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The Declaration of Helsinki:
A Matter of Principles
Prof. Dominique Sprumont
WMA, 50th Anniversary of the DoH
Institute of Health Law
University of Neuchâtel
Switzerland
Helsinki, November 11, 2014
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
Before the Declaration of Helsinki
• Nuremberg Code (1947) or the original
misunderstanding about the nature of
research governance
Jay Katz once remarked that most
investigators felt that «It was a good code
for barbarians but an unnecessary code
for ordinary physician-scientists»
Jay Katz 1992
• The West’s Dismissal of the Khabarovsk Trial as «Communist
Propaganda» : Ideology, evidence and international bioethics, Jing-Bao
Nie, Journal of bioethical inquiry vol. 1 (2004), n° 1, pp. 32-42
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
Declaration of Helsinki (1964)
• The medical profession self declared independance
«The World Medical Association interpreted the
Nuremberg Code so it was responsive to the needs
of the practice »
Robert J. Levine 2002
• US/pharmaceutical industry influence
– Research with prisoners (banned in the DoH 1962 draft)
– Research with institutionalised children (banned in the
DoH 1962 draft)
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
The DoH: A Predictable Success?
• Taking as a point of departure the ten “basic principles” set
forth by the Nuremberg judges, numerous attempts have
been made to propose “improved” codes of ethics to guide
medical research. The proliferation of such codes testifies
to the difficulty of promulgating a set of rules that does
not immediately raise more questions than it answers. At
this stage of our confusion, it is unlikely that codes will
resolve many of the problems, though they may serve a
useful function later. Even the much endorsed Declaration
of Helsinki“ – praised, perhaps, because it is the newest and
therefore the least examined – will create problems for those
who wish to implement it.
Jay Katz, The Education of the Physician-Investigator, in DAEDALUS, Journal of
the American Academy of Arts and Sciences, Spring 1969, pp. 293-314
19694
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
Effectiveness of the DoH at its Origin
• 1966: Henry K. Beecher, Ethics and
Clinical Research (NEJM)
• 1967: Maurice H. Pappworth, Human
Guinea Pigs: Experimentation on Man
– 1962: Human Guinea Pigs: A Warning,
special edition of Twentieth Century
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
DoH and the Development of Health
Research Regulation
Nuremberg Code 1947
FDA Revision
1962
Draft DoH
1962
DoH
1964
EU directive
on TP 1965
DHEW Policy
Inf. Consent
1966
DHEW Policy
Protection of Human
Subject 1971
Federal Regulation
of Human
Experimentation
DHEW 1974
Belmont Report
1978
Coordinated
revision of the FDA
and DHEW
regulation 1981
Common Rule
1991
CIOMS
Guidelines
1982
DoH
1975
DoH
1983
DoH
1989
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WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
Belmont Report
1978
Coordinated
revision of the FDA
and DHEW
regulation 1981
Common Rule
1991
CIOMS
Guidelines
1982
France 1988
ICH – GCP
1996
CoE Convention
HR and Biomedicine
1997
EU
CT Directive
2001
CoE Protocol
Research 2004
Taiwan
2011
CH 2011
EU
CT Regulation
2014
7th Revision DoH
2013
DoH and the Development of Health
Research Regulation
DoH
1989
DoH
1989
DoH
1996
DoH
2000
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
• Rules exist because they are violated
• The violation of a legal or ethical rule preceeds
its adoption. In other words, if everyone would
act according to the recognized ethical and
legal standards, there would be no need to
specify them.
– If doctors would always spontaneously
inform their patients before asking their
consent, there would be no need to specify
the rule of informed consent…
Why rules need to be formalized into
ethical codes or laws?
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
• 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 it was adopted by the WMA, but
on the fact it has been and still is reflecting
the accepted and applicable ethical
principles in the field.
Clarification of the relation between the
DoH and research ethics
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
Parallelism between the legal order
and ethical reasoning (a theoretical view)
10
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
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
• Every rule or norm is characterized by its
normative density that 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)
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
• 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
– The fact a principle requires more detailed
instruction to be implemented does not mean
the principle should be revised
– In principle, the rules of implementation do not
belong to the DoH as they are not principles…
Nature of the DoH
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WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
Nature of the DoH: a Matter of Principles
Seeking Harmony within Differences
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
• 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 contain is the expression
of a careful consensus within the medical
profession and also the research community, the
RECs and the competent authorities worldwide
Why is there a mix of principles and
specific rules in the DoH?
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
Trends in research ethics and regulation
during the last 50 years
• From broad principles to detailed regulation
• From a limited set of norms to a dense and
complex regulatory framework
• From self-regulation to legislation
• Institutionnalization of research (REC/CA)
• Bureaucratization of research (EU regulation/
FDA)
• Globalization of the research ethics and
regulation (ICH – GCP)
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
The Declaration of Helsinki:
Challenges and Opportunities
• Globalization:
– If there can be a consensus at the level of
principles (human rights), it is unlikely that it
could be achieved at the regulatory level (see
EU v. US regulation)
• Regulatory inflation:
– While researchers/industry ask for more detailed
and precise regulation, they are simultaniously
limiting their own freedom and responsibilities
WMA, 50th Anniversary of the DoH Helsinki, November 11, 2014
• The WMA should maintain the DoH as it stands: a
document of principles focusing on the protection of
human participants
• If people have a clear understanding of their
responsibilities in view of the ethical principles, there is
less need for specific regulation
WMA should assess carefully the need
for further revision of the DoH and, if
need be, develop specific guidance
documents for emerging issues
The DoH: a Matter of Principles
Institute of Health Law
Av. du 1er Mars 26
CH-2000 Neuchâtel
Dominique.Sprumont@unine.ch
www.unine.ch/ids www.trree.org
Happy Anniversary and Long Life
To the Declaration of Helsinki
and WMA
Helsinki, November 11, 2014WMA, 50th Anniversary of the DoH