Table 1

How the research ethics policy documents fulfil the three conditions discussed in the article.

OrganisationValid scienceSocial benefits to host countryFavourable individual risk:benefit ratio
CIOMS, Council for International Organization of Medical Sciences; EGE, European Group on Ethics in Science and New Technologies; NBAC, National Bioethics Advisory Commission; UNAIDS, United Nations Programme on HIV/AIDS.
UNAIDS10The research protocol should be scientifically appropriatePlans should start during initial stages of vaccine development to ensure availabilityThe minimum should be to provide the highest level of care attainable in the host country
NBAC8There needs to be a justification for the alternative trial designAn explanation of how interventions proven to be effective from the research will become available to the host country populationEthics committee needs to assess the risks to the participants
CIOMS6Established effective intervention would not yield scientifically reliable resultsTrial should be responsive to the health needs of the trial population and there should be assurance of reasonable availabilityPotential risks and benefits are reasonably balanced and risks are minimised
EGE7Research methods are necessary to the aims pursued and that no alternative more acceptable methods are availableJustification may be to simplify or reduce costs of treatment for host countrySpecial attention should be paid to the risk/benefit ratio at the individual level
Nuffield Council9There must be an appropriate research design to answer the research questionSustainability and affordability of the standard of care used need to be consideredMinimum should be the standard of care country endeavours to provide nationally