Quiz

1. Once a project has been initially reviewed and approved by the IRB, no
further review is necessary.

The correct answer is: False

Regular reevaluation by the IRB is necessary to ensure that research is being conducted ethically and responsibly.

2. The death of a study subject should be reported to the IRB if it is believed
to be unrelated to the study.

The correct answer is: True

The death of a subject should be reported to the IRB, whether or not it is believed to be related to the study.

3. Unexpected problems whose nature, severity, or frequency are not
described in the information provided to the IRB or to participants are
called:

The correct answer is: A

Adverse events are unexpected problems that are not provided initially to the IRB.

4. Continuing review of a study by the IRB occurs at least:

The correct answer is: C

Continuing review of a project occurs at least annually. However, the IRB may require more frequent review.

5. The terms of a continuing review are outlined when original approval is
granted.

The correct answer is: True

The terms of the review, as well as the documentation required for any special review, are outlined when approval is originally granted.