A recent finding by the Office for Human Research Protections (OHRP), a federal agency that safeguards participants in government-financed research, concluded that parents of extremely premature babies who agreed to participate in university studies were not fully informed of the potential health risks in the study. The agency claims that the study had an effect on whether infants could die or develop a condition resulting in blindness as a result of their participation. This study further maintains information about these risks was not effectively communicated to parents such that there was no informed consent.
The study, conducted by more than 20 academic institutions, examined the effect of oxygen levels on 1,300 premature infants born between 24-27 weeks of gestation, a group at particularly high risk of death or development of eye disease. Nearly 20 percent of babies placed in the low-oxygen group died. A similar percentage of babies in the high-oxygen group developed an eye disease that can lead to blindness. In a letter to the University of Alabama at Birmingham, the lead site in the study, the OHRP said that the consent form provided to parents did not sufficiently provide information about the seriousness of the risks. The OHRP added that even before beginning the study, researchers had enough scientific information to better outline the potential outcomes.
The consent forms used in the study were written by researchers at the University of California, San Diego and approved by the review boards of all the participating universities. Possible skin abrasion from an oxygen monitoring device was the only mentioned risk. The forms even highlighted a decreased risk of eye surgery as a possible benefit of taking part in the study. A doctor from the University of Alabama at Birmingham says steps will be taken to ensure that future informed consent forms will be more effective at conveying the risks suggested by previous studies.
At a time when procuring informed consent is a standard protection against medical malpractice, it's shocking to learn of a form that omits information rather than providing for every possible complication. Additionally troubling is the fact that the lack of complete information occurred in a study involving premature infants--overwhelmed parents in this situation might have relied on a doctor's advice rather than reading through the fine print of a consent form, leaving themselves and their babies vulnerable. The legal ramifications of this misstep by the leaders of this study could be widespread. It is quite possible, if not likely, that medical malpractice lawsuits will result from these findings by the Office for Human Research Protections.
New York Times, Study of Babies Did Not Disclose Risks, U.S. Finds, 4-10-13
Letter from the Department of Health and Human Services to Dr. Richard Marchase, 3-7-13