Tissue Regulation

The story of Henrietta Lacks is a tragic, but integral part of American bioethics. Henrietta Lacks (1920-1951), was a black woman from rural Maryland suffering from an aggressive cervical cancer. In 1951, she went to the Johns Hopkins Hospital “colored ward” suffering from discomfort and seeking treatment. Dr. George Otto Gay, collected a biopsy of the tumor in order to diagnose Lacks, but in the process of investigating Lacks’s sample, the cells exhibited a behavior he had never seen before: the cells never ceased to multiply. Upon her second visit,  Gay took more cells and conducted research on it without Lacks’s knowledge or consent. Later that year, Lacks died from cancer, but her cells–named HeLa cells after her–remained immortal, allowing for many scientific advancements to be made. Gay not only continued to conduct research on the cells, but he also patented and sold the cells around the world, making billions of dollars, while Lacks’s family had no knowledge of such use of these cells and remained in medical poverty (Khan, 2011). No profits were received until August 7th, 2023 (Willis, 2023).

Ethics is an important aspect of medicine. Despite its heavy emphasis, there have been countless instances where a patient’s ethical rights have been violated in modern-day medicine. The violation of Henrietta Lacks’s own ethical rights were not considered morally unsound because this was not uncommon in the 1950s. This issue can largely be attributed to the lack of regulation that existed and still remains as a result of the imminent ambiguity that is to be encountered as the medical world continuously advances (Mosely, 2008). In the past two decades, a highly debated topic within bioethics is tissue rights, which is especially under-regulated in the United States (Dye & Menikoff, 2024). Henrietta Lack’s story only uncovers a small portion of the unfortunate reality of American regulation of tissue rights.

As previously stated, tissue rights has been a highly debated topic in medicine due to a lack of regulation in the United States. This contrasts the guidelines of the European Union. Through the late 90s and early 2000s, laws and guidelines were put in place to better avoid the rise of issues that are not unfamiliar to the United States. In Article 21 of the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, they clearly state that “The human body and its parts shall not, as such, give rise to financial gain.” In Article 22, they go onto elaborate saying that a human body part should only be used for the purpose it was removed for unless the patient has been well informed and provided with consent. The Council of Europe’s definition of “human body parts” extended to organs, tissues, and blood (Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, 1997). The guidelines enumerated in this document are heavily adhered by medical communities across Europe as they are heavily enforced in countries that have ratified it (Oviedo Convention and its Protocols, n.d.).

The established guidelines within Europe contrast the United States’s own form of regulation in terms of specificity. For the past 30 years, the United States has been regulating tissue rights with The Federal Policy for the Protection of Human Subjects, otherwise known as Common Rule, which has since been revised in 2018. Common Rule essentially ensures the research on human subjects cannot be performed without “informed consent” from the patients, but this is not extended to “non identified tissue ”. As a result of this rule, it allows for research to be done without consent. Similar to “human body parts”, “non identified tissue” can be organs, tissue, or blood, but it cannot be traced back to the donor’s identity (Coded Private Information or Biospecimens Used in Research Guidance, 2018). Although Common Rule is successful in protecting the donor’s identity, it starkly differs from European regulation as financial gain from such tissue is allowed. Due to the fact that there are no laws or regulations on how to manage this, there have been many lawsuits, coming from disgruntled patients and families. 

California’s 1990 Supreme Court Case Moore v. Regents of the University of California set the precedent that donors no longer have ownership over their cells once their identity has been separated. After John Moore received a splenectomy, Drs. Gold and Quann asked Moore to sign a form consenting to research on his blood samples. What the consent form failed to mention was the subsequent commercial use and patenting the cell line made from the samples. Unfortunately for Moore, he did not receive a settlement after discovering profits were made from the cell line that came from his cells. Over a decade later in 2004, the Code of Medical Ethics of the American Medical Association specified that researchers must inform donors/patients of their economic interest when they perform research on their tissues, but other aspects of tissue rights have still been violated (Petrini, 2012). Earlier in May this year a judge reopened the Kanuszewski v. Michigan Department of Health & Human Services case. About 6 years ago, a newborn’s blood sample was used for disease screening without parental consent, which prompted an unsuccessful lawsuit despite there being a violation of Common Rule (Dye Menikoff, 2024). If this case were to win, this would alter the precedent of how tissue rights are approached in the United States.

Considering that conflicts are still arising under the established guidelines surrounding tissue rights, it is quite clear that changes need to be made. Common Rule should be structured so there is more specificity, allowing for the law to be better equipped for more scenarios. Outside of what can be done within the law, there can also be more responsibilities taken upon researchers to reduce conflict. Researchers should improve their practices in describing exactly what can and will happen to tissue samples once they have been removed. A very important aspect of the medical field is trust from its patients, but it can be hard to form when motives are not clear. The lawsuits made against research companies contribute to the stigma that research is not there to help others despite the fact that its primary motive is to help and educate others. Efforts should be made towards debunking this stigma in order to establish patient trust. A good direction towards that outcome is addressing the regulations towards tissue research and heavy consideration of the ethics behind its profit.