Posts Tagged ‘ Department of Health and Human Services ’

Premature Baby Researchers Failed to Warn Parents of Risks

Thursday, April 11th, 2013

A large-scale study on the effects of oxygen levels on premature babies is under scrutiny by an agency of the U.S. Department of Health and Human Services, which has issued a letter to parents warning them they were not cautioned that participating in the study could increase the risks of blindness of death afflicting their babies.  More from The New York Times:

The Office for Human Research Protections, which safeguards the people who participate in government-funded research, sent a letter to the University of Alabama at Birmingham last month, detailing what it said were violations of patients’ rights.

The university, which was a lead site for the study, had not detailed the risks in consent forms that were the basis of parents’ participation, the office said in the letter. Specifically, babies assigned to a high-oxygen group were more likely to go blind and babies assigned to a low-oxygen group were more likely to die than if they had not participated. Ultimately, 130 babies out of 654 in the low-oxygen group died, and 91 babies out of 509 in the high-oxygen group developed blindness.

Some of the 1,300 infants who participated in the study, which took place between 2004 and 2009, would probably have died or developed blindness even if they had not taken part. They were born at just 24 to 27 weeks gestation, a very high-risk category. But being assigned to one or the other oxygen group in the study increased their chances further, a risk that was not properly disclosed, the office said

Richard B. Marchase, vice president for research at the University of Alabama at Birmingham, said in a telephone interview that a similar group of infants born around the same time who did not participate in the study actually died at higher rates than those in the low-oxygen group. Those infants were not a control group in the study, but were roughly similar in number and in age to those in the study group; they had a 24 percent mortality rate, compared with a 20 percent mortality rate for the infants in the low-oxygen group.

He said the study kept the infants within the standard band of treatment for oxygen levels — 85 percent to 95 — and that its findings were forming the basis for a definition by the American Academy of Pediatrics about what the standard of care should be.

He said he had assured the Office for Human Research Protections that in the future, “we will to the best of our ability let the subjects or their parents know as thoroughly as possible what previous studies suggest in terms of risk.” He added, “We are going to be very sensitive to that going forward as we look at these consent forms.”

Image: Infant in incubator, via Shutterstock

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Child Abuse Rate Drops for Fifth Consecutive Year

Friday, December 14th, 2012

The number of children who are abused or neglected in America has dropped for the fifth year in a row, an annual report from the Department of Health and Human Services has announced. More from The Huffington Post:

The latest annual report from the Department of Health and Human Services, released Wednesday, estimates that there were 681,000 cases of child abuse or neglect across the nation in the 2011 fiscal year. That’s down from 695,000 in 2010 and from 723,000 in 2007.

“We have made excellent progress over the past five years,” said George Sheldon, HHS acting assistant secretary for children and families. “But what this report tells me is that we still have 681,000 children out there who need our help.”

The number of abuse-related fatalities was estimated at 1,570 – down from 1,580 in 2010 and from 1,720 in 2007. About four­fifths of those killed were younger than 4, and parents were deemed responsible for nearly four-fifths of the deaths.

Texas had the most fatalities, with 246, followed by Florida with 133, while Montana reported no abuse-related deaths. The highest rates of child fatalities were in Louisiana, Oklahoma and West Virginia.

Regarding the overall maltreatment figures, white children accounted for almost 44 percent of the victims, black children for 21.5 percent and Hispanic children for 22.1 percent. About 11 percent of the victims were physically or mentally disabled.

Regarding types of maltreatment, 78.5 percent of the victims suffered neglect, nearly 18 percent were physically abused and 9.1 percent were sexually abused. The report tallied 61,472 children who were sexually abused in 2011 – down dramatically from the peak of about 150,000 in 1992.

The report, formally known as the National Child Abuse and Neglect Data System, is based on input from child protection agencies in every state. About four-fifths of the reports received by the agencies do not lead to findings of maltreatment, according to the report.

Image: Sad girl, via Shutterstock

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