Exempt Review
Tasha Osafo, CIP
Assistant Director
IRB Office
OBJECTIVES
 Review Basic IRB Concepts
 Overview of Exempt Categories
TKO
10/14/2011 IRB Retreat
COMMON EXPRESSIONS
 “I’m not interacting with humans. My project is
exempt from the IRB.”
 “The PI is receiving de-identified data; her
project is exempt.”
 “I’m doing a QI project; is my project exempt?”
WHAT IS WRONG HERE?
TKO
10/14/2011 IRB Retreat
Misuse of the term “Exempt” when
referring to “Non-human subjects
research”
From IRB perspective, the project is either
 Non-human subjects research
or
 Human subjects research that meets Exempt,
Expedited, or Full Board review criteria
TKO
10/14/2011 IRB Retreat
Basic Decision Tree
Step 1: Research?
Yes
No
No IRB
Step 2: Human Subjects? Yes
No
No IRB
Step 3: Exempt, Expedited or Full Board?
Step 4: Submit to IRB for final determination
TKO
10/14/2011 IRB Retreat
Quick Facts about Exempt Research
 No continuing review required
 At NU, IRB Reviewer makes Exempt determination
 6 OHRP & 4 FDA categories(1 category overlaps)
 No prisoners; pregnant women allowed; minors
allowed, but restrictions apply (Subpart B & D
determination not needed)
 HIPAA requirements apply if PHI used or disclosed
TKO
10/14/2011 IRB Retreat
OVERVIEW OF EXEMPT CATEGORIES
 Review the Exempt Categories and
overlapping Expedited Categories.
 Case Scenarios
TKO
10/14/2011 IRB Retreat
Exempt Category 1
Research conducted in established or commonly
accepted educational settings, involving normal
educational practices, such as
(i) research on regular and special education
instructional strategies, or
(ii) research on the effectiveness of or the
comparison among instructional techniques,
curricula, or classroom management methods.
TKO
10/14/2011 IRB Retreat
Exempt Category 1
Key Points:
 Research in established or commonly accepted
educational settings, and
 Research of normal education practices
Examples:
 Evaluating the use of accepted or revised
standardized tests
 A program evaluation of pharmacy continuing
education
TKO
10/14/2011 IRB Retreat
Case Scenario
Chicago public schools have offered SAT
preparation workshops to its students for the last
10 years. The school tracks SAT results for its
own purposes. Professor Kim from NU wishes
to study the impact of these workshops on SAT
scores in the schools.
TKO
10/14/2011 IRB Retreat
Not Human Subjects Research Scenario
 The schools will give Dr. Kim de-identified SAT
scores from 2006 to 2011 for her research. Neither
Dr. Kim or the schools will be able to link the scores
back to the students. She will collect basic
demographics about the school from their websites.
 KEY POINTS: Dr. Kim is receiving a de-identified
dataset that was not originally collected for her
study. Human subjects are not involved; therefore,
IRB review is not required.
TKO
10/14/2011 IRB Retreat
Exempt Scenario
 Dr. Kim plans to administer a pre and post workshop
survey to participating students to measure
satisfaction and effectiveness of the workshop.
 Key Points: Dr. Kim is conducting research with
human subjects due to administration of the survey.
However, it meets Exempt category 1 as it is in a
commonly accepted education setting (high school)
and is studying the effectiveness of standard
instruction techniques (the workshops).
TKO
10/14/2011 IRB Retreat
Not Exempt Scenario
 Dr. Kim will assess if the workshops would be more
effective if held outdoors by randomizing ½ the
students to the normal workshop in the classroom;
the other ½ are randomized to the woods.
 Key Points: While Dr. Kim is still studying a
normal educational practice (the workshops), the
setting in the woods is not considered a commonly
accepted educational setting and the research does
not qualify for Exempt status. Expedited review or
Full Board review is required.
TKO
10/14/2011 IRB Retreat
Exempt Category 2
Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures,
interview procedures or observation of public behavior,
unless:
(i) information obtained is recorded in such a manner
that human subjects can be identified, directly or
through identifiers linked to the subjects; and
(ii) 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.
TKO
10/14/2011 IRB Retreat
Exempt Category 2
Key Points:
 Minors cannot be surveyed or interviewed. Investigator
may observe public behavior of children, but cannot
participate in that behavior or activity.
 Identifiers can be recorded if disclosure of the subject’s
responses will not place them at risk
Examples:
 Survey of physicians regarding new pt. triage process
 Focus group to study impact of exercise on QOL
TKO
10/14/2011 IRB Retreat
Exempt Category 2 v Expedited Category 7
 Expedited Category 7
Research on individual or group characteristics or
behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, and social
behavior) or research employing survey, interview, oral
history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies.
TKO
10/14/2011 IRB Retreat
Exemption applies if
 Data is identifiable but not sensitive
 Data is sensitive but recorded without identifiers
 Children are only undergoing educational tests or
observation of public behavior without interaction
with the investigator
Expedited applies if:
 Data is identifiable and sensitive but measures are in
place to protect confidentiality
 Children are to be surveyed, interviewed, or observed
with interaction by the investigator
TKO
10/14/2011 IRB Retreat
CASE SCENARIO
Dr. Jones, the Chair of the IRB, plans to survey
researchers at his institution to assess satisfaction
with the IRB review process. Approximately 50
researchers will be randomly selected to
complete an online survey.
TKO
10/14/2011 IRB Retreat
Not Human Subjects Research Scenario
Dr. Jones does not plan to disseminate the results
of his interviews. The results will be used within
the IRB Office to assess what changes can be
made to improve the review process.
 Key Points: While Dr. Jones is interacting
with individuals, this is not research (a
systematic investigation designed to develop or
contribute to generalizable knowledge). It is a
QI project and does not need IRB review.
TKO
10/14/2011 IRB Retreat
Exempt Scenario
 Dr. Jones and his colleagues at other sites believe there
is a correlation between satisfaction with the IRB and
departmental support. Each site will send surveys to
50 researchers. The surveys will be anonymous.
 Key Points: Dr. Jones is engaged in research with
human subjects and IRB review is required. Even
though the survey may ask sensitive information, he
meets Exempt Category 2 because results are
recorded without identifiers.
TKO
10/14/2011 IRB Retreat
Not Exempt Scenario
Dr. Jones plans to retain identifiers on the surveys so
that he can send out a second survey to those
researchers who score extremely high on the
dissatisfaction scale.
Key Points: This project does not qualify for
Exempt review due to retention of identifiers.
Expedited Category 7 may apply if the IRB reviewer
believes there are adequate measures in place to
protect confidentiality and the risk is minimal.
TKO
10/14/2011 IRB Retreat
Exempt Category 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:
(i) the human subjects are elected or appointed public
officials or candidates for public office; or
(ii) federal statute(s) require(s) without exception that the
confidentiality of the personally identifiable information
will be maintained throughout the research and thereafter.
TKO
10/14/2011 IRB Retreat
Exempt Category 3
Key Points: Research that otherwise doesn’t qualify for
exemption under Category 2 due to collection of
identifiable information that could place subjects at risk,
qualifies under this category if
 the human subjects are elected or appointed public
officials or candidates for public office; or
 federal statute(s) require(s) without exception that the
confidentiality of the personally identifiable information
will be maintained throughout the research and
thereafter.
TKO
10/14/2011 IRB Retreat
Exempt Category 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.
TKO
10/14/2011 IRB Retreat
Exempt Category 4
Key Points:
 Existing is defined as “on the shelf ” at the time of
initial IRB review.
 Information must be immediately recorded
without identifiers & codes. Nobody should be
able to link the data back to the subjects.
Examples:
 Analysis of existing dataset in which the PI
immediately removes MR#
TKO
10/14/2011 IRB Retreat
Exempt Category 4 v Expedited Category 5
 Expedited Category 5:
Research involving materials (data, documents,
records, or specimens) that have been
collected, or will be collected solely for nonresearch purposes (such as medical treatment
or diagnosis).
TKO
10/14/2011 IRB Retreat
Exemption applies if:
 All data is existing, and
 Immediately recorded without identifiers or
codes
Expedited applies if:
 Data is existing but identifiers retained, and/or
 Data will be prospectively collected for nonresearch purposes (identifiers can be kept)
TKO
10/14/2011 IRB Retreat
Case Scenario
 Dr. Adams has a freezer of blood samples that
were originally collected for a research study
which ended several years ago. Patient codes
(which can be linked to the Medical Record)
remain on the samples. The consent form
originally signed by the subjects of Dr. Adams
indicated whether or not their stored blood
could be used for future research.
TKO
10/14/2011 IRB Retreat
Not Human Subjects Research Scenario
A researcher wishes to use the samples for his own
study (non-FDA regulated). Dr. Adams removes the
patient code from the samples before giving the
samples to the researcher.
 Key Points: The researcher is conducting
research. However, the samples were not originally
collected for his project, and he is not receiving
identifiable information. Therefore, he is not
conducting human subjects research and does not
need IRB review.
TKO
10/14/2011 IRB Retreat
Exempt Scenario
Dr. Adams gives the researcher the samples with the
patient code. The researcher immediately removes the
code upon receipt of the samples.
 Key Points: Because he is given samples with the
patient code, the researcher is engaged in human
subjects research. However, Exempt Category 4
applies as he is using existing samples and he plans to
immediately remove the patient code.
TKO
10/14/2011 IRB Retreat
Non-Exempt Scenario
The researcher retains the patient code just in case he
needs to contact the patient for follow-up information.
 Key Points: Exempt Category 4 does not apply as
the researcher retains the patient code. The study
may qualify for Expedited Category 5 (research
involving materials that have been collected), as well
as Expedited Category 7 if he eventually contacts
subjects for follow-up information.
TKO
10/14/2011 IRB Retreat
Exempt Category 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:
(i) Public benefit or service programs;
(ii) procedures for obtaining benefits or services under those
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 those programs.
TKO
10/14/2011 IRB Retreat
Exempt Category 5 requirements
 The program under study must deliver a public benefit (e.g.,
financial or medical benefits as provided under the Social
Security Act) or service (e.g., social, supportive, or nutrition
services as provided under the Older Americans Act).
 The research or demonstration project must be conducted
pursuant to specific federal statutory authority.
 There must be no statutory requirement that the project be
reviewed by an Institutional Review Board (IRB).
 The project must not involve significant physical invasions or
intrusions upon the privacy of participants.
TKO
10/14/2011 IRB Retreat
Exempt Category 6 (overlaps with FDA)
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 FDA or approved
by the EPA or the Food Safety and Inspection Service of
the U.S. Department of Agriculture.
TKO
10/14/2011 IRB Retreat
Exempt Category 6 Examples
 Taste testing whole grain food products
 Comparing taste or smell of molasses,
cheese or milk
 Sampling texture of ice cream
TKO
10/14/2011 IRB Retreat
Questions?
TKO
10/14/2011 IRB Retreat
Contact Information
Tasha K Osafo, BA, CIP
Assistant Director
Institutional Review Board Office
Email: [email protected]
Phone: 312-503-4225
Fax: 312-503-0555
TKO
10/14/2011 IRB Retreat