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RESEARCHERS infected 18-year-old Jesse Gelsinger with an adenovirus on 13 September 1999 at the University of Pennsylvania. That virus carried a piece of DNA they hoped would correct a genetic fault that made his liver unable to break down a toxic by-product of protein metabolism. But the virus provoked an acute inflammatory response, and four days later he was dead.

Even if the treatment had been successful, Gelsinger and the other people in the trial stood to gain little, as a special diet could already compensate for their metabolic defect. What is more, the researchers had failed to report to the US Food and Drug Administration (FDA) that patients who received lower doses of the virus showed signs of liver damage.

The research protocol specified that the trial should have been stopped at this point because of this damage. And Gelsinger had not been provided with all the information he needed to give his informed consent.

In Lesser Harms Sydney Halpern traces the evolution of moral codes for conducting medical research right back to the 18th century, from the informal pressures exerted by professional networks during the testing of live polio vaccines through to the strict formal rules laid down by bodies like the FDA for gene therapy trials. She shows how far we鈥檝e come in protecting the people who volunteer for clinical trials, and demonstrates why it鈥檚 still not far enough.

Halpern鈥檚 dry and painstaking academic approach will make Lesser Harms unappealing to most general readers, but medical ethicists, researchers, policy makers and historians should read it. Volunteers in future clinical trials will thank them.