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For example, if I were to propose a clinical trial involving children and entice participation by giving out ice cream to those willing to participate, any Institutional Human Subject’s Safety Board (IRB) in the United States would reject that protocol. If I were to propose a clinical research protocol wherein the population of a geographic region would lose personal liberties unless 70% of the population participated in my study, once again, that protocol would be rejected by any US IRB based on coercion of subject participation. No coercion to participate in the study is allowed. In the case of human subject clinical research, in most countries of the world this is considered a bright line that cannot be crossed. So, now we are told to waive that requirement without even so much as open public discussion being allowed?
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