The study involved comparing one group of premature infants with another group. One group was given low-dose oxygen therapy while the other group was given a much higher dose. According to Public Citizen, the informed consent form given to study participants failed to disclose potential risks of blindness (retinal damage), neurological injury and death, even though “[i]t has long been known that, in general, giving high levels of oxygen to premature infants can lead to retinal damage, blindness and lung injury, while giving too little oxygen can cause brain damage and death.”
When data is collected from experimental treatment of human subjects for purposes of answering a question, certain protections must be afforded to the research subjects, including:
- Voluntary, informed consent
- The right to end participation in research at any time
- Benefits should outweigh cost
- Protection from physical, mental and emotional harm
- Access to information regarding research
- Protection of privacy and well-being
These rights emanate from the Nuremberg Code promulgated following World War II. More recently, protections have been codified by federal statute and regulated under the authority of the Department of Health and Human Services.
The oxygen study results showed that nine percent of newborns in the lower-dose oxygen group developed severe retinal problems, while twice that amount in the higher-dose oxygen group developed retinal problems. In addition, “a comparison of the two study groups clearly shows more deaths in the lower oxygen group….”
Medical malpractice cases involving children involve a number of unique considerations, including protection of funds recovered for a child through probate court and coordinating compensation and needs-based benefits to maximize the child’s resources. We have experience in those areas and are available to answer your questions.
