A federal judge has thrown out a lawsuit filed by parents who claimed their infants were injured as a result of research participation, the New York Times reported this week.
The study, known by its acronym SUPPORT, was in the news a few years ago, after the federal Office of Human Research Protections (OHRP) accused the researchers of not adequately disclosing potential risks during the informed consent process. The study took place at 23 academic medical centers, and was completed, with results published, before OHRP issued its letter to the lead site, the University of Alabama. The letter notes that the study was reviewed by “at least” 23 institutional review boards. The study involved examining the effects of varying levels of oxygen provided to premature babies. The researchers argued that the oxygen saturation levels provided (85 to 95 percent) were all within the standard of care, and that being assigned to the lower or higher range of oxygen saturation posed no additional risks.
After OHRP released its findings related to the study, some families of the babies involved sued the University of Alabama IRB, the principal investigator, and the company that manufactured the modified pulse oximeters used in the study. In the dismissing the case this week, the judge wrote that the families could not prove that the study probably caused the injuries their babies received.
Much as the original OHRP decision caused some discussion in research communities when it was first released, this court decision also renewed public debate about the study. The New England Journal of Medicine, which originally published the study results, published two commentaries about the decision, Support for SUPPORT and Vindication for SUPPORT. The latter included language that indicated the lawsuit made it seem “that, on some level, our whole system of research oversight was on trial.” Dr. Michael Carome, Director of Public Citizen’s Health Research Group and former associate director for regulatory affairs for OHRP and former director of OHRP’s Division of Compliance Oversight issued a statement taking issue with what the statement calls NEJM’s “ill-conceived campaign to defend the indefensible ethical failings of SUPPORT.”
What underpins the debate over the SUPPORT trial? Like any research, the subjects (premature infants, in this case), their parents (imagine yourself in their spot, being informed about this research right after their baby’s premature birth), and the challenging determinations IRBs must make when determining risk/benefit ratios of research and the way those risks and benefits are disclosed during the consent process.