Human Subjects Protection and Large-N Research: When Exempt is Non-Exempt and Research is Non-Research

Social scientists are well aware of the unintended consequences of public policies. The protection of human subjects regulations, which emerged in response to a serious problem in the medical community, provides an ideal example of such unintended consequences; to paraphrase an old aphorism, “the road to bureaucratic hell is paved with well-intentioned public policies.” In this essay I will seek to make three points. First, the protection of human subjects by federal regulation was long overdue. Second, this benefit to society has, in its application, ignored another widely accepted regulatory principle, namely that the costs of regulation should not outweigh its benefits; a combination of “bureaucratic creep” and litigation phobia has resulted in intrusive and counterproductive regulation of social science research, such that the cure has become worse than the disease. Third, ironically, because of institutional review boards' definition of what is and what is not research, the protection of human subjects is denied to subjects who actually could be at risk.