Before embarking on human subject research, it is incredibly important to understand the federal regulations and ethical guidelines that govern this work. However, understanding the historical contents of these laws allows researchers and administrators to understand the “why” behind modern rules and regulations. While many events shaped today's ethical landscape, the story of Henrietta Lacks remains one of the most common, accessible, and powerful stories.
Rebecca Skloot's book The Immortal Life of Henrietta Lacks illustrates the essential role of ethical oversight in modern research. Through the lens of the HeLa cell line, it offers a compelling look into foundational IRB concerns, including informed consent, participant rights, and the ethical handling of biological materials. The story of the HeLa cell line began in 1951 at John Hopkins Hospital, where Henrietta Lacks was receiving radium therapy for a malignant cervical tumor. During the course of her treatment, medical personnel extracted both healthy and cancerous tissue samples without obtaining her consent. While she passed away from the disease shortly thereafter, researchers found that her malignant cells were able to survive in vitro, leading to the creation of the first “immortal” cell line.
The harvested samples were given to Dr. George Gey, a researcher who struggled for years to grow human cells in vitro. Unlike any samples before, Henrietta's cells flourished, allowing Dr. Gey to establish the “HeLa” cell line, named using the first two letters of Henrietta's first and last name. This breakthrough sparked a scientific revolution as the cells were instrumental in developing the polio vaccine, where they were soon cloned and mass-produced for researchers worldwide.
Following the initial success of the HeLa cell line, researchers began highly unethical human trials. The cells were injected into cancer patients to monitor immune response without obtaining informed consent. Researchers then extended this study to healthy individuals, often recruiting them from penitentiaries, utilizing prisoners as a vulnerable research population. These healthy inmates were injected with the malignant cells as part of a broader pattern of medical paternism, where patients and inmates alike were denied the right to know what was being introduced into their bodies.
The ethical violations extended far beyond Henrietta herself, eventually reaching her children. Decades later, researchers approached the Lacks family to collect blood samples, yet failed to provide a clear explanation of their motives. Henritettas daughter, Deborah, lived in fear of the disease that killed her mother, providing her blood to the researchers under the impression that she was being tested for cervical cancer. Despite her repeated attempts to seek medical clarification and follow up on her “results”, the researchers never explained that her blood was actually being used to map her mothers DNA,
Unfortunately, the exploitation of the Lacks family is not an isolated incident in the history of medicine. It is a part of a dark lineage of unethical research that includes the Tuskegee Syphilis Study and the Milgram Conformity Experiment. However, these systematic failures became the impetus for chance. They paved the way for the Nuremberg trials, the Belmont Report, the Common Rule. These milestones transformed medical ethics, ensuring that today, informed consent and patients autonomy are non-negotiable requirements of scientific inquiry.
Citations:
Beskow, L. M. (2016). Lessons from HeLa Cells: The Ethics and Policy of Biospecimens. Annual Review of Genomics and Human Genetics, 17, 395–417. https://www.google.com/search?q=https://doi.org/10.1146/annurev-genom-083115-022536
Skloot, R. (2010). The Immortal Life of Henrietta Lacks. Broadway Paperbacks.