A bioethicist says scientists owe clinical trial volunteers support
Many insurance policies don’t cover experimental procedures or side effects that can follow
Some people see clinical trials as a chance for a miracle cure. In reality, these experimental drug tests and medical interventions often fail. With researchers in the United States now testing the gene editor CRISPR/Cas9 for the first time in people with cancer, blood disorders or inherited blindness (SN: 8/14/19), one bioethicist says it’s important to remind scientists running these trials and others about the responsibilities researchers bear for study volunteers.
That’s not to say that scientists doing clinical trials are doing anything wrong or that such studies should stop, says Laurie Zoloth of the University of Chicago. Her role as a bioethicist, she explains, is “to make sure that human progress goes forward in a way that’s safe and ethical.”
Clinical trials in people — whether testing new drugs, devices, surgical methods or CRISPR technology — must meet higher ethical standards than work conducted in a lab, she says. “Having a human being as a subject means you have different obligations than you would to an animal or a petri dish,” Zoloth says. A scientist conducting clinical trials on humans should be “responsible for them, in my opinion, forever.”
That means that researchers should pay not just for the experimental treatment, she says, but also for any treatment needed for treating side effects — including those that show up later — or if something goes wrong during the trial. Many people’s insurance policies do not cover experimental procedures, yet some informed consent forms required for participating in clinical trials contain clauses claiming that a subject’s insurance will cover side effects, she notes. When Zoloth and others who review research applications point this out to scientists, “sometimes they’re surprised that they haven’t thought of it,” she says. But “sometimes they hope that, by putting that [clause] in there, it will release them from some burden.”