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ExpeditedExpedited reviews are used for research presenting minimal risk to non-vulnerable participants or less-than-minimal risk to vulnerable participants.
Expedited reviews are used for research presenting minimal risk to non-vulnerable participants or less-than-minimal risk to vulnerable participants.
Expedited reviews do not require a convened meeting of the IRB. The director or chair of the IRB chooses a limited number of board members to review the protocol. The IRB members receive the protocol and return their comments to the director, who notifies the principal investigator of the results of the review. Note: Expedited reviewers cannot disapprove a protocol; it would then be referred to a full-board meeting of the IRB.
Research involving no more than minimal risk and in which the involvement of (non-vulnerable) participants is in one or more of the following categories may be reviewed through the Expedited review procedure:
1. Studies requiring the collection of biological materials: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; permanent teeth if patient care indicates a need for extraction; excreta and external secretions including sweat and uncannulated saliva; blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and two or less times per week, from participants 19 years of age or older and who are in good health and not pregnant.
2. Recording of data from participants 19 years of age or older using noninvasive procedures routinely employed at clinical practice (participants less than 19 years of age may be used with parental consent). 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 participant or an invasion of the participant'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).
3. Moderate exercise by healthy volunteers. (Use the ASCM's Guidelines for Exercise Testing and Prescription.)
4. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
5. Voice recordings made for research purposes such as investigations of speech defects.
6. Research that uses videotape or film recordings, such as investigations of husband-wife or parent-child interaction. Studies that involve audio recordings of interviews also fall into this category. (If audio tape recording is to facilitate accurate record keeping and will be erased following transcription, it may qualify as Exempt review)
7. The study of existing data, documents, records, pathological specimens, or diagnostic specimens in which the existing data contain the individual’s name or other identifying information. This category excludes studies of publicly authored documents, such as newspaper articles, novels, works of art, or other materials that may be subjected to content analysis.
8. Research on the behavior or characteristics of individuals or groups that may involve minor stress, discomfort, or embarrassment. Examples include:
9. Experiments in which participants are deceived about the purpose of the research may be reviewed as Expedited or Full Board. Most research which involves deception cannot be reviewed as exempt. Note: subjects must be debriefed about the real purpose of the study afterward. Participants cannot be deceived about the degree of potential risk or discomfort involved in the study.
