What is the scope of legal protection for research and development involving tissue or organs derived from biobanking?
In Delaware, research and development involving tissue or organs derived from biobanking are subject to certain legal protections. Biobanking involves collecting and storing biological materials such as human tissue or organs, often for research purposes. Under Delaware law, any person involved in the research and development of such materials is protected from civil and criminal liability under the Biomedical Research and Development Act (BRDA). The BRDA specifically provides that any person who participates in biobanking activities or research is immune from civil liability for any damage resulting from the exercise of reasonable judgment related to the activities. In other words, so long as researchers and developers exercise reasonable care in their research, they are not liable for any damage that may be caused. In addition to civil liability, the BRDA also protects researchers and developers from criminal liability for any activities related to biobanking and research. While criminal liability is rare, the BRDA provides that a researcher or developer who conducts biobanking activities in good faith and in compliance with all relevant laws and regulations is not criminally liable for their activities. Although the legal protection under the BRDA is limited, it nevertheless provides a measure of protection for researchers and developers involved in biobanking activities. By ensuring that researchers are immune from civil and criminal liability, Delaware law enables safe and effective research of biological materials.
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