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the prospect for benefit to the subject, and parents are not available to provide consent in a timely manner, then parental consent may be waived. o Children 6 and over must assent to participate in the study before the child can participate. In most cases, children age 7 or older are asked to provide written documentation of their willingness to be part of the study. ƒ Under 7. Assent from children under 7 should be obtained orally. A witness needs to document that the child has provided assent. ƒ Ages 7 to 13. In addition to verbal assent, the child’s signature on the written assent form must be obtained before the child can participate. The language of the assent form must be tailored to the developmental level of the child. (The child cannot give informed assent if the child cannot understand the language used.) The child assent form must be witnessed. ƒ Above age 13 – Adolescents also must assent. The assent form must be age appropriate, and the form should contain all the essential elements of an adult consent form. The adolescent assent form should be witnessed. ƒ There are circumstances in which research can be conducted even if the child does not provide assent. (e.g., the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research). • Levels of Review. NSU has three levels of review of research: center-level, expedited, and full review. NSU’s center-level review is what is termed by some other IRBs as exempt from review. NSU does not use this term, as all research must be reviewed by an IRB member to determine its status; the researcher is not authorized to make the determination that the research is exempt from IRB review. o Full review. Research involving children is presumed to require full review by the IRB, because children are a vulnerable population. In certain circumstances, the IRB representative / chair may determine that a lesser level of review is permitted. o Expedited review. In some circumstances, if there is no more than minimal risk, expedited review can be conducted on studies involving minors. In the following circumstances, the center-level representative and the IRB chair (or another IRB member that the chair designates) may review the study. The categories for expedited review are the same as in adult studies, but the blood collection limits differ. Research involving collection of PHI that is approved by both the parents and child with appropriate consent/assent forms can use expedited review. The categories for expedited review are: ƒ Surveys/interviewing of children, or observation of public behavior involving children when the researcher participates in the activity being observed. ƒ Surveys that request information that potentially 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 small. ƒ Collection of blood samples by finger stick, heel stick, ear stick or venipuncture, not to exceed 50 ml or 3 ml per kg (whichever is less) in an 8 week period, and collection may not occur more frequently than 2 times per week. ƒ Collection of hair and nail clippings in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction. ƒ Collection of excreta and external secretions including sweat or uncannulated saliva. ƒ 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 in accordance with accepted prophylactic techniques. ƒ Recording of data from subjects using noninvasive procedures routinely employed in clinical practice, excluding X-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. 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, electroretinography, 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. ƒ Voice, video, digital or image recordings made for research purposes, such as investigations of speech defects. For example: An audio tape on which subjects are asked to speak common words for the purpose of measuring voice timber would qualify for Expedited Review. A tape of a therapy session with a patient would not qualify for Expedited Review. Although the research involved an audio tape, the sensitive nature of the contents would require a Full Review. ƒ Research on individual or group behavior characteristics of individuals, (such as studies of perception, cognition, motivation, identity, language, communication,

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