Which of the following is a requirement for expedited review when adding an adolescent population to a study originally involving adults?

Prepare for the CITI Program HSR Social and Behavioral Education (SBE) Exam with flashcards and multiple-choice questions, each with hints and explanations. Get ready to excel in your certification!

The requirement for expedited review when adding an adolescent population to a study originally involving adults centers around the concept of risk. If the study's risk levels remain minimal, it demonstrates that adding adolescents will not significantly increase the ethical considerations or potential harm involved when compared to the risks that were already present for adult participants. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research is not greater than that ordinarily encountered in daily life or during routine physical or psychological tests.

In contrast, while interviews and consent processes are critical aspects of conducting research, they do not specifically address the expedited review process for adding new populations. Moreover, while changes must be disclosed to the IRB, this requirement is a standard practice for all modifications to a study and does not specifically pertain to the conditions for expedited review concerning risk levels. Thus, maintaining minimal risk is the essential criterion that underpins the ability to expedite the review when incorporating adolescents into research that initially involved only adult participants.

Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy