Understanding informed consent - June 2005 How does the informed consent process work in vaccine trials?


To ensure that the volunteer enrollment in vaccine trials meets high ethical standards there is a process known as informed consent. During this process trial investigators must fully explain the details of the trial and the vaccine candidate that will be tested, make sure that the volunteer understands the information, and allow the potential volunteer to freely decide if they wish to participate. The steps in the process of informed consent and cultural considerations are described.


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