How does the law protect the rights of participants in biomedical research?
Biomedical research in Delaware is subject to a variety of legal protections that work to safeguard the rights of research participants. Most generally, Delaware law requires that research involving the participation of human participants be conducted in accordance with ethical principles such as respect for the autonomy, individual rights, and welfare of the research subject. Additionally, the Delaware Code of Regulations requires that any research conducted on human participants be approved by a duly constituted Institutional Review Board. This board must review a variety of factors, such as the potential risks and benefits of the research, prior to allowing a research study to proceed. Every research participant must provide informed consent prior to participating in the research. This consent must be in writing and must clearly explain the purpose and potential risks of the research. Research participants are also entitled to a full explanation of the available alternatives to participating in the research, as well as their right to end their participation in the research at any time. Finally, Delaware law requires that all research participants be provided with access to adequate medical care or compensation in the event of an injury related to the research. As such, participant rights and safety are paramount to any biomedical research being conducted in Delaware.
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