Caroselli, Beachler & Coleman, L.L.C.

Government reviews consent rules for oxygenation studies

Pennsylvania residents may not have heard about a disagreement within the biomedical industry that has caused the U.S. Department of Health and Human Services to review informed consent rules regarding research studies involving premature infants. The controversy exploded when the Office for Human Research Protections criticized the National Institutes of Health for failing to properly inform parents whose children were involved in a medical study about the potential dangers to participants.

The OHRP claimed that study's researchers, who created the study to pinpoint the prime oxygenation level for premature infants, did not adequately warn parents about the babies' possible risk of disease and even death due to procedures like adjusting blood oxygen levels. The OHRP called for a hearing by the HHS to review informed consent guidelines.

Meanwhile, the NIH defended its practices, stating that all medical treatments administered throughout the study were regarded as the "standard of care," meaning that the practices all fell within the range of ordinary care that infants could receive at typical hospitals. A former OHRP member disagreed and claimed that the NIH study did not allow researchers to adjust the infant's oxygenation based on his or her symptoms.

Several families of infant participants have already sued the study's directors for failing to provide them with information about the potential health risks of the experiment. One couple claimed that their daughter developed a severe medical condition although the family did not say whether the disorder was a direct result of the infant's medical treatment during the experiment.

Pennsylvania residents whose children were harmed in experimental studies after not being informed about the potential perils could work with medical malpractice attorneys to potentially file lawsuits against study administrators. They may be able to build strong cases for medical malpractice and doctor negligence.

Source: Science Insider, "U.S. Weighs Informed Consent Rules in Wake of Infant Study Controversy", Arthur Allen, August 30, 2013

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