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The importance of consent in biomedical research

  • Consent is such a simple word. Two syllables, easy pronunciation; but every day we struggle to find new ways to educate people on its meaning. How exhausting! Consent, as defined by law, means voluntary agreement. In Biomedical Research, the definition is no different. It is the voluntary agreement or permission given by a person or patient (volunteer) to a medical practitioner or scientific researcher.

    For a long time, I associated the word with only sexually related matters. Never did I think that it is also strongly used in science. It is a concept that came into science, and medical science in particular, after the horror of the World Wars. In World War I, countries saw the development of Biological Weapons like the Mustard Gas which was used by the Germans against the British and French. This resulted in many British and French soldiers being disfigured and/or permanently blind because of the gas’ strong irritant action. in World War II, deadlier biological weapons were developed by the Germans including Zyklon B, a highly poisonous gas used in their extermination camps. Unethical experiments were carried out on humans without their knowledge and thousands of men, women and children were infected with diseases just to test effect of drugs or for other selfish interests in some cases.

    Mengele's experiment on twins

    A few days ago, while studying Philosophy of Science, my M.Sc. class was lectured on Bioethics, we discussed the 1st and 2nd world wars and the numerous war crimes that went on at those times. Dr Josef Mengele’s name came up in the discussion, and the entire class was enraptured, listening to his nefarious and perverted ways of practising science. It was obvious that we were hearing his name for the first time as we were all visibly shocked, disgusted and angry at his wickedness.

    Mengele was a Nazi doctor who worked as one of Adolf Hitler's physicians during the Second World War. He was the mastermind behind several horrifying crimes including the execution of Jews in gas chambers. Perhaps equally as perverted as or even more perverted than Hitler himself, Mengele was called the Angel of Death. History tells a lot about the World Wars, the first being as a result of Europe’s fight for power and the second because of one man’s notoriety and the sick idea of racial superiority; but the intricate details are often left out. Like the participation of certain individuals, the gruesome killings, the inhumanity, the fear; all these are not detailed in the history books we read perhaps because it was too gruelling or probably because it was too disturbing, so it was wordlessly agreed upon to avoid discussing it.

    Bringing up events of the past is particularly bothersome to several people because they do not want to go through the mental stress of imagining the horror that human beings lived, I admit that it could be emotionally draining, but I had to do this. My love for reading combined with my hunger for details prompted me to study deeply Josef Mengele’s notorious experiments on humans who were still ALIVE, his effort in cloning, the infamous twin experiments which he carried out on over 1000 Jewish twins and his many more contributions to Hitler’s wicked schemes.

    Mengele was obsessed with twins. He performed countless experiments on captured twins, showing visible excitement when a new batch of prisoners arrived at the concentration camp he worked. He isolated these twins in a special house in Auschwitz, Poland where he was deployed to carry out experiments on genetics in the medical facility. There, he was free to perform these experiments indiscriminately without being held accountable for the victims’ deaths and suffering.

    Josef Mengele was a protégé of Otmar von Verschuer, a Nazi Eugenic who believed that certain things such as diseases could only be inherited and not influenced by the environment. He wrote several papers on the superiority of the ‘Aryan’ race with which they attached themselves with and the inferiority of other races such as the Jews and Romani further influencing the Nazi policies.

    He would study twin telepathy, inject them with bacteria to test their resistance and progress of the disease, cut twins and sewed them back together to ‘create’ Siamese twins and sometimes he would inject them with fluid in an attempt to change their eye colour. If one of the twins being used in an experiment died, the other would be shot or sent to gas chambers to be killed. It was reported that between 1943 and 1944, he had carried out experiments on about 1500 twins and only 200 of those twins survived. Apart from his twin experiments, he also performed experiments on dwarfs.

    The fortunate or to some unfortunate thing about his experiments was that his reports were all destroyed before getting to Von Vershuer, his mentor whom he intended the reports to reach. (Fox, 2003)

    The worst part of this research was discovering that there were many other criminals like Mengele. Several of them again like Mengele protected by certain government officials, hiding and several more even walking freely despite the damages done to human lives.

    Check out this article for the history of the largest mass murder site in human history.

    The Tuskegee experiment on syphilis in African-Americans

    This was carried out in Tuskegee University, a predominantly black University in Alabama, United States.

    When African-Americans started the Black Lives Matter movement, many non-black people thought that they were being ‘too much’- too sensitive, too easily angered, too triggered. Perhaps they were and rightfully so, if I may add. All the anger and sensitivity can be justified, and this has been proven countless times. Black people across the world are seen as inferior in colour, in knowledge and in importance. And as such we are looked down upon, and even our lives mean nothing in most cases.

    The Tuskegee Experiment conducted by some scientists in the United States Public Health Service from 1932 to 1972 on black people cannot simply be forgiven by an apology. More than 200 black men were infected with syphilis and experimented upon for 40 years. Even when penicillin was discovered to cure the disease in 1940, it was not for them because they wanted to see how the disease progressed. There was no informed consent, and these men were told that they were being cured for ‘bad blood’ as if such a disease truly existed. Consequently, about 40 black women became infected and 19 children were born with congenital syphilis. For many years until President Bill Clinton in 1997, there was no apology and no compensation. This experiment is the "longest non-therapeutic experiment on human beings" in the history of medicine and public health.

    Perhaps Mengele was a crazy and sick Nazi who conducted experiments on humans because of the backing of the Adolf Hitler government which was known to be hateful, wicked and inhumane. But even now under our noses, non-consensual drug tests and other related experiments are being carried out without the pretext or cover of war.

    Pfizer drug test in Kano, Nigeria

    Let’s come back home to Nigeria for a minute.

    In 1996, an outbreak of cerebrospinal meningitis hit Kano infecting hundreds of children. Perhaps its biggest scandal yet, Pfizer rushed into the scene and claimed to have the drug to cure it. Pfizer administered Trovan, an experimental drug on about 200 critically ill children without informed consent. Convincing the illiterate, poor and desperate parents that the drug would cure their children of the disease. But here is what happened; 11 children died and several others were left injured from the drug. Pfizer packed up and left in the middle of the chaos with no apologies, no explanation and no justice for the victims. They would later agree to an out-of-court settlement of 75 million US dollars, but of course, that is not the case. Several rules of bioethics were broken. Parents lost their children and families grieved the loss of their loved ones. Perhaps to them, humans are just specimens or lab rats and the rule of consent can be ignored. Or perhaps they see no need for the rules at all. Pfizer did not get approval from the ethical committee before conducting the drug trial in Kano.

    Many people argue that although indiscriminate, these researches have helped science in one way or the other. I disagree. Neither the Tuskegee experiment nor the Pfizer drug trial was successful. Even if they were, truth must be told from the beginning especially concerning use of the drug, extract or supplement on previous animal study. The risk factors must be clearly stated; but most importantly, consent MUST be sought without deception as to the true nature of the experiment.

    Following the Second World War after the discovery of the Nazi medical facility in Auschwitz and uncovering of numerous unethical experiments, the US along with several other countries agreed to put the Nazi scientists who participated in such experiments on trial in Nuremberg, Germany. This is popularly called the Nuremberg Trial. In the course of the trial, the scientists claimed that they had done nothing wrong as they were no set standards on how to conduct human experiments leading to the setting up of the Nuremberg Code for Human Experiment in 1947;

    Directives for human experiment

    1. The voluntary consent of the human subject is absolutely essential.
    2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
    3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
    4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
    5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
    6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
    7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
    8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
    9. During the course of the experiment, the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
    10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.(Vollmann, 1996)

    To learn about getting informed consent on biomedical research in Nigeria, visit this link and download the document on Code of Health Research Ethics by the National Health Research Ethics Committee.

    Every country has its own set of guidelines governing ethics in research, but the guidelines are generally related. So, researchers embarking on investigations that involve human subjects are advised to check ethics policy affecting their demography.

    Imagine how many lives would be saved if we just respected each other’s rights, choices and lives in general. In medical research, the goal is the development and betterment of human lives. Everything else comes after this. In bettering human lives, they must be protected not sacrificed. Till today, drug tests are carried out on humans without their prior knowledge of the risk factors. The vulnerable members are mostly targeted and experimented as if they are lesser human beings that do not deserve the right to say ‘Yes’ or ‘No’. Every new drug must prove its efficacy in prior animal testing before being administered to humans. And no human should ever be subjected to any sort of physical or mental torture because of some medical experiment. Remember, consent is key.

    Related article: Importance of conducting clinical research


    Fox, W. (2003). Josef Mengele. Retrieved from Kawvalley:

    Vollmann, J. a. (1996). informed consent in human experimentation before the Nuremberg code. BMJ: British Medical Journal, 1445.

    Photo by Louis Reed on Unsplash