Clinical Trial Participant Loses Suit Over Informed Consent

A kidney transplant patient lost her suit against medical providers for allegedly failing to tell her of an experimental process’s risks because she didn’t establish the standards for acquiring consent or their breach, Kentucky’s top court said.

Reagan Shwab had to show her medical providers’ procedure for obtaining her informed consent to participate in a Phase I clinical trial, to reduce the need for post-transplant immunosuppressant drugs, fell below the accepted standards of medical practice, the Kentucky Supreme Court said.

But Shwab’s expert witness—though criticizing the informed consent form and process used by the providers—didn’t identify an accepted standard for ...