Who owns human tissue samples?
Known worldwide as HeLa cells, the first 'immortal' human cells grown in culture are still alive today, more than sixty years after they were taken from Henrietta Lacks - without her consent or knowledge.
By Dr Lesley Russell
A recent book by Rebecca Skloot, The Immortal Life of Henrietta Lacks, looks at the life of a young black woman (Henrietta Lacks) who, in 1951 and at the age of 30, was diagnosed with cervical cancer. The cancer was aggressive and she died eight months later in the segregated ward of Johns Hopkins Hospital. On the day of her death, the head of the hospital’s tissue-culture research lab, Dr George Gey, went before TV cameras, held up a tube of cells, and announced that a new age of medical research had begun, one that, someday, could produce a cure for cancer.
The cells in that test tube – now known worldwide as HeLa cells – were grown from Henrietta’s tissue, taken without her consent or knowledge. The first ‘immortal’ human cells grown in culture, they are still alive today more than sixty years after Henrietta’s death. HeLa cells have been vital in the development of many areas of biomedical research and they have been bought and sold by the billions. If all the HeLa cells ever grown were piled on to a scale, it is estimated they would weigh more than 50 million metric tons – as much as a hundred Empire State Buildings.
It was not until 1975 that the Lacks family came to understand her critical role in medical research – and their lack of benefit from this. Her daughter said recently: “If our mother is so important to science, why can’t we get health insurance? Truth be told, I cannot get mad at science, because it helps people live, and I’d be a mess without it. But I won’t lie. I would like some health insurance so I don’t got to pay all that money every month for drugs my mother’s cells probably helped make.”
Fortunately, times are changing. In April, the Arizona State University’s Board of Regents agreed to pay $700,000 to members of the Havasupai tribe, who live deep in the Grand Canyon, and to return blood samples taken from them. This was a significant settlement because it implied that the rights of research subjects could be violated when they were not fully informed about how their DNA might be used.
Members of the tribe had given DNA samples to university researchers starting in 1990, in the hope that they might provide genetic clues to the tribe’s devastating rate of diabetes – a study the tribe had requested. But later, they learned that their blood samples had been used to study many other things, including mental illness and theories of the tribe’s geographical origins.
Legal experts say that the Havasupai settlement is the first to individuals who claim their DNA was misused. It raises the question of whether scientists took advantage of a vulnerable population. The geneticist responsible for the research said that she had obtained permission for wider-ranging genetic studies, but admitted that the consent form was purposely simple, as English was a second language for many Havasupai and few members of the tribe had graduated from high school.
Genetics experts and civil rights advocates say it may fuel a growing debate over researchers’ responsibility to communicate the range of personal information that can be gleaned from DNA at a time when it is being collected on an ever-greater scale for research and routine medical care.
Although researchers and institutions that receive federal funds are required to receive informed consent from subjects to ensure that they understand the risks and benefits before they participate, when it comes to mining DNA, the rules are murky. It is not clear if it is necessary, for instance, to ask someone who has donated DNA for research on heart disease if that DNA can be used for Alzheimer’s or addiction research.
Could such issues arise in Australia? As I understand it, the issue is unclear. People can authorise the removal of their bodily material and its use, either during life or after their death, for medical or scientific purposes. Researchers who acquire such human body parts or tissue have a right to possess and use them according to the authorisation they have been given, but their rights fall short of full ownership.
Australian medico-legal expert Professor Loane Skene says that the legislation about who actually owns excised tissue is unclear and should be tightened up. She has argued that tissues should be treated like medical records, which are owned by doctors but can be accessed for medical research without the patient’s consent. The Australian Law Reform Commission has proposed making it an offence to test tissue without a person’s consent.
Several public opinion surveys suggest that most Australians are happy to have their tissues used to advance biomedical research. They are probably less happy to have that tissue used in the development of intellectual property and commercial biological products, but current Australian law does not provide them with any property rights in such cases.
Dr Russell (PhD) is the Menzies Foundation Fellow at the Menzies Centre for Health Policy, The University of Sydney/Australian National University, and a Research Associate at the US Studies Centre at The University of Sydney. She is currently a Visiting Fellow at the Center for American Progress in Washington, DC.
Published: 17 May 2010