Human biospecimens have been imperative in scientific and medical advances. Their continued widespread availability for research will be vital to realizing the goals of medicinal accuracy. Once tissue is removed from patients, they were used for diagnostic purposes, and later discarded. The research, very seldomly, resulted in the tissue becoming valuable to the medical community; yet, record of them were limited to “paper files, photographs in medical journals or textbooks, or fixed microscope slides buried in library archives.[footnoteRef:0]” The case of Henrietta Lacks ignited crucial change in policy, such as regulatory changes proposed in the United States surrounding informed consent for biospecimen research. Rebecca Skloot’s book: The Immortal Life of Henrietta Lacks; shed light on how researchers abused their power to conduct experiments where doctors did not provide full disclosure to patients, prior to partaking in the experiment. Through the use of HeLa cells, the medical community has made great strides in medicine. However, the discoveries had come with the deception of patients, due to the malpractice of Chester Southam. In 1951 physicians took a biopsy from Henrietta Lacks, and from the tissue sample scientist developed the first ever human cancer cell line. However, the sample was taken from the patient without her Lack’s knowledge or informed consent, however this was common practice at the time. She passed away in 1951, and her family became aware of HeLa cells in 1973. Her tissues led the medical community to many medical breakthroughs, ranging from the effects of Zero gravity in outer space and the development of the polio vaccines, to the study of leukemia, the AIDs virus and cancer world wide.[footnoteRef:1] Exploring Henrietta Lack’s case will develop an understanding of the ethical framework surrounding policy and informed consent. [0:] [1: ]
Section 2. Relevant Facts
Henrietta’s doctor obtained sample from her without knowledge and consent. Although this was common practice at the time, it was unlikely for a sample to lead to vast discoveries. Her family continued to live in poverty after Henrietta passed away, and did not receive anything from the groundbreaking discovery of HeLa cells. Scientists were amazed because they had found the first immortal cell like, or group of tissue samples that could survive in a lab- and reproduce indefinitely. Researchers claimed the cells would lead to revolutionary change in medicine, but this never occurred. Although, HeLa cells lead to, the polio vaccine, cancer treatments, and vitro fertilization. Physicians theorized, the subjects immune system rejected the cancer cells then they were cancer free, and if the cells grew then it the subject would be diagnosed with cancer. Chester Southam failed to gain the consent of his patients; when questioned he stated “phobia and ignorance,” will cause unnecessary fear amongst his participants, which result in subjects removing themselves from research. In the book, Skoolt states “to withhold such emotionally disturbing but medically non pertinent details … is in the best tradition of responsible clinical practice.” Southam was not the patient’s doctor, and the information withheld from the subjects was not simply up-setting health information. The deception was intentional, and for his benefit because patients were less likely to commit to his experimental trial if they were debriefed about the injection contained. It is likely he would have continues this practice had he not made an arrangement on July 5, 1963, with Emanuel Mandel (director of medicine at the jewish chronic disease hospital in Brooklyn.) Chester Southam planned on using the hospital’s patients for his research. They arranged for Mandel to instruct doctors to inject 22 JCDH patients with cancer cells for Southam. He instructed his staff to administer the injections without informing the patients of the fact that they contained cancer cells. 3 young jewish doctors refused, stating they would not conduct research on patients without their consent. All 3 had knowledge about research Mizis had done on jewish prisoners, as well as the Nuremberg trials. When the doctors refused, Mandel instructed residents to administer injections.
Section 3. Stakeholders
The Immortal Life of Henrietta Lacks had sparked controversy within policy. In the United States, federal regulations had evolved in response to several cases of extreme research abuses of vulnerable populations. The regulations were designed to protect human beings from the risks involved in experimental research.[footnoteRef:2] Before the 1950s, researchers were not required to debrief patients/subjects thoroughly, however after cases similar to Henrietta Lacks had been brought to the attention of the media changes began to occur within policy. Federal regulations, also known as The Common Rule defines a human subject as a living individual that a researcher can receive data from; through intervention or interaction with the individual, or through private information. Scientists all over the world have used HeLa in research. In 2013, scientists in Germany published an article stating they had sequenced the entire genome of HeLa cell. This contained the Lacks’s DNA sequence makeup on public platforms, and a result violating the privacy of the Lacks’s family. In 2013, the National Institute of Health announces that 2 members of the Lacks family would sit on the panel that reviews application for the genome and would monitor the use of HeLa cells. However, this agreement did not include financial compensation for the Lacks’s descendants.[footnoteRef:3] [2: ] [3: ]
Scientists discovered that many cell cultures were believed to be from other tissue types, such as breast and prostate cells, were found to be HeLa cells. Researchers discovered that HeLa cells could latch to dust particles in the air, as well as travel hands and contaminate other cultures. Scientists contacted Henrietta’s relatives in order to obtain sampled with the intentions using the DNA to create a map of Henrieetta’s genes in order to differentiate HeLa cells from other cell cultures. This would create cells that are not contaminated. They contacted her husband, however he had not understood the conversation, which lead to miscommunication. This communication cause fear to spark in the family and began to contact the hospital where Henrietta was treated.
Section 4. Ethical Considerations:
The term “informed consent were first seen in court documents in 1957, in a civil court ruling on the case of a patient named Martin Salgo. He went under anesthesia for what he believed to be a routine procedure and woke up permanently paralyzed from the waist down. The doctor had not made him aware of the risks the procedure had carried. The judge concluded, “a physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment.” He stated, “full disclosure of facts necessary to an informed consent.” Chester Southam injected prisoners in June 1956 using HeLa cells. 65 prisoners had tumors grow on the site of exposure. He found through every injection, their bodies responded faster, which led him to believe the inmates’ immunity to cancer grew. The media responded positively after he reported his findings, which allowed him to inject HeLa cells into more than 600 people for his ongoing research. When debriefing the patient he simply vaguely stated he was testing the patients for cancer. He based this statement on the fact that patients with cancer rejected the cells slower than those without it. Southam hypothesized through timing the rejection rate he may have could determine undiagnosed cases of cancer. Throughout the trial, he repeatedly stated: “it is, of course, inconsequential whether these are cancer cells or not, since they are foreign to the recipient and hence are rejected. The only drawback to the use of the cancer cells of the phobia and ignorance that surround the word cancer.” due to the “phobia and ignorance,” he refrained from informing his patients of the cancerous cells because he did not want to create unnecessary fear. The principle of informed is made up of 4 subparts, as according to NCBI:
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- a) Disclosure of information
- b) Competence of the patient (or surrogate) to make a decision
- c) Voluntary nature of the decision
Classic documents in the history of medicine such as Hippocratic writings display the flawed understanding of informed consent. The primary concern in these writing was to avoid disclosing any information that may harm or upset patients’. During the 1950s and 60s the physician’s duty to obtain consent in a few medical fields, such as surgery, evolved through the courts and required physicians to disclose certain forms of information and to obtain consent in practice as well as research. Informed consent is made up of two varying definitions; in the first, informed consent is an “autonomous authorization but individual patients or subjects.”[footnoteRef:4] Based on the first definition, informed consent is primarily a matter of autonomous and self-determining choice. In the second understanding of informed consent is resoluble in terms of institutional and policy rules of consent, in this definition consent is solely based on law or institutionally effective approval given by a patient or subject. An approval is lawful if it abides by the rules of the specific institutions. This form of consent is vastly used in the regulatory rules of the U.S federal agencies and healthcare institutions. [4: ]
The case of Henrietta Lacks had impacted policy regarding tissue rights. Two main issues arise when discussing tissue right: Consent and money. Only recently tissue research is legally to acquire informed consent, however storing blood and tissues is routine procedure that does not require informed consent. Researchers found that in 1999 in the United States alone, there were more than 307 million tissue samples from more than 178 million people, and it is estimated it has increased 20 million samples each year. A standing question is the ownership aspect of these tissues/cells; do patients still hold ownership once the biological material have been obtained?
Section 5 Conclusions
HeLa cells have played a vital role in scientific and medical advancements. Prior to the 1950s, physicians were not legally obligated to fully disclose all risks involved in experimental procedures. Once tissue is removed from a patient it was most likely to be discarded after the first use, however, specimens at times can be used in several other experiments due to their uniqueness. HeLa cells, provided scientists with cancerous cells that reproduced in a lab. Researchers began to theorize several cures for cancer with the use of HeLa cells, although most unsuccessful. The Immortal Life of Henrietta Lacks sparked change within policy for the reason that it exposed the ways in which researchers abused their power in order to take advantage of those with less power. HeLa cells assist the medical community in making vital strides that allowed for discoveries, such as the Polio vaccine, varying studies for Leukemia, as well as cancer worldwide. The case of Henrietta lacks lead to discussion of ownership, the ways in which informed consent would be enforced during experimental treatments, as well as surgeries. The groundbreaking discoveries were obtained through the deception of over 600 individuals. Although, Chester Southam stated his intentions were to protect patients from fear, through research it is clear he solely cared for the results the experiment would bring, and not the individuals he tested on. Informed consent will continue to evolve as scientists continue to obtain samples from human beings, and advance in the medical community.
- Beauchamp, T. L. (2011, August 16). Informed Consent: Its History, Meaning, and Present Challenges: Cambridge Quarterly of Healthcare Ethics. Retrieved from https://www.cambridge.org/core/services/aop-cambridge-core/content/view/S0963180111000259.
- Beskow, L. M. (2016, August 31). Lessons from HeLa Cells: The Ethics and Policy of Biospecimens. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5072843/.
- Brown, D. N. L. (2019, April 1). Can the ‘immortal cells’ of Henrietta Lacks sue for their own rights? Retrieved from https://www.washingtonpost.com/news/retropolis/wp/2018/06/25/can-the-immortal-cells-of-henrietta-lacks-sue-for-their-own-rights/.
- Butanis, B. (2017, April 11). The Importance of HeLa Cells. Retrieved from https://www.hopkinsmedicine.org/henriettalacks/importance-of-hela-cells.html.
- Shuster, B. (2017). In the Wake of Henrietta Lacks: Current U.S. Law and Policy on Control and Ownership of One’s Body Tissues Used in Medical Research. The Journal of Healthcare Ethics & Administration, 3(2), 8–18. doi: 10.22461/jhea.1.71614