STAT July 18, 2024
Thousands of people volunteer for clinical research trials in the United States every year. They put their bodies on the line, often seeking benefits from experimental treatments because existing care is ineffective. For most clinical trials, independent institutional review boards (IRBs) are legally required to review the protocol before enrollment can begin.
The majority of experimental treatments don’t work. Most people participating in clinical trials don’t gain direct benefits, so the risks and burdens volunteers face cannot be ethically justified by the possibility of direct benefit. Instead, they are justified by gains in scientific knowledge that might benefit others down the road.
IRBs are supposed to protect trial participants’ interests by assessing a trial’s scientific merit, as described in the...
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