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WHO World Health Organization Middle School Topic – Human Experimentation Introduction to the Committee The World Health Organization (WHO) is the world’s largest health-related organization. The idea of the international organization came to mind with the foundation of the United Nations in 1945, when a panel of experts proposed having a committee that deals with all health-related matters. Its constitution went into action on what is today known as the World Health Day on April 7th, 1948. The WHO covers a broad spectrum of topics, ranging from health systems and transmittable Figure 1-World Health Organization Logo diseases to preparedness, surveillance, and response. For a country to become a member of the WHO, it has to first be a member of the UN and then accept the WHO’s constitution. If a State is not a member of the UN, its admittance is subject to a simple majority vote by the World Health Assembly, the WHO’s highest governing body. The World Health Assembly, which contains all 193 member States, deals mainly with WHO policies like installment and amendments, budget allocations, and the appointment of the Director-General. The WHO’s Executive Board, composed of 34 technically qualified members (elected to 3-year terms), sets the Assembly’s agenda, and proposes resolutions to be considered by the assembly. The WHO mainly works to monitor and assess the global health situation, while making recommendations, monitoring health policies, and working with both the public and private sectors to ensure better health for all communities. Introduction to the Topic Human experimentation is a broad topic. It includes any experimentation in any field in which humans are a part of. For instance, the testing of a new drug by a pharmaceutical company is a human experiment. The testing of a prototype prosthetic limb is also human experimentation. Finally, psychological experiments and trials on humans also fall under the category of human experimentation. Experiments on humans usually fall under two categories: ethical and unethical. Although the definition around the term “ethics” is somewhat vague or subjective, the broad idea behind it is to cause no physical or mental harm to the subject taking part in the experiment. Ethics, as a whole, are a set of rules or guidelines agreed upon internationally, and are backed by scientific evidence that people who design experiments tend to abide by. They are a critical component of any experiment, aimed at ensuring correct results and protecting the safety of participants. Ethical guidelines, therefore, allow the installment of both international and local laws that define the framework in which an experiment is conducted. Ethical guidelines are generally centered on: - Full transparency between all parties partaking in the experiment; - Experiments abiding by legal frameworks; and - Making sure that volunteers are suitable to be tested: this not only ensures better results, but also protects the subject from unwanted side effects. The main barrier to meeting these points is the fact that tests are usually run by big corporations or governmental programs. This allows for the usage of money as “bait” to gather a bigger number of people who will ask fewer questions about the procedure. Furthermore, developing countries are prone to being “exploited” by big companies looking for quick, cheap results. This is mainly due to inadequate public health systems that do not cater to the needs of the people. In general, such countries struggle to find adequate laws and regulations regarding human experimentation, and that’s where the WHO plays an important role, through both its Ethics Research Committee (ERC) and its Department of Knowledge, Ethics, and Research. - Examples of unethical methods include but are not limited to: Public humiliation Emotional abuse Experimentation on babies and children, with the possibility of side-effects Giving drugs without the consent of the subject - Giving a placebo drug without informing the subject - Inflicting un-reparable damage - Misinforming test subjects Ethical issues are indeed a decisive factor in the feasibility of any experiment. On the other hand, it is important to keep scientific evidence in mind. When a drug and medical procedure are to be tested, they are first tested on mice or other animals that share high similarities with humans. Mice are genetically almost identical to humans; research suggests that so far, 4000 similar genes were found in both species. Results on non-human species must also be reproducible, coherent, and statistically significant before the experiment is submitted for approval for clinical trials. Furthermore, it is important to mention that some experiments require specific test subjects—ones that are not capable of giving consent. For instance, research on child behavior, or abnormal child psychology, requires that scientists observe and keep track of children. Patients with dementia might be legally allowed to give consent; they might not have the cognitive capabilities of doing so. This issue explains the presence of governing committees, known as international review boards (IRBs), and independent ethics committees (IECs). Other than reviewing experimental procedures and technicalities, such committees analyze the risk on subjects who cannot give consent for whatever reason that may be, and make sure that they are in no harm whatsoever. In the United States, for example, such tasks are carried by the US Department of Health and Human Services through several advisors and subcommittees. Human experimentation has contributed to the development of the medical field in ways no one deemed possible. Several drugs and medications we take today were proven effective because of tests run on human subjects (remember that accurate results cannot be extracted from experiments performed only on non-human subjects). In the US, the Food and Drug Administration (FDA) prohibits the sale of drugs and medication unless they pass several stages of clinical testing on humans. What is undeniable, however, is that human experimentation has allowed for huge developments in the medical and pharmaceutical fields. Most of the medications we take today, like penicillin, paracetamol, and vancomycin, were deemed suitable for disease treatment thanks to human experimentation. Furthermore, surgical procedures that shaped modern medicine are the result of an experiment, the procedure itself, conducted on a human subject or patient. It is therefore imperative to discuss the importance of this topic and its role in global healthcare. History of the Topic History remembers several civilizations that conducted experiments on humans. Archeological digs in France uncovered skeletal remains that appear to have been operated on (thanks to the fissures, cracks, and openings) back in 7000 B.C. Furthermore, archeological digs in Egypt uncovered surgical tools and drawn documentations of procedures believed to have been used in surgery. It was not until 1796 A.D., however, that the first human experiment was fully documented from beginning to end. Smallpox was eradicated in 1949, thanks to the development of smallpox vaccines. Before that, in 18th century Europe, the virus would kill around 400,000 people per year. At the same time, a virus known as cowpox was common amongst cows in Europe. Edward Jenner, a trained biologist and clinical surgeon from England, noticed that cows that had suffered from cowpox, when infected with smallpox, would not die. On the other hand, cows not infected with cowpox died from a smallpox infection. His curiosity and intuition pushed him to check if the same would apply to humans. He infected an 8-year-old boy called James Phipps with cowpox. Phipps developed nausea and malaises a few days after the infection. The thing about Jenner’s experiment is that he never got consent from the boy, and the boy never knew he was infected with something that could have killed him. Two weeks later, Jenner infected Phipps with smallpox by injecting the juice from lesions on the skin of a human infected with the same virus. The boy developed mild symptoms but survived. Edward Jenner had just discovered the first vaccine against smallpox. He started injecting people with juices containing the cowpox virus, and this soon led to the eradication of the disease known as the scourge of mankind. Modern-day medicine owes a lot to Jenner. However, had Jenner been a modern day scientist, his experiment would have never been approved for clinical testing because it is unethical; it posed a great risk on the life of the subject. Jenner remains, however, a founding father of human experimentation, as his procedure opened big doors that shaped modern medicine. Although Jenner’s experiment is notable for its controversy, it is not the only one of its kind. The history of human experimentation is full of controversial cases. Due to the lack of laws and regulations, the first half of the 20 th century saw a rainfall of unregulated and unethical human experimentation. The following list compiles some of them: Saint Quentin State: inmates are very easy targets for people or companies looking to experiment on humans. Their status does not really guarantee their right to choose, and it allows the experimenter to lure such subjects in easily (offers such as money and a reduced jail sentence were used). The biggest example is the experimentation on California’s San Quentin State Prison inmates, conducted by Dr. Leo Stanley. Stanley was working on organ transplants, and performed hideous acts like testicular implants and sex organ transplants (obtained from sheep, goats, and rams). This carried on between 1918 and 1922. Willowbrooke and Tuskigee: Willowbrooke State School was a holding point for mentally ill children (the combination of two targets for people conducting experiments). From 1956 until 1970, researchers infected the school’s 700 children with hepatitis. The aim of the experiment was to study the spread of the virus. Evidently, the school’s condition became horrid because of overcrowding and total absence of hygiene. The school closed down in 1970 due to public complaints. Figure 2-The Willowbrooke School The Tuskigee experiment was a 40-year-long study, aimed at uncovering the developments of untreated syphilis. The Public Health Service of the Tuskigee Institute launched it in 1932. The subjects were around 600 poor sharecroppers, of which 400 were never told they had syphilis. Subjects were lured in with free healthcare and burial money. Those who were told they have syphilis were not treated, although it was discovered in 1947 that syphilis could be easily cured with penicillin. The Public Health Service carried a similar experiment in Guatemalan prisons, where 700 men and women were infected with either syphilis or gonorrhea. The Public Health Service never obtained consent or informed the subjects of what was going on. Nazi Experiments during World War II: Nazis are known for a long list of crimes committed during the war, and experiments on humans are some of the most important ones. German physicians, notably Joseph Mengele and Karl Brandt, had 3 objectives in mind: keeping the troops safe, curing and treating injured soldiers, and contributing to the racial advancement of the Aryan race. Their experiments were performed on an uncountable number of prisoners, who were taken and used as test subjects without consent. Injections with chemicals, live dissections, and operations without anesthesia are only some of the ways Nazis used to torture their prisoners and work on medical advancements. Mengele was peculiarly fascinated with twins,and heterochromatic eyes (people whose eyes are of different colors). He spent a big part of his career experimenting on twins: dissecting them, studying them, and trying to understand their genetics. Most Nazi research was either destroyed or taken and published as the work of the victors of the war. Similarly, the Japanese had a secret complex known as Unit 731, by which experiments were conducted on more than 10,000 prisoners of war. International Actions International action against unethical human experimentation is not as common as action against international crimes that do not contribute to the progress of science. For instance, human experimentation was used in several political wars, most notably the Cold War. This doesn’t stop international organizations and NGOs from working to set international ethical guidelines for experiments conducted on human subjects. The two most important documents when it comes to human experimentation are the Nuremberg Code and the Declaration of Helsinki. The Nuremberg Code: released as part of the Nuremberg trial against Dr. Karl Brandt and 22 others in May 1947, this 10-point code represents the international community’s first effort to regulate experimentation on humans. Although not legally binding, this document is the cornerstone of medical experimental ethics. Its first point speaks about the vitality of consent and how it is the most essential part of any experiment. Other points discuss the importance of transparency and the infliction of unnecessary harm. The Declaration of Helsinki: the Declaration of Helsinki was released in 1964 in an international convention in Helsinki, Finland. Unlike than the Nuremberg code, it was the only international document that addressed the issue of ethics in human experimentation. The Declaration relates the Nuremberg Code to the Declaration of Geneva Figure 3-Experimentation on Humans (1948) that depicts the general ethical duties of a physician. The Declaration both deepened and relaxed some of the issues discussed by the Nuremberg Code, most notably the issue of consent: the Declaration stresses on the importance of consent, but also discusses some the cases where exceptions can or should be made. The Declaration has been revised seven times (the last revision was conducted by the General Assembly in 2013). Both documents introduced above are not binding; however, they are heavily used in lawmaking, the presenting of experimental procedures for assessment, and by lawyers in lawsuits involving alleged ethical breaches in medical experiments. NGOs invest heavily in the rationalization of human experimental research by working on reporting unethical experiments being conducted around the world. For example, Amnesty International, an NGO that aims to provide prison inmates with the right to security, food, and good treatment, depicts prisons or countries allowing the use of their inmates for medical research. Although international actions regarding this topic are not plentiful, it is important to mention that countries do take action but on a national level because of cultural clashes. The leading countries in monitoring and regulating human experiments are the United States, Russia, and Germany. Recommendations Treating the topic of human experimentation is certainly difficult. Several factors are at play when drafting a law or writing a declaration. Naturally, the most important one is scientific knowledge and evidence, after which come ethical issues. On the other hand, politics, international relations, and the economy all play important roles when it comes to legislation. When discussing this topic in a committee, it is important to keep track and think about the following: - The revision of current laws and regulations - What countries (based on cultural/religious beliefs) would agree or accept a given law or experiment - How to maximize scientific advances and minimize public risk - Should there be any rules about releasing all findings or could findings be kept confidential (especially when the research and experimentation are conducted by the private sector) - How to better contain the private sector (most notably the pharmaceutical industry) - The extent to which sacrifices should be made in the name of science - The possibility of drafting an international agreement Questions to Consider 1) 2) 3) 4) 5) What common ground can be found between countries on this issue? What degree of freedom should the private sector have? What barriers prevent the inception of an international agreement? How can an agreement deal with religious beliefs and customs? To what extent are the Nuremberg Code and the Declaration of Helsinki being neglected? References 1) United Nations, World Health Organization, Ethical Standards and Procedures for Research with Human Beings http://www.who.int/ethics/research/en/ 2) United Nations, World Health Organization, Governing Body Documentation, http://apps.who.int/gb/bd/ 3) Wrigley, Anthony, Human Experiments – The Good, The Bad, and the Ugly, The Conversation June 8th 2015 4) Physicians Committee for Responsible Medicine, Human Experimentation: an Introduction to Ethical Issues, http://www.pcrm.org/research/healthcareprofessionals/research-compendium/human-experimentation-an-introductionto-the 5) National Human Genome Research Institute, Why Mouse Matters, https://www.genome.gov/10001345 6) Riedel, Stephan, Edward Jenner and the History of Smallpox Vaccination, NCBI, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1200696/ 7) The United States Holocaust Memorial Museum, Nazi Medical Experiments, http://www.ushmm.org/wlc/en/article.php?ModuleId=10005168 8) United States Department of Health and Human Services, the Nuremberg Code, http://www.hhs.gov/ohrp/archive/nurcode.html 9) World Medical Association, Declaration of Helsinki, http://www.wma.net/en/30publications/10policies/b3/