What is the scope of legal protection for research and development involving tissue or organs derived from biobanking?

Biobanking – the process of collecting and storing tissue or organs from human bodies for research and development – is regulated by state-level biomedicine laws in Indiana. The scope of legal protection for research and development involving tissue or organs derived from biobanking is comparable to other types of medical research. To be legally protected, research must meet certain requirements as outlined by the Indiana Code, Title 35 (Health) Article 7 (Biomedical Research), Sections 1-7. These requirements include obtaining informed consent from participants, appropriate use of resources, and understanding the purpose of the study. Additionally, there are additional regulatory requirements which must be adhered to, such as those set forth by the Health Insurance Portability and Accountability Act (HIPAA). Research involving biobanking may also be protected under the Common Rule, which is a set of federal regulations that governs research conducted on human subjects. The Common Rule states that research on stored data must be conducted under the protection of institutional review boards (IRBs), and informed consent must be obtained from individuals before the data is collected or used. Overall, research and development involving tissue or organs derived from biobanking is legally protected under Indiana’s state biomedicine law and federal regulation. To ensure legal protection, researchers must follow the applicable laws and regulations and obtain informed consent from participants before conducting any research or development projects.

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What is the scope of legal protection for research and development involving tissue or organs derived from biobanking?

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