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IRB - Levels of Review

Exempt

Research conducted in established or commonly accepted educational settings, involving normal educational practices such as:
  • research on regular and special education instruction strategies
  • research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic aptitude, achievement), survey procedures, interview procedures, of observation of public behavior, unless:
  • information obtained in such a manner that human subjects can be identified, directly, or through identifiers linked to the subjects
  • 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.
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 the above criterion, if:
  • the human subjects are elected or appointed officials or candidates for public office
  • or Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Research involving the collection of existing data, documents, records, pathological 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.

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
  • possible changes in methods or levels of payment for benefits or services under those programs.
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 and for a use 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 USDA.

Expedited

Research on drugs or medical devices for which an investigational new drug application or an investigational device exemption is not required.

Collection of blood samples by venipuncture, in amounts not exceeding 550 millimeters in an eight-week period and no more than two times per week from subjects 18 years of age or older, who are in good health and not pregnant and who weigh at least 110 pounds. Or 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 than twice per week.

Prospective collection of biological specimens for research purposes by non-invasive means such as:
  • hair and nail clippings, in a non-disfiguring manner
  • deciduous teeth, and permanent teeth if patient care indicates a need for extraction
  • excreta and external secretions including sweat
  • uncannulated saliva
  • placenta removed at deliver, and amniotic fluid at the time of rupture of the membrane prior to or during labor
  • supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished 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.
Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes:
  • the use of physical sensors that are applied to the surface of the body or at a distance and do not involve input of matter or 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, 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.
The study of existing data, documents, records, pathological specimens, or diagnostic specimens that have been collected for non-research purposes.

Research on individual or group behavior or characteristics of individuals, such as:
  • studies of perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior
  • research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies (some of this may be exempt)
  • where the investigator does not manipulate the subjects' behavior and the research will not involve stress to subjects.

Full

All other studies, including those involving deception of subjects in ways that may lead to their distress or the collection of data in ways that may identify individual subjects.