IRB: Exemptions
Policy number:
401
References:
45 CFR 46 .101 (b)(1)-(6), 45 CFR 46.103(b)(4), 45 CFR
46.301(a), 45 CFR 46.401(b), 45 CFR 46.109, 45 CFR
46.116(b)(5)
21 CFR 56.104(c)-(d)
http://www.research.umn.edu/irb/forms.html
http://www.research.umn.edu/irb/guidance.html
AAHRPP II.2.A
AAHRPP II.2.B
AAHRPP II.3.A
Date: 03/14/2014
Policy Owner:
Executive Director, HRPP
Cross References:
502 Reporting Emergency Use of Test Article
400 Definition of Human Subject Research
Definitions:
None
1.0 Reason for Policy
To describe the research that does not require IRB review under 45 CFR 46.101 and 21 CFR 56.104 and
to outline the process for determination of exemption.
2.0 Scope of Policy
The scope of this policy is the University community and its healthcare components.
3.0 Policy Statement
Research activity in which the only involvement of human subjects will be in one or more specific
categories of the federal regulations, may be exempt from IRB review. Determination of exemption
must be based on regulatory and institutional criteria—DHHS 45CFR 46.101 and FDA 21 CFR
56.104. Determination must be made and documented by the IRB as delegated to HRPP staff. HRPP
staff reviewers determine that they have no conflict of interest prior to reviewing a project for possible
exemption. Researchers conducting research that is determined by HRPP to be exempt are expected to
complete an Exemption Request form and conduct their research according to ethical standards as
required by the University of Minnesota Code of Conduct. All exempt determinations are communicated
in writing to the researcher.
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Department of Health and Human Services Exemptions: DHHS 45CFR 46.101 Unless otherwise
required by department or agency heads, research activities in which the only involvement of human
subjects will be in one or more of the following categories are exempt from this policy:
(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. (This regulation does not apply to FDA regulated research.)
(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. (This regulation does not
apply to FDA regulated research.)
(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. (This regulation does not apply to
FDA regulated research.)
(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. (This regulation does not apply to FDA regulated research.)
(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. (This regulation
does not apply to FDA regulated research.)
(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.
(This regulation DOES apply to FDA regulated research, see below)
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Food and Drug Administration Exemption Criteria: FDA 21 CFR 56.104:
The following categories of clinical investigations are exempt from the requirements for IRB review:
 Emergency use of a test article, provided that such emergency use is reported to the IRB within
5 working days, any subsequent use of the test article at the institution is subject to IRB review
[21CFR56.104.(c)]
 Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without
additives are consumed or 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 contaminate at
or below the level found to be safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency of the Food Safety and Inspections Service of the U.S.
Department of Agriculture [21CFR56.104(d)]
Process:
The investigator may make an initial assessment of the probability of exempt status; however, the final
authority to determine actual status rests with designated HRPP staff. Once the appropriate application
form is completed, staff reviews the application to determine both the applicability of exempt status to
the project and the criteria under which that status is met. Prior to approval, the investigator may be
contacted by the reviewer soliciting additional information or advising the investigator of the need for
revision of the protocol or consent documents in order to meet exempt status. The research may not
begin until the exempt status is officially confirmed by the HRPP. Research that does not meet exempt
criteria may be referred back to the investigator with a request for other appropriate application forms.
Procedures:
UMN IRB standard for consideration of exemptions from further review:
Questions for exemption screener:
Does the activity:
 Meet the definition of research
 Meet the definition of “human subject”
If yes to above, proceed:
 Are there identifiers
 include protected populations or target vulnerable subjects
 Involve personal or sensitive topics which might induce harm?
If No to above, proceed:
If application qualifies for exemption, an HRPP staff member conducts review, grants
exemption, and documents it. If application does not qualify for exemption, it is routed for
further review. Staff will use judgment in determining which research projects qualify for
exemption from further review. This sometimes subjective decision can occur in consultation
with experts.
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Exceptions
Prisoners
Research that involves prisoners CANNOT be reviewed at the exempt level because of the regulatory
limitations required by Subpart C of the Common Rule 45 CFR 46 and 21 CFR.56.
Children
The exemption at §46.101(b)(2) regarding educational tests may be applied to research including
children.
HOWEVER,
The exemption at §46.101(b)(2) for research involving survey or interview procedures or observations
of public behavior does not apply to research including children, except for research involving
observation of public behavior when the investigator(s) do not participate in the activities being
observed.
Ethical Standards
Even though the IRB may determine that some research is exempt from the federal regulations, the IRB
expects that adequate provisions will be in place to protect research participants.
In making its consideration of exempt status, the HRPP/IRB may determine that:
 The research involves no more than minimal risk to participants
 Selection of participants is equitable
 If there is recording of identifiable information, there are adequate provisions to maintain the
confidentiality of the data
 If there are interactions with participants, there will be a consent process that will disclose such
information as:
o That the activity involves research
o Description of the procedures
o That participation is voluntary
o Name and contact information for the investigator
o There are adequate provisions to maintain the privacy of participants
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4.0 Required approvals for this document
Title
Executive Director, HRPP
5.0 Revision History
Revision
03/14/2014
10/06/09
06/01/09
05/01/06
Reason for change
AAHRPP Review
Update AAHRPP reference
Reformat
Date of release
09/02/14
10/06/09
06/01/09
To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654
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