IPI - Editorial

IPI
The 2008 Revised Declaration of Helsinki
and Proposed Solutions for Research
Ethics in Globalised Clinical Trials
In October 2008 the World Medical
Association (WMA) once again revised the
Declaration of Helsinki (DoH), this time at
its General Assembly Meeting in Seoul,
South Korea. While the WMA insisted that
this revision would be largely for editorial
purposes, the result is a significantly altered
'Ethical Principles for Medical Research
Involving Human Subjects’, the current
subtitle of the DoH. The revision contains
both ‘editorial’ changes, including a revised
use of wording in places and the integration
of ‘explanatory notes’ into the main text, as
well as the addition of new ‘principles’ and a
greater emphasis on the primacy of the DoH
Revised Ethical Principles
Significant revisions appear throughout the
2008 DoH. The following listing groups the
principle revisions according to the thinking
within the WMA that informed the revision.
1. An emphasis on the individual research
participant (‘subject’) whose wellbeing
‘must take precedence over all other
interests' (paragraph 8) and (when
competent) must ‘freely agree (consent) –
without exception – to the
research’(paragraph 22).
2. Greater emphasis on transparency in
clinical research, including (a) specified
information to be included in the protocol:
‘information regarding funding, sponsors,
institutional affiliations, other potential
conflicts of interest, incentives for subjects
and provisions for treating and/or
compensating subjects who are harmed
as a consequence of participation in the
research study' (paragraph 14) and (b)
specific information and methods for
delivering patient information / informed
consent (paragraph 24), and (c) a
requirement to register publically ‘every
clinical trial’.
3. A restatement of the WMA position on the
use of control arms in medical research,
specifically indicating two exceptions
where the use of placebos is allowed: (a)
above other national and international
ethical and legal requirements. The WMA
was clearly aiming at a text to strongly
impact both the international research ethics
discussion and real-time practical
requirements for medical research,
including (if not, primarily) clinical trials.
More recently, on 19 February 2009, the
New England Journal of Medicine published
an article entitled 'Ethical and Scientific
Implications of the Globalization of Clinical
Research’ in which a group of clinical
triallists from the Duke University School of
Medicine and the University of North
‘where no current proven intervention
exists’ and (b) 'where for compelling and
scientifically sound methodological
reasons’ in which research participants will
not be exposed ‘to any risk of serious or
irreversible harm’ (paragraph 32).
4. A stronger position on what research
participants are ‘entitled' to at the end of
studies: (a) ‘to be informed of the outcome
of the study' and (b) ‘to share any benefits
that result from [the study]’ (paragraph
33). The specific entitlement to ‘post-study
access by study subjects to interventions
identified as beneficial in the study or
access to other appropriate care or
benefits’ needs to be stated in the protocol
(paragraph 14).
5. A new concern with the role of ‘community’
along with ‘populations’ (introduced in
2000) insisting that research must be
‘responsive to the health needs and
priorities of this [wherein the research
takes place] population or community, and
if there is a reasonable likelihood that this
population or community stands to benefit
from the results of the research’
(paragraph 17). Importantly, paragraph 22
makes it clear that the individual’s interests
and decisions take precedence over those
of the community.
Carolina School of Medicine produced a
commentary raising the question: ‘To what
extent should people in developing
countries be enrolled in clinical trials?’ The
article by US clinical researchers challenges
the ethical and scientific value of clinical
trials in places such as Central and South
America, Eastern Europe, Southeast Asia,
the Middle East, Africa, China, and India.
Although they (Glickman et al.) reference the
current 2008 version of the DoH, they
indirectly quote the now debunked 2000-
2004 version in an overall argument that
says greater clarity of ethical principles is
needed, greater quality control regarding
clinical trial data and its geographic
relevance needs to be implemented, and
more government oversight is required.
Since the recent and, oftentimes, heated
discussion on revising the DoH began at the
WMA General Assembly in Hamburg in
November 1997, the WMA has repeatedly
emphasised its wish that in revising the DoH
12 IPI
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