Request for IRB Determination of Exempt Status
Tests, Surveys, Interviews, or Passive Observations
of Public Behavior
IRB Number
NOTE: Subjects under 18 years of age 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:
Principal investigator:
Date requested:
A.
B.
C.
D.
E.
F.
1.
1a.
Date study will begin:
INITIAL CRITERIA
Check type(s) of measures to be used.
☐ Passive observation of public behavior
☐ Educational tests (cognitive, diagnostic, aptitude)
☐ Survey
☐ Interview
Will subjects be elected or appointed
☐ No ☐ Yes
public officials?
Will subjects under 18 years of age be
☐ No ☐ Yes
studied?
If Yes, will researchers interact with
☐ No ☐ Yes If Yes, STOP; study does not qualify for
subjects other than in cognitive,
exempt status.
diagnostic, or aptitude testing context?
Will information be recorded
☐ No ☐ Yes If No, STOP; study does not qualify for
anonymously (i.e., no subject identifiers or
exempt status—unless subjects will be
codes that can be used to re-identify
elected or appointed public officials, in
subjects to be recorded)?
which case the study may qualify for
exempt status.
Will sensitive information be recorded
☐ No ☐ Yes If Yes, STOP; study does not qualify for
that could damage subjects’ reputation,
exempt status—unless subjects will be
employability or financial standing, or
elected or appointed public officials, in
place them at risk for criminal or civil
which case the study may qualify for
liability?
exempt status.
Will any information from this project be ☐ No ☐ Yes If Yes, STOP; study does not qualify for
submitted to the FDA?
exempt status.
SUPPORTING INFORMATION
Subjects
Who will be studied?
1b. Will children under the age of 18 be studied?
If Yes,
i. Provide a rationale for the specific age ranges of children to be included.
☐ No ☐ Yes
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.
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Request for IRB Determination of Exempt Status: Tests, Surveys, Interviews, or Passive Observations of
Public Behavior, continued
iv. Will sufficient numbers of children be studied to answer the scientific questions? Please
elaborate.
v. Is the research limited to educational tests or passive observations of
☐ No ☐ Yes
public behavior?
1c. Will you be interacting with non-English speaking subjects?
☐ No ☐ Yes
i.
If Yes, are you fluent in the language they understand?
☐ No ☐ Yes
ii. If No, indicate how you will communicate with subjects (e.g., with interpreter-if so, who will
serve in that role.
2. Recruitment
2a. How will potential subjects be identified and how and where will they be approached for
participation?
2b. Describe the recruitment materials (ads, letters, recruitment script, e-mails etc.) to be used, if
applicable, and attach a copy of each.
2c. i.
If applicable, attach the introductory script that describes the study and includes relevant
elements of consent (see informed consent templates at X:\Institutional Review
Board\Templates).
ii. If NOT applicable, explain why.
3. Methods
3a. List the measures (e.g., surveys, questionnaires, etc.) to be used, and attach a copy of each.
3b. Describe how information will be obtained (e.g., face to face, phone, mail, Internet).
3c. Describe where study will be conducted, and who will collect data.
3d. Indicate how often subjects will be contacted and why.
3e. Describe how confidentiality of data will be protected and maintained.
3f. If subjects will be paid or otherwise compensated or incentivized, indicate how much they will
receive, and how they will be compensated.
4. Analysis
How will results be analyzed to determine that study aims have been met?
5. Additional Information, Clarification, or Comments for the IRB Reviewer
CERTIFICATIONS AND ASSURANCES
I am responsible for the conduct of this research protocol, including the co-investigator(s) and other
research staff. I have certified that all co-investigator(s) and other research staff have completed the
training requirements.
I hereby certify that
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Request for IRB Determination of Exempt Status: Tests, Surveys, Interviews, or Passive Observations of
Public Behavior, continued


The information contained in this document is accurate and correct.
I will carefully follow the approved research protocol and submit all changes to the IRB for
consideration before incorporating them into the study.
 I will notify the IRB of any deviations from the approved research protocol taken in an
emergency to protect the subject from harm; and any unanticipated problem, or serious,
unusual, or unanticipated adverse event.
I or my designee will abide by the informed consent process with each subject and document this
process on the approved consent form, allowing each subject adequate time before the study to decide
voluntarily to participate in this study.
I will protect the rights and welfare of each subject to the best of my ability.
Principal Investigator’s Signature
Date
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