IRB Decision Making

Question 1

Actions that the IRB can take when reviewing a study are
A.) Approve
B.) Approve with conditions
C.) Defer pending major modifications
D.) Disapprove
E.) All of above may apply

Question 2

The decision to approve with conditions implies
A.) Make specified changes to the protocol
B.) Make specified changes to the informed consent
C.) Submit specific clarifications or specified additional documents
D.) All of the above

Question 3

The IRB may not approve a study if it is unable
A.) To make determinations about research risks
B.) To determine adequancy of privacy and confidentiality agreements
C.) To determine the adequancy of the informed consent or the informed consent process
D.) All of the above

Question 4

When an IRB defers a research project
A.) The research can proceed in the interim
B.) The research may not proceed until reviewed by the IRB chair
C.) The research may not proceed until reviewed by a qualified consultant to the IRB
D.) The research may not proceed until reviewed again and approved by a fully convened IRB

Question 5

When a study is reviewed under an expedite procedure the IRB may do all of the following except
A.) Approve the study without conditions
B.) Approve the study with conditions
C.) Defer the study pending major modifications
D.) Disapprove the study