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Types of Review

The role of the University's IRB is to ensure compliance with University policy as well as with applicable federal regulations for funded research as detailed in the CFR, (45 CFR Part 46), and any other federal regulations currently in force or which may be introduced in the future.

There are three general categories of review.

1. Exempted Review. There are several broad categories of social science, educational, and economic research which may be considered exempt. The Chair of the IRB determines whether a particular research project is exempt. As necessary, the Chair will consult with members of the IRB when making a decision on exemption requests. If exempt, the investigator will be so notified by the Chair.

IRB exemption will have no expiration date. However, any revisions/changes to the research protocol affecting human subjects may affect the original determination of exemption and therefore must be submitted for review and subsequent determination.

The following categories are considered eligible for Exempted Review:

a. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

b. 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 be identified, directly or 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.

c. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

d. 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.

e. 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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

f. 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 Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

2. Expedited Review. Research activities involving no more than "minimal risk" may be eligible for Expedited Review.

Protocols will be reviewed by the Chair and/or one or more experienced committee members. The reviewer(s) may either approve the protocol or refer it for full committee review. In the event the reviewer(s) does not approve the protocol under expedited review, the Chair will contact the investigator about the next step in the review process. Expedited review may also be used to approve minor changes in the protocol of an approved project.

The categories of research eligible for Expedited Review are:

a. Clinical studies of drugs and medical devices only when condition (i) or (ii) is met.

(i) Research on drugs for which an investigational new drug application 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.)

(ii) Research on medical devices for which an investigational device exemption application is not required; or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

b. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(i) 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

(ii) 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.

c. Prospective collection of biological specimens for research purposes by noninvasive means.

Examples: (i) hair and nail clippings in a nondisfiguring manner; (ii) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (iii) permanent teeth if routine patient care indicates a need for extraction; (iv) excreta and external secretions (including sweat); (v) 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; (vi) placenta removed at delivery; (vii) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (vii) 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; (ix) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (x) sputum collected after saline mist nebulization.

d. 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: (i) 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; (ii) weighing or testing sensory acuity; (iii) magnetic resonance imaging; (iv) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (v) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

e. 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).

f. Collection of data from voice, video, digital, or image recordings made for research purposes.

g. 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.

3. Full Committee Review. Any research not covered by the conditions of Exempted Review or Expedited Review, including all research which involves more than "minimal risk," or which could not be approved using other review categories, will be referred to the IRB for full review.