WILL THE DATA BE USED FOR RESEARCH, CLINICAL OR QA
PURPOSES?
|
Research |
Clinical or QA
Only: NO IRB INTERACTION REQUIRED
|
|
|
x |
DOES
THE STUDY ENTAIL MORE THAN MINIMAL RISK?
YES
NO |
| x |
DOES
THE STUDY FALL INTO ONE OF THE CATEGORIES OF EXPEDITABLE OR EXEMPTIBLE
RESEARCH? (See lists of criteria,
C.11 and C.15)
NO
YES |
| x |
WILL
THE INFORMATION BE LINKED TO INDIVIDUAL SUBJECTS?
(For survey/interview studies,
this applies only to information which may create some risk for the subject)
YES
NO |
|
x |
WILL
DATA BE GATHERED PROSPECTIVELY?
(Does not apply to survey/interview
data. "Retrospective" means the data already exist when the study
commences. )
YES
NO |
|
x |
DOES
THE STUDY FALL INTO A CATEGORY OF EXEMPT RESEARCH? (See
list of criteria, C.15)
NO
YES |
| |
|
|
|
| FULL
IRB REVIEW REQUIRED |
EXPEDITED
IRB
REVIEW ALLOWED x |
EXEMPTION
FROM
IRB REVIEW ALLOWED |
