Wiesing

The Future of the Declaration
of Helsinki –
Introduction: Remarks About
the Next Revision
Urban Wiesing
Institut für Ethik und
Geschichte der Medizin
Outline
• Character of the DoH
• Experiences of former revisions
• General considerations and limits of a revision
• Process of revision
• Aim of the satellite-meeting
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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
• The DoH has a certain size:
• 2008: 2047 words.
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Declaration of Helsinki – word count
4 | Elisabeth Ritter
Institut für Ethik und
Geschichte der Medizin
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
• Approximately 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
• 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
purely deontological or a purely 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
• Wording: “must” or “should”
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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 and
criticism in literature
• If all the suggestions will be implemented:
• The DoH will become a book!
• The workgroup agrees that the size and the
character of the DoH should be maintained.
• The same amount of suggestions has to be
expected in the current 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
subtitles?
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Options for a revision
• 6. Wording, editorial changes
• should/must
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Options for a revision
• 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!
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The next revision:
• The character of the DoH should remain.
• The size should not increase.
• The DoH must remain distinct from other
guidelines!
• Sensitive for ongoing ethical debates, scientific
and political developments
• The aim is a more appropriate and updated
version of the DoH.
• Not a revolution, but an evolution.
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The revision process
• Oktober 2011, Montevideo:
• General assembly: A new revision!
• Four conferences:
• Rotterdam 26.6.2012
• Cape Town 5.-7.12.2102
• Tokio 28.2.-2.3.2013
• (Washington August 2013)
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Public discussion
• A first draft will be published for public debate:
• April 2013 until June 2013 (subject to a decision
of the Council of the WMA)
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The process of revision
• The workgroup has to set up a proposal
• Discussed in public and within the WMA
• The final decision is made by the General
Assembly of the WMA
• A political decision!
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The revision process
• Nothing has been decided yet.
• We do not know the result of the revision
process, nor our proposal, neither the political
decision by the General Assembly!
• Certain limits have to be respected.
•Don‘t be sad if your suggestions will
not be implemented in the final
document!
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Goals of the satellite meeting
• We start the process of public debate within
the scientific community.
• The first public conference of the revision
process
• The Workgroup of the WMA is interested in
your ideas.
• We are grateful for your commentaries,
criticism, suggestions…!
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•The task of the
WMA-workgroup
for today:
•Listen!
Institut für Ethik und
Geschichte der Medizin
The Future of the Declaration
of Helsinki –
Introduction: Remarks About
the Next Revision
Urban Wiesing
Institut für Ethik und
Geschichte der Medizin
Issues for a revision
• Insurance/compensation
• Enhancement
• Medical devices
• Biobanks
• Resource poor settings
• Justice
• Vulnerable groups
• Status of DoH
• Research Ethics Committee
• Risk/benefit
• Publication
• Post-study-arrangements
• Placebo
• New structure
• Wording
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