SUPPORT Oxygen Study- Consent Forms Under Scrutiny
The Department of Health and Human Services (HHS) sent a letter to the University of Alabama on March 7, 2013 regarding allegations of noncompliance with their regulations for the protection of human research subjects. This letter was in regards to the SUPPORT study on premature infant oxygen levels conducted between 2004 and 2009. In this letter, the 2 ½ page parental consent forms used were specifically called into question.
130 Infants Died, 91 Developed ROP
The purpose of this trial was to find out if there was a difference between premature babies who receive a higher or lower range of oxygen in terms of likelihood of dying, experiencing neurological problems, or developing retinopathy of prematurity (ROP), an often blinding disorder.
According to the HHS letter, the infants who were assigned at random into high oxygen groups were more likely to develop ROP, and the infants assigned to the low oxygen groups were more likely to die.
Problems with Parental Consent Forms in SUPPORT Study
- According to the HHS letter, the consent forms used in the SUPPORT study failed to properly disclose risks.
- The consent forms did not include any prior findings from over 50 years of research which recognizes a relationship between higher oxygen exposure, ROP, and chronic lung disease.
- The consent forms omitted prior analyses on the connection between lower oxygen levels and mortality.
- Instead it suggested minimal risk, stating that all of the treatments in the study were “standard of care” and that there was “no predictable increase in risk for [the] baby.”
- However, the consent forms did include a specific section on the possible benefits to participating in the study by noting that “[t]here may be benefits to your child directly, including… a decrease in the need for eye surgery as a result of exposure to oxygen.”
Contact an Experienced Child Injury Attorney
At Thomas J. Henry, we have the experience and resources to handle your child’s case. If negligent care played a part in your child’s serious injury or death, contact our offices. We are available 24/7, nights and weekends, and we represent clients/victims all over the country.
If your child was injured in the SUPPORT clinical trial, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.