Recent JAMA Study Looks at Risk Standards for Child Enrollees in Clinical Trials
The Washington Post on Monday examined a study published last week in the Journal of the American Medical Association that looked at the risk standards used to regulate the involvement of children in medical studies. According to the Post, current federal regulation mandates that children may enroll in clinical trials with parental permission only if risks are "minimal" or a "minor increase over minimal" in some cases, as determined by a review board. "Minimal" risk means that the child will not be subjected to any harm that is more than "ordinarily encountered in daily life or during the performance of routine physical or psychological ... tests," according to the regulations.
However, this standard of minimal danger can create a "false sense of security," the Post reports. The JAMA study found that the daily risk the average child faces is fairly high. Children have a risk as high as one in 250 of being hospitalized for an injury, and the daily risk of accidental death for people ages 15 to 19 is one in 100,000. Although those risks might not "sound huge, ... studies have shown that research review boards routinely reject experiments whose risks are substantially lower than those," revealing a "disconnect between experts' intuitive sense of acceptable risk and the actual risks that regulations allow," the Post reports.
Study leaders Ezekiel Emanuel, chair of clinical bioethics at NIH, and David Wendler of NIH proposed a few alternatives to the regulation. One option would use the "de minimus" standard, which measures daily risk by excluding dangerous extracurricular activities, such as sports, while another would use the standard of charitable giving, which falls somewhere between the current standard and the de minimus standard. "We want safe and effective medicine for kids, but we don't want them exposed to risk, so we've closed our eyes," Wendler said. Some medical experts contend that risk standards should not be changed until further research is completed (Weiss, Washington Post, 8/22). An abstract of the study is available online.