Yale University Institutional Review Boards
100 GD.9 Guidance on Exemption from IRB Review
Overview
Federal regulation and Yale IRB policy acknowledge that certain federally prescribed categories of
research under 45 CFR 46 and 21 CFR 56 pose little risk to participants and hence do not require
continuing oversight by the IRB. In addition to these categories, Yale University has departed from
federal regulations by creating a new Exemption Category 7 as an extension of existing category (b)2 for
privately funded or unfunded projects involving response to non-physically invasive stimuli. Additional
exemptions may be considered, or additional flexibility in applying exemption categories may be
considered, for non-federally sponsored research that poses little or no risk to subjects for which another
institutional oversight mechanism is better designed.
Research which is limited to one or more of the exemption categories may be reviewed by the IRB or its
designate(s) and deemed exempt from approval and oversight by the IRB. Once the IRB or its designate
has determined that a project qualifies for exemption, no additional oversight is required by the IRB
except in cases where the study is to be modified in a way that would change the applicability of the
exemption determination, or when there are unanticipated problems involving risks to participants or
others.
Submission Process
The HRPP website (both biomedical and social and behavioral Forms and Templates pages) provides a
Request for Exemption Determination form: http://www.yale.edu/hrpp/forms-templates/index.html.
Principal investigators should complete the questions only for the category(ies) the under which the
request may qualify and delete all other categories. The request form, the consent script and any
interview questions, questionnaires, assessments, and measures (if applicable) must be submitted to the
IRB for review. Biomedical submissions should be submitted to hrpp@yale.edu. Social, behavioral and
educational requests should be submitted to human.subjects@yale.edu.
IRB review is not necessary again for a project once the exemption is granted UNLESS there are specific
changes being made to the project that may change its exempt nature.
Changes to the exempt project
Changes that require submission to the IRB prior to implementation:
Examples of changes that must be submitted (with tracked changes) for prospective IRB review are:
 Changing data collection methods from anonymous information to identified, or asking about new,
potentially harmful information (e.g., asking about child abuse, immigration status, etc.),
 Revising the kind of contact with human subjects (e.g., from no direct intervention with subjects to
face-to-face interviews),
 Adding prisoners or children as research participants,
 Adding a new research site (if the exemption is federally funded) that would require review by
another IRB,
 Adding questions to surveys/interviews that could increase the risk to subjects,
 Adding federal funding to a category 7 exemption
 Adding a prospective collection of data to a category 4 exemption
Changes that do not require submission to the IRB prior to implementation:
Examples of changes that do not need to be prospectively reviewed by the IRB and should be submitted
as notifications after implemented with attachment of the updated (tracked changes) documents only are:
 Personnel changes including Yale students, faculty or staff,
100 GD.9 – Exemptions
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Adding questionnaires/assessments/measures that contain minor modifications or a question that
does not involve risk or could cause potentially lead to the identity of a subject,
Adding a research aim that does not substantively change the intent or scope of the study or
increase the risk to subjects,
Making minor updates to the exemption request or consent script that do not change the scope of
the study or the plan to keep subjects’ identities and their data confidential.
Categories of Exempt Research
Exemption determinations rely on an understanding not only of federal regulation and university policy,
but also on current federal guidance and industry best practice standards; hence determinations of
exemption status are made by the IRB or specially trained IRB designates. This document provides
guidance on applying the exemption categories to human research. Additional federal guidance is
available at http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
45 CFR 46.101(b)(1) Educational Research
Educational research may qualify for exemption if the project meets all of the following criteria:

The research is conducted in commonly accepted educational settings. Commonly accepted
education settings include school class rooms, university class rooms, museums, educational
centers such as nature centers or music schools. The location should be such that the
participants are aware that learning occurs there.
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The research involves normal educational practices such as research on regular or special
education instructional strategies or research on the effectiveness of, or the comparison among,
instructional techniques. Normal education practices include lectures, seminars, didactic
sessions, workshops, and standardized testing. The educational practices involved in the
research, while they may be innovative, should not be outside the nature and/or scope of
methods used in standard education.
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The goal of the research is to improve aspects of education such as improvement of student
understanding, educational performance, ability to function productively in the class room, etc.
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The research is not regulated by the Food and Drug Administration (FDA) and does not involve
prisoners.
Investigators should also be aware that school based studies may also invoke other regulatory
requirements. In particular, academic records are subject to the Family Educational Rights and Privacy
Act (FERPA) which limits the ability of schools to release student records without appropriate
authorization. The Protection of Pupil Rights Amendment (PPRA) requires parental consent for surveys
involving sensitive topics such as sexuality, illegal behavior, and political affiliations.
45 CFR 46.101(b)(2) Educational Tests, Interviews, Surveys and Public
Observation1
Educational tests, interviews, surveys and public observation may qualify for exemption when the
research meets the following criteria:
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The research is limited to:
o educational tests including cognitive, diagnostic, aptitude and/or achievement, and/or
o survey procedures, and/or
o interview procedures, and/or
o observation of public behavior.
Additional, similar non-federally-regulated category 7 appears at the end of this guidance document.
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100 GD.9 – Exemptions
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The information collected is anonymous or, if identifiers are kept, the information collected does
not pose a risk of criminal or civil liability or could be damaging to the participants’ financial
standing, employability, or reputation if the information was disclosed.
o Note that these criteria allow sensitive information to be collected if the information can
not reasonably be associated with the identities of participants. Ability to identify
participants is determined based on the type and extent of information collected. For
example, in a small population, a sufficient amount of demographic information even
without name, social security number or address, may still be considered to be
identifiable.
o Also note that potential for disclosure includes both intentional disclosure by the
investigator (e.g., publication) as well as unintentional disclosure such as a breach of
data security. In this exemption category, whether or not the data will be disclosed or
protected from disclosure is irrelevant to the determination as to whether there is a risk of
harm from such a disclosure.
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May involve children only if the research is limited to public observation and the investigator does
not interact with the children.
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Is not regulated by the FDA and does not involve prisoners.
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Does not involve the Psychology subject pool operated by Yale University.
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Research deemed exempt under this category must still conform to Health Insurance Portability
and Accountability Act (HIPAA) requirements if the data is collected from a HIPAA covered entity
or the research will be conducted by University personnel subject to HIPAA. In particular, note
that the criteria for the ability to identify participants here do not require full de-identification under
HIPAA. Research may still be considered “anonymous” and hence exempt under this category
while including some of the HIPAA identifiers. Thus the researcher may be required to request
that the IRB issue a waiver of HIPAA authorization when the data is deemed personally
unidentifiable under the Common Rule (45 CFR 46) but not de-identified in accordance with
HIPAA.
45 CFR 46.101(b)(3) Educational Tests, Interviews, Surveys and Public
Observation not Qualifying for Exemption (b)(2) but Involving Public Officials,
Candidates for Office, or Statutorily Protected Information
Educational tests, interviews, surveys and public observation may qualify for exemption when the
research meets the following criteria:
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The participants are limited to (i) elected or appointed public officials or candidates for office, or
(ii) there are federal statute(s) which require without exception that the information collected will
be maintained confidentially throughout the research and thereafter.
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The research is limited to:
o educational tests including cognitive, diagnostic, aptitude and/or achievement, and/or
o survey procedures, and/or
o interview procedures, and/or
o observation of public behavior.
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Is not regulated by the FDA and does not involve prisoners.
45 CFR 46.101(b)(4) Existing Publicly Available or Anonymous Data Sets or
Specimens
Research involving existing data or specimens may be deemed exempt if the following criteria are met:
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Data are limited to data, documents, records, pathological specimens and/or diagnostic
specimens which are currently in existence at the time the research is proposed. No additional
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100 GD.9 – Exemptions
future data or specimen collection may be involved in research qualifying for this exemption
category.
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The data is either publicly available or the data will be recorded by the investigator such that
participants can not be identified either through collection of identifying information or through a
code linking the data to the participants’ identities. Data may be identifiable at the time of access
but must be recorded by the investigator without inclusion of any identifiers.
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Is not regulated by the FDA.
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Does not involve prisoners, was not collected from individuals while they were imprisoned or
include individuals known to currently be imprisoned.
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Research deemed exempt under this category must still conform to HIPAA requirements if the
data is collected from a HIPAA covered entity or the research will be conducted by University
personnel subject to HIPAA. In particular, note that the criteria for the ability to identify
participants here is not the same as de-identification under HIPAA so exempt research may still
require that the IRB issue a waiver of HIPAA authorization, if applicable.
45 CFR 46.101(b)(5) Public Benefit or Service Programs
The exemption for research and demonstration projects examining public benefit or service programs
requires that the project meet the following criteria:
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The research is designed to study, evaluate or otherwise examine a public benefit or service
program, such as:
o The program itself, or
o Procedures for obtaining benefits or services under the program, or
o Changes or alterations to those programs, or
o Changes in methods or levels of payment for benefits or services under the program(s).
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The program to be studied must deliver either:
o A public benefit such as financial or medical benefits under the Social Security Act, or
o A public service such as social, supportive, or nutrition services under the Older
Americans Act.
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The research or demonstration project must be conducted pursuant to specific federal statutory
authority, or if not a federally funded project, pursuant to specific authority of the funding source.
In either case, the authority must concur with the exemption determination.
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There is not a statutory requirement for IRB review.
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The research does not include any significant physical invasions or intrusions upon the privacy of
participants.
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The research does not propose to collect data in addition to that which is necessary for the study,
evaluation or examination of the public benefit or service program.
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Is not regulated by the FDA.
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Does not involve prisoners.
45 CFR 46.101(b)(6) Taste and Food Quality
Studies evaluating taste and food quality or consumer acceptance studies of food and food products may
be determined to be exempt if the following criteria are met:

Only wholesome foods without additives are consumed, or
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The food to be consumed includes a food ingredient at or below the level and for a use found to
be safe or includes an agricultural chemical or environmental contaminant at or below the level
found to be safe by the Food and Drug Administration (FDA), Environmental Protection Agency
(EPA) or the Food Safety and Inspection Service of the US Department of Agriculture (DOA).
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100 GD.9 – Exemptions
Yale University Special Exemption Category 7: Research Involving Response to
Non-Physically Invasive Stimuli
In addition to the six federal exemption categories above, the University grants exemptions under the
following seventh category for research that meets the criteria described below. This category is an
extension of the above category b(2) and does not exist in the federal regulations under 45 CFR
46.101(b):
Research in which participant interaction includes providing a response to non-physically invasive stimuli
(e.g., reading/writing tasks, minimal risk non-invasive physical activities such as walking, talking and
sitting, computer tasks, video games, viewing media, internet searches, etc.) or other normal public
behavior such as playing carnival games or holding a cup of coffee may be determined by the IRB to be
exempt if the following criteria are met:
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The research falls under the purview of the Yale University IRB,
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The research poses no more than minimal risk to participants, and
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The research does not include any of the following:
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federal funding or federal training grants
FDA regulated components
procedures that would be considered biomedical based
sponsor or other contractual restrictions
clinical interventions
prisoners as subjects
children as subjects
receipt of an NIH issued Certificate of Confidentiality to protect identifiable research data.
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