Is Federal Health Agency Undermining Its Own Ethics Body After Controversial Federal Study Resulted in Baby Deaths?

Too often, the very bodies set up to protect the public’s interests–to flag and punish bad conduct on the part of officials in power–are being undermined by those they’re supposed to police. That’s the allegation in the case of a federal ethics body that found a federal study called SUPPORT violated federal consent rules for testing on human subject.

It was a shocking finding.

The victims? Extremely premature infants and their parents: many of them poor, single African-American women. The women were never told that the oxygen monitors used on study babies, their extremely ill preemies, were rigged to provide false readings. Parents weren’t warned of the increased risk of death. As a result of the study, some infants died.

What happened after the ethics body, the Office for Human Research Protections, made its independent finding against colleagues at the National Institutes of Health (NIH) who funded and oversaw the study under the federal Department of Health and Human Services (HHS)? Did NIH and its research partners, 23 academic research institutions, do a mea culpa and promise it would never happen again?

Not quite. More than a year and a half after the ethics findings, the federal government has yet to take enforcement action or make changes to address the shortfalls. Instead, critics say it has pressured and marginalized the ethics office that made the critical findings.

Read the story here at

The New York Times Best Seller “Stonewalled”



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