In 1951, a black tobacco farmer and mother of five named Henrietta Lacks died of cervical cancer at the age of 31. But before she died, the doctors treating her at Johns Hopkins took samples of her cervical tumor — and without her knowledge or consent those samples went on to become the most prolific human cells in medical research.
The cells, commonly referred to as HeLa cells, have helped research treatments for everything from HIV to cancer. But they have also become a cautionary tale about the importance of ethical standards in research: Lacks’ own family didn’t even know about her research legacy for over 20 years. When European researchers published the full genome transcript of HeLa cells without the knowledge or consent of her family earlier this month, they started a new chapter in that tale about the complex relationship between researchers and the privacy of genetic information.
It’s a complicated chapter, as Dr. William Pewen, Assistant Professor of Public Health and Family Medicine at Marshall University, and a former top health care adviser to the now retired Sen. Olympia Snowe (R-ME), noted to ThinkProgress:
“The release of Henrietta Lack’s genome illustrates the fact that genetic information isn’t an individual matter — it impacts family members as well. This underscores the need to ensure the rights of individuals and preserve the confidentiality of research data. Once patient privacy is lost, problems are simply compounded. Just how can today’s family members give consent for the next generation?”
It’s easy to argue that HeLa cells have saved lives, that their net result was good — but to say so without acknowledging that they are also the result of a highly suspect act that demonstrated disregard for the privacy and consent of a patient ignores the ethical standards that should define scientific research. Similarly, with genetic information, many concerns are raised: It’s very difficult, if not impossible, to guarantee the long-term confidentiality of genetic information and it can reveal much more about an individual and their relatives than basic medical records.
And while the public may generally agree that there are great benefits to be gained through genetic research, it’s important that the concept of medical progress is not put ahead of the informed consent of patients — especially, as Pewen also notes because “[i]n an age of technology advances and ‘Big Data’ analytics, it’s clear that medical data can be used in countless detrimental ways. That will simply be fostered if we allow ethics and human rights to be undermined by expediency.”
The researchers who posted the HeLa genome sequence have already retracted their paper due to complaints from the Lacks family, but as other have noted Lacks’ genome sequence can still be gleamed from other databases.
Genetic information is health information protected by Health Insurance Portability and Accountability (HIPAA) Act disclosure rules and there have been legislative attempts to resolve some of the issues raised by advances in genetic testing, such as the Genetic Information Nondiscrimation Act (GINA) of 2008, which also prohibited employers and health insurance companies from discriminating based on genes — but those regulations won’t help Henrietta Lacks’ descendants: The final rule modifying HIPAA to implement GINA and Health Information Technology for Economic and Clinical Health Act (HITECH) protections effective yesterday does “not protect the individually identifiable health information of persons who have been deceased for more than 50 years,” conveniently excluding HeLa cell information.