{"id":3790,"date":"2017-01-20T12:25:36","date_gmt":"2017-01-20T12:25:36","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/DoH_Cape_Town_Introduction_DA.pdf"},"modified":"2017-01-20T12:25:36","modified_gmt":"2017-01-20T12:25:36","slug":"doh_cape_town_introduction_da-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/doh_cape_town_introduction_da-2\/","title":{"rendered":"DoH_Cape_Town_Introduction_DA"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

DoH_Cape_Town_Introduction_DA<\/a><\/p>\n

A New Revision of the
\nDeclaration of Helsinki:
\nChallenges and Limitation
\nUrban Wiesing
\nCape Town, WMA conference, 5 December 2012
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOutline
\n\u2022 Process of revision
\n\u2022 Character of the DoH
\n\u2022 Experiences of former revisions
\n\u2022 General considerations and limits of a revision
\n\u2022 Task of the workgroup
\n\u2022 Issues of this conference
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe revision process
\n\u2022 Oktober 2011, Montevideo.
\n\u2022 General assembly: A new revision of the DoH!
\n\u2022 Four conferences:
\nRotterdam 26.6.2012
\nCape Town 5.-7.12.2102
\nTokyo 28.2.-2.3.2013
\nWashington August 2013
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe revision process
\n\u2022 April 2012
\n\u2022 Request for comments from National Medical
\nassociations
\n\u2022 21 answers
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe revision process
\nA first draft for public debate will be published:
\nApril 2013 until June 2013 (subject to a
\ndecision of the Council of the WMA)
\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
\na detailed rule-book for research.
\n\u2022 It has a certain size.
\n\u2022 2008: 2047 words.
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nDeclaration of Helsinki \u2013 word count
\n7 | 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
\nCIOMS guidelines: more technical instruction (24649
\nwords, incl. commentary)
\nICH-GCP: technical instruction (48 pages)
\nUNESCO Declaration: not only related to research
\n(3542 words)
\nDeclaration of Oviedo of the EC (4096 words). Add.
\nResearch Protocol (4602 words): European 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
\nnot be changed.
\n\u2022 The DoH must remain distinct from other
\nguidelines!
\n\u2022 The DoH has a certain size; it should not become
\nmuch longer.
\n\u2022 The DoH must remain readable within 15 min!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nExperience of former revisions
\nSuggestions for the revision in 2008.
\nIt must be expected that many of these
\nsuggestions will be addressed once again in
\nthe next revision process.
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008
\n\u2022 Approx. 45 sets of comments to the 1st draft
\nof 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
\ncriticism.
\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
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008
\n\u2022 Placebo
\n\u2022 Post-study-arrangements
\n\u2022 Should \u201cpalliative care\u201d be mentioned
\nexplicitly?
\n\u2022 Unidentifiable data\/material?
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008
\nVulnerable populations?
\n\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
\nwith neglected diseases.\u201d (John Williams)
\nInterestingly, not suggested: children, women, pregnant
\nwomen!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008
\nThe DoH is not based on one single ethical
\ntheory:
\n\u201cThere was general agreement on most of the
\nprinciples; suggestions were mainly for clarification.\u201d
\n(John Williams)
\nIt is unrealistic that the next version will be a
\npure deontological or a pure 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
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nFrequent criticism in the literature
\n\u2022 Internal contradictions:
\nArt. 6: \u201cIn medical research involving human subjects,
\nthe well-being of the individual research subject must
\ntake precedence over all other interests.\u201d
\n\u2022 Is research possible, as it exposes
\nparticipants to additional risks?
\n\u2022 Placebo? Research without informed
\nconsent?
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nSuggestions for the revision 2008, criticism
\nin literature and suggestions in 2012
\n\u2022 If all suggestions are implemented: the DoH
\nwill become a book!
\n\u2022 The workgroup has agreed that the size and
\nthe character of the DoH should be maintained.
\n\u2022 The same amount of suggestions has to be
\nexpected in the further revision process.
\n\u2022 Therefore: Not all suggestions will be
\nimplemented!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n1. 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
\n2. 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
\n3. 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
\n4. 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
\n5. New structure of paragraphs:
\n\u2022 Some paragraphs repeat or specify what is
\nstated in other paragraphs.
\n\u2022 Merging paragraphs? New order? New
\nsubheadings?
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\n6. Wording, editorial changes:
\n\u2022 should\/must
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nIn Summary
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\nof DoH
\n1. New issues
\n2. Existing
\nissues in more
\ndetail
\n3. Changing
\nexisting issues
\n4. Deleting
\nexisting issues
\n5. New structure
\nof paragraphs
\n6. Wording,
\neditorial changes
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nOptions for a revision
\nof DoH
\n1. New issues
\n2. Existing issues
\nin more detail
\n3. Changing
\nexisting issues
\n4. Deleting existing
\nissues
\n5. New structure
\nof paragraphs
\n6. Wording,
\neditorial changes
\nNew regulations, new issues, changes etc.
\nmust be coherent with the rest of the DoH!
\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 Not a revolution, but an evolution.
\n\u2022 The aim is a more appropriate and updated
\nversion of the DoH.
\n\u2022 If there are no strong arguments for a change,
\nthe paragraph will remain.
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nThe process of revision
\n\u2022The workgroup has to set up a proposal
\n\u2022The final decision is made by the General
\nAssembly of the WMA
\n\u2022A political decision!
\nDon\u2018t be sad if your suggestions are
\nnot be implemented in the final
\ndocument!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nIssues of this conference
\n\u2022 Vulnerable groups
\n\u2022 Post-study-arrangements
\n\u2022 Biobanks
\n\u2022 Research Ethics
\nCommittee
\n\u2022 Enhancement
\n\u2022 Insurance\/compensation
\n\u2022 Use of unproven
\ninterventions\/off-label use
\n(para. 35)
\n\u2022 Broad consent
\n\u2022 Children
\n\u2022 \u2026
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nGoal of the conference
\nA public debate with a particular African
\nperspective.
\nThe workgroup is grateful for
\nyour comments, criticism,
\nsuggestions\u2026!
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin
\nA New Revision of the
\nDeclaration of Helsinki:
\nChallenges and Limitation
\nUrban Wiesing
\nCape Town, WMA conference, 5 December 2012
\nInstitut f\u00fcr Ethik und
\nGeschichte der Medizin<\/p>\n"},"caption":{"rendered":"

DoH_Cape_Town_Introduction_DA A New Revision of the Declaration of Helsinki: Challenges and Limitation Urban Wiesing Cape Town, WMA conference, 5 December 2012 Institut f\u00fcr Ethik und Geschichte der Medizin Outline \u2022 Process of revision \u2022 Character of the DoH \u2022 Experiences of former revisions \u2022 General considerations and limits of a revision \u2022 Task of the […]<\/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\/DoH_Cape_Town_Introduction_DA.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3790"}],"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=3790"}]}}