It was controversial when the FDA amended its version of the Common Rule (21 CFR Part 50
) in 1996
to add a provision that allows for emergency research when true informed consent isn't possible (§ 50.24
) -- the first time human subjects could be legally enrolled in research without their consent. The FDA defended the move as a modest exception for the relatively rare instances in which research would be stymied because of the impossibility of obtaining consent that would otherwise be required. As an article in yesterday's Washington Post
makes clear, such research is getting considerably less rare, renewing the decade-old debate about whether the FDA's
exception is really needed or is encouraging, as BU's George Annas
says, " lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible."
Department of full disclosure: I have been a member of a consultation group in Dallas in connection with the emergency research discussed in this article ("Clinical Trial of the Active Compression-Decompression (ACD) and Inspiratory Threshold Valve (ITV) Devices vs Standard CPR").