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What was the outcome of Doodeward's lawsuit regarding the corpse?
What was the outcome of Doodeward's lawsuit regarding the corpse?
Human tissues can be bought and sold for profit according to the Council of Europe’s Convention.
Human tissues can be bought and sold for profit according to the Council of Europe’s Convention.
False
What rights does a recipient gain when a body part is removed from the donor?
What rights does a recipient gain when a body part is removed from the donor?
The right to possess the body part.
The Supreme Court case established in 1908 allowed for the ownership of corpses under __________ conditions.
The Supreme Court case established in 1908 allowed for the ownership of corpses under __________ conditions.
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Match the following articles with their main focus:
Match the following articles with their main focus:
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What was Anthony-Noel Kelly accused of?
What was Anthony-Noel Kelly accused of?
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Hair and nails are excluded from the rules about human tissue ownership.
Hair and nails are excluded from the rules about human tissue ownership.
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What legal consequence did Kelly face for his actions?
What legal consequence did Kelly face for his actions?
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What is the primary function of a patent?
What is the primary function of a patent?
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A patent grants the holder the right to measure heart rate without additional permissions.
A patent grants the holder the right to measure heart rate without additional permissions.
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In the Moore v. Regents of the University of California case, why did the court rule Moore had no property rights over his modified cells?
In the Moore v. Regents of the University of California case, why did the court rule Moore had no property rights over his modified cells?
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In the Washington University v. Catalona case, the tissues were deposited in the ______ biobank.
In the Washington University v. Catalona case, the tissues were deposited in the ______ biobank.
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What was the main argument of Washington University in the lawsuit against Catalona?
What was the main argument of Washington University in the lawsuit against Catalona?
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Match the following cases with their key outcomes:
Match the following cases with their key outcomes:
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Patients have the right to authorize the transfer of their donated tissue samples after they have donated them.
Patients have the right to authorize the transfer of their donated tissue samples after they have donated them.
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What principle was established regarding human tissues in the Moore case?
What principle was established regarding human tissues in the Moore case?
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What did the Universal Declaration on the Human Genome and Human Rights declare about the human genome?
What did the Universal Declaration on the Human Genome and Human Rights declare about the human genome?
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Once a donor has donated their tissue, they __________ ownership of the donated material.
Once a donor has donated their tissue, they __________ ownership of the donated material.
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William Catalona obtained consent from patients to use their tissues for research.
William Catalona obtained consent from patients to use their tissues for research.
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Match the following cases with their take-home messages:
Match the following cases with their take-home messages:
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What did Washington University object to in the Catalona case?
What did Washington University object to in the Catalona case?
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What was the reaction of the scientific community to Craig Venter's actions regarding the human genome sequencing data?
What was the reaction of the scientific community to Craig Venter's actions regarding the human genome sequencing data?
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The court ruling stated that donated tissue samples were meant for the benefit of Catalona.
The court ruling stated that donated tissue samples were meant for the benefit of Catalona.
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What happens to a donor's say in the usage of their donated tissue once it is donated?
What happens to a donor's say in the usage of their donated tissue once it is donated?
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Which company was a primary investor when 23andMe was founded?
Which company was a primary investor when 23andMe was founded?
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23andMe was regulated from the time of its inception in 2006.
23andMe was regulated from the time of its inception in 2006.
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What did 23andMe do with clients' genetic data in 2018?
What did 23andMe do with clients' genetic data in 2018?
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In 2013, a famous actress underwent a double mastectomy due to a mutation in the BRCA1 and BRCA2 genes. Her name is ________.
In 2013, a famous actress underwent a double mastectomy due to a mutation in the BRCA1 and BRCA2 genes. Her name is ________.
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Which issue was raised due to the patenting of the BRCA1 gene?
Which issue was raised due to the patenting of the BRCA1 gene?
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Most users read the terms and conditions before consenting to genetic data usage.
Most users read the terms and conditions before consenting to genetic data usage.
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Match the following entities with their roles:
Match the following entities with their roles:
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The controversial sale of genetic data by 23andMe to GSK raised questions about patient ________ and consent.
The controversial sale of genetic data by 23andMe to GSK raised questions about patient ________ and consent.
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What is the main ethical concern regarding Henrietta Lacks' cells?
What is the main ethical concern regarding Henrietta Lacks' cells?
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HeLa cells were discovered to be immortal and could be grown indefinitely for research purposes.
HeLa cells were discovered to be immortal and could be grown indefinitely for research purposes.
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What significant medical advancements were facilitated by the use of HeLa cells?
What significant medical advancements were facilitated by the use of HeLa cells?
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Henrietta Lacks' cells were harvested in the year _____ before she died.
Henrietta Lacks' cells were harvested in the year _____ before she died.
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Match the following key terms with their definitions:
Match the following key terms with their definitions:
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In what year was HeLa's genome sequence published publicly?
In what year was HeLa's genome sequence published publicly?
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Henrietta's family has received financial benefits from the scientific use of her cells.
Henrietta's family has received financial benefits from the scientific use of her cells.
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Who was responsible for recognizing the unique properties of Henrietta Lacks' tumor cells?
Who was responsible for recognizing the unique properties of Henrietta Lacks' tumor cells?
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Which consent model requires donors to consent to all possible future research done on their biospecimen?
Which consent model requires donors to consent to all possible future research done on their biospecimen?
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In dynamic consent, donors cannot change their consent options once given.
In dynamic consent, donors cannot change their consent options once given.
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What is a patent?
What is a patent?
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Biological material that has undergone a ___ procedure in isolating or making it can be patented.
Biological material that has undergone a ___ procedure in isolating or making it can be patented.
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Match the following consent models with their descriptions:
Match the following consent models with their descriptions:
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Which type of biological sample can be patented?
Which type of biological sample can be patented?
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Patents confer unlimited rights to the holder for all time.
Patents confer unlimited rights to the holder for all time.
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What must be stated in a patent application for inventions taken from the human body?
What must be stated in a patent application for inventions taken from the human body?
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Study Notes
Biosecurity and Research Bioethics [APB1304]
- Focuses on the ethical considerations surrounding human tissue and genetic data.
- Ownership and control of human tissue are complex issues.
- Lecture 8 specifically addresses ownership and control of human tissue and genetic data.
- The case of Henrietta Lacks highlights the ethical dilemmas surrounding the use of human tissue in research.
- Lacks' cells, known as HeLa cells, were harvested without her knowledge or consent and used extensively in research.
- This case sparked a discussion about informed consent and equitable benefit sharing in research involving human samples.
The Immortal Life of Henrietta Lacks
- Henrietta Lacks was a patient who died of cervical cancer in 1951.
- Her cancer cells were harvested and cultured, leading to the HeLa cell line.
- HeLa cells proved invaluable in scientific research, contributing to major breakthroughs in medicine.
- However, her family was unaware of the use of her cells and the profit generated from them for decades.
Key Concerns with Henrietta's Story
- Was it ethical to use Henrietta's cells without her consent?
- Was research conducted on her cells ethically?
- Was the profit made from her cells justly distributed?
- Did the identity of the donor woman need to be widely recognized?
Publishing HeLa's Genome Sequence (2013)
- Researchers published HeLa's genome, which was available to the public.
- Public outcry led to the National Institute of Health (NIH) collaborating with the Lacks family.
- They created a database with controlled access, and established a committee involving the Lacks family to review related research.
Is the HeLa Case Generalizable?
- The HeLa case was unusual. Rare for a biospecimen to be valuable as HeLa cells.
- Usually, many samples from multiple people are needed for research.
- The high profile of Henrietta Lacks made the donor identity significant to the case.
Biobanks
- Biobanks are systematic collections of human biological samples (biospecimens) and associated information for research.
- Can be public or private (non-profit or commercial).
- Various types exist (e.g., population, tissue, digital, blood, organ-oid biobanks).
Biobanking Procedure
- Core steps of biobanking.
- Informed consent is crucial.
- Sampling, processing, and storage are key steps.
- Frozen storage methods are critical preservation techniques
The Ethics of Owning Body Parts
- John Locke believed every individual owns their own body, but it is limited.
- The Declaration of Human Rights prohibits the ownership of another person (slavery).
- The right of ownership over a corpse was traditionally not allowed, though some modern exceptions exist.
Ownership of a Dead Body
- The customary law, from 1614 to 1908, states that there can be no property in a corpse.
- However, the case of Doodeward v. Spence (1908) created an exception.
- Skilled modification or preservation of a corpse enabled ownership.
The 1998 Case of the Royal College of Surgeons
- Anthony Noel Kelly stole preserved body parts for art.
- This case, and the courts decision related to the prior Doodeward case, recognized a special category of ownership for skilled modification/preservation.
Human Tissue Ownership
- A recipient gains the right to possess a removed body part.
- Modification or processing of a body part adds to the recipient's rights.
- Ethical considerations dominate the ownership of human body parts.
Ethics of Human Tissue Commercialization
- Profit generation from buying and selling human tissues is explicitly prohibited by the Council of Europe's conventions.
- The human body and its parts, as such, cannot give rise to financial gain.
- Storing and utilizing removed body parts for purposes beyond the initial removal requires adherence to appropriate information and consent procedures.
- Exceptions exist if the body parts are hair or nails, as these are considered common waste products.
Consent Models for Biospecimens
- General notification: passive informing donors; default position (opt-in or out).
- Study-specific consent: contacting donors for consent before each study.
- Blanket consent: donor's consent to future research on their sample.
- Broad consent: donor consent to future research; particular rules may apply.
- Categorical consent: specific uses of the sample.
- Dynamic consent: adjustable consent with technological support.
Patenting Biological Samples
- Intellectual property rights include the creations of human intellect including ideas and inventions
- Patents are a form of legal monopoly; original, novel and non-obvious inventions can be patented and the rights are limited spatially and temporally.
- Specific biological samples are patentable if they result from technical procedures: isolating, changing, or modifying a biological sample in a new way. Procedures or new applications of a biological sample in some way are also patentable.
What Kind of Biological Samples can be Patented?
- Biological materials modified by technical procedures.
- Processes for making, modifying, or utilizing biological materials.
- Novel applications of biological materials.
- Inventions relating to human body material: proper application must be detailed in the patent document.
What Kind of Rights Do Patents Give Their Holders?
- Prevent others from importing, utilizing, or selling the invention.
- The patent holder does not automatically have additional rights (e.g., to actually perform the process/measure that the invention relates to).
- In some cases, additional rights require further steps and regulations.
Moore v. Regents of the University of California Case (1990)
- Supreme Court ruled in favor of the Regents of the University of California.
- Moore's cells, after modification, were considered property of the university (reclassifying the cells from their original nature/state).
- The modified state/condition of the cells gave the university ownership.
- Physicians should have obtained informed consent for the economic interests.
Washington University (WU) v. Catalona Case
- Catalona routinely removed tissues from patients with consent for research.
- WU objected to his transfer of tissue samples to a different lab.
- The court ruled that the patients had no ownership rights over the tissues.
- They had donated samples to the university, and the university held the ownership rights.
Take-Home Message from the Moore and WU v. Catalona Cases
- Tissue donors' rights to be informed on the use of their donated tissue, and about commercial and non-commercial uses.
- Donors lose ownership once donation is complete.
- Donors lose the right to specify future use once a donation is complete, unless specific agreements/restrictions have been defined in advance.
- Sufficiently processed donated tissues can be commercially utilized.
What About the Commercial Use of the Human Genome?
- Craig Venter's action of requiring access-rights to the Human Genome to only researchers who allowed commercial use; this raised significant ethical concerns.
- The Universal Declaration on the Human Genome and Human Rights declared that the human genome, in its natural state, should not give rise to financial gain.
What About Commercial Use of the Human Genome? (cont.)
- 23andMe and other companies offer direct-to-consumer genetic testing.
- These actions were unregulated until 2013, raising concerns about data ownership and use.
- Sales of clients' genetic data to major pharmaceutical companies highlight the potential for financial gain from human genetic data. These commercial uses are considered ethical/legal with the proper informed consent from the client/donor. Client consent can also be an issue that is influenced and/or defined by the surrounding terms and conditions of the practice.
What About Patenting Human Genes/Human Genome?
- Angelina Jolie's breast cancer diagnosis and genetic testing (BRCA1/2) highlighted the issue of patenting genes.
- Myriad Genetics' patenting of BRCA1 mutation testing resulted in high costs with limited accessibility.
Association for Molecular Pathology v. Myriad Genetics, Inc. Case
- The Supreme Court ruled that genes are products of nature, not inventions, and, as such, not patentable.
- Complementary DNA (cDNA), however, is patentable because of its transformation/process/modification.
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Description
This quiz covers significant legal cases and concepts surrounding the ownership of human tissues and corpses, including the outcomes of key lawsuits and the implications of human tissue laws. Test your knowledge on important rulings, rights related to body parts, and the legal status of human tissues in different contexts.
