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Ethical Considerations for Informed Consent in Medical Research and Clinical Medicine: Critical Essay

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Morality is an abstract concept that varies between individuals and societies. Today medical research must adhere to strict ethical and legal principles, however, in the past scientists were not bound by these restraints. While this era of minimal oversight within medical research led to numerous breakthroughs, many researchers were committing gross ethical and moral violations in the name of science. The case of Henrietta Lacks is a historically significant case of the malpractice and unethical behavior committed by scientists during the mid-twentieth century. Lacks’ cells were used to develop the first immortal cell line – HeLa cells, which would eventually facilitate numerous medical breakthroughs. However, Lacks was unaware of the distribution of her cells and was held under the belief that they were being used, solely for her cervical cancer diagnosis. Historically informed consent was largely neglected within medical research until the Nuremberg Code was written in 1947, although this code was not legally binding, and rampant ethical abuse continued for decades. Informed consent is also the subject of great ethical debate within the field of clinical medicine, where ethics are guided by the Hippocratic Oath and physicians must strive to uphold specific ethical standards. Despite the immorality associated with the deprivation of informed consent, the debate amongst ethicists continues today as the potential for medical advancement is measured against the ethical cost.

Informed Consent in Medical Research

The aim of medical research is to acquire new medical knowledge that will benefit the entire community, and historically, this mindset of benefitting the greater good was often at the expense of an individual’s basic rights. During the Second World War, Nazi scientists performed infamous experiments on Jewish prisoners within concentration camps, directly against their will. Outrage at the atrocities that the Nazi scientists committed led directly to the creation of the Nuremberg Code, which required subjects to both comprehend and give explicit consent for the experiments that they were being subjected to. However, the code was not legally binding as it served as a set of ethical guidelines for human experimentation. Furthermore, many scientists argued that it stood directly against medical advancement and outright dismissed its existence.

In 1964, the World Medical Association (WMA) attempted to create a code of conduct to regulate itself, rather than be bound by external lawmakers. The result of this was the Declaration of Helsinki, which mandated respect for the individual and required informed consent. Additionally, the Declaration of Helsinki stated that the researcher’s duty is solely to the patient and that the patient’s welfare takes precedence over any scientific results or legal requirements. While neither the Declaration of Helsinki nor the Nuremberg Code is legally binding, they are considered to be two of the most influential documents in the history of medical research ethics and are the basis for most current regulations in the field.

Excluding the development of the HeLa cell line, the Lacks family was further taken advantage of through the deprivation of informed consent; the most egregious of which was the mistreatment and experimentation of Elsie Lacks. Elsie was a mentally impaired minor without a guardian present to give consent. While at the time this type of experimentation was commonplace, it is a gross violation of today’s ethical standards. Additionally, researchers deliberately deceived Day Lacks in order to gain access to Henrietta’s body after she had died, claiming they were testing whether her cancer would affect her children. This blatant deception is a clear violation of informed consent and would not be considered ethically permissible today.

Another infamous example of unethical conduct within medical research in the mid-twentieth century was the ‘Tuskegee Study of Untreated Syphilis in the Negro Male’. During this study, 600 African-Americans from low socioeconomic groups were monitored for 40 years. The aim of this study was to observe the natural history of untreated syphilis, where patients were deliberately denied penicillin, which had been proven to successfully treat the disease. Furthermore, the subjects of this experiment were not informed about the clinical trial and were unaware of the fact that they had syphilis. This experiment would not meet the ethical standards of today and is an important historical case of why informed consent and ethical conduct are essential in medical research.

In the case of Henrietta Lacks, researchers never broke any laws at the time, however, they made several unethical decisions during the development of the HeLa cell line. The greatest ethical lapse in judgment was the violation of Lacks’ right to informed consent, by obtaining her cells for research purposes. Therefore, all subsequent research performed to develop the HeLa cell line and downstream research is associated with the cell’s unethical origins. Furthermore, the distribution of Lacks’ cells across the world without containing consent from either her or her family was a further ethical mistake. In today’s society, the unethical behavior of both Gey and John Hopkins Hospital would not be condoned and would leave them open to legal recourse.

Informed Consent in Clinical Medicine

The conversation surrounding the ethics of informed consent is quite different in clinical medicine than the debate in medical research. The intent of clinical medicine is to improve the well-being of the individual patient, rather than the beneficence of the whole community. Furthermore, every clinical physician is bound by the Hippocratic Oath, where the physician must endeavor to cause no harm to any patient under their care. However, the Hippocratic Oath has been associated with ethical concerns regarding informed consent as a physician’s judgment on what is best for a patient is entirely subjective.

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Informed consent in clinical medicine is especially complicated when a patient’s ethical right to select or reject treatment directly contradicts what a physician believes to be the most beneficial treatment strategy. Under these circumstances, the correct course of action for a physician is unclear, as it can be impossible to respect both values. The concept of therapeutic privilege may be invoked in rare situations where the physician believes that disclosing the information would pose a serious psychological threat to the patient. However, invoking therapeutic privilege is ethically questionable and is typically only recognized as a legal defense. Whilst the physician is bound by the Hippocratic Oath, it is unethical to deprive the patient of the right to reject treatment through the nondisclosure of information.

The appalling career of Dr. Henry Cotton is a notable example of the flaws that are inherent within the Hippocratic Oath and why it is essential that patients have the right to refuse treatment. Cotton was a psychiatrist at Trenton State Hospital in the early twentieth century, who was convinced that mental illnesses were caused by toxic body parts. Cotton would often remove the teeth, tonsils, colons, and other organs of mentally ill patients against their will. Technically, Cotton did not violate the Hippocratic Oath, as he believed he was treating his patients to the best of his ability, however, Cotton never attempted to gain the consent of his patients and often performed his procedures against their will. As such his behavior was wildly unethical and would be illegal in today’s society. The case of Dr. Henry Cotton shows the importance of informed consent and that the Hippocratic Oath alone is insufficient on ethical grounds.

In the case of Henrietta Lacks, doctors at John Hopkins Hospital deprived Lacks of informed consent during the treatment of her cervical cancer. Doctors placed radium inside her cervix to combat the cancer cells, however, this would also render her sterile. Lacks seemed unaware of this side effect and had expressed a desire to bear more children. Withholding knowledge of the side effects of this treatment is unethical because it prevented Lacks from making an informed decision on whether to undergo or reject treatment.

Value of the HeLa Cell Line in Cancer Research from 1950 to Present

Despite the unethical acquisition of Lack’s cells, the HeLa cell line has been responsible for numerous medical breakthroughs since its development. Scientists have learned to understand the etiology of cervical cancer due to downstream experiments on HeLa cells. It is now understood that there is a strong association between human papillomavirus (HPV) and cervical dysplasia, which often develops into cervical cancer. In fact, approximately 70% of patients suffering from cervical dysplasia have HPV infections. Due to this knowledge, scientists have developed new and more efficient diagnostic techniques that allow for an earlier diagnosis and, therefore, better treatment outcomes for patients. As such patients suffering from the same disease as Henrietta Lacks have a more favorable prognosis due to research conducted on her cell line.

At the time of Lacks’ death, polio was one of the most notable and devastating viral diseases due to its highly infectious nature and crippling symptoms. Dr. Jonas Salk had already developed a vaccine for the disease but did not have an economically efficient way to test it. Ideally, Salk needed cells that were available in large quantities and susceptible to infection by the poliovirus but would not be killed by it. There were no such cells available until the development of the HeLa cell line. Using these cells, Salk was able to successfully test his vaccine, which would go on to essentially eradicate polio from the developed world. Without the availability of HeLa cells, trials for the vaccine would have taken substantially longer and resulted in thousands of additional deaths.

The HeLa cell line has also been a critical component in understanding the mechanisms of cell aging and division – most notably the mechanisms of telomeres. Under normal conditions cell division results in the degradation of telomeres, which drives the aging of cells, however, HeLa cells are immortal and can seemingly divide infinitely. Scientists discovered the presence of an enzyme called telomerase in the HeLa cells and hypothesized that it was responsible for preventing the degradation of telomeres. Due to this research, scientists were also able to understand the role of telomerase in non-cancerous cells, which facilitates the rapid division of embryos early in life.

Human immunodeficiency virus (HIV) is one of the most notorious and feared viruses affecting modern society. Due to research conducted on HeLa cells, scientists have learned to understand the mechanism of HIV, which is essential for future treatment efforts. It has been discovered that HIV uses CD4 proteins expressed on the surface of T cells to invade other cells. Introducing CD4 proteins to HeLa cells allows them to be infected with HIV, which allows these cells to be used to test various HIV drugs. While this knowledge is yet to yield a viable HIV cure or vaccine, this information will be the backbone of future research efforts that may one day eradicate the disease completely.


Obtaining informed consent is an ethical and legal requirement in medical research today, however, this has not always been the case. Historical cases provide substantial evidence for the ethical abuse that can occur when informed consent is not required, with some of these cases being the worst crimes of human experimentation in recorded history. In the case of Henrietta Lacks, her cells resulted in numerous medical breakthroughs, including a better understanding of the disease that ultimately killed her. Due to this contribution to science, ethicists still debate whether the unethical acquisition of her cells is outweighed by the greater good of the community. Cases such as this have led to enormous medical advancement, however, they have also changed ethical standards and practices within both medical research and clinical medicine. As science advances, new ethical issues will continue to arise where the morality of researchers and physicians will be tested. In science, there is an inescapable need to constantly reevaluate and adjust what behaviors are considered ethical, as every experiment and every patient has a unique set of ethical standards and a proper code of conduct. When ethical issues arise, scientists should look to cases like Henrietta Lacks as an example of the importance proper of ethical conduct.

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Ethical Considerations for Informed Consent in Medical Research and Clinical Medicine: Critical Essay. (2023, October 11). Edubirdie. Retrieved March 2, 2024, from
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