Roles of IRBs Concerning PI Problems
|
IRBs define RI differently
IRBs interact differently with other institutional offices
IRBs differ in amounts of responsibility they feel they have for RI problems
|
Severity of Problems
|
|
What Are the Problems?
|
Poor informed consent
Non-submitting to the IRB
◆ Entire protocols
◆ Changes to protocols
“Merely paperwork” ◆ Changes in study design
|
How IRBs Learn of Problems
|
|
Causes of Problems
|
|
Responses to Problems
|
Vary in degree of severity and type
|
Implications
|
Most problems are minor, but not negligible and dismissible
Questions of whether better monitoring is warranted, and if so, what
|