Request for Exempt Determination:
Tests, Surveys, Interviews, or Passive Observations of Public Behavior
Note: This exemption is limited to individuals 18 years of age or older. Subjects under 18 can be
evaluated with educational tests only (no surveys or interviews). They can also be passively observed
in public places, but only so long as researchers do not participate in the activities being observed.
Title of Study:
A. Check type(s) of measures to be used:
Passive Observation of Public Behavior;
Educational Tests (cognitive, diagnostic, aptitude);
Survey;
Interview;
Other (Describe)
B. Will subjects under 18 years of age be studied? No
Yes
If yes, to what extent will researchers interact with subjects?
C. Will information be recorded anonymously (i.e., no subject identifiers or codes that can be used to reidentify subjects will be recorded)?
No
Yes ; If identifiers are recorded, provide justification:
D. Will “sensitive information” be recorded that could damage subjects’ reputation, employability or
financial standing, or place them at risk for criminal or civil liability? No
Yes
If yes, explain:
E. Will any information from this project be submitted to the FDA? No
Yes
If Yes, STOP and
contact the IRB at irb@pitt.edu.
1. Subjects
a. Who will be studied?
b. Will children be studied? No
Yes
i. Provide a rationale for the specific age ranges of children to be included.
ii. Describe the expertise of the investigative team for dealing with children of that
age range.
iii. Describe the adequacy of the research facilities to accommodate children of
that age range.
iv. Will sufficient numbers of children be studied to answer the scientific
questions? Please elaborate.
v. Will the investigators interact directly with the child subject?
No ; Yes
vi. Is the research limited to educational tests or passive observations of public
behavior? No
Yes
c. Will you be interacting with non-English speaking subjects? No
Yes
i. If Yes, are you fluent in the language they understand? No
Yes
1. If No, indicate how you will communicate with subjects (e.g., with
interpreter-if so, who will serve in that role:
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2. Recruitment
a. How will potential subjects be identified and how and where will they be approached
for participation?
b. Describe the recruitment materials (ads, letters, recruitment script, e-mails etc.) to be
used, if applicable, and upload a copy in OSIRIS question E 2.0.
c. Upload the introductory script that describes the study and includes relevant elements
of consent in OSIRIS question E 2.0. View the model introductory script on the IRB
website at http://www.irb.pitt.edu/irbforms/.
Not Applicable
If Not Applicable, why?
3. Methods
a. List the measures (e.g., surveys, questionnaires, etc.) to be used, and upload a copy of
each in OSIRIS question E 2.0 (unless measure does not require submission because it is
listed in the Standard Screening Instruments section in the Resources page on the IRB
web site (http://www.irb.pitt.edu/resources):
b. How will information be obtained (e.g., face to face, phone, mail, Internet)?
c. Where will study be conducted, and who will collect data?
d. How often will subjects be contacted, and why?
e. How will confidentiality of data be maintained?
f. If subjects will be paid or otherwise compensated or ‘incentivized’, indicate how much
they will receive, and how they will be compensated?
 Note: Review ‘Incentives for Participation in Research Studies’ under Section XV of the IRB
Policies and Procedures Manual at http://www.irb.pitt.edu/PandP and
http://www.bc.pitt.edu/wepay/index.php for WePay payments from University accounts.
4. Analysis
a. How will results be analyzed to determine that study aims have been met?
5. Additional Information, Clarification, or Comments for the IRB Reviewer:
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