Attach D_IRB Exempt

Title of Study: SSA Computer Adaptive Testing (CAT) Usability Project
Protocol Number: H-32412
RE: New Protocol
Review Type: Exempt
Action: Not Human Subjects Research
Date of Action: August 15, 2013
Protocol Version #: 1.1
Dear Alan Jette Dr, PhD,
A qualified member of the BUMC Institutional Review Board (IRB) staff has reviewed
the above referenced protocol and has determined that it does not require further
review by the BUMC IRB because it does not meet the definition of “human subject
research”.
The BUMC IRB has made this determination based on the regulatory definitions of
Human Subject and Research per the following:
1. According to HHS, Human Subject means a living individual about whom an
investigator (whether professional or student) conducting research obtains (1) data
through intervention or interaction with the individual, or (2) identifiable private
information (45 CFR 46.102(f)).
2. According to FDA, a Human Subject means an individual who is or becomes a
participant in research, either as a recipient of the test article or as a control (21 CFR
50.3(g)).
3. Research means a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to generalizable
knowledge (45 CFR 45.102(d)).
Protocol Specific Determinations
As a QA Project this falls under "clinical HIPAA" not research HIPAA. Please
consult with Mr. Sumit Sehgal the BMC Privacy Officer regarding any questions
about HIPAA requirements for QA projects.
Requirements
This approval corresponds with the version of the protocol indicated above.
All determinations regarding this project have been made based on the information
submitted by the investigator. Any modifications to the research plan (including any
H-32412

PI Name: Alan Jette Dr, PhD

Page 1

changes in funding) must be submitted to the IRB for review and approval prior to
initiation, and may change the IRB’s determination.
You may retain this letter in your files as documentation of this decision by the
BUMC IRB. No progress reports are required for this project as long as no changes
are made to the protocol.
It is the responsibility of the PI to ensure that any relevant HIPAA requirements have
been met. It is also the responsibility of the PI to ensure that all required institutional
approvals have been obtained prior to initiating any protocol related activities.
Sincerely yours,

Signature applied by Ashley Faber on 08/16/2013 02:12:06 PM EDT

Senior IRB Analyst

H-32412

PI Name: Alan Jette Dr, PhD

Page 2