new study on HIV trials in foster care

The Vera Institute of Justice released its report today on the participation of HIV positive NYC foster children in HIV drug trials from the last 1980s until 2005. The city's Administration for Children's services commissioned the report in 2005 when allegations arose concerning the participation of certain children in the study. These allegations included: that race was a factor in the selection of participants, that children were at times inappropriately removed from their homes and placed in foster care to facilitate their participation in the study, and that the trials themselves adversely affected the children's health.

First, the study found that no child died as a result of his or her participation in a study. Sadly, 80 of the 532 children enrolled in HIV trials over this period of time did die, but investigators could find no connection between these deaths and any clinical trial. The study also noted that while there were instances of side effects in the children, these side effects were consistent with the literature published about the drug at the time. The study also fond several instances in which physicians took note of these toxicities and made appropriate adjustments. Second, the study finds no evidence that children were removed from their homes to due parental refusal to allow children to participate in drug trials. The study notes that 3/4 of children enrolled in foster care were enrolled before they were one year old, and more than 1/2 were enrolled directly in the hospital from birth. Third, the study finds that the while the trials did predominantly involve black and Hispanic children, their representation in the trials was reflective of the demographics of the HIV epidemic at the time.

On the other hand, there were some findings of concern. A number of them centered around informed consent: in seven cases, consent was given by someone who had no legal right to do so, consent forms were often written in medical jargon, and consent was at times accepted in the form of handwritten notes or over the phone. Sixty four children were enrolled in trials that were never reviewed bu the city's own Medical Advisory Panel (MAP), which had been developed specifically for that purpose. Twenty one children were enrolled in trials that had been reviewed by MAP and were not recommended, although 13 of these had been enrolled prior to entering foster care.

The report concludes with a few concerns and recommendations, mostly centered around the need for clearer and more comprehensive policy around the participation of foster children in clinical trials.

Further coverage of the study can be found at the NYT website.

Finally, on a personal note, one of the study's seven authors is my roommate, Reena Gadhia, who used to work at Vera and is now an RN at the Allen Pavilion of Columbia Presbyterian. Reena worked on this project a lot while at Vera, and has since gone to DC to present her research at a conference. Congrats Reena!