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, March 8, 1983), and any other federal regulations currently in force or which may be introduced in the future.

There are three general categories of review.

1. Exemption Requested Review. There are several broad categories of social science, educational, and economic research which may be exempt from extensive committee review. The Chair of the IRB determines whether a particular research project is exempt. As necessary, the Director 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.

   The following types of research may be exempted from committee review if proper procedures to assure confidentiality and informed consent are evident and subjects are exposed to no more than "minimal risk" (see definitions).

   a. Research conducted in established or commonly accepted education settings, involving normal educational practices such as research on or comparison among instructional strategies, curricula, or classroom management methods.

   b. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if the data are recorded so that subjects CANNOT BE IDENTIFIED either by the use of names or special coded identifiers.

   c. Research involving surveys, interviews, or observations of public behavior except where all of the following conditions exist. In the event that subjects can be identified directly through identifiers, an exemption is allowable only if:
   

   1. the subject's responses (if they become public) will not place the subject at risk of criminal or civil liability, or be damaging to the subject's financial standing or employability;
   2. the subject's responses do not deal with sensitive aspects of personal behavior; for example, illegal conduct, drug use, sexual behavior, or use of alcohol.

   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. All research using survey or interview procedures is exempt when the respondents are elected or appointed public officials or candidates for public office.
   
   

2. Expedited Review. The Chair will expedite the review of certain types of "minimal risk" research. With expedited review, subjects may not be exposed to more than "minimal risk." 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. Collection of hair and nail clippings, in a nondisfiguring manner; deciduous teeth; and permanent teeth if patient care indicated a need for extraction.

   b. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, amniotic fluid at the time of rupture of the membrane prior to or during labor, urine, feces, expired gases, etc.

   c. 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 either 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. It also includes such procedures as weighing in air or underwater weighing, testing sensory acuity, electrocardiograph, electroencephalograph, thermography, detection of naturally occurring radioactivity, diagnostic echography, surface electromyography, electroculography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).

   d. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.

   e. Collection of both 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 in accordance with accepted prophylactic techniques.

   f. Voice recordings made for research purposes such as investigations of speech defects.

   g. Moderate exercise by healthy volunteers. (The American College of Sports Medicine Guidelines or those of the American Heart Association should be followed in research of this type.)

   h. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

   i. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.

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

3. Full Committee Review. Any research not covered by the conditions of Exemption Requested 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.