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assigned participants occurred at pre- and postintervention and at 3-month follow-up (intervention group only). Results: Compared to the wait list control, the TF-CBT group experienced significantly greater reductions in trauma symptoms (F(1,49) = 52.708, p CHILDREN/ADOLESCENTS IN RESEARCH • Restriction on using minors in research. If you conduct research using minors as subjects, there are special regulatory and ethical issues. The study cannot be approved unless the following criteria are met: o Research using children needs to have a firm theoretical background; where applicable, studies on animals and/or in adults must have already been completed. The study cannot use children just because they are a convenient population. o The research must minimize the risk to minors. o The research staff needs to have experience working with minors, and the study must be designed to be sensitive to the special needs of this population. • Investigation that is not considered research and not subject to IRB oversight. o Internal data collection for the purpose of determining the quality of an internal process, which is not used outside of the school/agency, is not research. Examples would include assessment of the progress of children in therapy, and educational achievement of children. If the data are to be presented to others outside the agency (other than to demonstrate accountability to a funding or oversight agency), then it is considered research (e.g. reporting results as an outcomes measurement study) and IRB oversight is required. o Class projects that involve data collection as an academic exercise, and do not result in dissemination of the results outside of the class, are not considered research. The instructor has discretion on how the class project is conducted, and is responsible for the legal and ethical behavior of the students completing the class project. However, interviews or surveys of children, or observations that involve the investigator interacting with children require IRB review, even if conducted only as a class project. • Risk classifications. o Minimal risk. Studies are considered as having minimal risk if they meet the following federal definition: “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” o Greater than minimal risk. If the study involves more than minimal risk, then the risk to benefit ratio of the study will be assessed. The researchers will be required to describe how the study risks have been minimized, and the study benefits maximized. Risk classification influences the level of review that NSU’s IRB conducts. • Types of research that can be approved by the IRB. Federal rules only permit approval of the following types of research involving children. o Research not involving greater than minimal risk. o Research involving greater than minimal risk but presenting the prospect of direct benefit to the subjects. o Research involving greater than minimal risk, with no prospect of direct benefit to the subjects, but likely to yield generalizable knowledge about the disorder/condition. o Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. If federally funded, this study requires review by Health and Human Services. If not federally funded, the review must be at a higher level than convened full IRB. • Informed consent and assent. Informed consent is generally a two-part process. The parents must provide informed consent, and then the child must assent to participate. Assent and consent must be obtained before a child can participate in research. o Informed consent from both parents or both guardians is generally required. If the IRB determines that a study has only minimal risk, or has more than minimal risk but has the prospect for direct benefit to that child, then consent of only one parent or guardian is acceptable. If the research involves more than minimal risk, and while benefiting the scientific community, the research project will not directly benefit the child, then both parents/guardians must consent. The other exceptions to the requirement for both parents/guardians to consent are as follow: ƒ one parent/guardian is deceased ƒ parent/guardian is unknown ƒ parent/guardian is incompetent ƒ parent/guardian is not reasonably available ƒ one parent/guardian has legal responsibility of minor/child o There are a few circumstances where the IRB may grant a waiver of parental consent for the participation of a child, when applicable law (state and local) has demonstrated that such a waiver would be acceptable. ƒ If the child is a victim of abuse or neglect and the study protects the child. If a guardian had been named, then the guardian’s consent is required. ƒ Research on mature adolescents that involves minimal risk. The decision on who is a mature minor is made on a case-by-case basis. The IRB would in no circumstances consider a child younger than 16 to be a mature minor. The State of Florida does not permit research on children below the age of 18 without parental consent. ƒ In emergency situations, where life or health is threatened, when there is no acceptable treatment for a disease/disorder, and the study holds
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