Human Tissue Ownership and Legal Cases

A type of human cell line derived from cancerous cells taken from Henrietta Lacks, a patient who died in 1951. HeLa cells are highly proliferative, and have been used extensively in scientific research, contributing to major medical breakthroughs.

The ethical principle of obtaining informed consent from individuals before using their biological material in research. This implies full disclosure of the purpose, risks, and potential benefits of the research, and the right of the individual to decline participation.

The use of human tissues and genetic data in research raises ethical concerns related to the rights and privacy of the individuals involved. It includes aspects like obtaining informed consent, protecting anonymity and ensuring fair benefit-sharing.

The concept that individuals should benefit from the use of their tissues and genetic data in research. This can include access to healthcare, financial compensation, or recognition for their contribution.

A controversial event where the genome sequence of HeLa cells was publicly shared in 2013. This raised concerns about the privacy of Henrietta Lacks and the potential ethical implications of sharing her genetic information.

The ethical issue of using Henrietta Lacks' cells without her consent for research and profit generation. This raises concerns about the exploitation of individuals and the lack of benefit for the family of the donor.

The issue of whether it's ethically acceptable to profit from the use of Henrietta Lacks' cells without her consent or the consent of her family. It raises questions about the equitable distribution of benefits associated with scientific discoveries.

The lack of benefit provided to Henrietta Lacks' family despite the tremendous profit and scientific advancement generated from her cells. This raises concerns about the equitable distribution of benefits from research and the exploitation of individuals.

This model gives donors the choice to either opt-in or opt-out of using their biospecimens for research, depending on whether the default position is for use or not.

This model requires donors to give consent specifically for each research study using their biospecimens.

This model allows donors to give consent for all potential future research on their biospecimens.

This model is similar to blanket consent, but it allows donors to maintain certain rights, such as withdrawing consent or overseeing research using their biospecimens.

This model presents donors with different options for how their biospecimens could be used in the future, enabling them to select their preferred research areas.

This model empowers donors to digitally update their consent preferences as new scientific developments emerge or their personal circumstances change.

A legal form of monopoly over intellectual property that grants the holder exclusive rights. It is conferred for novel, original, and non-obvious inventions or ideas.

Intellectual property produced by the human intellect and is intangible, like an idea or invention.

The Doodeward v Spence case established legal precedent for ownership over a preserved human corpse in 1908. The court ruled that modifications or skillful treatments of the corpse, like preserving it in a bottle, were enough to justify ownership.

The Royal College of Surgeons case involved an artist, Anthony-Noel Kelly, stealing preserved body parts to create sculptures. He was convicted of theft due to the Doodeward v Spence precedent, establishing that skillfully modified body parts could be owned.

The legal principle that ownership of a body part may be established after it is removed from the donor, especially when modified or processed.

The Council of Europe's Convention on Human Rights and Biomedicine prohibits commercial profit from the buying and selling of human tissues. This ethical principle emphasizes respect for human dignity and the body's inherent worth.

The Convention on Human Rights and Biomedicine specifies that removed body parts may only be stored and used for purposes other than the original removal if done with informed consent according to appropriate procedures.

The Convention on Human Rights and Biomedicine explicitly excludes hair and nails from the rules prohibiting commercial profit from human tissues, as these are generally considered disposable.

Informed consent is required for the storage and use of removed body parts for purposes other than the original removal. This ensures individuals understand how their body parts will be used, protecting their autonomy.

The Convention on Human Rights and Biomedicine, also known as the Oviedo Convention, emphasizes ethical standards for the use of human body parts and biospecimens, ensuring dignity and respect for individuals alongside scientific advancement.

A legal case where the Supreme Court of California ruled that modified human cells, like the Mo Cell line, can be owned as property, but the patient has no ownership rights over their modified cells.

A legal principle where property that is abandoned can be claimed as property by someone else.

The process of altering genetic material of a cell, often for research purposes.

The right of a patient to be informed about all possible risks and benefits of a procedure, including potential economic interests in their cells and tissues.

A legal case where a physician, Dr. Catalona, sought to transfer tissue samples from patients to a privately owned lab, leading to a dispute with the Washington University biobank.

A collection of biological samples used for research purposes.

The process of transferring biological samples from one location to another, often for further research.

The patients involved in the Washington University v. Catalona case had donated their tissue samples to the university and had signed away their rights to control the use of their samples. Therefore, they could not authorize the transfer of their samples to Northwestern University with Dr. Catalona.

In the Washington University v. Catalona lawsuit, the court decided that the university, Washington University, had intellectual property rights over the research outcomes generated from the donated tissue samples. This meant that even though the samples were donated by patients, they could not direct where the research should be conducted.

The court ruled in the Washington University v. Catalona case that patients did not have the right to authorize the transfer of tissue samples to another institution, even if they desired it. This decision highlighted that patients are not the owners of their donated tissues once donated.

The Moore v. Regents case and the Washington University v. Catalona case both highlight a crucial point: when donating biological material, individuals should be informed about the potential uses of their donations. This includes any commercial possibilities or potential financial gains derived from the material.

The case of Craig Venter and the Human Genome Sciences highlights a controversy in using human biological material for commercial purposes. Venter's claim to exclusive commercial rights over the human genome data sparked ethical concerns about the potential exploitation of human biological information.

The Universal Declaration on the Human Genome and Human Rights explicitly states that the human genome in its natural state should not be subject to commercial exploitation. This declaration emphasizes the ethical imperative to protect human dignity and integrity in the context of genetic research.

The commercialization of human body parts and the human genome is ethically problematic because it raises concerns about the potential exploitation of human beings and the violation of their inherent dignity. It raises questions about reducing human beings to mere commodities for economic gain.

Direct-to-consumer (DTC) genetic testing companies, like 23andMe, offer personal genomic analysis, providing insights into ancestry and health predispositions.

23andMe, founded in 2006 with Google as an investor, offered DTC genetic testing services, initially operating with minimal regulation.

The sale of genetic data from 23andMe's clients to GlaxoSmithKline (GSK) in 2018 for $300 million raised questions about data ownership and use.

When using 23andMe services, clients consent to their data being used for "research purposes." However, the extent and commercial nature of this use may not be fully understood by all clients.

Studies show that many users of online services, including genetic testing services, don't carefully read the terms and conditions, highlighting a potential gap in informed consent.

The patenting of genes, like the BRCA1 and BRCA2 genes associated with breast cancer, has raised ethical questions about the commercialization of human genetic information.

The patenting of the BRCA1 gene by Myriad Genetics created a monopoly on testing, making it costly and inaccessible to many women with a potential increased risk of breast cancer.

The case of Myriad Genetics' BRCA gene patent sparked a legal challenge, questioning the patentability of naturally occurring genes and the potential for restricting access to genetic testing.