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Date of Preparation:
UPIRB #:
(Include, if known)
University of Southern California
UNIVERSITY PARK
INSTITUTIONAL REVIEW BOARD
(MPA: M-1299-01)
Grace Ford Salvatori Hall, Room 226, Los Angeles, CA 90089-1695
Phone: 213/821-5272
FAX: 213/821-5276
Website: www.usc.edu/admin/provost/irb E-mail: upirb@usc.edu
Request for Claim of Exemption from Board Review1
Project Title:
Principal Investigator/Faculty
Sponsor:
Address:
Telephone Number:
E-Mail Address:
Co-PI or Student Investigator
Address
Fax Number:
Telephone Number:
E-mail Address:
Primary Contact Person:
Fax Number:
II. Funding
Federal
Internal Grant Program
Commercial/Foundation
None
Other, Specify:
Funding Source:
Contract or Grant Title*:
Contract or Grant #:
*Please indicate whether the study under review is being conducted under the auspices of a
larger umbrella grant (e.g., Training Grant, Center Grant, Program Project Grant)
1
This form is designed to be filled out on the computer, handwritten copies cannot be accepted.
UPIRB Claim of Exemption Form
Rev. 4/29/03
Yes
No
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III. Principal Investigator’s Assurance
Signature certifies that the Principal Investigator understands and accepts the following obligations to protect the rights
and welfare of research subjects in this study.
 I recognize that as the Principal Investigator it is my responsibility to ensure that this research and the actions of all
project personnel involved in conducting the study will conform with the IRB approved protocol, IRB
requirements/policies, and all applicable HHS/FERPA/PPRA/HIPAA regulations.
 I recognize that it is my responsibility to ensure that valid informed consent/assent has been obtained from all
research subjects or their legally authorized representatives. I will ensure that all project personnel involved in the
process of consent/assent are trained properly and are fully aware of their responsibilities relative to the obtainment
of informed consent/assent according to the IRB guidelines and applicable federal regulations. I will use only the
currently approved, IRB stamped informed consent form or script for recruiting subjects.
 I will inform the IRB of any unanticipated adverse event or injury no later than two (2) business days following the
time it becomes known that a subject suffered an adverse event/injury.
 I will not initiate any change in protocol without IRB approval except when it is necessary to reduce or eliminate a
risk to the subject in which case the IRB will be notified as soon as possible.
 I will maintain all required research records and recognize the IRB is authorized to inspect these records.
 I will inform the IRB immediately of any significant negative change in the risk/benefit relationship of the research
as originally presented in the protocol and approved by the IRB.
 I understand that IRB approval is valid for a maximum period of one year with continuing review by the IRB
required at least annually in order to maintain approval status. I will not enter subjects on the study before IRB
approval or if IRB approval expires. In the latter case, I will immediately contact the IRB to obtain permission to
continue subjects in the research study.
 I will inform the IRB immediately if I become aware of any violations of HHS regulations (45 CFR 46), FERPA
regulations (34 CFR 99), PPRA regulations (34 CFR 98), HIPAA regulations (45 CFR 164.530), or IRB Policies
and Procedures for the protection of human subjects.
 I understand that failure to comply with all applicable HHS/FERPA/PPRA/HIPAA regulations, IRB Policies and
Procedures and the provisions of the protocol as approved by the IRB may result in suspension or termination of
my research project, notification of appropriate governmental agencies by the IRB, and/or suspension of my
freedom to present or publish results.
 I certify that as faculty sponsor that the student investigator is knowledgeable about the IRB Policies and
applicable federal regulations governing research with human subjects and has sufficient training and experience to
conduct this study in accord with the approved protocol. In addition I will meet with the student investigator on a
regular basis to monitor study progress. Should problems arise I agree to be available personally to supervise the
student investigator in solving them. If I will be away, I will arrange for an alternate faculty sponsor to assume my
responsibilities.
 I certify that all study personnel have completed the HIPAA education program and are certified, if applicable.
_____________________________________________________________
PRINCIPAL INVESTIGATOR (FACULTY SPONSOR) Printed Name, Signature & Date
_____________________________________________________________
CO-PRINCIPAL INVESTIGATOR Printed Name, Signature & Date
_____________________________________________________________
DELEGATED REVIEW CHAIR Printed Name, Signature & Date
IV. Student Investigator’s Assurance (if applicable)
Student Investigator’s (Co-Principal Investigator’s) Assurance: By my signature as student investigator, I certify
the above applicable assurances and that I will meet with my faculty sponsor on a regular basis to monitor study
progress. If my faculty sponsor is away, I will meet with his/her arranged alternate faculty sponsor who will assume
his/her responsibilities.
__________________________________________________________
CO-PRINCIPAL INVESTIGATOR (STUDENT) Printed Name, Signature & Date
UPIRB Claim of Exemption Form
Rev. 4/29/03
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Exemption Categories Checklist
Exempt status applies to research activities in which the only involvement of human subjects will fall in one or
more of the categories listed below. Please check-off the appropriate categories that apply to your research
project. Note: These exemptions do not apply to research: a) involving prisoners, fetuses, pregnant women, human in
vitro fertilization; b) when there is additional involvement of human subjects beyond the categories listed below; c)
when deception of subjects may be an element of research; or d) when the activity might expose the subject to
discomfort or harassment beyond levels encountered in daily life.
Exemption Categories

1. Research conducted in established or commonly accepted educational settings involving normal educational
practices, such as i) research on regular and special educational instructional strategies, or ii) research on the
effectiveness of or the comparison among instructional techniques, curricula, or classroom management
methods. Note: This exemption is applicable to individuals with mental handicaps only if research involved
no change in the content, location, or procedures of instruction from those normally experienced by the
subject.
2.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior, unless the following two conditions
exist: i) information is recorded in such a manner that the human subjects can be identified directly, or
through identifiers linked to the subjects; and ii) any disclosure of the subjects’ responses outside the
research could reasonable place the subjects at risk of criminal or civil liability or be damaging to the
subjects’ financial standing, employability, or reputation. Note: This exemption applies to research with
children or individuals with mental handicaps as follows: i) research involving the use of educational tests
is exempt; ii) research involving survey or interview procedures is not exempt; iii) research involving
observations of public behavior is exempt only when the investigator does not participate in the observed
activities.
3.
All research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures or observation of public behavior that is not exempt under category 2 above, i) if the human
subjects are elected or appointed public officials or candidates for public office; or ii) federal statue(s)
require(s) without exception that the confidentiality of personally identifiable information will be
maintained throughout the research and thereafter.
4.
Research involving the collection or study of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if the information is recorded by the
investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the
subjects. Note: this category is applicable to data, specimens, etc. that are already existing at the time that
the research is proposed.
5.
Research and demonstration projects which are conducted by or subject to the approval of the Department
of Health and Human Services (DHHS), and which are designed to study, evaluate, or otherwise examine: i)
public benefit or service programs; ii) procedures for obtaining benefits or services under these programs;
iii) possible changes in or alternatives to those programs or procedures; or iv) possible changes in methods
or levels of payment for benefits or services under these programs.
6.
Taste and food quality evaluation and consumer acceptance studies, i) if wholesome foods without additives
are consumed or ii) if a food is consumed that contains a food ingredient at or below the level and for a use
found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be
safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the
Food Safety and Inspection Service of the U.S. Department of Agriculture.
Other: Not human subject research (e.g., research with cells from cadavers); please specify.
UPIRB Claim of Exemption Form
Rev. 4/29/03
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Summary Information
1. Please describe the study population(s).
2. Please indicate the number of subjects:
3. What is (are) the source(s) of the subjects?
4. Briefly describe the purpose of the project (attach a copy of any separate research protocol).
Complete this section if you are requesting permission to study existing data, documents, records and/or
biological specimens (Exemption category #4).
If you are requesting permission to study products of in-vitro fertilization or human fetuses, please do not complete this
form. Submit an application to the Health Sciences Campus IRB.
5. Will only existing or archived data, documents, records, or biological specimens be used (no prospective
collection of information or specimens as of this date)?
Yes
No
(If yes, please answer the following questions)
a. What is (are) the type(s) of specimens that will be used?
b. Were the data/biological specimens originally collected solely for research purposes?
(If “yes” is checked, please attach a copy of the IRB notice and approved consent form for the
research responsible for the original data collection.)
c. What is the source of the existing or archived data/biological specimens?
d. Is the source publicly available2?
Yes
Yes
NoNo
No
No
e. How are data/biological specimens identified when they are made available to your study team?
i.
Direct Identifier
(e.g., subject name, address, social security number, medical record number, etc.)
ii.
Indirect Identifier (e.g., an assigned code used to track specimens)
iii.
No Identifier
(neither the researcher nor the source providing the data/biological specimens can identify
a subject based upon information provided with the data/biological specimens)
f. If (i) or (ii) is checked above and you are requesting permission to study biological specimens,
will the identifier provided with the specimens be removed and destroyed upon receipt by your
study team?
g. If (i) or (ii) is checked above and you are requesting permission to study archived data, will you
abstract and record any subject identifiers as part of the data collection process?
h. Will any data or biological specimen(s) be collected from subjects after submission of this
application?
2
Yes
No*3
Does not
apply
Yes*
No
Does not
apply
Yes*
No
“Publicly available” means that the general public can obtain the data/biological specimens. Sources are not
considered “publicly available” if access is limited to researchers.
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UPIRB Claim of Exemption Form
Rev. 4/29/03
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* Your research protocol does not qualify for exemption from IRB review.
Please complete questions # 6 #7 and #10 below and submit the materials for UPIRB review.
Please complete this section if you are requesting
Exemption under categories #1, 2, 3, 5, or 6.
6. In order to ensure voluntary participation, describe briefly the recruitment procedures. Attach a copy of any
material (verbal or written) used to recruit subjects (e.g., flyers, cover letters, verbal recruitment, etc.)
7. Describe the procedures in which subjects will participate. If survey instruments will be used, describe the
time that it will take subjects to complete them, the frequency of administration, and the setting in which they
will be administered. Please submit a copy of all instruments for this study, including all surveys,
questionnaires, surveys, etc. Note: exploration of sensitive or private topics is not an exempt activity.
8. Will subjects be identifiable either by name or through demographic data?
Yes
No
If yes, please describe how the confidentiality of subjects’ identities will be maintained and plans for maintaining or
destroying identifying links to subjects after the study is completed.
9. Will data be recorded by audiotape or videotape?
If yes, please describe how subjects will be identified in the study records/taped responses.
Yes
No
10. Informed Consent - Please attach an appropriate informed consent document 4 to this application. If subject
participation is anonymous, an information sheet is recommended. If subject participation is not anonymous, please
attach a consent form to this application or provide justification for a waiver of informed consent. Waiver or
alteration of the requirements for informed consent should be justified by addressing the items listed below.
a. Why does the proposed use of existing data or biological specimens present no more than minimal risk 5 to
the subjects?
b. Why could the research not practicably be carried out without the waiver of informed consent?
c. Why will a waiver of informed consent not adversely affect the rights and welfare of the subjects?
d. Why the privacy risks to the individuals whose private health information is to be used or disclosed are
reasonable in relation to the anticipated benefits, if any, to the individuals and the importance of the
knowledge that may reasonably be expected to result from the research.
e. How will pertinent information be provided to the subjects, if appropriate, at a later date?
Additionally, indicate your plan for destruction of the identifiers at the earliest opportunity consistent with the
conduct of the research, unless there is a health or research justification for retaining the identifiers or such
retention is required by law.
4
5
An appropriate consent document can consist of a consent form, information sheet, survey cover letter, verbal
consent script, or a letter to the subjects.
DHHS defines minimal risk as "The probability and magnitude of harm or discomfort anticipated in research are
not greater in and of themselves than those ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests."
UPIRB Claim of Exemption Form
Rev. 4/29/03