Does the study protocol respect the principles of autonomy, beneficence and justice?
The three basic principles of clinical and epidemiological research autonomy, beneficence and justice have been described in various international statements and guidelines. The first principle also provides protection to people with impaired or diminished autonomy. In the leprosy vaccine trial, information about the nature of the study was made available by oral presentations in the local language to groups of people in the villages taken up for study, and efforts were made to motivate individuals to participate, without compromising the voluntary nature of the programme. Regarding the principle of beneficence, patients detected with leprosy were given prompt treatment. And as for the question of justice, random allocation of individuals to the five arms of the trial ensured equal distribution of risks and benefits among trial participants. However, it is common in trials of this nature for children and women to get better coverage than men. Some questions regarding the just nature of
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