Children as Research Subjects: The Overbroad Regulations in 45 C.F.R. § 46, Subpart D, in Conjunction with Legislative Economic Incentives Allow for Exploitation of this Vulnerable Subject Population

Abstract

After describing and examining the disparity in research conducted on adults with that on children and why it exists, this paper will discuss the recent legislative response, will highlight a number of the ambiguities and the questionable ethics of the unsatisfying regulations governing children as research subjects, and will recommend improvements in striking the delicate balance needed to protect children from research abuse and improve their health through useful, careful research.