DoH_Cape_Town_2012-_Bou__sseau
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Expert Conference on the Revision of the Declaration of Helsinki
5 – 7 December 2012
Cape Town, South Africa
Dr Marie-Charlotte Bouësseau
Ethics and Health
Strengthening ethics review systems
Overview
• Normative framework
– Consultative Expert Working Group on Research and
Development – Financing and coordination
– UNAIDS/ WHO guidance document
• Vulnerable populations
• Availability of outcomes
• Strengthening ethics review systems
– Operational standards /RECs – Oversight of RECs
– Improving transparency in research (ICTRP)
e.g. Pan African Clinical Trials Alliance
• Building global consensus
e.g. working group of NECs on Biobanking
Consultative Expert Working Group on Research
and Development – Financing and coordination
on Research and Development – Financing and
coordination
• To facilitate equitable access to the benefits of
research, suggestions are made to delink the
costs of R&D and the prices of health products
UNAIDS/WHO guidance document on Ethical
Considerations in Biomedical HIV Prevention Trials
• Vulnerable populations (Guidance 8)
– Multiple vulnerabilities: cultural, social, economical,
political
– Multiple groups: women, children, adolescents, MSM,
PWID (IDU), sex workers, indigenous, poor, etc.
Asses determinant of vulnerability at an early stage
Design of the protocol should consider incidental risks of
social harm and establish measures to prevent them.
“If the risk of exploitation is severe, the research should
not be conducted.”
UNAIDS/WHO guidance document on Ethical
Considerations in Biomedical HIV Prevention Trials
• Availability of outcomes
“Researchers should inform trial participants and their communities
of the trial results. During the initial stages of development of a
biomedical HIV prevention trial, trial sponsors and countries should
agree on responsibilities and plans to make available as soon as
possible any biomedical HIV preventive intervention demonstrated
to be safe and effective, along with other knowledge and benefits
helping to strengthen HIV prevention, to all participants in the trials
in which it was tested, as well as to other populations at higher risk
of HIV exposure in the country.”
Strengthening ethics review systems
Standards and Operational Guidance
for Ethics review of Health related
Research with Human Participants
http://www.who.int/ethics/publications/research_standards
_9789241502948/en/index.html
Indicators for the oversight of RECs at
country level
Strengthening ethics review systems
• Joint reviews of multicenter trials
e.g. DNDi proposal on African Trypanosomiasis Treatment
African Vaccine Regulatory Forum (AVAREF)
• Recommendations for the implementation of
existing guidance in specific cases
e.g. placebo controlled vaccine trials
International Clinical Trial Registry
Platform (ICTRP)
• WHA 2006
“A voluntary platform to link clinical trials registers in order to
ensure a single point of access and the unambiguous
identification of trials with a view to enhancing access to
information by patients, families, patient groups and others”
• Network of 15 WHO data providers
• More than 220 000 registered
Data providers
ICTRP (cont.)
A shared responsibility aiming to
• improve transparency
• ensure greater accountability
• prevent unnecessary duplication
• identify gaps in research
• prevent publication bias and selective reporting
• improve trial design
• improve public trust
Future perspectives/ trial registration
• Include information on ethical approval:
– RECs
– Justification for the ethics approval
• Include information about results of the
research
WHO technical support to countries
Pan African Clinical trial Alliance
– RECs and NRAs from 20 Sub Saharan African
countries (AVAREF)
– Focus on coordination and harmonization of ethics
review and approval including clinical trail
registration
– Common procedural framework
Consensus building
• Global Summit of NECs, Working group of on
Biobanking
– Identification of questions to be addressed
• Consent
• Public engagement
• Role of RECs
• Harmonization of legal frameworks
• Governance
• Benefit sharing
• etc.
– Coordination with on going initiatives in other
international organizations
Conclusion
Strengthening national ethics review systems
– Ethical norms based on universal principles
(e.g. DoH – CIOMS – UNAIDS/WHO)
– Strong institutions (RECs)
– Harmonized procedures (including registration of CT
publication of results, etc.) to ensure good
governance: transparency, accountability, equitable
access to information, participation of all
stakeholders
bouesseaum@who.int
http://www.who.int/ethics/en