Are there any special considerations regarding the use of children in biomedical research?

Yes, special considerations regarding the use of children in biomedical research must be taken into account in Wisconsin and throughout the United States. The use of children in biomedical research is subject to a myriad of federal and state laws and regulations. All research involving the use of children must follow the guidelines set by the US Department of Health and Human Services and the Food and Drug Administration. The Wisconsin Department of Health Services has also issued its own set of regulations for the use of children in biomedical research. These laws provide to minors the additional protection from risk that they require due to their status as minors. All research involving the use of children must be reviewed and approved by an Institutional Review Board (IRB). This board assesses the proposed research for potential risks and benefits to the child, and reviews the proposed consent forms. The IRB also reviews the methods used to recruit children, the plan for monitoring their safety, and the plan for analyzing and disseminating results. In addition, any research involving the use of children must only be conducted when the benefits far outweigh the risks. This means that the benefits of the research must be greater than the potential risks to the child, both physical and psychological. Finally, researchers must comply with the guidelines related to the use of children, such as obtaining their assent and parental consent, and must also provide methods for monitoring the safety of the minors throughout the research process.

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Are there any special considerations regarding the use of children in biomedical research?

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