July 5, 2000

Ethical Considerations in the Public Policy Laboratory

JAMA. 2000;284(1):85-87. doi:10.1001/jama.284.1.85

Standards for evaluating clinical innovations are very different from standards for evaluating policy innovations. In the case of the former, the research community appropriately insists on exquisite attention to fair participant selection, a favorable risk-benefit ratio of the intervention, informed consent, and respect for enrolled subjects.1 Conversely, innovations in public policy are initiated by legislative action or agency dictate; evaluation (if it occurs) is often retrospective and conducted without the oversight of an institutional review board (IRB) or without informed consent. In this issue of THE JOURNAL, Kerpelman et al2 describe an admittedly controversial program that used the threat of sanctions of welfare benefits to encourage compliance with early childhood immunizations. Their evaluation highlights some of the ethical problems involved in policy evaluations.