Exempt

In order for human subject research to be exempt it must involve little to no risk (benign risk) to the research subjects and the research as a whole must fit the criteria of one or more of the exempt categories. 

Exempt Categories:

Category 1

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

·       research on regular or special education instructional strategies

OR

·       research on the effectiveness of, or the comparison among, instructional techniques curricula, or classroom management methods.

Category 2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, UNLESS:

·       information obtained is recorded in such a manner that human subjects can be identified (directly or through identifiers linked to the subjects)

AND

·       any disclosure of the human subjects' responses (data colelcted about them) outside of the reserach could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation

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

·       research with prisoners;

·       survey/interview research with children;

·       observations of children, if the researcher is also involved in the observed activity;

·       research that deals with sensitive or private aspects of the participants’ behavior;

·       surveys that may cause discomfort or distress (e.g. detailed personality inventories).

Category 3

Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under category 2 of this section, if:

·       the human subjects are elected or appointed public officials or candidates for public office

OR

·       federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category 4

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if:

the 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.

Category 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:

·       public benefit or service programs;

·       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.

Category 6

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 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.



The IRB makes the final judgment as to whether a particular activity is exempt.​

Expedited

Minimal risk is defined as Information About Expedited Review:

  • 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. E.g.,

o   hair and nail clippings in a nondisfiguring manner

o   deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction

o   permanent teeth if routine patient care indicates a need for extraction

o   excreta and external secretions (including sweat)

o   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

o   placenta removed at delivery

o   amniotic fluid obtained at the time of rupture of the membrane prior to or during labor

o   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

o   mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings

o   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.) E.g.,

o   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

o   weighing or testing sensory acuity

o   magnetic resonance imaging

o   electrocardiography, electroencephalography, thermograph, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography

o   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). (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. (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:

0.     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

1.     where no participants have been enrolled and no additional risks have been identified

2.     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

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.

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)​​

Full Board

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 or 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 pla​ced on the next available meeting agenda.

Non-Reviewable

Activities are considered to be non-reviewable if they do not meet the definition of research or do not involve human subjects as defiend under the federal regulations (45 CFR 46).

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, since the activity would not meet the "generalizable knowledge" standard of research as defiend in the Federal regulations. If the activity or data from the activity will be utilized outside the classroom in any way, it would require IRB review and approval.  For important additional information, please refer to FAQ #4: What sort of review is needed for class-related projects? and to DePaul’s Best Practices in Designing & Conducting Non-Reviewable, Classroom Based Research.

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