DoH_Revision_Sprumont

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Revising the Declaration of Helsinki
Points to Consider
Professor Dominique Sprumont
Institute of Health Law, University of Neuchâtel (Switzerland)
TRREE – FMH
WMA Conference
Cape Town, South Africa
December 6, 2012
TRREE for Africa
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Overview
 TRREE – FMH position statements
 Clarification of the relation between the DoH and the law
– Legal order – ethical reasoning
– Normative density
– Nature of the DoH
 Why is threre a mix of principles and detailed rules in the
DoH and what to do about it
 Conclusions
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TRREE – FMH position statements
 If there is no urgency for the revision of a law, it is
urgent not to revise it (FMH – TRREE)
 If specific issues deserve more detailed guidances,
they should be convered in a separate set of
documents (FMH – TRREE)
 The placebo rule must be maintained (and even
strenghtened) (FMH – TRREE)
 The consultation process should be open to non-
English speaking stakeholders, with special
attention to interested parties in developing world
(TRREE – NHREC Cameroon – FCRM Congo – Odile Ouwe
Missi Oukem, Niger – Dr. Morenike Ukpong, Nigeria – etc.)
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 The law is not limited to the legislation
and case law
 Research ethics is not limited to code of
ethics such as the DoH or professional
standards such as the ICH – GCP
The value of the DoH is not based
primarily on the fact that it was adopted
by the WMA, but on the fact that it
reflects the applicable ethical principles in
the field.
Clarification of the relation between the
DoH and the law: Preamble
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Parallelism between the legal order
and ethical reasoning (a theoretical view)
5 WMA Conference, Cape Town, 2012
Constitution (Human rights)
Law (Statutes/Case law)
Regulatory implementation
Administrative practices
Professional Standards
Ethical rules
Technical rules, etc.
«Ethical reasoning is, and ought to be, hierarchical and deductive»
(Robert Levine on the Belmont Report)
Principles
General rules
Detailed rules
&
Issue specific
rules
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 Every rule or norm is characterized by its
normative density. This includes two
elements:
– Specificity
– Clarity
 The more specific and the more detailed
is a rule, the higher is its normative
density
Normative density (rule of law)
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The pyramid of norms (a pragmatical view)
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At the light of the concept of normative
density, the hierarchy of norms is reversed.
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 The DoH is focusing on principles. It may
be considered as the Constitution of
research ethics.
 The normative density of the DoH is low
 It requires more detailed rules to be
implemented
 In principle, those rules of implementation
do not belong to the DoH as they are not
principles…
Nature of the DoH
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 The DoH is not merely an academic
document. It is the product of history,
lobbying from various stakeholders, of the
development strategy of the WMA, etc.
 Its present structure and content is the
expression of a careful consensus within
the medical profession and also the
research community, the RECs and
competent authorities worldwide
Why is there a mix of principles and
specific rules in the DoH?
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 Rules exist because they are violated
 The violation of a legal or ethical rule
preceeds its adoption
– The placebo rule hurts the interests of
those wanting research to go faster but
it contradicts the Council of Europe and
EU principle of the primacy of the
interests of the participants v. the sole
interests of science or society
Why rules exist?
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 The WMA should only revise the provisions that
do create problems.
 The fact that a principle requires more detailed
instruction to be implemented does not mean the
principle should be revised.
 For emerging issues or issues requiring more
detailed rules, the WMA should adopt guidance
documents separated from the DoH which
should be implemented in the light of the DoH (cf.
Council of Europe Convention of Human Rights
and Biomedicine and its additional protocols).
Conclusions
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Thank you for your attention
And see you soon on
TRREE…
Thank you
for your
attention
See you soon
on TRREE
www.trree.org