Human Experiments - Inform consent - Essay Example

Human Experimentation-Informed Consent Human experimentation has been a part of medical research for over a century. It entails the use of human beings as subjects of experiments. In this type of research, human beings are usually subjected to experimentation and observation, with these observations recorded and compiled in order to answer research questions and to predict patterns of behavior and responses to stimuli or phenomenon. The most common area where human experimentation is conducted is medical research. Drug testing is often done on humans in order to determine their effectiveness and their adverse effects. Medical research is usually carried out on animals, however, many researchers and practitioners do not find these methods of experimentation as accurate and as reliable as research conducted on humans. Hence, human experimentation is becoming a very popular mode of medical research for many practitioners and researchers. Human experimentation was first used in the nineteenth century where there was an increased demand for human experimentation in the areas of bacteriology, immunology and physiology. These researches were usually done without the knowledge and consent of the patients. When injury resulted for some of the patient-subjects, the public and the medical community was outraged. Questions were subsequently raised abut the suitability of these experiments. The first restrictions on human experimentation were issued by the Prussian minister for religious, educational, and medical affairs. These regulations became imperative because of the actions of Albert Neisser—professor of dermatology and venerealogy at the University of Breslau. In order to establish preventive means for syphilis, he injected prostitutes who were admitted to the hospital (for different medical reasons) with cell free serum from patients with syphilis. These prostitutes were not informed about the experiment that would be undertaken on them. When the patients were infected with syphilis, Neisser concluded that the vaccination and treatment he administered did not work. He was later fined and reprimanded by the Royal Disciplinary Court for his unethical actions. The court said that although his tests may have been harmless to the patients, he should have sought their consent before administering the serum to them. As a result of the Neisser case, a directive was issued to all hospitals and clinics advising that all medical interventions which were not related to diagnosis, healing and immunization should not be performed on minors and on persons who did not give their consent. These regulations however, did not gain widespread popularity and support from the public and the medical community. Human experimentation by the Germans and the Japanese during World War II gained more attention from the rest of the world. The Nuremberg Code was formulated in order to detail the ethical guidelines for human and animal experimentation (Vollman & Winau, 2006). The Nuremberg Code detailed regulations on how to keep risks to human subjects of experiments, to a minimum. The code also set forth that “[h]uman experimentation on dying patients was absolutely prohibited” (Vollman & Winau, 2006). The special responsibilities of the physician conducting the experiment and trials are also emphasized by the Code. The exploitation of the social and economic needs of the patient or subjects of the experiments was also rejected by the Code. The Nuremberg Code is now the standard by which other ethical codes and regulations set by our medical profession and by our government are being based on. These regulations emphasize the importance of informed consent before conducting human experimentation. There are parameters of informed consent which are also set by the code. “Informed consent exists only when there is full disclosure of known relevant information and known risk presented to a patient in a manner that they can understand” (Radford, n.d). In human experimentation, the subject of the experiment should be properly informed about the experiment, the process involved in the experiment, and the risks that he will now take upon himself as part of the experiment. The subject of the experiment should be able understand clearly the words used by the researcher, and the latter should make sure that the subject has understood the implications and risks of the experiment. Barring these circumstances, there can be no informed consent on the part of the test subject. According to the Nuremberg Code, consent in human experimentation requires legal capacity to give consent, the subject must be in a situation as to be able to “exercise free power of choice” (Grad, 1984), the subject must have sufficient knowledge and information about the experiment before he decides, and the subject must understand the decision adequately in order to make an enlightened decision. Some practitioners argue that patients would not be able to ever fully understand the experiment and the procedure to be undertaken, and what information they would be able to understand from the researchers would only serve to frighten them. Nevertheless, the general consensus in the medical community is that the researcher and the medical practitioner should still inform the patient about the experiment and the procedures to be undertaken on his person. The Nuremberg Code was later followed by the Declaration of Helsinki which supported the provisions of the Code and expressed “the need for informed consent and the importance of conducting animal experimentation before proceeding to human experimentation” (Weikart, 2008). Many physicians believed that the declaration in effect made American and European physicians and researchers re-think some of their practices in conducting experiments on prisoners and institutionalized children who did not have the sufficient capacity to refuse. Many practitioners criticize some researchers for not gaining their subject’s informed consent. They argue that some researchers do not want to get their subject’s informed consent because they cannot explain to their subject the risks involved in the study. Some of them are not even sure what the risks of the experiment are. They also believe that some researchers do not gain their subject’s consent because they are afraid that after explaining the experiment to their subjects, their subjects might become confused and frightened, and in the end refuse to consent to the experiment. They emphasize that humans who are subjected to experimentation should have a chance to say no, even if the end-results of the experiment would be for the greater good of the greater community. Experiments pose many unknown dangers to patients. Therefore, many practitioners believe that subjects must be given a chance to indicate their personal preferences regarding procedures to be undertaken on their bodies. Medical expertise in research studies is an immeasurable concept, and on deeper introspection, does not really exist. Consequently, patients have no reason to depend on it. “No one proves a better expert than the patient in resolving the core moral concern of experimentation, ie. whether he should volunteer his body to augment medical knowledge” (Quittell, 2001). Therefore, the decision should be really left to the patient, not the researcher. Experimentation brings little benefit for the subject. Informed consent gives the subject a chance to consider all these factors and decide either to still submit himself to the experiment or not. Widespread human experimentation has been conducted for cancer and AIDS research. History has been littered with cases of human experimentation in order to test the effectiveness of drugs and vaccines against these deadly illnesses. Some of these experiments have gone through the process of obtaining their patient-subject’s consent, however there have been instances where consent has not been properly obtained from subjects, or if it was, the subject was not properly informed of the risks involved in the experiment. Cases involving biomedical research for cancer patients are sometimes conducted on terminally ill subjects. In several instances, test subjects were not properly informed of the risks involved in the experiment, and some of them were given false assurances about the effectiveness of the drugs and vaccines that were being tried on them. These drugs and vaccines later produced adverse effects-like difficulties in swallowing, continuous vomiting, and anxiety attacks. “Too often…these experiments are conducted with meager oversight and without proper informed consent” (Washburn, 2001). Subjects are often not informed that these experiments and test vaccines are done by untrained staff in cramped rooms without quality control measures. Most times, they are not even informed that the vaccines or drugs may not really work. Federal authorities who later check consent forms of test subjects discover that risks and other vital drug information are not properly stated and relayed to the test subjects in the consent forms. The potential benefits of the drugs or vaccines are also oftentimes exaggerated and overly stated in subjects’ consent forms (Washburn, 2001). A news report revealed that foster kids are sometimes used as test subjects for AIDS research. These researches produced adverse results for many of the foster children who suffered many side-effects, such as rashes, vomiting, and plunging white blood cell counts. Death rates in these children were also higher for those who took higher doses of experimental drugs. These cases have not gained enough attention from the general public, but they have caught vital attention from many interest groups. The researchers are quick to defend their actions by claiming that, “this was all for the good of the foster children…because they were trying to save helpless children suffering from AIDS” (Ross, 2005). Some interest groups have criticized this experiment for being unethical, despite its beneficial end-result. Many medical scholars and practitioners have criticized researchers for taking advantage of people’s economic difficulties by offering them quick and easy ways to earn money. The most common victims to these experiments have been immigrants who often have trouble finding legitimate jobs. Venezuelan immigrant Oscar Cabanero stated that, “it’s not the job I would choose, but financial circumstances require you to do it sometimes” (as quoted by Veracity, 2006). The immigrants’ economic difficulties often make them vulnerable to the whims of unscrupulous researchers and practitioners who are willing to try just about anything to gain approval for their drugs and vaccines. Some practitioners argue that the rules set by the Nuremberg Code and the Declaration of Helsinki, in the near future will be susceptible to abuse. They believe that ethics committees may block necessary and important research for some vague philosophical or ethical reason. These committees may even block researches and new studies for reasons that have nothing to do with ethics. Their opposition may be based on their dislike of the direction some new researches might take “and they might utilize their position to block such research” (Grad, 1984). However, there are too many other dangers that human experimentation can bring to human subjects if properly obtained informed consent is not sought. These are the greater evils that need to be prevented before any other concerns about new researches may be brought to the spotlight. Since the issue of human experimentation without informed consent has been promptly brought to the limelight, it has since received widespread attention from the public and the medical community. However, there are grey areas in this subject. One of them is the undeniable fact that the mandate of informed consent may be used to block vital and important research studies needed to study and treat various diseases. Many practitioners insist that researchers should follow the mandates of the Nuremberg Code and the other regulations set by the medical community, bioethics, and medical research. These rules are there for a reason, to prevent the mistakes of the past from being repeated, and to regulate the practices of various researchers who may be more concerned with marketing their drugs and vaccines than caring for the rights and welfare of their test subjects. Some researchers insist that they do get the informed consent of their patients; however their choice of test subjects leaves something to be desired. Their test subjects are often individuals who are desperate for a quick buck and who are down on their luck. On the part of the test subject, this is not a matter of really going through the process of informed consent, but of being taken advantage of, of having one’s hardship be used as a tool of manipulation. The medical community is sometimes divided on the issue of human experimentation and informed consent. However the general consensus and rules are set, test subjects should be given the right to say no, to be properly informed of the risks and dangers that may befall them should they agree to the experiment. Works Cited Grad, R. (15 October 1984) Human Experimentation and Informed Consent. MedCentral. Retrieved 10 December 2008 from http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1483724&blobtype=pdf Human Experimentation. (2008). Internet FAQ Archives. Retrieved 10 December 2008 from http://www.faqs.org/health/topics/36/Human-experimentation.html Human Experimentation, Plutonium, and Colonel Stafford Warren (n.d) The Burton Report. Retrieved 10 December 2008 from http://www.burtonreport.com/InfForensic/HumanExperPlutonium.htm Lerner, R. (12 August 2004) Sins of Omission-Cancer Research without Informed Consent. The New England Journal of Medicine. Retrieved 10 December 2008 from https://content.nejm.org/cgi/content/full/351/7/628 Quittell, R. (24 April 2001) Informed Consent and Human Experimentation: Present Status, Pitfalls and the Need for Reform. Legal Electronic Document Archive. Retrieved 10 December 2008 from http://leda.law.harvard.edu/leda/data/407/Quittell.pdf Radford, R. (n.d) Informed Consent: Reality or Myth? The Burton Report. Retrieved 10 December 2008 from http://www.burtonreport.com/InfForensic/InformedConsent.html Ross, G. (19 May 2005) Human Experimentation In America: Foster Children Used As AIDS Guinea Pigs. Newtopia Magazine. Retrieved 10 December 2008 from http://www.newtopiamagazine.org/articles/54?POSTNUKESID=24ed05666a384a1b6ffac406986de830 Veracity, D. (7 March 2006) Human medical experimentation in modern times: How immigrants, poor people, minorities and children are modern-day guinea pigs for Big Pharma. Natural News. Retrieved 10 December 2008 from http://www.naturalnews.com/019193.html Vollman, J. & Winau, R. (07 December 1996) Nuremberg Doctors’ Trial. British Medical Journal. Retrieved 10 December 2008 from http://www.bmj.com/cgi/content/short/313/7070/1445 Weikart, R. (November 2008). The Debate over Human Experimentation. Humanities and Social Sciences. Retrieved 10 December 2008 from http://www.h-net.org/reviews/showrev.php?id=22960 Washburn, J. (30 December 2001). Informed Consent: One Lawyers Assault on the Medical Research Establishment. The New America Foundation. Retrieved 10 December 2008 from http://www.newamerica.net/publications/articles/2001/informed_consent Read More