Introduction_Jack Resneck, Jr

Jack Resneck, Jr, MD
Immediate Past President, American Medical Association
Chair, WMA Workgroup to Revise the DoH
The Declaration of Helsinki:
Ethical Principles for Medical Research
Involving Human Subjects
The Declaration of Helsinki:
Ethical Principles for Medical Research Involving Human Subjects
• 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
• Chair appointed 18 countries
• Has met regularly to review feedback from regional
meetings
Working Group Identified Priority Areas
• New or Evolving
• Big Data (Data storage, machine learning, AI, dynamic consent, coherency with Taipei)
• Challenge trials and Ethical Standards during Emergencies/Pandemics (in light of COVID-19)
• Compassionate use of Unproven Interventions (misinterpretation to justify questionable
therapies during COVID-19)
• Emerging trial designs (Adaptive/Enrichment trial designs, Master Protocols (Umbrella,
Basket, and Platform Trials), Decentralized Trials, Real-world data/evidence
• Gender-inclusive language
• Ongoing
• Use of placebos
• Application only to physicians or also to others?
• Vulnerable populations (neither exploiting nor excluding)
• Post-trial access/benefits
• Informed consent from those who lack capacity
• Prevention trials (vulnerable vs concerned groups)
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
• 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
• 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?
• Other Issues Arose
• Need for ethics committees to have adequate resources and training
• Importance of Scientific Rigor to avoid research waste
• Concept of Social Value
Third Regional Meeting Held in Copenhagen
Emerging Trial Designs
• Pandemics
• Non-Pandemic Health Emergencies
• Conflict Settings
• Vaccine Challenge Trials (the COVID experience)
• Vulnerable Populations during Pandemics
• Compassionate Use
Fourth Regional Meeting Here in Tokyo
Research during Pandemics & Health Emergencies
• Public Comment Period (Phase 1) begins in January
• Vatican City, Jan 18-19
• Research in resource-poor settings
• 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
*Meetings in blue will focus on
vulnerable populations
A 2-Year Process with Many
Opportunities to Contribute