Before continuing to explore this website, please answer the questions on this Intro Survey.
- Should biomedical researchers have the ability to override the right to informed consent if it would result in breakthrough scientific discoveries?
- Considering the millions of lives Henrietta Lacks’ cells have directly saved, how should one manage benefitting the public good with respecting individual rights?
- How ought the Henrietta Lacks case to be handled from a reparative justice standpoint?
Intro to the Henrietta Lacks Case
In 1951, an African American woman named Henrietta Lacks was diagnosed with cervical cancer at a free clinic ward for color people. The doctors collected tissue samples from her cancerous tumor and sent them to a research facility in order to study the cells and learn more about the disease. Henrietta’s doctors did not inform her of what they were doing, nor did they get permission to collect tissue samples. The only consent they received was from her husband to autopsy her after her death. Henrietta Lacks’ cells were used to create the first successful stable human cell line. These cells have been involved in breakthrough medical research regarding testing vaccines, genetics discoveries, cancer and AIDS research, and developing drugs. Many companies have profited millions of dollars from mass producing her cells and selling them commercially, but her family has not received any compensation. The video below provides more information.
Defining Informed Consent
Informed Consent must be received by healthcare providers in order to ensure a patient’s right to self-determination (autonomy) is protected. This falls under the idea that patients know what is best for themselves. There are FIVE elements:
- The individual can understand the situation and the consequence of their actions
- This is usually assumed unless there is a demonstrated lack of rationality
- Adequate Disclosure
- Healthcare provider must disclose all potential benefits and risk of all feasible options
- Adequate Understanding
- It is the provider’s responsibility that the patient understands what they have agreed to
- Voluntary Decision Making
- The decision is made under the patient’s free will
- Explicit acknowledgment of the decision made
As a rational individual, the principle of autonomy states that Henrietta Lacks is able to make decisions best for herself and therefore should be allowed to. Therefore, her doctors took away her right to autonomy by taking her cells without her informed consent. Henrietta Lacks had no reason to be deemed mentally incompetent, yet no elements of informed consent were followed. She did not receive adequate disclosure, express adequate understanding, make the decision voluntarily, or provide consent.
- Nonmaleficence and Beneficence
From the perspective of the Lacks family, the doctors did not act in a way to benefit the patient. Although Henrietta Lacks died in 1951, her family was never notified that her cells were being used until the mid-1970s. Since then, the amount of money that has been made by companies selling these cells commercially is incalculable. Meanwhile, there are members of the Lacks family who cannot afford health insurance. Also, a team of researchers published the entire genome sequence of a strain of HeLa cells – completely legally – as part of their research which contained private genetic information about Henrietta Lacks and her descendants and made it available to the public domain.
On the other hand, her cells continue to aid important scientific research, have resulted in countless breakthrough medical discoveries and are often referred to as the “cornerstone of modern medicine.” They have directly saved millions of lives. For example, HeLa cells were critical in the discovery of the polio vaccine because, as a result of their highly proliferative nature, her cells were the ideal source to test the antibody production by the body in response to the poliovirus infection. According to John Hopkins Medicine, although the cell line from Henrietta Lacks is not the only cell line in use today, HeLa cells have directly aided advances in almost every field of medical research. This includes research of vaccines, cancer and AIDS and even the effects of zero gravity in outer space. Overall, the immense benefits to the public good by HeLa cells— although they do not justify the overriding of informed consent — must be considered and their indispensability must be acknowledged.
The historical context of Henrietta Lacks as an African American women in the South in the 1950s significantly impacts the analysis of this case. She came from a poor black family and therefore, at the time, she did not receive the respect from the public hospital she deserved. The doctors did not follow the principle of justice because she did not give permission for them to take and analyze her cells.
Reparative Justice and the Media
The US federal regulation regarding the ethics of biospeciman research set in 1981, known as the Common Rule, has the primary goal of protecting human beings from physical risks resulting from experimental research. Through this regulation, biospeciman fell under the definition of human subjects and required informed consent if the researchers obtained the data through interacting with the individual or if it contained identifiable private information. But, informed consent was not required by researchers if the biospeciman had already been collected for another purpose. This meant that if Henrietta Lacks had been a patient in the United States under this regulation, biospecimens left over from what had been collected for her clinical care would not require her consent for use in research.
The increased attention to the Henrietta Lacks case as a result of its presence in the media has brought to light the need for policy changes as a result of the revolution in genomic science (because we now understand it is almost impossible for genomic data to be 100% anonymized). Rebecca Skloot published The Immortal Life of Henrietta Lacks in 2010 and in 2017, the film The Immortal Life of Henrietta Lacks was released starring Oprah Winfrey.
In 2015, the federal government published a notice of proposed rule making, known as the NPRM, to overhaul to the Common Rule. The goal of the NPRM was to give human subjects increased ability and opportunity to make informed decisions in order to reduce the chances of harm and to increase justice. Although this NPRM does not specifically reference Henrietta Lacks, she clearly influenced it and its focused on increasing the involvement of and respect for research participants. Also, in a step towards reparative justice, recently the National Institutes of Health stated that all research of the Lacks Genome must be approved by a panel of which 2 Lacks family members are a part of.
After reading through this site, how has your perspective on the Henrietta Lacks case and the ethics of informed consent and reparative justice changed? Below, please re-answer the questions from the original poll you took prior to reading this website. Please feel free to comment below regarding your change in responses!
featured image: https://www.newsmax.com/thewire/hela-cells-henrietta-lacks-family/2013/08/08/id/519420/