What are the consent requirements for collecting and using biological samples for research?
In Wisconsin, consent requirements for collecting and using biological samples for research depend on the type of research being conducted. For instance, if the research involves the collection of healthy samples from living individuals, consent is required from the individuals from whom the samples are collected. Additionally, if the research involves the use of medical records or information, the researchers must obtain written informed consent from the individuals or their legal representatives. In cases of research involving samples of human tissue or other body fluids, researchers must obtain written consent from the individual providing the sample. This consent must be obtained before the sample is collected and is required even if the individual’s identity is unknown. The written consent must include information about the research activity, the rights and obligations of the individual, and any risks associated with the sample use. In cases where the research involves samples from deceased individuals, researchers must obtain consent from the next of kin or legal representative. This consent is required even if the individual’s identity is unknown. In general, biological samples for research in Wisconsin should only be collected and used if the research has been reviewed and approved by an institutional review board or if the research meets the criteria for exemptions from review. All individuals providing samples must be informed of their rights, including their right to withdraw from the research or refuse to provide a sample.
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