Are there any special considerations regarding the use of children in biomedical research?
When it comes to the use of children in biomedical research, special considerations are required in California. The California Health and Safety Code outlines that children must have advanced permission from the responsible parent or guardian prior to participating in research, as well as permission from an institutional review board that is authorized by the California Department of Public Health. The research must also meet several requirements, including: ensuring a balance of risks and benefits to the child, having a direct benefit to the child’s health, being conducted in a manner that is age appropriate and respectful of the child, and allowing the child to withdraw at any time without consequences. Furthermore, the research must not prohibit or significantly limit the child’s ability to access needed medical and mental health services. The California Health and Safety Code requires that children aged 12 and older must give their informed consent before participating in any research, meaning they must understand the research, its potential risks and benefits, and have the capacity to consent. Lastly, biomedical research involving California children is also regulated by the federal Common Rule, which requires that extra precautions be taken to ensure that the interests of the children are protected.
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