academics writing
about this subject to mention the WHO documents as if they carried any
meaningful regulatory or other weight.
WHO is at the time of writing in the process of developing
procedures for the selection and use of such experimental agents in Ebola virus
disease patients.I suspect the status of these documents won’t
be of more significant regulatory weight than that of any of its other Ebola
crisis triggered documents. That is not to say that they will be bad documents.
It appears to be the case that these documents will be an amalgam of best
practice guidelines from nations that have many decades of regulatory
experience with emergency access to investigational agents in patients with
catastrophic illnesses. However, if, for instance, Liberia and the USA decided
to establish an emergency access program for a particular therapeutic
experimental agent, and they chose to ignore WHO (who is apparently keen to
inject itself into these bilateral processes) what exactly would WHO be able to
do about that? Nothing that I can think of.
What is the value of these sorts of guidance documents then?
I think they are valuable as documents that drive debate among interested
parties about the substantive controversial issues that they address. They
might also be of value to organisations such as the International Committee of
the Red Cross, Doctors without Borders, and others, who want guidelines for
their own emergency access plans without spending too much time thinking about ethically
defensible operational frameworks themselves. Last but not least, they might be
useful to developing nations without the capacity to develop their own
regulatory frameworks and who decide to resort to WHO guidance documents and
However, given these questions about the status and the
legitimacy of these documents, if the old adage caveat emptor ever applied anywhere, it should apply to these
guidelines, declarations and policies. Anyone choosing to adopt them ought to
adopt them because they consider them ethically defensible, and not because
they happen to come from WMA, CIOMS or indeed the WHO.
Schuklenk, U. 1998. Unethical
Perinatal HIV Transmission Trials Establish Bad Precedent. Bioethics 12:
 Schuklenk U. 2004. The Standard of Care Debate:
Against the Myth of an ‘International Consensus Opinion’. Journal of Medical Ethics 30: 194-197.