S0-4 Resneck DoH Vatican Intro

1/23/24
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Jack Resneck, Jr, MD
Immediate Past President, American Medical
Association
Chair, WMA Workgroup to Revise the DoH
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The Declaration of Helsinki:
Ethical Principles for Medical Research Involving Human
Participants
• One of WMA’s seminal documents
• First adopted in Helsinki, Finland in June 1964
• Last revised in Fortaleza, Brazil in October 2013
• Multi-Year undertaking for current revision in 2024
• Working group established April 2022 by WMA Council
• Council Chair appointed 18 countries
• Has met regularly to review feedback from regional meetings
and craft proposed revisions for public comment
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1/23/24
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First Regional Meeting Held in Tel Aviv
Strengthening language to address Technological
Advancements in Big Data, Machine Learning, and Augmented
Intelligence
• Current DoH language on biobanks
• Inadequate to address consent for collection, storage, reidentification,
reuse of data
• Fails to address specific risks of AI, machine learning, big data (loss of
privacy, creation of tools that cause harm)
• Alignment with Declaration of Taipei
• Need to remedy lack of reference
• Doesn’t cover dynamic consent
or risk of reidentification
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• Paragraph 33: Complex subject with differing
perspectives
• When is the use of placebo, or no intervention, acceptable?
• When is the use of an intervention less effective than the best
proven one acceptable?
Second Regional Meeting Held in São
Paulo
Ethical Considerations on Use of Placebo
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1/23/24
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• Adaptive/Enrichment trial designs, Master Protocols (Umbrella, Basket, and
Platform Trials), Decentralized Trials, Real-world data/evidence, Challenge Trials
(not really new)
• Do we have best practices for obtaining informed consent for these types of trials?
• Are ethics committees prepared to evaluate emerging ethical issues with them?
• Do high-level principles of DoH already apply, or are new ones required?
Third Regional Meeting Held in Copenhagen
Emerging Trial Designs
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• Pandemics
• Non-Pandemic Health Emergencies
• Conflict Settings
• Vaccine Challenge Trials (the COVID experience)
• Vulnerable Populations during Pandemics
• Compassionate Use
Fourth Regional Meeting in Tokyo
Research during Pandemics & Health Emergencies
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1/23/24
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• Principles are fundamental and should be upheld by all individuals and teams
involved in medical research on humans
• Replacing subjects with participants out of respect for the rights, agency, and
importance of those individuals
• Need for ethics committees to have adequate resources and training
• Importance of scientific rigor to avoid research waste
• Concepts of social value and public health
• Environmental impacts of research
• Honoring prior expressed preferences when using legally authorized
representative for consent
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Other Issues Arose during Prior
Meetings
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• The geography of vulnerable populations
• Experiences of diverse stakeholders in low-resource settings
under the current DoH
• Post-Trial Access
Fifth Meeting: We’re here at the Vatican
Research in Resource-Poor Settings
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1/23/24
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• Public Comment Period (Phase 1) beginning this month
• Johannesburg, South Africa, Feb 18-19
• Vulnerable populations: community inclusiveness, post-trial access
• Munich, Germany, May 14-15
• Vulnerable groups: elderly, children, pregnant, incarcerated,
stigmatized, etc.
• Public Comment Period (Phase 2) in late spring
• Washington, DC, USA, August 14-16
• Communications and final revisions
A 2-Year, Inclusive Process with Many
Opportunities to Contribute
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