{"id":3767,"date":"2017-01-20T11:54:03","date_gmt":"2017-01-20T11:54:03","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Wiesing.pdf"},"modified":"2017-01-20T11:54:03","modified_gmt":"2017-01-20T11:54:03","slug":"wiesing-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/wiesing-2\/","title":{"rendered":"Wiesing"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Wiesing<\/a><\/p>\n

The Future of the Declaration
\nof Helsinki \u2013
\nIntroduction: Remarks About
\nthe Next Revision
\nUrban Wiesing
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOutline
\n\u2022 Character of the DoH
\n\u2022 Experiences of former revisions
\n\u2022 General considerations and limits of a revision
\n\u2022 Process of revision
\n\u2022 Aim of the satellite-meeting
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe DoH has a certain Character
\n\u2022 It is a document of ethical principles for
\nresearch involving human beings
\n\u2022 It contains only few procedural rules, it is not a
\ndetailed rule-book for research
\n\u2022 The DoH has a certain size:
\n\u2022 2008: 2047 words.
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nDeclaration of Helsinki \u2013 word count
\n4 | Elisabeth Ritter
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe DoH has a certain Character
\n\u2022 The DoH is distinct from other competing
\nguidelines.
\n\u2022 All other documents on medical research are
\nyounger than the DoH and longer.
\n\u2022 They have another character:
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOther Guidelines\/Laws
\n\u2022 CIOMS guidelines: more technical instruction
\n(24649 words, incl. commentary)
\n\u2022 ICH-GCP: technical instruction (48 pages)
\n\u2022 UNESCO Declaration: not only related to
\nresearch (3542 words)
\n\u2022 Declaration of Oviedo of the EC (4096 words).
\nAdd. Research Protocol (4602 words):
\nEuropean law!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nCurrent consensus in the workgroup
\n\u2022 The character of the DoH is unique and should not be
\nchanged.
\n\u2022 The DoH must remain distinct from other guidelines!
\n\u2022 The DoH has a certain size, it should not become much
\nlonger.
\n\u2022 The DoH must remain readable within 15 min!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nExperience of former revisions
\n\u2022 Suggestions for the revision in 2008.
\n\u2022 It must be expected that many of these
\nsuggestions will be addressed once again in the
\nnext revision process.
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008
\n\u2022 Approximately 45 sets of comments to the 1st
\ndraft of a revised version,
\n\u2022 80 sets of comments after a 2nd draft was
\npublished.
\n\u2022 Some of them very long (up to 46 pages)
\n\u2022 From \u201ccongratulations\u201d to fundamental criticism
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008
\nMain discussions:
\n\u2022 Editorial changes\/wording: e.g.
\nmedical\/biomedical, human\/human beings?
\n\u2022 For whom? Doctors? Other researchers?
\n\u2022 Justice
\n\u2022 Placebo
\n\u2022 Post-study-arrangements
\n\u2022 Should \u201cpalliative care\u201d be mentioned explicitly?
\n\u2022 Unidentifiable data\/material?
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008
\n\u2022 Vulnerable populations?
\n\u2022 \u201cThere were suggestions to include the elderly, women
\nof child-bearing potential, poor people, illiterate people,
\nstudents, prisoners, those suffering from mental illness
\nor disabilities, ethnic and religious minorities, aboriginal
\npeoples, people in developing countries and people with
\nneglected diseases.\u201d (John Williams)
\n\u2022 Interestingly, not suggested: children, women, pregnant
\nwomen!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008
\n\u2022 The DoH is not based on one single ethical
\ntheory.
\n\u2022 \u201cThere was general agreement on most of the
\nprinciples; suggestions were mainly for
\nclarification.\u201d (John Williams)
\n\u2022 It is unrealistic that the next version will be a
\npurely deontological or a purely utilitarian
\ndocument!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nFrequent criticism in the literature
\n\u2022 Placebo
\n\u2022 Post-study arrangements
\n\u2022 Research in resource poor settings, justice
\n\u2022 Missing issues: biobanks
\n\u2022 Unclear status of the DoH, relation to law
\n\u2022 Wording: \u201cmust\u201d or \u201cshould\u201d
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nFrequent criticism in the literature
\n\u2022 Internal contradictions:
\n\u2022 Art. 6: \u201cIn medical research involving human
\nsubjects, the well-being of the individual
\nresearch subject must take precedence over all
\nother interests.\u201d
\n\u2022 Is research possible, as it exposes participants
\nto additional risks?
\n\u2022 Placebo? Research without informed consent?
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008 and
\ncriticism in literature
\n\u2022 If all the suggestions will be implemented:
\n\u2022 The DoH will become a book!
\n\u2022 The workgroup agrees that the size and the
\ncharacter of the DoH should be maintained.
\n\u2022 The same amount of suggestions has to be
\nexpected in the current revision process.
\n\u2022 Therefore: Not all suggestions will be
\nimplemented!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n\u2022 1. New issues
\n\u2022 Which issues?
\n\u2022 Why?
\n\u2022 New technologies? Medial innovations? New
\ncircumstances (globalization\u2026)? New ethical
\narguments?
\n\u2022 The length of the DoH!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n\u2022 2. Existing issues in more detail
\n\u2022 DoH 2008: 21 general paragraphs and 14 more
\ndetailed paragraphs (in particular \u201cinformed
\nconsent\u201d)
\n\u2022 Which issues in more detail?
\n\u2022 Length?
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n\u2022 3. Changing existing issues
\n\u2022 Which issues need new norms?
\n\u2022 Why?
\n\u2022 New technologies? Medial innovations? New
\ncircumstances (globalization\u2026)? New ethical
\narguments?
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n\u2022 4. Deleting existing issues
\n\u2022 Which one?
\n\u2022 Danger: Can be misunderstood politically!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n\u2022 5. New structure of paragraphs
\n\u2022 Some paragraphs repeat or specify what is
\nstated in other paragraphs.
\n\u2022 Merging paragraphs? New order? New
\nsubtitles?
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n\u2022 6. Wording, editorial changes
\n\u2022 should\/must
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n\u2022 1. New issues
\n\u2022 2. Existing issues in more detail
\n\u2022 3. Changing existing issues
\n\u2022 4. Deleting existing issues
\n\u2022 5. New structure of paragraphs
\n\u2022 6. Wording, editorial changes
\n\u2022 New regulations, new issues, changes etc. must
\nbe coherent with the rest of the DoH!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe next revision:
\n\u2022 The character of the DoH should remain.
\n\u2022 The size should not increase.
\n\u2022 The DoH must remain distinct from other
\nguidelines!
\n\u2022 Sensitive for ongoing ethical debates, scientific
\nand political developments
\n\u2022 The aim is a more appropriate and updated
\nversion of the DoH.
\n\u2022 Not a revolution, but an evolution.
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe revision process
\n\u2022 Oktober 2011, Montevideo:
\n\u2022 General assembly: A new revision!
\n\u2022 Four conferences:
\n\u2022 Rotterdam 26.6.2012
\n\u2022 Cape Town 5.-7.12.2102
\n\u2022 Tokio 28.2.-2.3.2013
\n\u2022 (Washington August 2013)
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nPublic discussion
\n\u2022 A first draft will be published for public debate:
\n\u2022 April 2013 until June 2013 (subject to a decision
\nof the Council of the WMA)
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe process of revision
\n\u2022 The workgroup has to set up a proposal
\n\u2022 Discussed in public and within the WMA
\n\u2022 The final decision is made by the General
\nAssembly of the WMA
\n\u2022 A political decision!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe revision process
\n\u2022 Nothing has been decided yet.
\n\u2022 We do not know the result of the revision
\nprocess, nor our proposal, neither the political
\ndecision by the General Assembly!
\n\u2022 Certain limits have to be respected.
\n\u2022Don\u2018t be sad if your suggestions will
\nnot be implemented in the final
\ndocument!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nGoals of the satellite meeting
\n\u2022 We start the process of public debate within
\nthe scientific community.
\n\u2022 The first public conference of the revision
\nprocess
\n\u2022 The Workgroup of the WMA is interested in
\nyour ideas.
\n\u2022 We are grateful for your commentaries,
\ncriticism, suggestions\u2026!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\n\u2022The task of the
\nWMA-workgroup
\nfor today:
\n\u2022Listen!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe Future of the Declaration
\nof Helsinki \u2013
\nIntroduction: Remarks About
\nthe Next Revision
\nUrban Wiesing
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nIssues for a revision
\n\u2022 Insurance\/compensation
\n\u2022 Enhancement
\n\u2022 Medical devices
\n\u2022 Biobanks
\n\u2022 Resource poor settings
\n\u2022 Justice
\n\u2022 Vulnerable groups
\n\u2022 Status of DoH
\n\u2022 Research Ethics Committee
\n\u2022 Risk\/benefit
\n\u2022 Publication
\n\u2022 Post-study-arrangements
\n\u2022 Placebo
\n\u2022 New structure
\n\u2022 Wording
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin<\/p>\n"},"caption":{"rendered":"

Wiesing The Future of the Declaration of Helsinki \u2013 Introduction: Remarks About the Next Revision Urban Wiesing Institut f\u00fcr Ethik und Geschichte der Medizin Outline \u2022 Character of the DoH \u2022 Experiences of former revisions \u2022 General considerations and limits of a revision \u2022 Process of revision \u2022 Aim of the satellite-meeting Institut f\u00fcr Ethik […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Wiesing.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3767"}],"collection":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/comments?post=3767"}]}}