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
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