Is it “research”?
No
Yes
Do you need to
access private,
“identifiable”
information?
Yes
No
No submission
Required
Except when…
Expedited
review
Yes
Does it involve
direct identifiers?
OR
Does the study
require FDA
oversight?
No submission
required
No
No
submission
required
No
Expedited
review
Indirect: Exempt
review with
HIPAA waiver
Yes
Will any of the data
used be prospectively
collected?
No
Could research be
carried out if consent
was required?
Yes
Yes
Could research be carried out
if consent was required?
Yes
Yes
No
Does it involve
indirect identifiers?
Yes
Will results
be sent back
to source?
No
Expedited review Expedited review
with consent
with HIPAA
process
waiver
Indirect: Exempt review
with consent process
Direct: Expedited review
with consent process
Direct: Expedited
review with
HIPAA waiver
•“Research”: a systematic investigation, including
research development, testing and evaluation,
designed to develop or contribute to generalizable
knowledge.
•Use: When research requires identifiers to select or
identify appropriate charts.
•Collected: When research requires recording
identifiers for any length of time.
•“Identifiable”: When the data contains any of the
18 identifiers (i.e. name, MRN, age, etc.)
•Prospective collection: When the data are not all
“on the shelf” at the time of IRB submission.
•Direct/Indirect identifiers: See HIPAA waiver for
list.