Researcher Guidance

In some cases, the IRB may provide additional safeguards for research involving economically or educationally disadvantaged individuals.

Neonate: Newborns from the time of delivery up until 28 days old. The IRB may have additional considerations for the research that involves children and neonates.

Federal regulations require additional safeguards when approving research involving pregnant women and fetuses. 

Federal regulations place additional safeguards on research that involves prisoners as participants. The IRB reviews all research involving prisoners using the expertise of a prisoner representative (with no association to the prison involved in the research) and who is a member of the IRB.

The IRB must conduct an assessment of the risks to participants in order to determine whether a study is approvable.

The University of Illinois Urbana-Champaign IRB has determined that data in the datasets in this guidance document has been stripped of identifiers and is publicly available. As a result, research using this data does not rise to the level of "human subjects research" under the federal Common Rule and University policies, and therefore, does not require IRB review.

In order for a record (or research data set) to be considered de-identified, each of the 18 identifiers must be removed. 

This guidance outlines the specific determinations the IRB must make to approve a waiver or alteration of informed consent.

Federal regulations may require additional safeguards for research involving wards of state.  In Illinois wards are called "Youth in Care".