The use of biological human tissue is directed by various legal regulations. Understanding these rules and how to obtain meaningful informed consent is essential for researchers and laboratorians to maximize the tissue’s potential for research, to respect the patients’ and subjects’ participation while avoiding lawsuits and destruction to valuable specimens. Regarding laws and regulations (Drabiak-Syed 2010), the Common Rule, included in the Code of Federal Regulations, establishes protection for human research participants and require the researchers to obtain informed consent to collect and use human tissues from donors after clearly explaining what and how the tissues will be used. The IRB (Institutional Review Board) will review and determine if the research met specific guidelines, such as minimizing risk and increasing benefits to subjects, ensuring the subject’s healthy status physically and mentally to give consent, and informing
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However, there was no legal consent for biopsy tissues to be retrieved during treatment and used in laboratory research, because physicians and researchers believed that the act will contribute to the greater good for the society, which was encouraged and expected. Scientists knew little about cellular functions and mechanism, and they did not imagine that HeLa cells would be valuable in research and medical breakthroughs at the time. It was a completely different mind-set in the past although researchers and physicians did not have ill intentions. In the case of Havasupai Tribe v. ASU in 2004, the Tribal Council approved the collection and use of samples to research diabetes in the community in 1990s, but researchers subsequently transferred samples to third parties to study schizophrenia, migratory
However, there was no legal consent for biopsy tissues to be retrieved during treatment and used in laboratory research, because physicians and researchers believed that the act will contribute to the greater good for the society, which was encouraged and expected. Scientists knew little about cellular functions and mechanism, and they did not imagine that HeLa cells would be valuable in research and medical breakthroughs at the time. It was a completely different mind-set in the past although researchers and physicians did not have ill intentions. In the case of Havasupai Tribe v. ASU in 2004, the Tribal Council approved the collection and use of samples to research diabetes in the community in 1990s, but researchers subsequently transferred samples to third parties to study schizophrenia, migratory