Exempt studies should also include children as participants. The research topic is irrelevant to children. There are laws or regulations barring the inclusion of children in the research. The knowledge being sought is already available for chilren or will be obtained from another ongoing study. A separate, age-specific study in children is warranted and preferable.
Insufficient data are available in adults to judge potential risks in children.
If you have any questions about implementation of this policy, please call the GCRC office at 384-8305. The University of Iowa General Clinical Research Center, Iowa City.