{"id":3744,"date":"2017-01-20T11:53:26","date_gmt":"2017-01-20T11:53:26","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Macklin.pdf"},"modified":"2017-01-20T11:53:26","modified_gmt":"2017-01-20T11:53:26","slug":"macklin-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/macklin-2\/","title":{"rendered":"Macklin"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Macklin<\/a><\/p>\n

Science at the heart of medicine
\nRuth Macklin, PhD
\nThe Future of the Declaration of
\nHelsinki
\nMaintaining a leadership role in global health research
\nethics
\n| 17\/3\/2012
\nWhat will the future be?
\nSciencat the heart of medicine
\n\u2022 No crystal ball to guide predictions
\n\u2022 Ethics deals with what should be, not what will be the
\ncase
\n| 27\/3\/2012
\nWhat should the DoH be?
\n\u2022 DoH has stood the test of time since its first skeletal
\nversion in 1964 through many revisions and
\namendments in almost 50 years
\n\u2022 DoH should remain relevant to changing
\nsocial circumstances and scientific advances
\n\u2022 DoH should be leading the way toward global justice in
\nhealth research
\nSciencat the heart of medicine
\n| 37\/3\/2012
\nDoH 2008 and \u201cstandards\u201d
\n\u2022 \u201cMedical research is subject to ethical
\nstandards that promote respect for all human
\nsubjects and protect their health and rights\u201d
\n(Paragraph 9)
\n> Noble statement but does not give specific guidance
\n> If the statement were amended to read equal respect
\nfor all human subjects, it could be interpreted to
\nendorse a single global ethical standard
\nScienceat the heart of medicine
\n| 47\/3\/2012
\nDoH 2008 and \u201cstandards\u201d
\n\u2022 Physicians should consider the ethical, legal and
\nregulatory norms and standards for research
\ninvolving human subjects in their own countries as
\nwell as applicable international norms and
\nstandards (Paragraph 10)
\n> What follows from exhorting physicians to \u201cconsider\u201d the
\nnorms and standards?
\n\u2022 Anyone may \u201cconsider,\u201d then reject norms
\n> Insufficient clarity to determine whether the Declaration calls for
\na single international standard or can permit
\n\u201cdouble\u201d standards
\nSciencat the heart of medicine
\n| 57\/3\/2012
\n| 67\/3\/2012
\nInternational standard: CIOMS guideline
\n\u2022 In externally sponsored research \u201c\u2026the ethical
\nstandards applied should be no less stringent than they
\nwould be for research carried out in [the sponsoring]
\ncountry\u201d
\n\u2013 Guideline 3, Ethical Review of Externally Sponsored
\nResearch
\n> Still not enough clarity on what constitutes \u201cstandards\u201d
\n> But requires standards in developing countries to be
\nequal or equivalent to those in industrialized countries
\nSciencat the heart of medicine
\n| 77\/3\/2012
\nRecent revisions of the DoH
\n\u2022 Weakened in some respects
\n\u2022 Strengthened in other respects
\nSciencat the heart of medicine
\n| 87\/3\/2012
\n2000-2002 statement on post-trial obligations
\n\u2022 At the conclusion of the study, every patient
\nentered into the study should be assured of
\naccess to the best proven prophylactic,
\ndiagnostic and therapeutic methods
\nidentified by the study.
\nSciencat the heart of medicine
\n| 97\/3\/2012
\nWeakening the DoH: 2008
\n\u2022 At the conclusion of the study, patients entered into
\nthe study are entitled to be informed about the
\noutcome of the study and to share any benefits that
\nresult from it, for example, access to interventions
\nidentified as beneficial in the study or to other
\nappropriate care or benefits (Para. 33)
\n> No clear obligation to provide beneficial interventions
\n> What other care is appropriate?
\n> What other benefits are appropriate?
\n> Who is under an obligation to share the benefits?
\n> Who should decide?
\nSciencat the heart of medicine
\n| 107\/3\/2012
\n2002 paragraph on control groups
\n\u2022 A placebo-controlled trial may be ethically acceptable,
\neven if proven therapy is available, under the following
\ncircumstances:
\n> Where for compelling and scientifically sound
\nmethodological reasons its use is necessary to determine
\nthe efficacy or safety of a prophylactic, diagnostic or
\ntherapeutic method; OR
\n> Where a prophylactic, diagnostic or therapeutic method is
\nbeing investigated for a minor condition and the patients
\nwho receive placebo will not be subject to any additional
\nrisk of serious or irreversible harm.
\nSciencat the heart of medicine
\n| 117\/3\/2012
\nStrengthening the DoH: 2008
\n\u2022 The benefits, risks, burdens and effectiveness of a new
\nintervention must be tested against those of the best
\ncurrent proven intervention, except in the following
\ncircumstances:
\n> The use of placebo, or no treatment, is acceptable in studies
\nwhere no current proven intervention exists; or
\n> Where for compelling and scientifically sound methodological
\nreasons the use of placebo is necessary to determine the
\nefficacy or safety of an intervention and the patients who
\nreceive placebo or no treatment will not be subject to any risk of
\nserious or irreversible harm. Extreme care must
\nbe taken to avoid abuse of this option
\nSciencat the heart of medicine
\n| 127\/3\/2012
\nThe way forward
\n\u2022 What\u2019s missing from the current DoH?
\n> A paragraph addressing women in biomedical research
\n\u2022 Other leading international ethical guidance address
\nwomen
\n\u2013 CIOMS International Ethical Guidelines
\n\u2013 UNAIDS\/WHO Guidance Document
\n> Community participation
\n\u2022 Community engagement before, during, and after
\nresearch concludes
\n\u2013 UNAIDS\/WHO Guidance Document
\nSciencat the heart of medicine
\n| 137\/3\/2012
\nWomen in research
\n\u2022 Long history of excluding women from biomedical
\nresearch
\n\u2022 Current restrictions still exclude pregnant women from
\nmost research not directed at pregnancy
\n\u2022 Potentially relevant paragraph in DoH
\n> Paragraph 5: Medical progress is based on research that
\nultimately must include studies involving human subjects.
\nPopulations that are under-represented in medical
\nresearch should be provided appropriate access to
\nparticipation in research
\nSciencat the heart of medicine
\n| 147\/3\/2012
\nExample: CIOMS Guidelines 16 & 17
\n\u2022 Guideline 16 Women as research subjects
\n> Investigators, sponsors or ethical review committees
\nshould not exclude women of reproductive age from
\nbiomedical research. The potential for becoming pregnant
\nduring a study should not, in itself, be used as a reason
\nfor precluding or limiting participation\u2026.
\n\u2022 Guideline 17 Pregnant women
\n> Pregnant women should be presumed to be eligible for
\nparticipation in biomedical research\u2026.
\nSciencat the heart of medicine
\n| 157\/3\/2012
\nCommunity engagement
\n\u2022 Current paragraph addressing communities
\n> 18. Every medical research study involving human
\nsubjects must be preceded by careful assessment of
\npredictable risks and burdens to the individuals and
\ncommunities involved in the research in comparison with
\nforeseeable benefits to them and to other individuals or
\ncommunities affected by the condition under investigation.
\n\u2022 What more is needed?
\nSciencat the heart of medicine
\n| 167\/3\/2012
\nExample: UNAIDS\/WHO Guidance document
\n\u2022 Community Participation: Guidance Point 2
\n> To ensure the ethical and scientific quality and outcome of
\nproposed research, its relevance to the affected
\ncommunity, and its acceptance by the affected
\ncommunity, researchers and trial sponsors should consult
\ncommunities through a transparent and meaningful
\nparticipatory process which involves them in an early and
\nsustained manner in the design, development,
\nimplementation, monitoring, and distribution of results of
\nbiomedical HIV prevention trials
\n\u2022 This provision need not apply only to HIV
\nprevention trials
\nSciencat the heart of medicine
\n| 177\/3\/2012
\nConclusion
\n\u2022 The US FDA abandoned adherence to the DoH for
\nforeign studies
\n> The rest of the world still looks to the DoH as
\nthe leading ethical guidance for research
\n\u2022 The World Health Organization\u2019s Ethics Review
\nCommittee is guided in its work by the Declaration of
\nHelsinki
\n\u2022 To remain timely and relevant, the Declaration of
\nHelsinki should remain at the forefront of international
\nethical guidance for research involving
\nhuman beings
\nSciencat the heart of medicine
\n| 187\/3\/2012
\nGlobal Justice in Health Research
\nSciencat the heart of medicine<\/p>\n"},"caption":{"rendered":"

Macklin Science at the heart of medicine Ruth Macklin, PhD The Future of the Declaration of Helsinki Maintaining a leadership role in global health research ethics | 17\/3\/2012 What will the future be? Sciencat the heart of medicine \u2022 No crystal ball to guide predictions \u2022 Ethics deals with what should be, not what will […]<\/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\/Macklin.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3744"}],"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=3744"}]}}