What are the legal requirements for obtaining informed consent in biomedical research?
In New Hampshire, individuals must obtain informed consent prior to participating in any biomedical research. Informed consent means that the individual must be fully aware of the risks and benefits of the research before agreeing to participate. To obtain informed consent, the researcher must provide information about the research, its risks, and its benefits in a language that the participant can understand. The researcher must also explain a participant’s rights. These include the right to stop participating at any time, the right to ask questions about the study, and the right to contact the appropriate medical authority if they have any concerns. The informed consent process should be completed by a qualified medical professional. This professional should provide the participant with a copy of the informed consent form and answer any questions the participant may have. The informed consent form should include a statement that the participant understands the information presented, agrees to participate, and knows their rights. Additionally, the researcher must obtain approval from an Institutional Review Board (IRB) before conducting biomedical research. The IRB will review the research protocol, potential risks and benefits, and the process for obtaining informed consent. Once approved, the researcher must follow the informed consent procedure to ensure that participants are fully informed and consent to participate.
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