Ethics of Research During Transport
The future health of children depends on conducting clinical research in which children participate. Both ethical and legal requirements govern research with human participants. This is especially true of research that involves children and other vulnerable groups, particularly when those groups are in the midst of an emergency.
Because of the inherent vulnerability of children, research must be designed carefully to ensure that the participants are not placed at excessive risk or unfairly denied potential benefit. Federal regulations governing research involving children and local institutional review boards (IRBs) exist to ensure that research involving children occurs in a way that protects their welfare. For research in the transport setting to satisfy ethical and legal requirements, it must be scientifically sound and significant; subject selection must be fair; approaching families for enrollment must avoid pressure; risks to participants cannot be excessive and must be minimized; risks must be justified by the benefits of the research; informed consent, parental permission, and assent must be obtained when appropriate; enrolled subjects must be respected; and the protocol must have been approved by an IRB. In most cases, the best source of information and guidance about research protocols will be the local IRB.In some cases, research in the transport environment is designed to study emergency procedures that offer the prospect of direct benefit to potential participants. In this case, enrollment must take place immediately, and the parents or guardian may not be available to provide permission. This presents a special situation governed by special rules. Under these circumstances, the research can proceed without permission of the parents only under restricted guidelines outlined by federal regulation (Table 18.1). Public disclosure of study results also is required by law in this situation.
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