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Pepperdine University
Graduate and Professional Schools Institutional Review Board (GPS IRB)
Reviewer Guidelines: EXEMPT RESEARCH
Introduction
Please use this form in completing your review of the exempt research application. Federal guidelines
have designated six categories of human subjects’ research that qualify for exempt status. These
categories are described in the appendix of this form. Research that qualifies for exemption must pose
little if any risk to human subjects. Please note that it is Pepperdine University’s policy that all human
subjects’ research, including research that is ultimately determined to be exempt from further IRB review,
have an informed consent procedure in place.
As you read through the exempt application, please check “Yes”, “No”, or “N/A” for each item in the
checklist. Any item marked “No” may raise human subjects concerns that will need to be addressed or
may require a higher level of review before approval for exempt status is given. There are spaces
throughout the reviewer form for you to make additional comments that may clarify or expand upon items
marked “No” on the checklist.
Please email an electronic copy of your completed checklist to gpsirb@pepperdine.edu or mail a hard
copy to Jean Kang, Manager GPS IRB, Pepperdine University GSEP, 6100 Center Drive 5th Floor, Los
Angeles, CA 90045.
Thank You!
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Updated 1/16/07, 4/10/07
Pepperdine University
Graduate and Professional Schools Institutional Review Board (GPS IRB)
Reviewer Guidelines: EXEMPT RESEARCH
Instructions: Please fill in the IRB application information for the protocol that you are reviewing. The
checklist below can be used as a guide when reviewing applications submitted as Exempt. Items #1-9
should be checked “YES”, “NO”, or N/A. A “No” to any of these items requires clarification from the
investigator and may result in application for exempt status being denied (i.e., research would require
application for expedited or full review).
Principal Investigator (s):
IRB Protocol #:
Title:
Faculty Advisor
(if applicable):
Psy.D.
School/Program:
Education
Administration
GSBM
SOL
SPP
Other:
IRB Reviewer:
Date:
Item #
Application Item
Issue/Items to Check
o Is description of proposed research understandable?
Y
N
N/A
1.
Summary of
Proposed
Research, goals,
objectives
o
Are goals/objectives clearly stated?
Y
N
N/A
o
o
Is one of 6 exempt categories clearly listed?
Which category is listed?
Y
N
N/A
Subjects are NOT members of a
protected/vulnerable group are subjects (e.g.,
prisoners, pregnant women, fetuses or products of
labor & delivery, decisionally impaired individuals)
Y
N
N/A
o
Study DOES NOT involve deception
Y
N
N/A
o
If study involves observation of children, the
investigator DOES NOT participate in the activities
being observed
Y
N
N/A
o
Procedures involve no or minimal risk (see definition
below)
Y
N
N/A
o
Subjects are not placed at risk for criminal, civil,
financial, employability or loss of reputation.
Y
N
N/A
2.
Category of
research activity
qualifying for
exemption
(categories can be found in Appendix B of Investigator’s
Manual: 45 CFR 46 101(b))
o
3.
4.
Nature of human
subjects’
participation
Why should
protocol be
considered
exempt?
YES/NO/NA
2
o
Explain how
records will be kept
5.
o
Data recorded so
subjects can be
identified?
6.
o
o
o
Copies of data
collection tools
7.
Permission from
cooperating
institutions
N
N/A
Is explanation provided of who will have access to
keys linking data to specific identifiable individuals?
Does this seem restricted to only necessary
personnel?
Y
N
N/A
If mental health/health questionnaires used, is a
procedure described for referring participants for
follow-up assistance if illness/risk indicated?
Y
N
N/A
Y
N
N/A
Y
N
N/A
Is plan in place for how record of participants’
names/codes will be handled once study is
complete?
Are copies of any measures, forms, questionnaires,
surveys, flyers, etc. that participants will see
included?
Are copies of any scripts of information to be given
to participants included?
Y
N
N/A
o
Are copies of any data collection forms/database
formats included?
Y
N
N/A
o
Are all relevant bulleted points summarized
application under item #7 (i.e., research being
conducted to fulfill course/thesis requirements,
purpose of study, anonymity/confidentiality
statement) included in any relevant data collection
tool?
Is an informed consent form included that contains
elements listed in (45 CFR 46 116 (a)(1-8))
OR
a Waiver/Alteration of Informed Consent Form
Application completed?
Y
N
N/A
Y
N
N/A
Are letters of permission from cooperating
institutions included that specify investigator is
permitted to recruit subjects from site?
Y
N
N/A
o
Does investigator explain if HIPAA is applicable?
Y
N
N/A
o
If HIPAA applies, are copies of the covered entity’s
HIPAA Authorization and Revocation of
Authorization forms attached to the application?1
Y
N
N/A
Is Application for Use or Disclosure of PHI Without
Authorization form included if investigator plans to
disclose PHI without authorization?
Y
N
N/A
o
HIPAA
9.
Y
o
o
8.
Are reasonable safeguards in place for protecting
subject identities if information is recorded in a
manner that could identify participants (i.e., nonanonymous data) such as locked files for hard
copies, password protected computer files, etc.
o
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If the covered entity does not provide such forms, investigator can use those in Section X of the Pepperdine
University’s Protection of Human Participants in Research: Policies and Procedures Manual.
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Consent Document Required Elements (from 45 CFR 46.116)
o
YES/NO/NA
Statement that the study involves research, an explanation of the purposes of the
research and the expected duration of the subject’s participation, a description of the
procedures to be followed, and identification of any procedures which are experimental.
This information should be stated in lay language.
Y
N
N/A
o
A description of foreseeable risks or discomforts to subjects
Y
N
N/A
o
A description of any benefits to the subject or to others which may reasonably be
expected from the research
Y
N
N/A
o
(A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject) – May not be applicable
Y
N
N/A
o
Statement describing the extent, if any, to which confidentiality or records identifying the
subject will be maintained
Y
N
N/A
o
Statement that participation is voluntary, and that refusal to participate or discontinuing
participation at any time will involve no penalty or loss of benefits to which the subject is
otherwise entitled.
An explanation of whom to contact for answers to pertinent questions about the
research (e.g., investigator, dissertation chairperson) and research subjects’ rights (IRB
chairperson)
Y
N
N/A
Y
N
N/A
o
Minimal risk definition: “The probability and magnitude if harm or discomfort anticipated in the 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 test” (45 CFR 46.102(i)).
Reviewer Decision:
Please check one:
Approve Exemption - As submitted the protocol is exempt from further IRB review.
Approved with Minor Modifications (Provisionally Approve) – The principle investigator must
make minor modifications before final GPS IRB exemption can be given (list comments below).
Approved with Major Modifications (Clarifications Needed) - Substantive revisions and/or
requested information must be made to the application before final GPS IRB exemption can be
given (list comments below).
Reviewer Comments:
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Categories of Exempt Research According to the Code of Federal Regulations 45 CFR 46.101 (b)
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1. Research conducted in established or commonly accepted educational settings, involving
normal educational practices, such as:
a. Research on regular and special education instructional strategies
OR
b. Research on the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures2, interview procedures or observation of public behavior, unless:
a. Information obtained is recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects;
AND
b. Any disclosure of the human subjects' responses outside the research could reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial
standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures, or observation of public behavior that is not exempt
under paragraph (b)(2) of this section, if:
a. The human subjects are elected or appointed public officials or candidates for public office;
OR
b. Federal statute(s) require(s) without exception that the confidentiality of the 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.
5.
Research and demonstration projects which are conducted by or subject to the approval of
department or agency heads, and which are designed to study, evaluate, or otherwise
examine:
a.
b.
c.
d.
Public benefit or service programs
Procedures for obtaining benefits or services under those programs
Possible changes in or alternatives to those programs or procedures
Possible changes in methods or levels of payment for benefits or services under those
programs.
6. Taste and food quality evaluation and consumer acceptance studies, if:
a. Wholesome foods without additives are consumed
OR
b. 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.
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The exemption at 45 CFR 46.101 (b)(2), for research involving survey or interview procedures or observations of
public behavior, does not apply to research with children, Subpart D, except for research involving observations of
public behavior when the investigator(s) do not participate in the activities being observed.
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