Informed consent is an essential ethical obligation for clinical trials. It should seek to ensure that the participation of the subjects in the trial is entirely voluntary. Informed consent should ideally be more than the conventional signing of a standard dated consent form. The Act provides that where the safety profile of a particular vaccine cannot be guaranteed but the risk of the disease is serious, then the vaccine should be administered after obtaining consent from the client. All vaccines used in Kenya are subject to the Pharmacy & Poisons Act Cap.244, Laws of Kenya. Informed consent arises both from an ethical principle of basic human rights and from a legal viewpoint. The process of shaping opinion, attitudes, and perceptions was termed the ‘engineering of consent’ by one of the founders of the modern public relations industry, Edward Bernays.
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