A proposal that has recently surfaced from the Federal Food and Drug Administration boggles the mind. Under the suggested guidelines for Emergency Research, certain individuals would not be giving their consent ahead of time.
In the FDA memo, it is noted that an exception may be requested from the requirement to obtain informed consent for each subject or the subject’s legally authorized representative if, the research would involve human subjects who have a life-threatening medical condition (for which available treatments are unproven or unsatisfactory) or subjects who because of their medical condition (unconsciousness, for example) cannot give informed consent.
This sounds very much like human experimentation without accountability. To register your concerns, after you review the document, please send your comments to the FDA.
