{"id":3799,"date":"2017-01-20T12:25:52","date_gmt":"2017-01-20T12:25:52","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/DoH_Revision_Sprumont.pdf"},"modified":"2017-01-20T12:25:52","modified_gmt":"2017-01-20T12:25:52","slug":"doh_revision_sprumont-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/doh_revision_sprumont-2\/","title":{"rendered":"DoH_Revision_Sprumont"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

DoH_Revision_Sprumont<\/a><\/p>\n

TRREE for Africa
\nhttp:\/\/www.trree.org\/
\nRevising the Declaration of Helsinki
\nPoints to Consider
\nProfessor Dominique Sprumont
\nInstitute of Health Law, University of Neuch\u00e2tel (Switzerland)
\nTRREE \u2013 FMH
\nWMA Conference
\nCape Town, South Africa
\nDecember 6, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\nOverview
\n\uf06c TRREE \u2013 FMH position statements
\n\uf06c Clarification of the relation between the DoH and the law
\n\u2013 Legal order \u2013 ethical reasoning
\n\u2013 Normative density
\n\u2013 Nature of the DoH
\n\uf06c Why is threre a mix of principles and detailed rules in the
\nDoH and what to do about it
\n\uf06c Conclusions
\nWMA Conference, Cape Town, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\nTRREE \u2013 FMH position statements
\n\uf06c If there is no urgency for the revision of a law, it is
\nurgent not to revise it (FMH \u2013 TRREE)
\n\uf06c If specific issues deserve more detailed guidances,
\nthey should be convered in a separate set of
\ndocuments (FMH \u2013 TRREE)
\n\uf06c The placebo rule must be maintained (and even
\nstrenghtened) (FMH \u2013 TRREE)
\n\uf06c The consultation process should be open to non-
\nEnglish speaking stakeholders, with special
\nattention to interested parties in developing world
\n(TRREE \u2013 NHREC Cameroon \u2013 FCRM Congo \u2013 Odile Ouwe
\nMissi Oukem, Niger \u2013 Dr. Morenike Ukpong, Nigeria \u2013 etc.)
\nWMA Conference, Cape Town, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\n\uf06c The law is not limited to the legislation
\nand case law
\n\uf06c Research ethics is not limited to code of
\nethics such as the DoH or professional
\nstandards such as the ICH \u2013 GCP
\nThe value of the DoH is not based
\nprimarily on the fact that it was adopted
\nby the WMA, but on the fact that it
\nreflects the applicable ethical principles in
\nthe field.
\nClarification of the relation between the
\nDoH and the law: Preamble
\nWMA Conference, Cape Town, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\nParallelism between the legal order
\nand ethical reasoning (a theoretical view)
\n5 WMA Conference, Cape Town, 2012
\nConstitution (Human rights)
\nLaw (Statutes\/Case law)
\nRegulatory implementation
\nAdministrative practices
\nProfessional Standards
\nEthical rules
\nTechnical rules, etc.
\n\u00abEthical reasoning is, and ought to be, hierarchical and deductive\u00bb
\n(Robert Levine on the Belmont Report)
\nPrinciples
\nGeneral rules
\nDetailed rules
\n&
\nIssue specific
\nrules
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\n\uf06c Every rule or norm is characterized by its
\nnormative density. This includes two
\nelements:
\n\u2013 Specificity
\n\u2013 Clarity
\n\uf06c The more specific and the more detailed
\nis a rule, the higher is its normative
\ndensity
\nNormative density (rule of law)
\nWMA Conference, Cape Town, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\nThe pyramid of norms (a pragmatical view)
\n7 WMA Conference, Cape Town, 2012
\nAt the light of the concept of normative
\ndensity, the hierarchy of norms is reversed.
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\n\uf06c The DoH is focusing on principles. It may
\nbe considered as the Constitution of
\nresearch ethics.
\n\uf06c The normative density of the DoH is low
\n\uf06c It requires more detailed rules to be
\nimplemented
\n\uf06c In principle, those rules of implementation
\ndo not belong to the DoH as they are not
\nprinciples\u2026
\nNature of the DoH
\nWMA Conference, Cape Town, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\n\uf06c The DoH is not merely an academic
\ndocument. It is the product of history,
\nlobbying from various stakeholders, of the
\ndevelopment strategy of the WMA, etc.
\n\uf06c Its present structure and content is the
\nexpression of a careful consensus within
\nthe medical profession and also the
\nresearch community, the RECs and
\ncompetent authorities worldwide
\nWhy is there a mix of principles and
\nspecific rules in the DoH?
\nWMA Conference, Cape Town, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\n\uf06c Rules exist because they are violated
\n\uf06c The violation of a legal or ethical rule
\npreceeds its adoption
\n\u2013 The placebo rule hurts the interests of
\nthose wanting research to go faster but
\nit contradicts the Council of Europe and
\nEU principle of the primacy of the
\ninterests of the participants v. the sole
\ninterests of science or society
\nWhy rules exist?
\nWMA Conference, Cape Town, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\n\uf06c The WMA should only revise the provisions that
\ndo create problems.
\n\uf06c The fact that a principle requires more detailed
\ninstruction to be implemented does not mean the
\nprinciple should be revised.
\n\uf06c For emerging issues or issues requiring more
\ndetailed rules, the WMA should adopt guidance
\ndocuments separated from the DoH which
\nshould be implemented in the light of the DoH (cf.
\nCouncil of Europe Convention of Human Rights
\nand Biomedicine and its additional protocols).
\nConclusions
\nWMA Conference, Cape Town, 2012
\nTRREE for Africa
\nhttp:\/\/www.trree.org\/
\nThank you for your attention
\nAnd see you soon on
\nTRREE\u2026
\nThank you
\nfor your
\nattention
\nSee you soon
\non TRREE
\nwww.trree.org<\/p>\n"},"caption":{"rendered":"

DoH_Revision_Sprumont TRREE for Africa http:\/\/www.trree.org\/ Revising the Declaration of Helsinki Points to Consider Professor Dominique Sprumont Institute of Health Law, University of Neuch\u00e2tel (Switzerland) TRREE \u2013 FMH WMA Conference Cape Town, South Africa December 6, 2012 TRREE for Africa http:\/\/www.trree.org\/ Overview \uf06c TRREE \u2013 FMH position statements \uf06c Clarification of the relation between the DoH […]<\/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_Revision_Sprumont.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3799"}],"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=3799"}]}}