Vulnerable subjects and inform assent

Ethical dilemma and special issues revolve around clinical trials especially when the subject involve vulnerable human participants such as children or pregnant women or ethnicity or socioeconomic. One of the major reasons why a clinical trial involving children is very challenging and complex is the idea surrounding the ability to understand the inform assent clause, and what is expected of them during clinical trials (National Cancer Institute. 2011). Ethically, for anyone to participate in any clinical trial, the international regulatory or regional agencies and the institutional review board (IRB) require informed consent from the participating subjects unless if it is a special situation where the individuals’ mental state is diminished, challenged or under legally authorized treatment to improve their health (Lemaire, 2005). Thus, if any of the aforementioned health status is the case for a given individual, although subjects are protected under the law against medical malpractice, a subject may

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