Ethics & Informed Consent of Human Research

By definition, ethics is “a set of moral principles” and “dealing with what is good and bad with moral duty and obligation” (Ethic, Merriam-Webster). The general concept of ethics can be considered very subjective, depending on the scenario. When it comes to ethics in science, it is not black and white, nor will it ever be. As for the ethical principles of human subjects in research, there are three general principles to follow: respect, beneficence, and justice. The International Ethical Guidelines for Biomedical Research Involving Human Subjects, which was prepared by the Council for International Organizations of Medical Sciences, or CIOMS, and the World Health Organization, states that these three basic ethical guidelines are in place to assist and guide the preparation of a proposal for scientific studies (CIOMS 2002).

Along with the principles stated above, the American Psychological Association describes their five principles for research ethics. These principles include discussing intellectual property straightforwardly, being conscious of multiple roles, following informed consent rules, respecting confidentiality and privacy, and looking into other ethics resources (Smith 2003).

According to the Office for the Protection of Research Subjects, or OPRS, informed consent is simply the voluntary agreement to participate in research. Not only is it the signed form, but it is also a process in which the participating subject has a complete and thorough understanding of what the research entails. The informed consent process is meant to provide enough information regarding the study they are volunteering for, and allows them to make an informed, thoughtful decision as to whether or not to partake in the study. When obtaining consent, it is required that the voluntary subject is informed of certain aspects of the research. This includes the purpose of the research, the procedures involved, any alternatives to participation, any and all potential risks, the benefits of participating in regard to the individual, as well as society, and time requirements for the research. Also, required is a statement confirming that participation is completely voluntary, and the refusal to participate will not result in any loss or consequences for the subject (Shahnazarian et al. 2013).

Along with the informed consent being given, the research must be approved by the Institutional Review Board, also known as the IRB. The IRB must approve any and all scientific research involving human subjects prior to the start of the experiment. Essentially, the goal of the IRB is to make sure that conducted research is in accordance with all institutional, federal, and ethical guidelines. The term “human subjects,” is defined by the American Public University System and federal regulations as “a living individual whom an investigator conducting research obtains [regarding] data through intervention or interaction with the individual, or identifiable private information (American Public University System 2016).

The Nuremberg Trials

In 1946, an American military tribunal decided to open criminal proceedings against 23 Germans. These 23 people were the physicians and administrators who willingly took part in the participation of various war crimes, as well as crimes against humanity. During World War II, German physicians and administrators conducted scientific experiments on the concentration camp prisoners without their consent. Prisoners were exposed to an injection in order to examine blood clotting, infected with viruses and were examined while the disease took its course, injected with poisoned bullets in order to find more effective and efficient ways of killing, and exposed to high altitude conditions to examine how long one could live in an area with low air pressure and a lack of oxygen (Schneider 2005).

As a result of these unethical experiments, the Nuremberg Code was put into place. The Code, which was put in place after the completion of the Nuremberg Trials following World War II, contains ten points, which serve as guidelines regarding the research ethics for human experimentation. The first point in the code, which is by far the most important, states that “the voluntary consent of the human subject is absolutely essential.” With that being said, the potential subject should have legal capacity to give consent. This means that they need to have the free power of choice, without the influence or intervention of fraud, force, or other forms of coercion or constraint. Also, the person should have sufficient knowledge and comprehension of the experiment being completed so that they can make an informed, thoughtful decision (The Nuremberg Code).

The Guatemala Syphilis Study

Another major event regarding unethical, non-informed consent has to do with the Guatemala syphilis study. Between 1945 and 1956, the U.S. government infected approximately 1,500 Guatemalan prisoners, mental health patients, orphans, and sex workers with syphilis and gonorrhea in order to research and learn about the effectiveness of penicillin. Even though the subjects did not give their consent, the National Institutes of Health funded it. Also, from 1932 to 1972, almost 400 African American men, from Alabama, were purposely and deliberately left untreated with syphilis. In 1947, penicillin became the standard for treating syphilis, but the men were told that they did not have the infection, but rather had “bad blood,” and were being the given the best care possible. However, the doctors of the U.S. Public Health Service were continuing to experiment on the men as they grew sicker and sicker. Not only were these experiments highly unethical and inhumane, but they were also extremely hypocritical. Ultimately, while the U.S. government was taking part in highly unethical research, it was in the process of prosecuting the Nazi German scientists involved in the Nuremberg trials (Yasmin 2015).

Henrietta Lacks & HeLa Cells

When Henrietta Lacks went to John Hopkins in 1951, she had no idea that she would eventually change the world of medicine. While her goal was to have her cervical cancer taken care of, the doctors and surgeons had other ideas once realizing that her cancer was too strong to be treated by the doctors at John Hopkins. Unbeknownst to Lacks, a surgeon collected a sample of her cells and passed them off to George Gey, the director of the Tissue Culture Laboratory at John Hopkins in the 1950s. Following the collection of these cells came the research and distribution of them to many different doctors and research facilities (Carpio 2014). However, neither Lacks nor her family knew that her cells were being researched, which is a major violation of scientific ethics as well as informed consent.

To this day, HeLa cells are still being used and researched in medicine, but it was not until recently that the Lacks family has had any say in what happens to their family member’s cells. Furthermore, the family has yet to be compensated financially, even though researchers and companies have made billions of dollars selling HeLa cells. Although the circumstances regarding Henrietta’s scenario do not follow common sense in ethics and informed consent, the actions of the doctors involved ended up resulting in many discoveries and advancements in medicine.

When considering if there was any logic as to why ethics were disregarded, it can be presumed that the doctors acted as if they were following the ethical theory known as utilitarianism. Essentially, utilitarianism is the idea that a morally good action is one that can and will help or benefit the greatest number of people (Utilitarianism. Merriam-Webster). With that being said, generally speaking, while the doctors were in the wrong to take the cells without permission, they were acting upon the concept of utilitarianism, since the researchers involved were looking to improve and benefit the lives of as many people as possible, even if that meant breaking rules of consent.

Furthermore, another issue regarding this case is that there is a major lack of informed consent. Alongside the lack of informed consent is the lack of patient autonomy. Because the cancer was so prominent, the doctors did not treat Henrietta as someone capable of making her own decisions when it came to medical treatment. However, it can be speculated that Lacks would have denied and opted out of treatment had she been informed and aware that the treatment would result in her being unable to still have children, for she had hoped that she could remove the cancer and still be fertile. But since the doctors neglected her patient autonomy as well as informed consent, the ethics of the intentions of the doctors and researchers involved need to be examined.

The cells removed from Henrietta Lacks have not only thrived since they were originally extracted, but they also have aided in various discoveries and advancements in the medicinal world. Upon examining a karyotype of HeLa cells, it is evident that while a normal cell of a human contains 46 chromosomes, HeLa cells contain anywhere from 76 to 80 very heavily mutated chromosomes, which supposedly is due to the human papilloma virus, or HPV, which is the cause of most, if not all, cervical cancers. However, HeLa cells grow quite rapidly, even more so than regular cancer cells. George Gey was astounded to discover that within 24 hours of researching his first sample of HeLa cells, the number of cells had doubled (Carpio 2014). But what have HeLa cells accomplished since their extraction? To this day, HeLa cells have accomplished many different things in the medicinal world. Examples include vaccinating girls against cancer, assisting in the creation of the polio vaccine, mapping the human genome, and helping to develop medicines used to fight cancer, the flu, and Parkinson’s Disease (Claiborne and Wright 2010).

Also, HeLa cells practically created the field of virology. Over time, researchers and scientists have infected HeLa cells with multiple different viruses, including HIV, herpes, Zika, measles, mumps, etc., in order to try and understand how to fight them. By infecting HeLa cells with these various viruses, researchers discovered that the measles virus constantly mutates upon infecting HeLa cells. This makes the disease more difficult to fight and keep under control. Furthermore, microbiologists have discovered that the Zika virus is unable to reproduce and multiply in HeLa cells (Samuel 2017).

While the advancements and discoveries credited to HeLa cells have saved countless lives, there are still some major drawbacks in this case. For instance, to this day, the Lacks family has yet to receive any financial compensation for their family member’s life-saving cells, even though HeLa cells have resulted in companies making billions of dollars. Not only has the family not received any compensation, they also did not know about any of the research taking place for almost 20 years after the first HeLa cells were extracted. And to make matters worse, while companies were making billions of dollars because of these cells, Henrietta’s family had a very scarce amount of money, and ironically, some of the family members were unable to afford health insurance. However, as time moved forward and the Lacks family became better educated about the medicinal advances that HeLa cells contributed to, their initial anger turned into pride (Claiborne and Wright 2017).

While the original collection of HeLa cells for research broke ethical code and informed consent, the doctors and researchers responsible were acting upon utilitarianism. However, there are some scenarios in which HeLa cells were used for sinister purposes. According to Rebecca Skloot’s “The Immortal Life of Henrietta Lacks,” reviewed by Tanfer Emin Tunc, cancer researcher Charles Southam injected unaware and unsuspecting patients with HeLa cells in order to learn whether or not any cancerous outgrowths would appear. He would then remove the formed tumors from only some of the patients. Southam soon became obsessed with seeing how HeLa cells reacted in healthy human bodies, and two years after his initial sinister research, he had placed an ad in a newsletter looking for more volunteers for “cancer research.” Although he had initially intended for 25 volunteers, he quickly ended up reaching 150 volunteers. Unfortunately, Southam convinced himself that his volunteers were merely criminals, who were therefore his prisoners. And as Tunc states in his review: “Prisoners, after all, were captive specimen who would cooperate without resistance, informed consent, or questions about the nature of the experiment” (Tunc 2011).

As of 2013, HeLa cells have been the subject of over 74,000 studies, which have provided various insights into cancer, vaccines, biology, and in vitro fertilization. However, the fact that Henrietta never consented to her cells being studied comes into question once again, as the family finally begins to somewhat get a say in the use of the cells. In 2013, the National Institute of Health came to an agreement with the Lacks family, allowing them to have some control over how Henrietta Lacks’ genome is studied and used. Unfortunately, the agreement did not provide the family the right to any potential financial compensation. It did, however, attempt to protect the privacy of the people whose genomes are being studies, as well as the encourage the benefits of studying genomes. And soon after this agreement was made, scientists at the European Molecular Biology Laboratory published the genome for a line of HeLa cells, which was public and readily available to download. Following this publication, the National Institutes of Health at the University of Washington was about to publish another study involving HeLa cells. The problem? The Lacks family was completely unaware of either study. To make ends meet, the National Institutes of Health and the Lacks family reached yet another agreement. They agreed that the data found from both the studies that the Lacks family were not aware of would be stored in the N.I.H.’s database of genotypes and phenotypes. Therefore, any researcher who would want access to and use the data would have to apply for access, as well as submit reports annually regarding their research (Zimmer 2013).

Overall, despite the many arguments against the history and use of HeLa cells, the world of medicine would not be anywhere near as advanced as it is today without the research and use of HeLa cells. Also, agreements have been put in place to help protect the Lacks family and allow them to have somewhat of a say in the use and publication of their family member’s cells. Personally, I believe that the Lacks family needs to be financially compensated, as well as continue to have a say as to how HeLa cells are used. Although scientific ethics have been majorly violated, because HeLa cells have resulted in so many advancements in medicine, stopping research involving HeLa cells could be detrimental to the medicinal community. If HeLa cells have advanced research in various medicinal areas, why stop now? Even though informed consent was absent entirely from this case, in regard to utilitarianism, countless lives have been saved, which makes up for lack of informed consent and autonomy of Henrietta Lacks.

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