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A New Revision of the
Declaration of Helsinki:
Challenges and Limitation
Urban Wiesing
Cape Town, WMA conference, 5 December 2012
Institut für Ethik und
Geschichte der Medizin
Outline
• Process of revision
• Character of the DoH
• Experiences of former revisions
• General considerations and limits of a revision
• Task of the workgroup
• Issues of this conference
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The revision process
• Oktober 2011, Montevideo.
• General assembly: A new revision of the DoH!
• Four conferences:
Rotterdam 26.6.2012
Cape Town 5.-7.12.2102
Tokyo 28.2.-2.3.2013
Washington August 2013
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The revision process
• April 2012
• Request for comments from National Medical
associations
• 21 answers
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The revision process
A first draft for public debate will be published:
April 2013 until June 2013 (subject to a
decision of the Council of the WMA)
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The DoH has a certain character
• It is a document of ethical principles for
research involving human beings.
• It contains only few procedural rules, it is not
a detailed rule-book for research.
• It has a certain size.
• 2008: 2047 words.
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Declaration of Helsinki – word count
7 | Elisabeth Ritter
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The DoH has a certain character
• The DoH is distinct from other competing
guidelines.
• All other documents on medical research are
younger than the DoH and longer.
• They have another character.
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Other Guidelines/Laws
CIOMS guidelines: more technical instruction (24649
words, incl. commentary)
ICH-GCP: technical instruction (48 pages)
UNESCO Declaration: not only related to research
(3542 words)
Declaration of Oviedo of the EC (4096 words). Add.
Research Protocol (4602 words): European law!
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Current consensus in the workgroup
• The character of the DoH is unique and should
not be changed.
• The DoH must remain distinct from other
guidelines!
• The DoH has a certain size; it should not become
much longer.
• The DoH must remain readable within 15 min!
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Experience of former revisions
Suggestions for the revision in 2008.
It must be expected that many of these
suggestions will be addressed once again in
the next revision process.
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Suggestions for the revision 2008
• Approx. 45 sets of comments to the 1st draft
of a revised version.
• 80 sets of comments after a 2nd draft was
published.
• Some of them very long (up to 46 pages)
• From “congratulations” to fundamental
criticism.
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Suggestions for the revision 2008
Main discussions:
• Editorial changes/wording: e.g.
medical/biomedical, human/human beings?
• For whom? Doctors? Other researchers?
• Justice
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Suggestions for the revision 2008
• Placebo
• Post-study-arrangements
• Should “palliative care” be mentioned
explicitly?
• Unidentifiable data/material?
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Suggestions for the revision 2008
Vulnerable populations?
“There were suggestions to include the elderly, women
of child-bearing potential, poor people, illiterate people,
students, prisoners, those suffering from mental illness
or disabilities, ethnic and religious minorities, aboriginal
peoples, people in developing countries and people
with neglected diseases.” (John Williams)
Interestingly, not suggested: children, women, pregnant
women!
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Suggestions for the revision 2008
The DoH is not based on one single ethical
theory:
“There was general agreement on most of the
principles; suggestions were mainly for clarification.”
(John Williams)
It is unrealistic that the next version will be a
pure deontological or a pure utilitarian
document!
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Frequent criticism in the literature
• Placebo
• Post-study arrangements
• Research in resource poor settings, justice
• Missing issues: biobanks
• Unclear status of the DoH, relation to law
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Frequent criticism in the literature
• Internal contradictions:
Art. 6: “In medical research involving human subjects,
the well-being of the individual research subject must
take precedence over all other interests.”
• Is research possible, as it exposes
participants to additional risks?
• Placebo? Research without informed
consent?
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Suggestions for the revision 2008, criticism
in literature and suggestions in 2012
• If all suggestions are implemented: the DoH
will become a book!
• The workgroup has agreed that the size and
the character of the DoH should be maintained.
• The same amount of suggestions has to be
expected in the further revision process.
• Therefore: Not all suggestions will be
implemented!
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Options for a revision
1. New issues:
• Which issues?
• Why?
• New technologies? Medial innovations? New
circumstances (globalization…)? New ethical
arguments?
• The length of the DoH!
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Options for a revision
2. Existing issues in more detail:
• DoH 2008: 21 general paragraphs and 14 more
detailed paragraphs (in particular “informed
consent”)
• Which issues in more detail?
• Length?
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Options for a revision
3. Changing existing issues:
• Which issues need new norms?
• Why?
• New technologies? Medial innovations? New
circumstances (globalization…)? New ethical
arguments?
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Options for a revision
4. Deleting existing issues:
• Which one?
• Danger: Can be misunderstood politically!
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Options for a revision
5. New structure of paragraphs:
• Some paragraphs repeat or specify what is
stated in other paragraphs.
• Merging paragraphs? New order? New
subheadings?
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Options for a revision
6. Wording, editorial changes:
• should/must
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In Summary
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Options for a revision
of DoH
1. New issues
2. Existing
issues in more
detail
3. Changing
existing issues
4. Deleting
existing issues
5. New structure
of paragraphs
6. Wording,
editorial changes
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Options for a revision
of DoH
1. New issues
2. Existing issues
in more detail
3. Changing
existing issues
4. Deleting existing
issues
5. New structure
of paragraphs
6. Wording,
editorial changes
New regulations, new issues, changes etc.
must be coherent with the rest of the DoH!
The next revision:
• The character of the DoH should remain.
• The size should not increase.
• The DoH must remain distinct from other
guidelines!
• Not a revolution, but an evolution.
• The aim is a more appropriate and updated
version of the DoH.
• If there are no strong arguments for a change,
the paragraph will remain.
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The process of revision
•The workgroup has to set up a proposal
•The final decision is made by the General
Assembly of the WMA
•A political decision!
Don‘t be sad if your suggestions are
not be implemented in the final
document!
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Issues of this conference
• Vulnerable groups
• Post-study-arrangements
• Biobanks
• Research Ethics
Committee
• Enhancement
• Insurance/compensation
• Use of unproven
interventions/off-label use
(para. 35)
• Broad consent
• Children
• …
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Goal of the conference
A public debate with a particular African
perspective.
The workgroup is grateful for
your comments, criticism,
suggestions…!
Institut für Ethik und
Geschichte der Medizin
A New Revision of the
Declaration of Helsinki:
Challenges and Limitation
Urban Wiesing
Cape Town, WMA conference, 5 December 2012
Institut für Ethik und
Geschichte der Medizin