Module 5

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:

Must occur within 12 months of the approval date.

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

Prisoners

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

Officials of the institution may overrule an IRB approval.

According to the federal regulations, research is eligible for exemption, if:

The research falls into one of eight categories of research activity described in the regulations.