Do research studies involving Children, Prisoners, Pregnant women and Fetuses qualify for Exempt Category Research?

The inclusion of children in a research study can qualify as Exempt under Categories (1) and (3)-(6). For Category (2), ONLY research activities involving educational testing and observation of public behavior where investigators DO NOT participate in research procedures can be considered Exempt. Research involving children engaging in surveys or interviews CANNOT be approved under Exempt category.

Under federal regulations certain studies involving pregnant women and neonates/fetuses may be considered Exempt under Categories (1)-(6). However, these studies must meet the definition of minimal risk and may be subject to full board review, if the IRB chair deems it necessary.

The inclusion of prisoners in research is NOT considered to qualify for Exempt category research at UNTHSC. Federal regulations are specific in regard to prisoner research and the manner to which it must be reviewed.

 

Pages in Exempt Review

Exempt Category Review

What is Exempt Review

Who decides whether or not a project has “minimal risk”

Which Research Studies fall under Exempt Category Review

Do studies involving Children, Prisoners, Pregnant women and Fetuses qualify

What do I submit

How will I know that a Protocol has been approved