III. Expedited review eligibility requirements - (Complete and attach IRB form 3)
 
According to federal regulations, a research study is only eligible for expedited review if:
  1. The research activities involve no more than minimal risks.

    As defined in U.S. Department of Health and Human Service, 45 Code of Federal Regulations, Part 46.102i, “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.
     
  2. Research protocol does not involve any of the following groups:
     
    1. Minors (<21 years)
    2. Pregnant Women
    3. Prisoners
    4. Mentally Retarded
    5. Mentally Disabled
    6. Fetuses
    7. Abortuses

       
  3. Research protocol does not include questionnaires with sensitive areas (alcohol/drug abuse, sexual behavior, HIV status).
     
  4. The only involvement of human subjects is one or more of several specified categories listed below.
     
    1. Collection of hair and nail clipping in a non-disfiguring manner; deciduous teeth and permanent teeth if patient care indicates a need for extraction.
       
    2. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
       
    3. Recording of data from subjects 21 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 subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
       
    4. 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.
       
    5. 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.
       
    6. Voice recordings made for research purposes such as investigations of speech defects.
       
    7. Moderate exercise by healthy volunteers.
       
    8. Research on individual or group behavior or characteristics of individuals such as studies of perception, cognition, game theory, or tests development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
       
    9. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required. (Note: if an FDA approved drug is to be used for an unapproved use, the research is NOT eligible for expedited review.)
       
    10. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
       
  5. In addition, the IRB may also use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. In case where any drugs are involved in the proposed study, at least one IRB member must be a medical physician for the expedited review.