Informed consent will be obtained by first briefing possible participants about the study, including the experimental nature of the vaccine, and the treatment policy. Two days following the initial briefing the individuals return to the Institute where they are given a brief oral and written exam to see if they fully understand the study and their rights. Only if they pass the test, are they enrolled. The study is submitted to the Ethical Review Board of the Institute and to a firm that conducts ethical reviews for companies in the private sector who wish to conduct research on human subjects. That Subcommittee approves the protocol and forwards it to the Ministry of Public Health Ethical Committee.
All review boards approve the study.
They feel that the study, as presently designed, would never be passed by either a UK government or university ethical review committee. In addition, the physicians in Vietnam would be unfamiliar with the therapy and unaware of all the possible side effects. And lastly, by offering the best care available in the world, the study would be giving an unfair inducement to participate. It would in essence be offering a form of coercion to receive the vaccine. Because of the much lower rate of seroconversion in the IDU population, however, it will take an additional three years to complete the study.