Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...) in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (shrink)
Subjects and Simulations presents essays focused on suffering and sublimity, representation and subjectivity, and the relation of truth and appearance through engagement with the legacies of Jean Baudrillard and Philippe Lacoue-Labarthe.
Is it right to wage war to export democracy, or - as Kant would have said - to forcibly interfere in the constitution and in the government of another state with the goal of transforming it into a republic? The answer of Kant, contained in the fifth preliminary article of the Perpetual Peace, leans towards non-interventionism: a bad constitution can never justify a war, because it may be the root only of a scandalum acceptum. To understand the meaning of scandalum (...) acceptum we have to become aware that it is a term originating from moral theology, which we should translate into the language of international law. The scandal, as it was still clear to Kant’s contemporaries, is the sin of advertising a sinful behavior: but it is just a scandalum acceptum if the act that inspired others to sin has been done without the intention to give them a bad example. A flawed constitution can be only the occasion of a scandalum acceptum because its legal power does not spread its influence beyond the border of its state. If a nation chooses to imitate the allegedly wrong constitution of another state, its choice depends only on its sovereignty, because it is a matter of internal constitutional law. On the other hand, waging war against another country because of its allegedly flawed constitution is a worse kind of scandal, the scandalum datum, because it involves an international law principle of limited sovereignty according to which every state has the right to assault another state because of its constitution. (shrink)