Federal Agency Faces Fallout From Controversial Study That Put Babies at Risk

A federal agency has taken controversial new steps to marginalize its own ethics body, according to new information revealed by the watchdog group Public Citizen. That after the federal ethics body criticized a government study that resulted in the deaths of some premature babies.

The government-backed study in question was called “SUPPORT.” It was conducted from 2006 to 2009 on 1,316 extremely premature infants at 23 academic institutions under the National Institutes of Health, which is part of the Department of Health and Human Services.

Controversy surfaced in March 2013 when the government’s own ethics body, the Office of Human Research Protections, dropped a bombshell.

The ethics office found the federal study’s consent forms violated government rules designed to protect human research subjects. According to OHRP, the consent forms “failed to describe the reasonably foreseeable risks of blindness, neurological damage and death” to babies in the study.

More than a year and a half later, 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.