Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit.

United States federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer participants a "prospect of direct" benefit only when the risks are minimal or a "minor" increase over minimal. The federal regulations define minimal risks based on the risks "ordinarily encountered in daily life or during routine physical or psychological examinations or tests." In the absence of empirical data, IRB members may assume they are familiar with the risks of daily life and with the risks of routine examinations and tests and rely on their own intuitive judgment to make these assessments.

Medical researchers' ancillary clinical care responsibilities.

Investigation of participants in clinical trials may identify conditions unrelated to the study. Researchers need guidance on whether they have a duty to treat such conditions

The general agreement on trade in services: implications for health policymakers.

The General Agreement on Trade in Services (GATS), created under the auspices of the World Trade Organization, aims to regulate measures affecting international trade in services-including health services such as health insurance, hospital services, telemedicine, and acquisition of medical treatment abroad. The agreement has been the subject of great controversy, for it may affect the freedom with which countries can change the shape of their domestic health care systems. We explain the rationale behind the agreement and discuss its scope.