DePaul University Research Services > Research Protections > Institutional Review Board (IRB) > Levels of Review

Levels of Review

Exempt Categories

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.

Category 1

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.

Category 2

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 :

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human sujects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects' responses outside 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
(iii) 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).

Please Note: Important exceptions that would require the research be reviewed at the expedited or full level:

  • Research with prisoners, when prisoners are specifically targeted for the research versus incidentally being included in the research
  • When the research under 2 (i) and 2(ii) involves educational tests or observations of public behavior and when the investigator(s) participate in the activities being observed
  • Research in category 2 (iii) cannot involve children
  • Surveys or interviews that may cause more than momentary discomfort or distress

Category 3

(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.

    Category 4

    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:

    (i) The identifiable private information or identifiable biospecimen are publicly available;
    (ii) Information, which may include information about biospecimens, 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, the investigtor does not contact the subjects, and the investigtor will not re-identify subjects;
    (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR Parts 160 and 164, subparts A and E, for the purpose of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purpsoes" as described under 45 CFR 164.512 (b); or
    (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected inforamtion obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C, 3501 et seq.

    Category 5

    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.

    • (i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or dtration project must be published on this list prior to commencing the research involving human subjects.

    Category 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 Adminsitration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department o Agricutlrue.

    Category 7
    Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary reearch use if an IRB conducts a limited IRB review and makes the determinations required by 45 CFR 46.111(a)(8).

    Category 8
    Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
    (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116(a)(1) through (4), (a)(6), and (d);
    (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117;
    (iii) An IRB conducts a limited IRB review and makes the determination required by 45 CFR 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
    (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

    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.

    Information About Expedited Review and Minimal Risk Research

    • Research activities that (1) present no more than minimal risk to the human participants, and (2) involve only procedures listed in one or more of the categories described below, may be reviewed by the IRB through the expedited review procedure. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human participants.
    • Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
    • The categories in this list apply regardless of the age of the participant, except as noted.
    • The expedited review procedure may not be used where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
    • The expedited review procedure may not be used for classified research involving human participants.
    • The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review - expedited or convened - utilized by the IRB.

    Categories of Research that May Receive an Expedited Review

    Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

    1. Clinical Studies of drugs and medical devices only when condition (1.a) or (2.a) is met:
      1. a. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review).
      2. a. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
    2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
      1. From healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week.
      2. From other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
    3. Prospective collection of biological specimens for research purposes by noninvasive means. For example:
      • Hair and nail clippings in a nondisfiguring manner
      • Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
      • Permanent teeth if routine patient care indicates a need for extraction
      • Excreta and external secretions (including sweat)
      • Uncalculated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue
      • Placenta removed at delivery
      • Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
      • Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
      • Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
      • Sputum collected after saline mist nebulization
    4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) For Example:
      • Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant’s privacy
      • Weighing or testing sensory acuity
      • Magnetic resonance imaging
      • Electrocardiography, electroencephalography, thermograph, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography
      • Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual
    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).
      (Please Note: Some research in this category may be exempt from the HHS regulations for the protection of human participants. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt).
    6. Collection of data from voice, video, digital, or image recordings made for research purposes.
    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.
      (Please Note: Some research in this category may be exempt from the HHS regulations for the protection of human participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt).
    8. Continuing review of research previously approved by the convened IRB as follows:
      • Where (i) the research is permanently closed to the enrollment of new participants; (ii) all participants have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of participants
      • Where no participants have been enrolled and no additional risks have been identified
      • Where the remaining research activities are limited to data analysis
    9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

    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), or the activity does no engage DePaul or DePaul personnel in the conduct of the research.

    Example: Student Classroom Based Projects

    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?

    Example: External Researcher Wants to Recruit Research Subjects on DePaul's Campus

    An external researcher who has obtained IRB approval at his/her own institution and who will not involve anyone at DePaul in the conduct of the research, does not require IRB approval from DePaul to recruit research subjects from DePaul faculty, staff or students. The researcher may post flyers on campus or ask faculty or staff to post an announcement or forward an IRB approved recruitment item for themwithout engaging them in the conduct of the research. There are insitutional policies outside of the IRB for posting flyers on campus that need to be followed and the external researcher should contact the Office of Student Affairs or the Student Center about the rules for psoting flyers on campus and in cmapus buildings.

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