Ethics and Consensual Issues of Medical Community

Ethics is defined as a system of moral principles. It has played a vital role in human research and the health system for many decades and helped guide moral decisions and ensured no harm or suffering comes as a consequence of human research. Informed consent falls under the area of bioethics and is a big component in medicine today. However, many human and biospecimen research cases in the past have had major ethical and consensual issues that have impacted the medical community. In this review, the focuses are Henrietta Lacks and HeLa cells, the World War 2 experiments, and the Tuskegee Syphilis Study. This review will look at websites that have looked into the issues of consent and ethics in each case and outline the expected paths that each should have taken to make the experiments ethical. 

Henrietta Lacks was a 30-year-old African American woman that was diagnosed with an aggressive form of cervical cancer after having her 5th child at John Hopkins Hospital in 1951. Tissue samples were taken and given to a researcher that used her cells to try and grow human cells outside the human body. This was common practice at the time and was not unethical as Henrietta had signed a form stating that she gave consent to anything to be done to her and her cells, however, this was not informed consent. The cells went on to create an immortal line of what is now known as HeLa cells and have helped create vaccines and better the understanding of diseases and viruses. Informed consent is a process enabling patients to make an ‘informed’ voluntary decision in participating in human research, understanding the purpose, procedure, risks, benefits, and alternatives to the research they might be involved with. This kind of consent is based on ethical principles. 

Federal regulations in the US state that a human subject is a living individual that has given data to an investigator with an interaction with the individual or as identifiable private information. Hence when an investigator interacts with an individual and collects biospecimens specifically for research, informed consent in required as this would be considered human research. However, if an investigator uses biospecimens that have already been collected for another purpose and the specimen is from an anonymous person, it is no longer considered human research, allowing for there to be no informed consent required. Therefore, in order to have not violated consent laws, HeLa cells would have had to be labeled with a code that was unidentifiable by a research scientist, in order for the study to be classified as not being human research. The mistake was that the researcher knew who the cells belonged to and named them as HeLa cells, derived from the patient’s full name. Henrietta Lacks also was not asked for her consent as well as her family not knowing what had happened to her cells. This again was the common practice in the 50s and is still a practice today. However, now there are more standards in place for getting consent. 

In Rebecca Skloot’s book, she wrote that lack of understanding may be more important than outright consent. “ If you spoke another language and you needed to see the doctor, you’d be provided with a translator – but if it’s the science you don’t understand, there’s no one there to translate for you, so you go away simply not knowing what’s been said. I think there should be science translators, who are trained to communicate complicated medical stuff in a straightforward, easily digestible manner. It would have made a huge difference to Henrietta’s family.” ‘The Immortal Life of Henrietta Lacks’- Rebecca Skloot 2010. Privacy was also a major issue. Dr. Gey (the researcher) used parts of Lack's name when naming the samples, without her permission. There should be some anonymity and protection for Henrietta Lacks and other patients like her. As Henrietta’s story gets more and more known, information about her and her family’s medical history is becoming more publicly known. There is also no known owner of the HeLa cells and John Hopkins never patented the cells. Due to the questionable ethics in the use of her cells, she is not named the ‘Mother of Modern Medicine’ but is considered a powerful symbol of informed consent.

The ethical misconduct that occurred in the Nazi concentration camps during World War 2 is a great example of ethical and consensual issues. Nazi Germany believed that the dominant race was the Aryan race and introduced practices of ethnic cleansing to somewhat ‘purify’ the population. They often sterilized non-Aryan individuals to prevent the propagation of ‘unclean’ races by X-ray radiation of the testes and ovaries. This method was later found to be non-successful. Dr. Mengele was one of the 200 or so Nazi doctors that experimented on all types of non-Aryan races in critically harming and crippling ways. Experiments were conducted for many reasons, the three main ones being military research ( finding ways to advance the Nazi military in medical ways such as high altitude and freezing experiments), miscellaneous experiments ( experiments that carried no scientific inquiry, such as poison and wound experiments) and racially motivated experiments. It was estimated that around 70 medical research programs at the Nazi concentration camps connected to the German medical establishment used human subjects in the camps for testing of pharmaceutical drugs to fight infectious diseases and gas poisoning. Although this was a horrific event that violated many ethical morals, one of the most significant codes came out of it to help ethical and informed consent, The Nuremberg Code. 

The American Medical Association code of ethics did not address human research until 1946 and 1947 (The Nuremberg Code). Prior to World War 2, there were no explicit written codes on ethical human research but there were norms on what could be done in the context to human research. According to unwritten, but real, ethical standards before World War 2, human research was done only after animal experimentation and it was acceptable for a researcher to experiment on themselves or their family before going on to other research individuals. In relation to norms concerning consent, if the research were tied to the possibility of harm it would require consent but otherwise would not for non-invasive research. Some people were also not thought to be capable of consenting, for example, young children and patients in mental asylums. Paying subjects was also accepted at the time and if a subject granted a researcher to do anything to him or her, they would be considered mental and may be deemed suicidal. Due to the horrible ethical misconduct of the Nazi experiments, it has now sparked a conversation about the ethics behind using the data from these experiments in modern research. Some believe that the Nazi’s data could have the potential to save lives. Even though the data is morally tainted, the data collected by Nazi doctors may have learned something that could help save countless lives or benefit society. Kristine Moe suggested that by using data from these experiments ‘good’ would be derived from evil. 

“Nor, however, should we let the humanity of such experiments blind us to the possibility that some ‘good’ may be salvaged from the ashes” A study that raised a large amount of controversy was the Tuskegee Syphilis Study. This experiment began in 1932 and consisted of 600 participants originally enrolled with the promise of free health care. The doctors from the U.S. Public Health Service running the study told these men they were being treated for bad blood (a commonly used term to refer to a variety of illnesses) but were really seeing a full progression of syphilis. There was a control group of 201 and a group of 399 participants with latent syphilis. The men were monitored by health workers and given only placebos, despite the fact that the recommended syphilis treatment was penicillin in 1947. 

Physicians were convinced by the public health service not to treat the patients while there were still researching at the Tuskegee institute. As the main aim of the study was to see the full progression of syphilis, no effective care was provided when the participants died, became blind, or ended up going insane due to their untreated syphilis. After public outrage, the study was forced to shut down in July 1972 due to it being very unethical. At that time 28 participants had died due to syphilis; 100 from related complications and 40 spouses were diagnosed with syphilis. It had also been passed on to 19 children at birth. The last patient of the study died in 2004. The Tuskegee study had many major ethical issues involved. This included that none of the participants gave informed consent, participants may have been pressured to agree or might not understand what they're agreeing to, the withholding of treatment for medical purposes, and the beliefs of African American health and diseases clouding the judgment of research. 

Informed consent was not given as it was never explained that the study aimed to detect syphilis. Participants were also never told if they did have syphilis or that there was any treatment available for their pain or discomfort. The welfare of the participants was overlooked when they were withheld from treatment. When it came to trial, doctors felt that the repair of existing damage would be minimal or that the damage that may result from penicillin therapy would outweigh the benefits. At the time of the study, there was no data to show the efficiency of penicillin therapy, and short and long-term effects were not documented. When the study was evaluated, it was judged that the benefits of nontreatment would outweigh the benefits of the treatment. Nonetheless, patients were never offered penicillin when it became available, they were instead prevented from being given penicillin treatment. 

Although the cases of HeLa cells, the World War 2 experiments, and the Tuskegee Syphilis study occurred decades ago, they are very significant in the world of ethics and informed consent. They helped create, as well as build on ethical codes and rules that bettered human research and biospecimens. With a common issue being informed consent throughout this review, it reveals that even though it isn’t a common thought about part of medicine, it can play a crucial role in deciding what may happen in medicine and research that patients may be involved with. The standards of ethics have been built on these cases and created a better moral standard for doctors today.