How the research ethics policy documents fulfil the three conditions discussed in the article.
| Organisation | Valid science | Social benefits to host country | Favourable 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. | |||
| UNAIDS10 | The research protocol should be scientifically appropriate | Plans should start during initial stages of vaccine development to ensure availability | The minimum should be to provide the highest level of care attainable in the host country |
| NBAC8 | There needs to be a justification for the alternative trial design | An explanation of how interventions proven to be effective from the research will become available to the host country population | Ethics committee needs to assess the risks to the participants |
| CIOMS6 | Established effective intervention would not yield scientifically reliable results | Trial should be responsive to the health needs of the trial population and there should be assurance of reasonable availability | Potential risks and benefits are reasonably balanced and risks are minimised |
| EGE7 | Research methods are necessary to the aims pursued and that no alternative more acceptable methods are available | Justification may be to simplify or reduce costs of treatment for host country | Special attention should be paid to the risk/benefit ratio at the individual level |
| Nuffield Council9 | There must be an appropriate research design to answer the research question | Sustainability and affordability of the standard of care used need to be considered | Minimum should be the standard of care country endeavours to provide nationally |