Consent to the use of tissue and cell lines
Cells and tissue taken from a patient can become a cell line that research depends on, and cases in which that happened without the person's knowledge raise questions of consent, privacy and who benefits. The law on human tissue sets when consent is needed for its storage and use, and who owns tissue once it is removed remains an open question.
The HeLa cell line
Henrietta Lacks, a 31-year-old African American, died of cervical cancer in 1951. Her biopsied cancer cells were taken without her permission, propagated seemingly forever after and shared by research laboratories across the world. The resulting HeLa cell line is an integral, multimillion-dollar constituent of the scientific and medical research industry, from which her family has not materially benefited. Her story is rooted in the institutionalised racism of the 1950s and 1960s. Informed consent for the use of her tissue was never sought or obtained, and her privacy was not protected once the provenance of the cell line became widely known.
The HeLa tissue culture became vital to the development of a wide array of new drugs and diagnostic tests, and its contributions to science include the development of the flu vaccine, advances in gene mapping, and insights into cancer and ageing.
More than 20 years after her death, her family learned, to their shock and incomprehension, that cells taken without her knowledge were still living. David Lacks recalled the phone call from a researcher: "They said they got my wife and she part alive… They said they been doin' experiments on her…" Her daughter Deborah recognised the paradox: she could not get mad at science, because it helps people live and she would be a mess without it. She was a walking drugstore, and she could say nothing bad about science, but she would like health insurance so that she did not have to pay all that money every month for drugs her mother's cells probably helped make.
The WI-38 cell line
A Swedish woman known as Mrs X was never informed that her aborted fetus was used to create the WI-38 cell line in 1962. Great pains were taken to hide this from her while regulators sought proof that she was healthy enough for the fetus's cells to be used in vaccine production, and her medical record was eventually sent to US researchers without her consent.
Consent and privacy under UK tissue law in 2012
In the United Kingdom in 2012 there was little absolute clarity on either consent or privacy for human tissue. The Human Tissue Act led the Human Tissue Authority to revise its codes of practice in September 2009, and by 2012 these were codified into UK law. Under the Act, data about the tissue did not have to be permanently or irrevocably unlinked, and could be pseudonymised where, for example, a system of coding was used.
Consent from the living was needed to store and use tissue for research in connection with disorders, or the functioning, of the human body, but tissue could be stored or used without consent if the material was used for a specific research project with ethical approval. Nor was consent needed to store and use tissue for education or training relating to human health, including training for research into disorders, or the functioning, of the human body. Loopholes for exploitation existed, and on privacy and consent the UK in 2012 may have been no better off than the USA in the 1950s.
Who owns tissue once it is removed
Who should own tissue once it is removed from an individual is an unresolved argument. Commercialisation of tissue and the research associated with it was and is the inevitable result of the appetite for new drugs and diagnostic tests, and material benefit for donors is unlikely ever to happen, despite the huge gains made by institutions and companies.