What happens when a researcher adds adolescents to a previously expedited study with no planned changes?

Adding adolescents to a previously expedited study with no planned changes raises important considerations regarding the nature of the research and the associated risks. When a study is reviewed under an expedited process, it is typically because the research poses minimal risk to participants and qualifies under specific categories set by the Institutional Review Board (IRB).

If the addition of adolescents does not alter the primary objectives or the risks involved in the study, the research may still qualify for expedited review, provided that the risks to this new group remain minimal and comparable to those already present. The IRB's initial assessment would have determined that the study was low-risk for the original participant cohort, and if incorporating adolescents does not elevate that risk level, it may continue to be reviewed under expedited procedures.

It is important to note that, although the expedited review process could remain in effect if risks are minimal, researchers must still uphold ethical standards regarding parental consent when participants are minors. Consequently, while additional layers of compliance and permission processes may apply, the core review process can remain expedited if risk assessments favor that decision.