Exempt Review of Human Subjects Research
Tip Sheet
Criteria for Consideration of Exempt Status:
1. The research cannot place subjects at greater than minimal risk;
2. The selection of subjects is equitable;
3. The research activities MUST fall entirely within one or more of the six categories for exemption;
4. There are adequate provisions to maintain the confidentiality of the data;
5. The research CANNOT involve pregnant women, human fetuses, in vitro fertilization, or prisoners.
Research studies declared Exempt by the IRB must be reviewed in the same ethical manner and with the same
respect for the privacy and confidentiality of research subjects as approved under full board or expedited
procedures. If there are interactions with participants, there should be a consent process that will disclose such
information to subjects including:
1. A description of the activity including a statement that it is research
2. A description of the procedures
3. That participation is voluntary
4. Name and contact information for the Researcher
Important Notes:
 FDA regulations do not allow for the IRB to designate research Exempt or Not Human Subjects Research
(NHSR).
 Studies involving pregnant women, human fetuses, or in vitro fertilization should not be reviewed under
exempt procedures. Due to the vulnerability associated with these populations, studies involving these
types of subjects may be reviewed by expedited or full board processes.
 Studies involving prisoners cannot be reviewed and approved under one of the exemption categories.
 Studies involving deception should not be reviewed and approved under one of the exemption categories.
 PIs DO NOT have the authority to make an independent determination that research involving human
subjects is exempt, this is the responsibility of the IRB.
 Studies cannot be initiated prior to receiving an IRB approval letter of the proposed research.
 Each project requires a separate review and approval for exemption.
 Studies not meeting the criteria for exemption can be sent for expedited or full board review.
 All exemptions, except exemption category 2, are applicable to children. However under exemption
category 2, educational testing is applicable to children, but research involving survey or interview
procedures or observations of public behavior is NOT applicable to children. The only exception is research
involving observation of public behavior when the investigator(s) do not participate in the activities being
observed.
Exempt Review Categories and Examples:
Category 1: Research conducted in established or commonly accepted educational settings, involving normal
educational practices, such as (i) research on regular or special educational instructional strategies, or (ii) research
on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management
methods.
For this category to apply, investigators must provide evidence that the educational practices to be studied are
frequently used educational practices carried out in a place where such practices are commonly accepted to. This
category DOES NOT include radically new or innovative classroom techniques. This category does not include
research which assigns students to different teaching methods. Commonly accepted places can include: a car for a
driver education program, a clinic for a medical student or resident education programs, a repair facility for a
technician education program.
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’t be identified, directly or indirectly 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.
For this category to apply, investigators must provide evidence that the collected data are recorded in such a way
that no information can be linked to a subject either directly, such as by recording names, codes, or SSN, or
indirectly, such as acrostics. If the data CAN be linked to subjects, the research still may be exempt provided the
data does not include sensitive information that could reasonably place the subjects at risk of criminal or civil
liability, or be damaging to the subjects’ financial standing, ability to gain or maintain employment, or reputation.
Research involving observation of public behavior is usually exempt, unless the investigator participates in the
public behavior, or manipulates the environment in order to elicit certain kinds of behavior.
Category 3: Research involving the use of education tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt
under Exemption category (2) (above) of this section if: (i) The human subjects are elected or appointed public
officials or candidates for public office; or (ii) federal statutes require, without exception, that the confidentiality of
the personally identifiable information will be maintained throughout the research and thereafter.
Public officials are not considered to be entitled to the same degree of privacy that applies to private individuals.
For this exempt category to apply, investigators must provide evidence that the research involves only education
tests, or survey, interview or observation of the public behavior of public officials. If the research is intended to
include educational tests, surveys interviews or observation of public behavior carried out under specific federal
programs supported by the Department of Justice or the National Center for Education Statistics of the U.S. Dept.
Of Education, then it may qualify for exemption. This exception is allowed because other federal law regulates the
security of information in these programs. If studies are conducted using federal databases operated by the
agencies identified above, the investigator should check with the agency to determine whether their research
qualifies for exemption. This information should be communicated to the IRB.
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.
For this exempt category to apply, investigators must provide evidence that ALL the data, documents, records or
specimens to be used in the research are already in existence at the time of review by the IRB, and that all the data
has been recorded in such a manner that subjects cannot be identified directly or indirectly. Prospective collection
of data or specimens should not be reviewed and approved as exempt. Retrospective chart reviews will not usually
qualify for this exemption as investigators typically record identifying information to access medical records again
at a later date. Therefore, retrospective chart reviews should be processed as expedited reviews under category 5.
Category 5: Research and demonstration projects which are conducted by or subject to approval of [federal]
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 these programs; (iii) possible changes or
alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payments for
benefits or services under those programs.
This exemption addresses the need to evaluate methods of administering certain federal programs. For this
exempt category to apply, investigators must provide evidence that the proposed research is intended to evaluate
methods for administration of federal programs authorized under the Social Security Act, Medicare, Medicaid or
other public benefit programs. To make this determination, it is helpful for the investigator to provide the IRB with
a letter from the relevant federal department or agency head. The following additional criteria should be used in
determining whether or not this exemption category applies: the program under study must deliver a public
benefit; he 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 IRB; and the project must not involve
significant physical invasions or intrusions upon the privacy of participants. The IRB should consider the
vulnerability of subjects and whether or not the information is considered private when reviewing research under
this exemption category.
Category 6: Taste and food quality evaluation and consumer acceptance studies, (I) if wholesome food without
additives is 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 (FDA) or approved by the Environmental Protection Agency (EPA) or the Food
Safety and Inspection Service of the U.S. Department of Agriculture (USDA).
This exemption pertains to food testing where the food cannot be consumed. For this exempt category to apply,
investigators must provide evidence that the research involves the examination of consumer taste and acceptance
of 1) unprocessed naturally occurring foods, or 2) processed foods containing added ingredients, agricultural
chemicals, or environmental contaminant at or below the level found to be safe by the FDA, EPA, or USDA. Studies
involving consumption of alcohol, vitamins, or supplements do not qualify under this exempt category.