AN ENGLISH EXPERT'S VIEW OF AMERICAN "INFORMED CONSENT"

Abstract

Scientists also feel that overzealous ethical review boards and, in particular, informed consent rules have driven science away. In the mid-80's, Dr. Richard Peto, a well-known epidemiologist at Oxford University, approached American cardiologists to enlist patients for a study of the drug streptokinase as a treatment for heart attacks. Although the Americans were enthusiastic, in the time that British doctors referred 6,000 patients, only 400 entered from the other side of the Atlantic. He holds consent procedures largely to blame. "The American documents were three pages of legalistic junk," Dr. Peto said, who had written a single page consent form for British use. "That's not the sort of thing you want to push under someone's nose as he's having a heart attack, terrified, with chest pain, on morphine. You want to tell him about the trial, but you want to be humane." Although countries in Europe require that researchers discuss a study with potential subjects, the requirement is far less formalized.