When seriously ill patients for whom existing treatments are inadequate are invited to participate in clinical trials that offer a new treatment, should those persons be considered “vulnerable”? And if so, what additional protections should they be accorded? This article attempts to provide some answers.

Individuals with limited resources are often presumed to be vulnerable in research. Concerns include the possibility of impaired decision making, susceptibility to undue inducement, and risk of exploitation. Although each of these concerns should be considered by investigators and IRBs, none justifies categorical exclusion of individuals with limited resources.

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed over 20 years ago with a goal of harmonizing research regulations among the European Union, United States, and Japan. Harmonization was intended to speed approval of pharmaceuticals, avoid unnecessary repetition of studies, and ensure protection of research participants. This paper examines United States, European Union, and ICH pediatric research regulations in five domains: parental permission, assent/dissent, payment, risk/benefit and inclusion of disabled children/wards (...) of state. The purpose is to examine similarities and differences among the regulations to help investigators, policy makers and the public to understand what each regulatory framework can learn from the others. Additionally, the paper suggests philosophical differences in how these entities view pediatric research which may serve as barriers to harmonization in the future. (shrink)