{"id":3784,"date":"2017-01-20T12:25:26","date_gmt":"2017-01-20T12:25:26","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/DoH_Cape_Town_2012-Macklin.pdf"},"modified":"2017-01-20T12:25:26","modified_gmt":"2017-01-20T12:25:26","slug":"doh_cape_town_2012-macklin-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/doh_cape_town_2012-macklin-2\/","title":{"rendered":"DoH_Cape_Town_2012-Macklin"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

DoH_Cape_Town_2012-Macklin<\/a><\/p>\n

Science at the heart of medicine
\nRuth Macklin, PhD
\nPost-trial access to beneficial
\nproducts of research
\nAn ethical obligation
\n| 112\/10\/2012
\nTwo underlying premises: Purpose of research
\n\u2022 The purpose of biomedical research is to investigate
\n> Safe, effective diagnostic and therapeutic methods to
\nbenefit future patients
\n> Safe, effective preventive methods to benefit at-risk
\npopulations
\nScience at the heart of medicine
\n| 212\/10\/2012
\nTwo underlying premises: justice in research
\n\u2022 The principle of justice (as stated in the Belmont Report)
\n> \u2026whenever research supported by public funds leads to
\nthe development of therapeutic devices and procedures,
\njustice demands both that these not provide advantages
\nonly to those who can afford them and that such research
\nshould not unduly involve persons from groups unlikely to
\nbe among the beneficiaries of subsequent applications of
\nthe research.
\n\u2022 Two necessary modifications
\n\u2013 Not limited to support by public funds
\n\u2013 Not limited to therapeutic methods
\nScience at the heart of medicine
\n| 312\/10\/2012
\nRights-based approach
\n\u2022 International Covenant on Economic, Social, and
\nCultural Rights
\n> 1. The States Parties to the present Covenant recognize
\nthe right of everyone
\n\u2022 (b) To enjoy the benefits of scientific progress and its
\napplications
\n> \u201cStates Parties\u201d refers to governments that have signed
\nand ratified the Convention
\n> Human rights approach also recognizes a role for
\nnon-state actors
\nScience at the heart of medicine
\n| 412\/10\/2012
\nThe Declaration of Helsinki
\n\u2022 In versions before 2000, the DoH made no explicit
\nmention of post-trial benefits
\n\u2022 In the DoH 2000-2002, two paragraphs addressed post-
\ntrial benefits
\n> Statement of benefits to the population in Para. 19
\n\u2022 \u201cMedical research is only justified if there is a
\nreasonable likelihood that the populations in which the
\nresearch is carried out stand to benefit from the results
\nof the research\u201d
\n\u2013 Sufficiently vague to allow a wide range of possible
\ninterpretations
\nScience at the heart of medicine
\n| 512\/10\/2012
\nDoH 2000-2002
\n\u2022 Explicit statement of benefits to participants in Para. 30
\n> \u201cAt the conclusion of the study, every patient entered into
\nthe study should be assured of access to the best proven
\nprophylactic, diagnostic and therapeutic methods
\nidentified by the study.\u201d
\n\u2022 Unrealistic?
\n\u2022 Impossible to implement?
\n\u2022 Would deter sponsors from initiating needed research?
\n\u2022 Who should \u201cassure\u201d access?
\nScience at the heart of medicine
\n| 612\/10\/2012
\n2004 Note of Clarification
\n\u2022 The WMA hereby affirms its position that it is necessary
\nduring the study planning process to identify post-trial
\naccess by study participants to therapeutic, diagnostic,
\nand therapeutic procedures identified as beneficial in
\nthe study or access to other appropriate care.
\n\u2022 Post-trial arrangements or other care must be described
\nin the study protocol so the ethical review committee
\nmay consider such arrangements during its review.
\nScience at the heart of medicine
\n| 712\/10\/2012
\n2008 Para. 33: Weakening the obligation
\n\u2022 At the conclusion of the study, patients entered into the
\nstudy are entitled to be informed about the outcome of
\nthe study and to share any benefits that result from it,
\nfor example, access to interventions identified as
\nbeneficial in the study or to other appropriate care or
\nbenefits.
\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?
\nScience at the heart of medicine
\n| 812\/10\/2012
\nProposal for strengthening the paragraph
\n\u2022 Version (1) of new paragraph (preferred version)
\n> \u201cIn advance of a clinical trial, sponsors, researchers, and
\nhost-country governments should make provisions for
\npost-trial access for all participants who still need an
\nintervention identified as beneficial in the study. All study
\nparticipants should be informed about the outcome of the
\nstudy.\u201d
\n\u2022 Names the responsible agents
\n\u2022 Includes host governments as agents
\n\u2013 Improvement over CIOMS guideline
\n\u2022 Reverts to essence of 2002 version
\nScience at the heart of medicine
\n| 912\/10\/2012
\nProposal (2) for strengthening
\n\u2022 Sponsors, researchers, and host-country governments
\nshould ensure that all participants who still need an
\nintervention identified as beneficial in a clinical trial have
\naccess to that intervention at the conclusion of the
\nstudy. All study participants should be informed about
\nthe outcome of the study.
\n> Names the responsible agents
\n> Less specific than proposal 1
\n> Does not mention when provision should be arranged
\nScience at the heart of medicine
\n| 1012\/10\/2012
\nProposal (3) for strengthening
\n\u2022 At the conclusion of a clinical trial, participants in the
\nexperimental and control arms who still need an
\nintervention identified as beneficial in the study are
\nentitled to have access to that method. All study
\nparticipants should be informed about the outcome of
\nthe study.
\n> Weakest of three proposals
\n> Does not identify responsible agents
\n> Specifies the control arm as potential beneficial method
\n\u2022 Does not require that access to the
\nexperimental product be provided
\nScience at the heart of medicine
\n| 1112\/10\/2012
\nConclusions
\n\u2022 Ensuring post-trial access is a shared responsibility
\n> Burden does not fall on sponsors alone
\n> Burden does not fall solely on governments in host
\ncountries
\n> \u2018Ensuring access\u2019 does not simply mean \u2018paying for
\nsuccessful products of research\u2019
\n\u2022 Creative means are needed to develop cooperation
\nbetween researchers and sponsors, on one hand, and
\nother sources of funds
\n\u2013 Global Fund
\n\u2013 PEPFAR
\n\u2013 Gates Foundation
\nScience at the heart of medicine<\/p>\n"},"caption":{"rendered":"

DoH_Cape_Town_2012-Macklin Science at the heart of medicine Ruth Macklin, PhD Post-trial access to beneficial products of research An ethical obligation | 112\/10\/2012 Two underlying premises: Purpose of research \u2022 The purpose of biomedical research is to investigate > Safe, effective diagnostic and therapeutic methods to benefit future patients > Safe, effective preventive methods to benefit […]<\/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_2012-Macklin.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3784"}],"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=3784"}]}}