External IRB Review with 100% Correct Answers

External IRB Review with 100% Correct Answers
Centralized review refers to one IRB's review of
multiple sites. Which of the following describes
external, non-centralized review? -
ANSWER -An IRB hired by an institution to
review all non-biomedical studies.


A central IRB can be described as: -
ANSWER -A single IRB reviewing one
study for multiple investigators.


Which of the following factors contributed to the
growing acceptance of use of a central IRB? -
ANSWER -Common Rule mandated
centralized review


When does FDA have the authority to inspect an
independent IRB? - ANSWER -FDA has
the authority to inspect independent IRBs
regarding the IRB's review of any FDA-regulated
studies.


Are inter-institutional agreements between an
institution and an external IRB always required? -
ANSWER -No, no agreement is required by
regulation unless the research is subject to the
Common Rule.


When does OHRP have the authority to inspect
an independent IRB? - ANSWER -OHRP
has the authority to inspect independent IRBs
that are named as the IRB of record for the
federal grant.


Must an Independent IRB organization obtain a
Federalwide Assurance (FWA)? -
ANSWER -No, because they are not
considered "engaged in" research, according to
OHRP.

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