Are there any special considerations regarding the use of children in biomedical research?
In the state of Hawaii, special considerations must be taken into account when using children in biomedical research. Typically, research conducted using children is more heavily regulated than research conducted on adults. This is because children are considered to be a vulnerable population, meaning that they may be unable to give informed consent to participate in the research or they may not be able to fully comprehend the risks involved. In accordance with the Common Rule, researchers must receive approval from an Institutional Review Board (IRB) via a formal process before conducting any research involving human subjects. This review process is especially important when conducting research with children, as the IRB must assess the potential risks of the research, as well as the potential benefits. In addition to gaining approval from an IRB, researchers must also obtain a signed consent form from the parent or guardian of any child involved in the research. This consent form must include detailed information on the risks and benefits of the research, as well as an explanation of what will occur if the child decides to withdraw from the research project. Finally, the researcher must demonstrate that they have taken reasonable steps to ensure that the risks to the child in the research are minimized. This includes ensuring that the child has appropriate physical and psychological support throughout the process and that the research is conducted in a safe and secure environment.
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