The Department of Health and Human Services (HHS) has proposed sweeping revisions to the federal regulations for the protection of human research participants. The goal is to “enhance protection while simultaneously eliminating unreasonable burdens.”1 Although the goal is admirable, some changes intended to remove unnecessary regulatory burdens may allow serious risks (ie, the probability of harm is significant, not merely possible or conceivable), particularly to highly vulnerable participants (ie, participants' ability to give free and informed consent is seriously compromised).
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The Rational Clinical Examination
The criteria for valid consent to medical treatment vary from state to state but are based on...
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