A Controversial Rewrite For Rules To Protect Humans In Experiments

Throughout history, atrocities have been committed in the name of medical research.

Nazi doctors experimented on concentration camp prisoners. American doctors let poor black men with syphilis go untreated in the Tuskegee study. The list goes on.

To protect people participating in medical research, the federal government decades ago put in place strict rules on the conduct of human experiments.

Now the Department of Health and Human Services is proposing a major revision of these regulations, known collectively as the Common Rule. It's the first change proposed in nearly a quarter-century.

"We're in a very, very different world than when these regulations were first written," says Dr. Jerry Menikoff, who heads the HHS Office of Human Research Protections.
"The goal is to modernize the rules to make sure terrible things don't happen."

Many of the revisions are long overdue and would significantly improve oversight of scientific research, say researchers, bioethicists and officials who oversee human research studies.

But many of the updates are also triggering intense debate and criticism.

The new rules are too complex...