DePaul University Research Services > Research Protections > Institutional Review Board (IRB) > Levels of Review
In order for human subject research to be exempt it must involve little to no risk to the research subjects and the research as a whole must meet the criteria of one or more of the exempt categories listed below. The revised regulations, which became effective on January 21, 2019, made substantial changes to the exempt categories.
Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide intruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curriculum, or classroom management methods.
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is :
Please Note: Important exceptions that would require the research be reviewed at the expedited or full level:
(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the interventon and information collection and at least one of the following criteria is met:
(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects' responses outside of the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7).
(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide to allocate a nominal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purpose of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
Taste and food quality evaluation and consumer acceptance studies:
Researchers cannot make their own exemption determinations. The IRB/ORS must make the exemption determination. The IRB/ORS makes the final judgment as to whether a particular activity is non-reviewable, exempt, or requires a higher level of review.
Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
Please Note: An expedited review procedure consists of a review of research involving human participants by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
Please Note: Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).
Research with human participants or their data that is not eligible for exemption or expedited review must be reviewed by the convened IRB. Protocols requiring full review involve greater than minimal risk, minimal risk activities that do not meet the criteria of the expedited categories, or involve prisoners and, when applicable, other vulnerable subjects requiring additional protections.
The IRB convenes monthly throughout the academic year, and once in the summer (usually August). The IRB accepts full board submissions year round, and protocols requiring full review will be placed on the next available meeting agenda.
Activities are considered to be non-reviewable if they do not meet the definition of research or do not involve human subjects as defined under the Federal regulations (45 CFR 46).
IRB review of classroom-related activities is not required at DePaul when the collection of information from people is exclusively for the purpose of class discussion, paper or a grade, or teaching research methodology, since the activity would not meet the "generalizable knowledge" standard of research as defiend in the Federal regulations.
If the information or biospecimens from the activity will be utilized outside the classroom in any way (i.e., present at a conference, publish an abtract, used for a thesis or dissertation), the activity would require IRB review and approval because the intent is to generalize the information. Therefore, the activity would meet the definition of research. For important additional information, please refer to FAQ #4: What sort of review is needed for classroom-related projects?