Human Subjects Protection - Research Paper Example

Human s Protection. Bioethics. This paper is devoted to the topic of Bioethics, its basic rules and the protection of human subjects. Also we examined the cases where these rules are broken or their observance is doubtful. The practice of protecting the human subjects is relevantly young but a lot of scientists are working on its development. Here we used the information from the following sources: Belmont Report: Ethical Principles And Guidelines For The Protection Of Human Subjects Of Research. Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law; A Conspiracy of Cells: One Womans Immortal Legacy and the Medical Scandal It Caused written by Michael Gold; Human experimentation and research edited by George F. Tomossy and David N. Weisstub. In the modern world the Bioethics isn’t just a theoretical science of what is admissible and what is not, but the science which consolidates the whole world’s knowledge in the fields of medicine, philosophy, psychology and etc. In this paper we mentioned the cases that concern all these fields. During the work on this paper we also found several very interesting cases which, were not considered by us as those which relays to the field of Bioethics, before we started this work. Keywords: right to health protection, biomedical research, medical experiment, bioethics, human subject. The second half of XX and the beginning of XXI century, are characterized by serious scientific and technical discoveries in the fields of biology and medical studies and the rapid rise of medical technology to a new level of higher quality. Cloning, genetic engineering, organ and tissue transplantation - this is not a complete list of studies that can change the life of humanity, find a way to treat many serious diseases. Scientific research in the field of medicine today is the most important sphere of human activity, whose main aim is to preserve the patients life and health. During the recent years, medical science has made great strides, the doctors became able to penetrate into the underlying processes occurring within the human body; to affect the reproductive health, the process of dying, genetic status and etc. The appearance of completely new high technologies, the expand of the horizons of human activity in the field of medical and biological sciences produces new relations like researcher - human subject, which undoubtedly leads to the necessity of legal regulation of these relations. To test the theoretical propositions brought up by the scientists, for the reason of their practical verification and providing the secure of the new developed therapies, invariably there appears a need for biomedical experiments on humans. One of the fundamental principles governing the development of all social institutions which build the solid base for the formation of the attitude to the person as the supreme value is the principle of humanism. At the modern stage, having passed a significant way of development, the society is forced to admit that there are many issues the decision of which is not yet comprehensible for the humans. Each new evolutionary stage is accompanied by a mass of new diseases, viruses, carrying away many lives and pose a serious threat. HIV (AIDS), cancer, bird flu - is just the tip of the iceberg of the most serious diseases the treatment for which is not yet found, even in the present time, the time of the rapid development of science. Disappointing statistics inevitably emphasizes the unique need to combat these diseases and to search for fundamental means for their prevention, diagnosis and treatment. So this is the primary aims of the modern medicine, the implementation of which, in turn, is inconceivable without experimental studies that involve human subjects. But there are the cases when this questions concerns the sphere of medicine together with legal one. For example one of my friends acquaintances told me a story that he was ill and the doctor offered him to try some experimental medicine instead of classical treatment, but the patient said no. Ive heard this story about two years ago and at that time I was curious why didnt he accept the doctors offer, but only when I started working on this paper I realized that that very example concerns the bioethical issues. Now I see that the pharmaceutical companies suggest their new medicine to be used in the hospitals just because they need a statistics that will confirm that the medicine works properly. So they, actually, get this statistics for free because they do not pay for the participance in the experiments. The patients are to subscribe the agreement that they realize and take the responsibility, but sometimes they arent given the full information about the experiments details such as for example side effects of the preparations. So I consider that even if the patient signs up the agreement for the experimental treatment the doctor still has a responsibility and the Nurnberg rules still in effect for such cases. One more example of forcing people is following - in some countries of the world the vaccination (against such diseases as diphtheria, whooping-cough and etc.) is compulsory. The vaccine is free but people are obliged to make the injections in the clinics, but the quality of the vaccine is doubtful. The consequences (especially is cases of vaccination of newborns) could be lethal. I think that such things shouldnt happen in the modern society. Ive thought a lot about the problem of bioethics while working on this project and the most interesting was the question "What shall we do if the patient who need a dangerous surgery is unconscious (for example in coma), so he/she is not able to sign the and has no relatives?" This question is well described in the popular serial House MD. I realize that all the stories are factious, but they do concern the question under the study. In the serial the circumstances turned for thr best, but can it be so in real life? In reality the doctor stays on the thin verge between the Asclepiades [Hippocratic] Oath and the legal liability. So this question can have two different answers which are both suitable in different situations for different patients and doctors. Medical Doctor is a person who, in the modern world, is endowed with special rights. In this case, the more technologically effective medicine is, the wider is the circle of these rights, but the more they are problematic from the point of view of ethics. An example of this - the intense debate about the legality of euthanasia. Euthanasia is the deliberate, purposeful acceleration of death of seriously ill patients which is done by doctors and justified, as a rule, considerations of hopelessness of the patients condition and his/her rescue from suffering. Ive never really thought about this problems as one that refers to the Bioethics. It involves medical acts, directly leading to death (active euthanasia) or implies lack of medical care needed to extend the life of the patient, i.e., the omission or inaction of the doctors in those cases where a doctors assistance is absolutely necessary (passive euthanasia). Sometimes, euthanasia is understood as the assistance in committing a suicide, if it meets the definition of "easy death," with accordance to the original meaning of the term suggested by F. Bacon in the XVII century. Modern culture has become increasingly so to say medicalized. The impact on everything natural in human is getting more sophisticated, but at the same time and more aggressive, and the consequences get much more risky and dangerous, which naturally raises the question of "markup" of the boundary between acceptable and unacceptable. Until the present days the problem of euthanasia was treated differently; public opinion is split. In case of full legalization of euthanasia, many people will continue to assume that euthanasia (as killing the innocent) is the absolute evil. On the other hand, to live in suffering is not the answer. Not all the life situations can be strictly measured by our theoretical, religious or philosophical beliefs, and the people who face the reality of this problem, begin to treat it differently than those who used to talk about the issue of euthanasia, not fully realizing that death is sometimes the best way when the person is destined for long suffering from the untreatable illness. The question of organ transplants also relates to issues of Bioethics. The so called ‘organs market’ isn’t a new thing today as a mechanism it has its own demand and supply, but from the point of view of the ethics. The most difficult issue is still the confidence in the services, ensuring the removal of organs (the controlling the absence of abuse). Potentially dangerous precedents are those in which bringing patients to the donors death takes place; the failure to provide an adequate assistance to the potential donor, and even the removal of organs from healthy people, under the pretext of certain operations artificially imposed by the physician. Equally important is the issue of abortion, both from a legal, ethical and psychological point of view. In most modern states it is believed that the bodily autonomy of women gives her the right to dispose of her body, and the emergence of a new personality with his/her own rights occurs at the time of the birth. Therefore, in all these countries, abortion is allowed. In the dispute between the two principles, one of which is based on the mothers right to choose, and the other - on the right of the fetus to live, there is a contradiction, which makes it impossible to solve. That is a fact that the principle of the right choice equally applies to the fetus and the woman herself. As a result, the dispute becomes purely scholastic. There is one more acute point - the question of racial abuse. Here I should remind the famous case concerning the HeLa cells - «immortal» cells, which are used in scientific researches. These cells were obtained on the February 8 year 1951 from the cancerous growth of the patient Henrietta Lacks who died because of this disease. The HeLa cells are used for studying the cancer. I was interested in the role played by HeLa cells in the development of medicine, biology and pharmaceutical discoveries. Immortal cancer cells, through which were quite a lot of discoveries that were taken without the permission of their bearer - Henrietta Lacks. Her family for many years knew nothing about it. I do not think that the right to use the cells completely belong to commercial factory because developed and debugged technology of growing cells was developed by many other people and of course the Henriettas descendants have the right to get a part of the money the company gained. The family of Henrietta Lacks tried to sue the company because of the use of cells without the consent of the patient, but did not win the case. I find it very unfair that the family of the woman whose cells have saved millions of lives, can not afford health insurance and treatment. The history of HeLa cells made me to change my mind concerning biomedical ethics. Obviously, the protected rights of the certain person can not be protected from possible conflicts between the rights of other people. Let us take the situation where a patient has a right to get qualified assistance of the experienced physician, on the one hand. On the other hand, we see the young doctor, who admits postmortem human right to preserve the physical integrity of the patient’s corpse and does not want to improve his skills, practicing on the corpses of humans or animals. So, there is obviously a conflict between their interests. One more example: the consumer has the right to receive Biosafety cosmetics or medicine. But this right may conflict with the point of view of the manufacturer who refuses to use the laboratory animals for testing new agents. Clashes between the rights and freedoms of people - between the individual patients physicians rights, the individual personality of the experimenter and the human subject - they are not accidental. They are related to the fact that the normative principles and moral values ​​of different people do not always coincide, and sometimes even stay in contradiction. Bioethics protects human rights, who is being the patient or the subject may suffer from the actions of the doctor or the experimenter. But at the same time Bioethics performs a social function to protect the individual professional physicians and biologists rights. Medical doctor is not a robot, mechanically and mindlessly executing existing laws. Biologist experimenter is also not a robot, which can be defined strictly by certain actions and subject to certain rules. In the history of psychology, there were a few enthusiastic scientists who conducted a series of fascinating experiments, which are in contradiction to modern notions of psychological ethics. As the most vivid and at the same time terrible example may serve the experiment concerning the destruction of the childs mind which was carried out 20 years of John Watson, the founder of behaviorism - the branch of psychology, who studied not mind, but only the behavior of humans and animals. Watson, inspired by the experiments of Pavlov, and among other things, interested in the formation of conditioned emotional reactions of the children. By simple learning and stimulating the negative reactions, the psychologist successfully taught one of his subjects, Albert B. to be afraid of everything of white color. Watson concluded that the reactions of fear cn get transferred (first he taught the boy to be afraid only of a white mouse). Watson suggested that many fears, dislikes and anxieties of the adults are formed in early childhood. Unfortunately, Watson did not manage to save little Albert from his causeless fear, which was fixed for the rest of his life. In regard to the psychology of the modern world, another ethical issue is the ability to apply an involuntary measures to certain categories of mentally ill people among these measures we can mention the coercion, in particular, we are talking about involuntary treatment. In the ethical and legal terms - this is a typical "problem situation", as in this case, the patient must be provided with special safeguards to protect his civil rights. Thus, the ethical problem of the psychiatrist - to limit the scope of coercion in psychiatric care to the limits determined by medical necessity. A special case of this "problem situation" is considered to be present and defined in the relevant legal documents a patients right to refuse treatment as a source of bioethical dilemmas. On one of its poles lays the right of every patient to refuse treatment - generally accepted ethical and humanistic value and legal-norm. At the other pole there are the peculiarities of the mentally ill, whose refusal of treatment may complicate the work of the psychiatrist, and to update the problem of the dangers of the person suffering from a mental disorder, for him/ herself and for the others. Thus, the next task psychiatric ethics is the regulation of social sanctions against the mentally ill persons. Unjustified restriction of the rights of patients, dismissive attitude towards them and the humiliation of human dignity articulated the need for reflection of the problem and the formation of the ideology protecting the rights of the mentally ill people. In conclusion I want to say that in the recent years the world community developed a wide range of rules and laws protecting the rights of both the human subjects and the experimenter. In the modern world the guarantee of security of mankind is represented primarily in the creation of moral and ethical barriers, fixed by legislation. With the emergence of bioethics the question of "eternal" social and philosophical issues such as the definition of life and death, the meaning of life and quality of health, the relationship of doctor and patient, medicine and society, man and nature emerged anew. Scientific and technological progress in biomedicine didnt not only expand the possibilities in the field of biomedicine, but also affected the traditional notions of good and evil, the good of the patients understanding and gave one additional impetus to the development of this sphere of knowledge. We also can conclude that that experiments which involved the human subjects can help and accelerate the development of the different spheres of science such as medicine, psychology, sociology, but they should be carried out only according to all the laws that protect all the participants of the experiment from performing any kinds of crimes (even by accident). References Perlman David Ph.D. Ethics in clinical research. A history of human subjects protections and practical implications of ethical standards. SoCRA source. 2004. Belmont Report: Ethical Principles And Guidelines For The Protection Of Human Subjects Of Research. Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council LawNo. 10", Vol. 2, Washington, D.C.: U.S. Government Printing Office, 1949. Michael Gold A Conspiracy of Cells: One Womans Immortal Legacy and the Medical Scandal It Caused. — State University of New York Press, 1986 Human experimentation and research / edited by George F. Tomossy, David N. Weisstub. Burlington, VT : Ashgate, 2003. - (International library of medicine, ethics, and law). Read More