{"id":3830,"date":"2017-01-20T12:26:41","date_gmt":"2017-01-20T12:26:41","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Presentation_Emanuel.pdf"},"modified":"2017-01-20T12:26:41","modified_gmt":"2017-01-20T12:26:41","slug":"presentation_emanuel-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/presentation_emanuel-2\/","title":{"rendered":"Presentation_Emanuel"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Presentation_Emanuel<\/a><\/p>\n

The Eighth Revision of the
\nDeclaration of Helsinki:
\nWhat Should be Done?
\nEzekiel J. Emanuel, M.D., Ph.D.
\nVice Provost, Global Initiatives
\nChair, Department of Medical Ethics & Health Policy
\nUniversity of Pennsylvania
\nThanks
\n\u2022 I have been a critic of the Declaration.
\n\u2022 Inviting me to address the WMA during
\nthis revision process displays a deep
\ncommitment to openness and to
\nconsidering views of critics.
\n\u2022 You are to be admired and thanked.
\nOutline
\n\u2022 Status of the Declaration
\n\u2022 Problems with the Current Version of
\nthe Declaration
\n\u2022 Recommendations for the Revised
\nDeclaration
\nStatus of the Declaration
\n\u2022 Declaration of Helsinki stands as an
\nhonored guidance document on human
\nsubjects research.
\n\u2022 In 1964, it was pre-eminent.
\n\u2022 In 2012, it is not alone but in a crowded
\nfield.
\nStatus of the Declaration
\n\u2022 A revision of the Declaration needs to
\naccomplish two things:
\n\uf0a7 Distinguish itself from other guidance
\ndocuments.
\n\uf0a7 Justify why it should be followed relative to
\nother documents.
\nStatus of Declaration
\n\u2022 Unlike other guidance documents,
\nDeclaration is short\u201435 paragraphs
\nand just over 2000 words.
\n\u2022 The aim is to keep it as a short
\ndocument\u2014 i.e. to be read in under 15
\nminutes.
\nStatus of Declaration
\n\u2022 As a short document, the Declaration
\nmust be a statement of broad principles
\nthat guide reasoning about the ethics of
\nhuman subjects research.
\n\uf0a7 A broad Constitution requiring
\nelucidation and interpretation.
\n\uf0a7 Not detailed legislation or regulation.
\nStatus of Declaration
\n\u2022 Consequently, the revision must be
\nscrutinized to remove
\n\uf0a7 Provisions that do not relate to human
\nsubjects research\u2014e.g. animal research,
\nimpact of environment, and unproven
\ninterventions.
\n\uf0a7 Detailed specifications of requirements\u2014e.g.
\nwhat should go into protocols, operations of
\nREC, who is and is not vulnerable.
\nStatus of Declaration
\n\u2022 Consequently, the revision must
\n\uf0a7 Address everyone who is engaged in the
\nresearch endeavor not just physicians. As a
\nbroad statement of principle it applies to all
\nwho participate in research.
\n\uf0a7 Adopt broad language\u2014 \u201cSeparation of
\nChurch and State\u201d \u201cEqual Protection under
\nthe Law\u201d
\nProblems with the Declaration
\n\u2022 The Declaration has grown from 11
\nprovisions to 35 provisions.
\n\u2022 The provisions never reflected a
\ncoherent view of the ethics of research.
\nIt has always been an apparent random
\ncollection of provisions rather than a
\ncoherent framework.
\nProblems with the Declaration
\n\u2022 Past revisions of the Declaration have
\nsignificantly changed the document and
\nthen changed it back.
\n\u2022 Seems as if there is no limit on the
\nchanges. If a Constitution, should aim
\nfor carefully worded document\u2014not
\none that changes with the times.
\nProblems with the Declaration
\n\u2022 At least 6 major problems:
\n\uf0a7 Confuses patient care and research
\n\uf0a7 Disorganized bordering on incoherent.
\n\uf0a7 Repetitive provisions
\n\uf0a7 Contradictory provisions.
\n\uf0a7 Contains vacuous statements
\n\uf0a7 Makes ethical judgments that appear to
\nlack justification.
\nProblems with the Declaration
\n\u2022 The introduction \u2013especially provisions
\n3, 4, and 35\u2014confuse patient care and
\nresearch.
\n\u2022 Research subjects are not patients and
\ndo not have the same ethical
\nentitlements.
\nProblems with the Declaration
\n\u2022 One consequence of the confusion is
\nnarrowing the audience for the
\nDeclaration to physicians and then
\nstating that \u201cother participants\u201d are
\nencouraged to adopt these principles.
\n\u2022 Also sanctions some types of non-
\nresearch clinical interventions.
\nProblems with the Declaration
\n\u2022 Disorganization:
\n\uf0a7 No coherent framework. Having a coherent
\nframework does not mean Declaration has
\nto adopt either a utilitarian or deontological
\nphilosophy, but it must have a view that it is
\narticulating.
\n\uf0a7 No clear rationale or logical flow informing
\nthe order of the provisions and how they
\nconnect.
\nProblems with the Declaration
\n\uf0a7 Risks-Benefits\u2013 provisions 8, 18, 20, 21, 27
\n\uf0a7 Informed consent\u201422, 24, 25, 26, 27, 28,
\n29 with three provisions\u201427-29\u2014 related to
\nincompetent patients
\n\uf0a7 Why animals or environment or advice to
\neditors?
\n\uf0a7 Why providing access to research for
\nunder-represented populations in the
\nintroduction?
\nProblems with the Declaration
\n\uf0a7 Why does registering a trial occur in the
\nmidst of provisions about risk and benefits?
\n\uf0a7 No clear specification of who has an
\nobligation for fulfilling various provisions\u2014
\neg providing post-trial access.
\nProblems with the Declaration
\n\u2022 Repetitive provisions
\n\uf0a7 Voluntary consent in provision 22 and then
\nagain in 24 and maybe 34.
\n\uf0a7 Relationship between value of research
\nand risk in provisions 21 and 31.
\nProblems with the Declaration
\n\u2022 Contradictions
\n\uf0a7 Addressed to physicians but then has
\nprovision addressed to authors, editors
\nand publishers as well as to \u201cother
\nhealthcare professional\u201d.
\nProblems with the Declaration
\n\uf0a7 Well-being takes precedence over all other
\ninterests (provision 6), but in other places
\nother interests\u2014privacy, self-
\ndetermination, benefits to communities\u2014
\nmust be considered with no ordering of the
\ninterests\u2014provision 11.
\nProblems with the Declaration
\n\u2022 Vacuous provisions
\n\uf0a7 \u201cmost interventions involve risks and
\nbenefits.\u201d
\n\uf0a7 \u201cIt is the duty of physicians who participate
\nin research to protect the life, health,
\ndignity, integrity, right to self-
\ndetermination, privacy and confidentiality
\nof personal information of research
\ninformation of research subjects.\u201d
\nProblems with the Declaration
\n\u2022 There are many provisions that seem to
\nlack ethical justification:
\n\uf0a7 Why require such extensive disclosure of
\nconflict of interest but not prohibit conflicts of
\ninterest or require they be managed?
\n\uf0a7 Why require the research with unconscious
\npatients be done only if the condition that
\nprevents consent is the one being
\nresearched\u2014unconsciousness post MI?
\nFixing the Declaration
\n\u2022 Need careful and consistent wording of
\nbroad principles\u2014avoiding elaboration
\nof details
\n\u2022 Need to address all those engaged in
\nresearch
\n\u2022 Need coherent framework
\n\u2022 Need to try to develop an enduring
\ndocument.
\nHow to Fix the Declaration
\n1) Begin with necessity for and purpose of
\nmedical research\u2014provisions 5 and 7.
\n2) Emphasize the purpose of an ethical
\ncode on human subjects research\u2014to
\nprotect subjects from exploitation and
\nharm to their interests\u2014health, well-
\nbeing, self-determination, privacy\u2014
\nCombine provision 6, with relevant
\nparts of 9 and 11.
\nHow to Fix the Declaration
\n3) State to whom the ethical principles
\napply\u2014e.g. everyone engaged in
\nresearch.
\n4) State that broad ethical principles
\nrequire interpretation and application
\nand that this will occur in individual
\ncountry research regulations. This
\nclarifies relation of Declaration to
\nindividual country laws.
\nHow to Fix the Declaration
\n5) State that research must be informed by
\nscience and conducted rigorously to
\nproduce valid and reliable data. Expand
\nprovision 12.
\n6) State that research needs to enroll
\npeople fairly\u2014include under-
\nrepresented, not target vulnerable, etc.
\nCombine provisions 5, 17, 29, maybe 35
\nHow to Fix the Declaration
\n7) Discuss the need to assess likelihood
\nand magnitude of risks and benefits in
\nquantitative manner and how to weigh
\nrisks and benefits of research. Refine
\nprovisions 8, 18, 20, 21,
\n8) Require elaboration of research
\nprotocol. Provision 14. Maybe less
\ndetail.
\nHow to Fix the Declaration
\n9) Require independent review by
\nresearch ethics committee. State when
\nexpedited review is permissible and
\nwhen comprehensive review is
\nappropriate. Revise provision 15.
\nHow to Fix the Declaration
\n10)State qualifications and obligations of
\nresearchers\u2014eg not only physicians,
\netc. Specify the requirements on
\nconflict of interest\u2014e.g. no conflict of
\ninterest or managed. Provision 16 and
\nmore. Consider shortening to
\nprinciples rather than shopping list.
\nHow to Fix the Declaration
\n11) Informed consent\u2014 divided into four
\nprovisions:
\n\uf0a7 Mentally competent
\n\uf0a7 Mentally incompetent
\n\uf0a7 Emergency research
\n\uf0a7 Human material and data.
\nSpecify what it requires in terms of information,
\nvoluntariness (avoidance of coercion, etc).
\n9) ,
\nHow to Fix the Declaration
\n12) Specify researchers\u2019 ethical
\nobligations including
\n\uf0a7 Protecting enrolled subjects of research
\n\uf0a7 Data security and maintaining
\nconfidentiality of data,
\n\uf0a7 Informing research subjects of results.
\n13) Compensation for research related
\ninjuries.
\nHow to Fix the Declaration
\n14) Registration of research\u2014might limit
\nthis to clinical research with greater
\nthan minimal risk
\n15) Public dissemination of results
\n16) Post-trial access to interventions.
\nConclusion
\n\u2022 Declaration of Helsinki has a special
\nplace as guidance document.
\n\u2022 While in 1964 the Declaration was
\nalone and preeminent, today it has
\nsignificant competition from other
\ndocuments.
\n\u2022 There is a need to clarify and specify its
\nspecial role.
\nConclusion
\n\u2022 The Declaration is to remain relevant
\nand to remain a short document, then
\n\uf0a7 It must become a broad statement of
\nprinciples much like a Constitution.
\n\uf0a7 This means it will be interpreted and
\nspecified by particular laws and
\nregulations in countries.
\n\u2022 Thus the Declaration is \u201cConstitution-
\nlike\u201d and its form should reflect this.
\nConclusion
\n\u2022 Currently Declaration does not reflect
\nthis role.
\n\u2022 Declaration has serious problems that
\nhave been compounded by revisions\u2014
\nincoherent structure, contradictions,
\nunjustified provisions, too much detail
\nto be a broad statement of principles.
\nConclusion
\n\u2022 Reformat and refocus the Declaration.
\n\u2022 Given you an initial attempt at that
\nreformulation.
\n\u2022 Careful, statement of principles is
\nneeded.<\/p>\n"},"caption":{"rendered":"

Presentation_Emanuel The Eighth Revision of the Declaration of Helsinki: What Should be Done? Ezekiel J. Emanuel, M.D., Ph.D. Vice Provost, Global Initiatives Chair, Department of Medical Ethics & Health Policy University of Pennsylvania Thanks \u2022 I have been a critic of the Declaration. \u2022 Inviting me to address the WMA during this revision process displays […]<\/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\/Presentation_Emanuel.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3830"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3830"}]}}