Institional Review Boards

1. A protocol that has been previously reviewed by the full IRB is always eligible for
expedited review.
A. TRUE
B. FALSE

2
Changes to a study protocol, via a protocol amendment, can be implemented at the site as soon
as it is submitted to the IRB.
A. TRUE
B. FALSE

3
The purpose of an IRB is to safeguard the rights, safety, and well-being of all human research
participants.
A. TRUE
B. FALSE

4
The site staff has prepared a postcard to be sent to past study participants telling them about a
new study that they may have an interested in. This postcard does not have to be reviewed by the
IRB.
A. TRUE
B. FALSE

5
All of the following statements are True or False:

 The purpose of an Institutional Review Board (IRB) is to safeguard the rights, safety, and
well-being of all human research participants.
 Any federally funded research involving human participants must be reviewed and
approved by an IRB.
 Any clinical investigation involving a product regulated by the FDA must be reviewed
and approved by an IRB.
 An IRB has the authority to approve or disapprove all human research activities that fall
within its jurisdiction. It also has the authority to suspend or terminate a research study
that it previously approved.

A. TRUE
B. FALSE