Institutional Review Board (IRB) Processes Flashcards

Under the Common Rule, who may carry out an expedited review of a research protocol?

Answer: The IRB chair or one or more experienced IRB members designated by the chair

45 CFR 46.110 allows expedited review by the chair or experienced reviewers the chair designates from among IRB members.

What action is an expedited reviewer NOT permitted to take on their own?

Answer: Disapprove the research

An expedited reviewer can exercise all IRB authorities except disapproval, which needs the convened IRB.

For a convened IRB meeting to have a valid quorum under the Common Rule, which condition must be met?

Answer: A majority of members present, including at least one member whose primary concerns are nonscientific

Research is reviewed at meetings where a majority of members are present, including at least one nonscientist.

What is the minimum number of members an IRB must have under 45 CFR 46.107?

Answer: Five

Each IRB must have at least five members with varying backgrounds.

Under the 2018 revised Common Rule, continuing review is generally NOT required for which type of study?

Answer: Research eligible for expedited review, unless the IRB documents why it is needed

The 2018 rule removed continuing review for expedited-eligible research unless the IRB documents a reason for keeping it.

How often must research approved by a convened IRB that still needs continuing review be re-reviewed, at minimum?

Answer: At intervals appropriate to the degree of risk, but not less than once per year

Continuing review must happen at least annually, or more often when risk warrants it.

According to OHRP guidance, who should determine whether a study qualifies as exempt human subjects research?

Answer: Someone other than the investigator, such as the IRB or a designated institutional official

OHRP recommends that investigators not make their own exemption determinations, because of the potential conflict of interest.