Research that presents no more than minimal risks to non-vulnerable participants is exempt from the IRB’s review and approval process. The IRB chairperson or coordinator determines that a research project proposal qualifies as exempt from Expedited or Full Review.

Research that may be exempt

• Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
• Research on regular and special education instructional 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), or observation of public behavior, unless:
• Information obtained is recorded in a manner that human subjects can be identified, directly or through identifiers linked to the subjects.
• Any disclosure of human subject 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 watching public behavior of children, where the investigator does not take part in the activities.
• Research involving data, documents, pathological specimens, or diagnostic specimens publicly available or recorded in a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
• Research and demonstration projects conducted by or subjected to the approval of department or agency heads and designed to study, evaluate, or otherwise examine public benefit or service programs and related procedures or changes.
• Taste and food quality evaluation and consumer acceptance studies under the conditions specified in the IRB guidelines.

Guidelines for Humans BAU Institutional Review Board 11 10

• Research and demonstration projects which are conducted by or subjected 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.
• If consumed food containing a food ingredient at or below the level of toxicity is found to be safe or if agricultural chemicals or environmental contaminants at or below the level of toxicity are 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 regulatory bodies.

In some circumstances, if there is no more than minimal risk, expedited review can be conducted even on studies involving minors.

Categories for expedited review

• Surveys/interviewing of children or observation of public behavior involving children when the researcher participates in the activity being observed.
• Surveys requesting information that expose the informant to criminal or civil liability or are extremely personal in nature in which the likelihood of associating the individual with the responses is very big.
• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture not exceeding 50 ml or 3 ml per kg (whichever is less) in an eight week period, and collection may not occur more frequently than two times per week.
• Collection of hair and nail clippings in a non-disfiguring manner or of deciduous teeth and permanent teeth if patient care indicates a need for extraction.
• Collection of excreta and external secretions, including sweat or uncannulated saliva.
• Collection of both supra-and sub-gingival 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.
• Recording of data from subjects using non-invasive procedures routinely employed in clinical practice, excluding X-rays or microwaves. Where medical devices are employed, they must be cleared/approved for the market. Examples include 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 invasion of the subject’s privacy, magnetic resonance imaging, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic infrared imaging, Doppler blood flow, and electroretinography. Subjects can participate in moderate exercise, muscular strength testing, body composition assessment, and flexibility testing, where appropriate given the age, weight, and health of the individual.

Full review by the entire IRB panel is reserved for studies that have potential risk to human subjects.

Examples include

• Research involving the administration of new drugs or other substances.
• Research that materially affects the pregnancy of a woman or the health/well-being of fetuses in utero.
• Research involving subjects with life-threatening physical conditions.
• Research involving physically intrusive procedures.
• Research which potentially could put the subject at risk for legal or civil liability or invade a subject’s privacy regarding sensitive aspects of his/her behavior (e.g., illegal conduct, drug use, sexual behavior, alcohol use) when there is a possibility that the subject could be identified.
• Research involving prisoners.
• Research that places protected populations (such as children, mentally retarded individuals, mentally ill individuals, and patients with medical disorders) at more than minimal risk.

Continuing review of research conducted on human subjects by academic staff and students must be done in accordance with the policies and procedures outlined in the manual at intervals appropriate to the degree of risk, but not less than once per year.

The IRB cannot approve a research project for more than 12 months. All reviews for continuation will be conducted by expedited review if no changes have been made to the research protocol and no adverse or unexpected reactions or side effects have occurred or are expected. (However, the full IRB will be allowed to review the continuation/renewal report). In all other instances, continuing review will be conducted by the full IRB.