摘要：The legal case of Grimes v. Kennedy Krieger Institute, Inc, has raised concerns in the public health research community regarding the acceptable level of risk in research involving children, parental authority for informed consent, and exploitation of research subjects for the benefit of public health. We provide an overview of the case and discuss the impact of the court's decision and its possible effect on future research protection policies and practices. (Am J Public Health. 2002;92:1073–1076) THE AUGUST 2001 DECISION in the case of Grimes v Kennedy Krieger Institute, Inc , 1 sent shockwaves through the public health research community. The court had challenged the acceptable level of risk in pediatric research studies, concluding that parents in the state of Maryland could not consent to their minor children's participation in research that posed even a minimal risk of harm if it offered no prospect of direct medical benefit to the subjects. Researchers feared that valuable public health research that complied with long-standing federal standards for research on children would be halted altogether or subjected to judicial oversight and intervention. Two months after the initial decision was handed down, the court indicated that it had not intended to apply a zero-risk standard to “nontherapeutic” pediatric research studies. The court articulated acceptable risk in this context as including the “minimal kind of risk that is inherent in any endeavor,” which appears to be consistent with the federal regulatory standard. 2 Despite the welcome clarification, Grimes deserves analysis of the ethical issues it raises and its relevance to future research. Here we provide a brief overview of the case, discuss some of the ethical issues raised by the court (risk–benefit assessment, informed consent, and exploitation), and offer opinions on the impact of the court's decision on research involving children and its possible effect on future research protection policies and practices.
