Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final ...

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 ...

The US Food and Drug Administration (FDA) needs to do a better job of tracking and monitoring the activities of institutional review boards (IRBs); not doing so compromises the safety of research ...

For years, ethicist Arthur Caplan warned medical researchers that paying businesses to evaluate their clinical trials was a bad idea. He condemned trials that didn’t rely on hospital or academic ...

GAO calls for more oversight of institutional review boards in clinical trials. FDA should step up its oversight of institutional review boards (IRBs) to better assure the safety of participants in ...