The Code of Federal Regulations define vulnerable research subjects, and how those vulnerable subjects should be protected. 21 CFR 50.53 describes the circumstances under which children may participate in an investigation involving greater than minimal risk and no prospect of direct benefit . In order for these subjects to participate in clinical research trials, it is the researcher’s duty to ensure that these special protections are respected. It is unimaginable that these federally mandated laws and regulations could be discounted and ignored.
However, a recent article describes how researchers conducting a series of drug trials to treat pediatric AIDS patients did just that. As a result of these oversights, the thousands of foster children - ranging from infants to teenagers - who participated in these trials were denied the protection of mandated independent advocates.
According to the article, researchers conducting these NIH-funded trials defend their choice to ignore a regulation requiring an independent advocate be appointed for each child ward participating in a greater-than-minimal-risk clinical trial. The argument was that as a result of their participation, these impoverished children had access to some of the best physicians in the field, and received state-of-the-art treatments in an attempt to slow their disease progression. But critics cite the dangers of enrolling child wards without advocates: these vulnerable children were exposed to substances possessing serious risks and side effects and an unknown safety profile in pediatric populations. Indeed, one study noted an unexplained and “disturbing” higher death rate associated with consumption of higher doses of one study drug.
The article also describes the failure of IRBs in protecting vulnerable research subjects. This is a valid concern, as IRBs are often overwhelmed with the number of studies conducted as well as industry pressure for approval.
While ethical and moral questions of potential benefits and rights to participation hover in a shady gray area, it is the Code of Federal Regulations that sorts these difficult questions into black and white. Have you worked on a study with vulnerable populations? Did you find that there was difficulty following the regulations? Please share your stories with us.