What existing laws govern the use of human stem cells in research?
In Delaware, the use of human stem cells in research is regulated by both state laws and federal laws. The Delaware General Assembly has adopted the Uniform Anatomical Gift Act of 2006. This legislation requires researchers to obtain informed consent from those from whom stem cells are collected, and any research using stem cells obtained from fetal tissue must be approved by an Institutional Review Board. The federal government has implemented regulations to protect human subjects from unethical research using stem cells. This includes the Common Rule, a set of regulations that outlines the ethical use of human subjects in medical research. It prohibits clinical research with stem cells that are obtained without informed consent, and any research involving the use of stem cells must be approved by an Institutional Review Board. The Food and Drug Administration (FDA) also has regulations regarding stem cell research. This includes the Good Manufacturing Practices for Human Cells, Tissues, and Cellular and Tissue-Based Products, which requires that all stem cell collections, processing, and storage must be done following FDA regulations. Finally, the National Institutes of Health (NIH) has established guidelines to ensure that scientists follow ethical practices while conducting stem cell research. This includes requiring researchers to obtain patient informed consent and to register all clinical trials in the ClinicalTrials.gov registry. In conclusion, Delaware and the federal government have enacted laws and regulations that require researchers to obtain informed consent before collecting and using human stem cells in research, and any stem cell research must be approved by an Institutional Review Board or the FDA. These laws help protect human subjects from unethical practices and ensure that all stem cell research is conducted in an ethical manner.
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