Undark: For Volunteers Harmed in Clinical Trials, an Imperfect Safety Net

[SNT Gatchaman]

https://undark.org/2023/11/20/clinical-trial-injury/

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. If an experimental device backfires, or a new drug lands a research subject in the hospital — or worse — the person or their family may find themselves entirely on the hook for medical care and other expenses.

For decades, ethics experts have raised concerns about the current system. So have several federal advisory panels, including a 2011 presidential commission that requested the Department of Health and Human Services “move expeditiously to study the issue.” Little has come of those efforts. “I’ve never come across anybody who tries to defend it,” said University of Minnesota bioethicist Carl Elliott. “But it never changes.”

 

[Hutan]

It's really important that anyone who participates in a clinical trial with significant risk of harm asks about compensation in case of injury and gets something in writing from the researcher. Ethics committees should not approve studies that do not have adequate insurance - the researcher should make a statement about their cover.

And, things can be more complicated than you expect. For example, while NZ has the Accident Compensation Corporation with its support of people who are harmed in an accident, people who participate in commercially sponsored clinical trials are not covered. So, ask and make sure you get the details of the trial's insurance in writing. How much cover? Would you have to hire your own lawyer and deal with a court in another country in order to get compensation? Is the insurance cover that an overseas-based sponsor holds valid for participants in your country?

 

[Kitty]

How much cover?

And does it cover something that wrecks your life, but doesn't show up on a test?

Does it cover something that doctors claim can't cause ill-effects, like – I dunno – vaginal mesh?