{"id":23597,"date":"2024-10-23T14:42:24","date_gmt":"2024-10-23T13:42:24","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2024\/10\/DoH-for-GA-Keynote-Oct-2024-Helsinki-v1.pdf"},"modified":"2024-10-23T14:42:25","modified_gmt":"2024-10-23T13:42:25","slug":"doh-for-ga-keynote-oct-2024-helsinki-v1","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/doh-for-ga-keynote-oct-2024-helsinki-v1\/","title":{"rendered":"DoH for GA Keynote Oct 2024 Helsinki v1"},"author":17,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"<p class=\"attachment\"><a href='https:\/\/www.wma.net\/wp-content\/uploads\/2024\/10\/DoH-for-GA-Keynote-Oct-2024-Helsinki-v1.pdf'>DoH for GA Keynote Oct 2024 Helsinki v1<\/a><\/p>\n<p>\u00a9 2024 American Medical Association. All rights reserved.<br \/>\nThe Declaration of Helsinki<br \/>\nProposed Revisions 2024<br \/>\nWMA General Assembly<br \/>\nHelsinki, Finland<br \/>\nOctober 2024<br \/>\nJack Resneck, Jr., MD<br \/>\nFormer President, American Medical Association<br \/>\nChair of Finance and Planning, World Medical Association<br \/>\nChair, WMA Declaration of Helsinki Workgroup<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n2<br \/>\nThe Declaration of Helsinki<br \/>\nThe First Set of International Principles Guiding Medical Research involving<br \/>\nHuman Participants<br \/>\n\u2026and A Prominent Pillar in the WMA\u2019s Seminal Ethical Documents<br \/>\n\u2022 Declaration of Geneva (1948)<br \/>\n\u2022 Pledge outlining basic ethical principles for physicians<br \/>\n\u2022 The International Code of Medical Ethics (ICoME) (1948)<br \/>\n\u2022 Ethical principles defining professional duties of physicians<br \/>\n\u2022 Declaration of Helsinki (DOH) (1964, 60 years ago)<br \/>\n\u2022 Ethical principles for medical research involving human subjects\/participants<br \/>\n\u2022 Declaration of Tokyo (1975)<br \/>\n\u2022 Guidelines for Physicians Concerning Torture and other Cruel, Inhuman or Degrading<br \/>\nTreatment or Punishment in Relation to Detention and Imprisonment<br \/>\n\u2022 Declaration of Lisbon (1982)<br \/>\n\u2022 Rights of the Patient<br \/>\n\u2022 Declaration of Taipei (2016)<br \/>\n\u2022 Ethical considerations regarding health databases and biobanks<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n3<br \/>\n\u2022 World Health Organization (WHO) Guidance for Best Practices<br \/>\n\u2022 Council for International Organizations of Medical Research (CIOMS)<br \/>\n\u2022 International Conference for Harmonization (ICH) Good Clinical Practice<br \/>\n(GCP) Guideline<br \/>\n\u2022 Regulation 536\/2014 of the European Parliament on Clinical Trials<br \/>\n\u2022 UNESCO Universal Declaration on Bioethics and Human Rights<br \/>\n\u2022 US Belmont Report of 1979<br \/>\n\u2022 US Subpart A of 45 CFR Part 46 (Common Rule): no specific reference<br \/>\n\u2022 Codified in many national laws \/ regulations<br \/>\nThe DoH in Context<br \/>\nAn Important Set of High-Level Principles Referenced by many<br \/>\nInternational Bodies and by More Granular Guidelines<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\nThe DoH as a Living Document<br \/>\n1954 \u2022 Resolution on Human Experimentation endorsed by WMA<br \/>\n1961 \u2022 Draft Code on Human Experimentation by WMA Cmte on Med Ethics published in BMJ<br \/>\n1964 \u2022 Declaration of Helsinki Adopted<br \/>\n1975 \u2022Tokyo: Ethics committees, Research protocols, Environment, Animal use<br \/>\n1983 \u2022Venice<br \/>\n1989 \u2022Hong Kong<br \/>\n1996 \u2022Somerset West: Limited placebos to when no proven therapy exists<br \/>\n2000 \u2022Edinburgh: Test against best current, Post-trial Access, Vulnerable Populations, Monitoring<br \/>\n2002 \u2022Washington: Clarification on Placebos (compelling methodological reasons, minor conditions)<br \/>\n2004 \u2022Tokyo: Clarification on Post-Trial Access (considered, not required)<br \/>\n2008 \u2022Seoul: Trial registration, dissemination of results<br \/>\n2013 \u2022Fortaleza: New structure, stronger protection for vulnerable groups, compensation for harm<br \/>\n2024 \u2022Helsinki: (in progress)<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\nWhy Revise?<br \/>\n\u2022 Some argue ethical principles should be timeless<br \/>\n\u2022 Sustaining relevance requires the Declaration evolve as<br \/>\n\u2022 Evidence of new risks\/harms comes to light<br \/>\n\u2022 Research enterprise presents new challenges<br \/>\n\u2022 Society Advances<br \/>\n\u2022 Stresses and tensions are inherent as ethical principles<br \/>\nsometimes collide and resonate differently across<br \/>\ncultures\/geographies<br \/>\n\u2022 Openly wrestling with them is essential<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n6<br \/>\nThe 2024 Revisions<br \/>\nA 30-month, Thorough, Inclusive Process<br \/>\n\u2022 WMA Council established Working Group in April 2022<br \/>\n\u2022 19 Countries and Associate WMA members represented, plus many invited<br \/>\nbioethics expert advisors<br \/>\n\u2022 Smaller Drafting Group also engaged<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n7<br \/>\n\u2022 Associate Members: Syed<br \/>\nHussain, Natalia Solenkova,<br \/>\nAnthea Mowat<br \/>\n\u2022 Bangladesh: Jamal Chowdhury<br \/>\n\u2022 Belgium: Vincent Lamy<br \/>\n\u2022 Brazil: Carlos Serrano<br \/>\n\u2022 China: Yuguang Huang, Yali<br \/>\nCong, Haihong Zhang<br \/>\n\u2022 Denmark: Camilla Rathcke,<br \/>\nJeppe Berggreen Hoj, Katrine<br \/>\nKrause-Jensen<br \/>\n\u2022 Finland: Janne Aaltonen, Mervi<br \/>\nKattelus<br \/>\n\u2022 Germany: Ramin Parsa-Parsi<br \/>\n\u2022 Israel: Leah Wapner, Malke<br \/>\nBorrow<br \/>\n\u2022 Japan: Hidehito Imamura<br \/>\n\u2022 Malaysia: Ashok Philip, Azizan<br \/>\nbinti Abdul Aziz<br \/>\n\u2022 Netherlands: Rene Heman,<br \/>\nKrista Tromp, Antina De Jong<br \/>\n\u2022 Nigeria: Joan Emien Enabulele<br \/>\n\u2022 South Africa: Mvuyisi Mzukwa<br \/>\n\u2022 Taiwan: Brian Chang, Daniel Tsai<br \/>\n\u2022 UK: Dominic Norcliffe-Brown,<br \/>\nJulian Sheather<br \/>\n\u2022 Vatican: Pablo Requena<br \/>\n\u2022 Uruguay: Alarico Rodriguez<br \/>\n\u2022 USA: Jack Resneck<br \/>\n\u2022 Bioethics Advisors: Dominique<br \/>\nSprumont, Hans Van Delden,<br \/>\nUrban Weising, Amber Comer,<br \/>\nElliott Crigger, Jake Young<br \/>\n\u2022 WMA Staff: Otmar Kloiber,<br \/>\nSunny Park, Julia Tainijoki<br \/>\n\u2022 AMA Staff: Beth LaRocca,<br \/>\nHannah Longstaff<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n8<br \/>\nThe 2024 Revisions<br \/>\nA 30-month, Thorough, Inclusive Process<br \/>\n\u2022 WMA Council established Working Group in April 2022<br \/>\n\u2022 19 Countries and Associate WMA members represented, plus many invited<br \/>\nbioethics expert advisors<br \/>\n\u2022 Smaller Drafting Group also engaged<br \/>\n\u2022 Regional and Topical Meetings Across the Globe to Gather Feedback<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n9<br \/>\nRegional and Topical Meetings<br \/>\n\u2022 Tel Aviv: Implications of Big Data, Machine Learning, AI<br \/>\n\u2022 S\u00e3o Paulo: Ethical Considerations on Use of Placebo<br \/>\n\u2022 Copenhagen: Emerging Trial Designs<br \/>\n\u2022 Tokyo: Research During Public Health Emergencies \/<br \/>\nPandemics<br \/>\n\u2022 Vatican: Research in Resource-Poor Settings, Global Justice<br \/>\n\u2022 Johannesburg: Community Inclusiveness, Post-Trial Access,<br \/>\nVulnerability<br \/>\n\u2022 Munich: Specific and Particularly Vulnerable Groups<br \/>\n\u2022 Washington, DC: Final Consolidation<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n10<br \/>\nThe 2024 Revisions<br \/>\nA 30-month, Thorough, Inclusive Process<br \/>\n\u2022 WMA Council established Working Group in April 2022<br \/>\n\u2022 19 Countries represented (including Associate WMA members), plus many<br \/>\ninvited bioethics expert advisors<br \/>\n\u2022 Smaller Drafting Group also engaged<br \/>\n\u2022 Regional and Topical Meetings Across the Globe<br \/>\nto Gather Feedback<br \/>\n\u2022 Public Comment Periods<br \/>\n\u2022 Phase 1 Occurred last winter<br \/>\n\u2022 Phase 2 Occurred earlier this summer<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\nKey Revisions Proposed for 2024<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n12<br \/>\nParticipant and Community Engagement<br \/>\n\u2022 Replaced subjects with participants throughout the DoH out of respect<br \/>\nfor the rights, agency, and importance of those individuals<br \/>\n\u2022 Recognizes that participants may include patients and healthy<br \/>\nvolunteers<br \/>\n\u2022 New language in \u00b66 demands \u201cmeaningful engagement with potential<br \/>\nand enrolled participants and their communities \u2026 before, during, and<br \/>\nfollowing medical research\u201d in recognition of study participants as<br \/>\npartners in co-creation.<br \/>\n\u2022 Specifically sharing priorities\/values, participating in study<br \/>\ndesign\/implementation, engaging in understanding\/disseminating results<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n13<br \/>\nWMA Urging DoH to be Broadly Upheld<br \/>\n\u2022 New language in \u00b62 states that \u201cthese principles should be upheld by all<br \/>\nindividuals, teams, and organizations involved in medical research, as<br \/>\n[they] are fundamental to respect for and protection of all research<br \/>\nparticipants\u2026.\u201d<br \/>\n\u2022 Language in many paragraphs now addresses \u201cphysicians and other<br \/>\nresearchers\u201d<br \/>\n\u2022 While some question the WMA\u2019s authority to address nonphysicians, the<br \/>\nDeclaration is more than solely an exercise in self-regulation<br \/>\n\u2022 The medical profession\u2019s morals and broader ethics include a duty to ensure<br \/>\nrespect for the health, dignity, integrity, autonomy, and privacy of research<br \/>\nparticipants, no matter who is performing the research<br \/>\n\u2022 New \u00b68: Essential to uphold DoH principles during public health<br \/>\nemergencies<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n14<br \/>\nDistributive and Global Justice<br \/>\n\u2022 New language in \u00b66 calls on researchers to \u201ccarefully consider how the<br \/>\nbenefits, risks, and burdens of research are distributed.\u201d<br \/>\n\u2022 Also recognizes that medical research enterprise does not have the capacity<br \/>\nor bear sole responsibility to resolve all structural inequities<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n15<br \/>\nPurposes of Medical Research<br \/>\n\u2022 Contemplated adding \u201csocial value\u201d to revised \u00b67<br \/>\n\u2022 but there was public concern with vagueness and different interpretations<br \/>\nacross cultures<br \/>\n\u2022 Instead added that new knowledge generation, in addition to<br \/>\nfurthering understanding of diseases and improving interventions,<br \/>\nshould ultimately \u201cadvance individual and public health.\u201d<br \/>\n\u2022 Retained existing language about those purposes never taking<br \/>\n\u201cprecedence over the rights and interests of individual research<br \/>\nparticipants\u201d<br \/>\n\u2022 Does not negate the fact that participants, with freely given informed<br \/>\nconsent, often make benevolent choices to take risks for the good of<br \/>\nothers with minimal expectation of personal benefit<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n16<br \/>\nVulnerability<br \/>\n\u2022 Rewritten \u00b619 Recognizes that:<br \/>\n\u2022 individuals, groups, and communities may be in situations of vulnerability due to<br \/>\nfactors that may be fixed or contextual and dynamic.<br \/>\n\u2022 their default exclusion from medical research has resulted in enormous gaps in<br \/>\nmedical knowledge and can potentially perpetuate or exacerbate disparities.<br \/>\n\u2022 Requires that \u201cthe harms of exclusion must be considered and weighed<br \/>\nagainst the harms of inclusion\u201d<br \/>\n\u2022 Calls for fair and responsible inclusion with specially considered support<br \/>\nand protections<br \/>\n\u2022 Rewritten \u00b620 retains additional protections for some particularly vulnerable<br \/>\ngroups.<br \/>\n\u2022 Responsive to their health needs\/priorities<br \/>\n\u2022 Stand to benefit<br \/>\n\u2022 Cannot be carried out in non-vulnerable (unless exclusion perpetuates or<br \/>\nexacerbates disparities)<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n17<br \/>\nScientific Requirements<br \/>\n\u2022 \u00b621 newly calls out importance of scientific rigor to avoid research<br \/>\nwaste<br \/>\n\u2022 New language in \u00b612: \u201cScientific integrity is essential in the conduct of<br \/>\nmedical research involving human participants. Involved individuals,<br \/>\nteams, and organizations must never engage in research misconduct.\u201d<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n18<br \/>\nResearch Ethics Committees<br \/>\n\u2022 \u00b623 specifies need for ethics committees to have<br \/>\n\u2022 Adequate \u201cindependence and authority to resist undue influence\u201d<br \/>\n\u2022 \u201cSufficient resources to fulfill its duties\u201d<br \/>\n\u2022 \u201cAdequate education, training, qualifications, and diversity\u201d among its<br \/>\nmembers and staff<br \/>\n\u2022 At least one public member and \u201cfamiliarity with local circumstances and<br \/>\ncontext\u201d<br \/>\n\u2022 Authority to \u201cwithdraw approval and suspend ongoing research\u201d<br \/>\n\u2022 Inclusion of ethics review in both sponsoring and host countries when<br \/>\ncollaborative international research is performed<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n19<br \/>\nGrowing Use and Risks of Personal<br \/>\nData Stored After Trials<br \/>\n\u2022 Complete rewrite of \u00b632<br \/>\n\u2022 Calls for free and informed consent for the \u201ccollection, processing, storage,<br \/>\nand foreseeable secondary use of biological material and identifiable or re-<br \/>\nidentifiable data,\u201d and for ethics committee approval and monitoring of such<br \/>\ndatabases and biobanks.<br \/>\n\u2022 Cross-references the WMA DoT\u2019s more detailed guidelines on rights of<br \/>\nindividuals and principles of governance for health databases and biobanks<br \/>\n\u2022 Pertains to data collected \u201cfrom research participants for multiple and indefinite<br \/>\nuses\u201d beyond the clinical care of individual patients\u201d<br \/>\n\u2022 Acknowledges that consent for unanticipated secondary research on<br \/>\nstored data is sometimes impossible or impracticable to obtain \u2013 but requires<br \/>\nethics committee consideration and approval of such unforeseen uses.<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n20<br \/>\nUse of Placebo<br \/>\n\u2022 Maintenance of balanced language in \u00b633 limiting use of placebo or<br \/>\nno intervention, or control groups using anything other than best<br \/>\nproven intervention(s).<br \/>\n\u2022 Amendment was considered broadening use of placebo to when no<br \/>\n\u201cproven safe and effective intervention exists\u201d<br \/>\n\u2022 Ultimately rejected after extensive consultations<br \/>\n\u2022 S\u00e3o Paolo regional DoH meeting with participants from &gt;10 countries in<br \/>\nWMA\u2019s Latin American region, and leaders from CONFEMEL and the Pan-<br \/>\nAmerican Health Organization<br \/>\n\u2022 Feedback from CONFEMEL<br \/>\n\u2022 Focused session on DoH revisions at the World Conference in Bioethics in<br \/>\nBras\u00edlia<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n21<br \/>\nOther Revised Principles<br \/>\n\u2022 Strengthening post-trial provisions in \u00b634<br \/>\n\u2022 Must be arranged for participants who still need intervention identified as<br \/>\nbeneficial and reasonably safe in a trial<br \/>\n\u2022 Recognition that access can be provided by researchers, sponsors,<br \/>\nhealthcare systems, or governments<br \/>\n\u2022 Exceptions allowed but require ethics committee approval<br \/>\n\u2022 \u00b628\/29: When seeking informed consent from legally authorized<br \/>\nrepresentative, must consider the preferences and values expressed by<br \/>\nthe potential participant<br \/>\n\u2022 \u00b637: Use of unproven interventions (compassionate use) must never be<br \/>\nundertaken to circumvent the protections for research participants<br \/>\n\u2022 Strengthened \u00b611: \u201cMedical research should be designed and conducted<br \/>\nin a manner that avoids or minimizes possible harm to the<br \/>\nenvironment and strives for environmental sustainability.\u201d<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n22<br \/>\nThe 2024 Proposed Revisions<br \/>\n\u2022 Emerged from inclusive and lengthy worldwide stakeholder<br \/>\nengagement<br \/>\n\u2022 Entail substantial changes to address a rapidly innovating<br \/>\nresearch ecosystem and enhance future relevance<br \/>\n\u2022 Maintain brevity while some thirst for specificity<br \/>\n\u2022 Meaningfully renew this seminal ethical document that demands<br \/>\nrespect for and protection of all medical research participants<br \/>\n\u00a9 2024 American Medical Association. All rights reserved.<br \/>\n23<br \/>\n\u2022 Associate Members: Syed<br \/>\nHussain, Natalia Solenkova,<br \/>\nAnthea Mowat<br \/>\n\u2022 Bangladesh: Jamal Chowdhury<br \/>\n\u2022 Belgium: Vincent Lamy<br \/>\n\u2022 Brazil: Carlos Serrano<br \/>\n\u2022 China: Yuguang Huang, Yali<br \/>\nCong, Haihong Zhang<br \/>\n\u2022 Denmark: Camilla Rathcke,<br \/>\nJeppe Berggreen Hoj, Katrine<br \/>\nKrause-Jensen<br \/>\n\u2022 Finland: Janne Aaltonen, Mervi<br \/>\nKattelus<br \/>\n\u2022 Germany: Ramin Parsa-Parsi<br \/>\n\u2022 Israel: Leah Wapner, Malke<br \/>\nBorrow<br \/>\n\u2022 Japan: Hidehito Imamura<br \/>\n\u2022 Malaysia: Ashok Philip, Azizan<br \/>\nbinti Abdul Aziz<br \/>\n\u2022 Netherlands: Rene Heman,<br \/>\nKrista Tromp, Antina De Jong<br \/>\n\u2022 Nigeria: Joan Emien Enabulele<br \/>\n\u2022 South Africa: Mvuyisi Mzukwa<br \/>\n\u2022 Taiwan: Brian Chang, Daniel Tsai<br \/>\n\u2022 UK: Dominic Norcliffe-Brown,<br \/>\nJulian Sheather<br \/>\n\u2022 Vatican: Pablo Requena<br \/>\n\u2022 Uruguay: Alarico Rodriguez<br \/>\n\u2022 USA: Jack Resneck<br \/>\n\u2022 Bioethics Advisors: Dominique<br \/>\nSprumont, Hans Van Delden,<br \/>\nUrban Weising, Amber Comer,<br \/>\nElliott Crigger, Jake Young<br \/>\n\u2022 WMA Staff: Otmar Kloiber,<br \/>\nSunny Park, Julia Tainijoki<br \/>\n\u2022 AMA Staff: Beth LaRocca,<br \/>\nHannah Longstaff<\/p>\n"},"caption":{"rendered":"<p>DoH for GA Keynote Oct 2024 Helsinki v1 \u00a9 2024 American Medical Association. All rights reserved. The Declaration of Helsinki Proposed Revisions 2024 WMA General Assembly Helsinki, Finland October 2024 Jack Resneck, Jr., MD Former President, American Medical Association Chair of Finance and Planning, World Medical Association Chair, WMA Declaration of Helsinki Workgroup \u00a9 2024 [&hellip;]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{"filesize":1209776,"sizes":{}},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2024\/10\/DoH-for-GA-Keynote-Oct-2024-Helsinki-v1.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/23597"}],"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\/17"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/comments?post=23597"}]}}