IRB Review Categories and Definitions

/https://siu.edu/search-results.php

Last Updated: Apr 10, 2026, 11:40 AM

Review Categories

The IRB, not the researcher, determines the review category. This page is provided as a reference. No work with human subjects may start until an IRB determination or approval is recieved. Questions? Contact the IRB Coordinator at siuhsc@siu.edu or 618-453-4534.

Exempt Categories

An exempt study is a type of research involving human subjects that falls into specific low-risk categories defined by federal regulations. Although exempt, it must still follow basic ethical standards, such as protecting participants’ privacy and minimizing harm."Exempt" does not mean exempt from IRB review. Exempt studies must be submitted and reviewed.

Exempt 1 - Normal educational practice

Research conducted in established educational settings involving normal educational practices, such as instructional strategies or curriculum comparisons, where participation does not adversely affect students' academic standing.

Exempt 2(i) - Educational tests, surveys, interviews, or observations

Research involving educational tests, surveys, interviews, or observation of public behavior, provided the information 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.

Example: An anonymous online survey about study habits.

Research involving children may qualify for exemption under this category only in limited cases. It is eligible if it consists solely of educational tests and/or observation of public behavior, provided the investigator does not take part in the activities being observed and all other exemption criteria are satisfied. However, studies with children cannot be considered exempt if they include survey or interview procedures, or if the researcher participates in the observed activities.

Exempt Category 2(ii) - Educational tests, surveys, interviews, or observations

Research involving educational tests, surveys, interviews, or observation of public behavior, provided that 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;

Example: a survey of participants aged 18+ collecting identifiable data on favorite campus study locations.

Research involving children qualifies for this exemption only under specific conditions. It may be considered exempt when it is limited to educational tests and/or observation of public behavior, as long as the investigator does not participate in the activities being observed and all other exemption requirements are met. However, research with children is not exempt if it involves surveys, interviews, or any observation of public behavior in which the researcher takes an active role.

Exempt Category 2(iii) - Educational tests, surveys, interviews, or observations

Research involving educational tests, surveys, interviews, or observation of public behavior AND 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 disclosure of responses outside the research could reasonably place the subjects at risk.

Research involving children cannot be classified as exempt 2(iii).

Exempt 2(iii) is a limited review category. This means the IRB must conduct a specific review to determine that adequate provisions are in place to protect the privacy of participants and to maintain data confidentiality.

Exempt Category 3(i)(a) - Benign behavioral interventions

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording if the subject prospectively agrees to the intervention and information collection and:

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.

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. 

If the research involves deception about its purpose or nature, exemption 3(i)(a) only applies if participants provide prospective agreement to participant, meaning they are informed in advance that they may be unaware of or misled about the nature or purposes of research. Participants should also be provided with a debriefing statement after participation. 

Research involving children cannot be classified as exempt 3(i)(a).

Exempt Category 3(i)(b) - Benign behavioral interventions

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording if the subject prospectively agrees to the intervention and information collection and:

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.

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. 

If the research involves deception about its purpose or nature, exemption 3(i)(a) only applies if participants provide prospective agreement to participant, meaning they are informed in advance that they may be unaware of or misled about the nature or purposes of research. Participants should also be provided with a debriefing statement after participation. 

Research involving children cannot be classified as exempt 3(i)(b).

Exempt Category 3(i)(c) - Benign behavioral interventions

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording if the subject prospectively agrees to the intervention and information collection, and:

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 the an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7).

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. 

If the research involves deception about its purpose or nature, exemption 3(i)(a) only applies if participants provide prospective agreement to participant, meaning they are informed in advance that they may be unaware of or misled about the nature or purposes of research. Participants should also be provided with a debriefing statement after participation. 

Research involving children cannot be classified as exempt 3(i)(c).

Exempt 3(i)(c) is a limited review category. This means the IRB must conduct a specific review to determine that adequate provisions are in place to protect the privacy of participants and to maintain data confidentiality.

Exempt Category 4(i) - Secondary research using existing data

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, and:

The identifiable private information or identifiable biospecimens are publicly available

Example: Analysis of a publicly available government dataset

Exempt Category 4(ii) - Secondary research using existing data

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, and:

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 investigator does not contact the subjects, and the investigator will not re-identify subjects.The

Exempt Category 4(iii) - Secondary research using existing data

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, and:

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 purposes of 'health care operations' or 'research' as those terms are defined at 45 CFR 164.501 or for 'public health activities and purposes' as described under 45 CFR 164.512(B).

Exempt Category 4(iv) - Secondary research using existing data

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, and:

The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with E-Government Act of 2002, the Privacy Act of 1974, and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995.

Exempt Category 5 - Federal demonstration projects

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 the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and:

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.

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. 

Exempt Category 6(i)- Taste and Food Quality Evaluation

Taste and food quality evaluation and consumer acceptance studies, and:

wholesome foods without additives are consumed.

Exempt Category 6(ii)- Taste and Food Quality Evaluation

Taste and food quality evaluation and consumer acceptance studies, and:

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.

Expedited Review

Expedited studies involve human subjects and pose no more than minimal risk. They are reviewed by the IRB Chair or a designated reviewer rather than the full board, which typically means a faster turnaround than full board review.

Expedited Category 1 - Clinical studies of drugs and medical devices

Clinical studies of drugs and medical devices only when condition (a) or (b) 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. 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.

Expedited Category 2 - Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture

  • (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, 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; or
  • from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, 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.

Expedited Category 3 - Prospective collection of biological specimens for research purposes by noninvasive means

Examples:

  • 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);
  • Uncannulated 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.

Expedited Category 4 - Noninvasive data collection (not involving general anesthesia or sedation

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.)
Examples:

  • 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 subject or an invasion of the subject=s privacy;
  • Weighing or testing sensory acuity;
  • Magnetic resonance imaging;
  • Electrocardiography, electroencephalography, thermography, 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.

Expedited Category 5 - Research using materials that have already been collected or will be collected for nonresearch purposes

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).

Example: Recording interviews for a qualitative study.

NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

Expedited Category 6 - voice, video, digital, or Image recordings made for research purposes

Collection of data through voice recordings, video recordings, digital images, or similar recordings for research purposes.

Example: Recording interviews for a qualitative study.

Expedited Category 7 - Research on individual or group characteristics or behavior

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.

Example: Most social and behavioral research at SIU falls under this category.

NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.

Expedited Category 8 - Continuing review

Continuing review of research previously approved by the convened IRB as follows:
  1. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
  2. where no subjects have been enrolled and no additional risks have been identified; or
  3. where the remaining research activities are limited to data analysis.

Expedited Category 9 - Continuing review of research where categories 2-8 do not apply

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.

Full Board Review

Research that does not qualify for exempt or expedited review is reviewed by the full IRB at a convened meeting. This typically applies to studies involving more than minimal risk to participants.

Full Board Review

Research that does not qualify for exempt or expedited review is reviewed by the full IRB at a convened meeting. This typically applies to studies involving more than minimal risk to participants.

The SIU IRB meets on the second Friday of each month. All materials for full board review must be submitted no later than the preceding Friday. Board decisions require a quorum.

Studies that commonly require full board review include those involving vulnerable populations (children, prisoners, or pregnant persons), significant physical or psychological risk, or clinical trials.

Key Definitions

When reviewing a proposed project, the IRB uses the operationalized definitions below. If a project is determined to fall outside the definition of human subjects research, the IRB will issue a formal Not Human Subjects Research (NHSR) determination. The IRB does not issue such determinations for projects that have already begun.

All definitions are drawn from 45 CFR 46.102.

Research

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. This applies to all such activities at SIUC regardless of funding source.

The following activities are generally not considered research for IRB purposes: oral history, journalism, biography, literary criticism, legal research, historical scholarship, and criminal justice investigations authorized by a law enforcement agency. The IRB does not conduct post hoc review. If there is any question about whether a project qualifies as human subjects research, IRB review and approval must be obtained before any involvement of human subjects.

Generalizable Knowledge

Conclusions or findings applicable to populations beyond the research participants, used to predict future events or broadly advance scientific or academic understanding.

Human Subject

A living individual about whom an investigator:

  • Obtains information or biospecimens through intervention or interaction, or,
  • Obtains identifiable private information or identifiable biospecimens.

Identifiable Private Information

Private information from which the identity of the participant is or can readily be determined by the researcher.

Interaction

Communication or interpersonal contact between researcher and participant, such as surveys, interviews, or focus groups conducted by phone, email, video, or in person.

Intervention

Physical procedures by which data or biospecimens are gathered (such as a blood draw), or manipulations of the subject or their environment performed for research purposes.

Private Information (reasonable expectation of privacy)

Information about behavior occurring in a setting where a person could reasonably expect not to be observed or recorded, or information shared for a specific purpose with the expectation it will not be made public.