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May 11, 1994

The Letter or the Spirit Consent for Research in CPR

JAMA. 1994;271(18):1445-1447. doi:10.1001/jama.1994.03510420077037

Major scientific advances may begin serendipitously. The idea for active compression-decompression cardiopulmonary resuscitation (ACD CPR) came from an anecdotal account of successful resuscitation using a toilet plunger.1 Subsequent research supported the concept, as better cardiovascular hemodynamics among animals2,3 or humans4-7 or better short-term survival among humans8,9 was found with ACD CPR compared with standard CPR. One study even suggested that ACD CPR might improve neurological outcomes, as pigs receiving ACD CPR had better cerebral hemodynamics, oxygenation, and metabolism.10

This issue of The Journal describes a study11 of ACD CPR that was terminated by the US Food and Drug Administration (FDA) before completion, primarily because of concerns about informed consent. The project was funded by Ambu International, the maker of the Ambu CardioPump ACD CPR device; there was no federal support. The protocol had been approved by the institutional review board (IRB) of the St