X-Message-Number: 4964 Date: Wed, 11 Oct 1995 08:02:45 -0700 (PDT) From: Joseph Strout <> Subject: FDA restrictions loosening? Hi Mike, I remember your (justified) anger about the mechanical CPR aid which you claimed could never be approved in the U.S., because FDA requires informed consent, and patients in cardiac arrest are seldom able to give it. So I thought of you when I read a blurb in Science yesterday: Apparently, experimental devices can be used in life-threatening situations without informed consent if special permission is given by an institution's review board. This has been fairly rare and atypical in the past, but new guidelines being proposed should make it easier. (It is interesting to note that the example described in the article involved cooling head trauma patients to reduce ischemic damage.) I don't have the article in front of me, so I apologize if I have misrepresented anything, but I'm sure you'll want to read for yourself anyway. Would these new guidelines offer hope for getting the CPR device approved? -- Joe ,------------------------------------------------------------------. | Joseph J. Strout Department of Neuroscience, UCSD | | http://www-acs.ucsd.edu/~jstrout/ | `------------------------------------------------------------------' Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=4964