IRB: Ethics & Human Research

Are the New EPA Regulations Concerning Intentional Exposure Studies Involving Children Overprotective?

The Environmental Protection Agency has adopted new regulations that prevent the agency from conducting or funding intentional exposure research involving children, pregnant women, or fetuses.  I argue that these regulations overprotect children, and that the EPA should revise them to conform with Subpart D of the Department Health and Human Services’ regulations governing research with humans.

Key words/concepts:  Environmental Protection Agency, children, intentional exposure studies, Common Rule