For Volunteers Harmed in Clinical Trials, an Imperfect Safety Net
November 21, 2023

(Undark) – Each year, hundreds of thousands of Americans volunteer for clinical trials. They swallow doses of experimental drugs and undergo novel surgeries. Some allow doctors to implant unproven devices into their bodies. Most trials end up being perfectly safe, and they often allow patients access to innovative medical care. But in the rare case that something does go wrong during a study, the research organization may not be under any legal obligation to pay for a volunteer’s medical bills, cover lost wages, or offer any other assistance.
It’s a quirk of United States law that has long bedeviled bioethicists: Unlike in many other countries with lots of clinical research, U.S. regulations do not guarantee support for people who are harmed during clinical trials. (Read More)