effectiveness and efficiency of the system for protecting human research participants.

Investigators play a central role in the system for protecting child participants in research. Ensuring that they understand their obligations is a high priority as is further work to build an administrative, financial, and information infrastructure that makes it easier for investigators to know and fulfill their responsibilities. IRBs and research institutions can clearly improve their guidance and tools to help investigators design and implement ethically and scientifically sound clinical studies. Similar improvements by government agencies will, in turn, assist IRBs and research institutions as well as investigators.

Government policymakers can also fund research and demonstration projects to expand the knowledge base for strengthening the performance of the system for protecting child participants in research, for example, by testing strategies to improve the quality and consistency of reviews for multisite research projects and reduce unnecessary burdens and frustrations for their investigators and sponsors. Such improvements will not eliminate tensions between the goal of protecting today’s children from research harms and the goal of advancing research that improves the health and well-being of tomorrow’s children. They can, however, help all parties feel more confident that the system for protecting child research participants is trying to identify and remove needless burdens on those who undertake these critical investigations.

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