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The effectiveness of physicians for human rights
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Comparative analysis of Helsinki declaration October 2013 compared to the 1996 version
The Helsinki declaration 2013 compared to the one 1996 states that one of the reasons of biomedical research is to continuously evaluate medical interventions apart from the improvement of diagnosis and prevention of diseases which is also stated in the older version. In addition in the newest declaration the importance of final experimentation on human subjects is mentioned, whereas in the previous edition the experimentation in humans is mentioned only as a part of the final experimental design. Regarding the role of ethical committees and the approval of experimental protocol, there are some implementations in the 2013 declaration which give the ability to the committee to control the whole experimental procedure and the adverse effects during the study. In addition, the fact that changes cannot be made in the protocol during the study is mentioned clearly, this part was not mentioned in the 1995 declaration and the clear explanation of this fact does not leave any free space for different types of behavior. Finally, new considerations regarding the protocol have been added in the newest version of Helsinki declaration in which all the details including ethical aspects and compensation for the subjects should be included in the experimental protocol, which will be under consideration by the ethical committee.
Duties of physicians
In both editions of the Helsinki declaration the role of the physician in protecting the human subject involved in the study is stressed out. However in the 2013 declaration in a more detailed way all the parameters that should be protected by the health care professional are described and those include not on...
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... obtained regardless of being negative or positive should be published openly. Moreover liable for the ethical aspects of the study are not only the physicians but also the editors and the publishers. Increasing the liability in all individuals involved in the implementation and publication of the study decreases the possibility of a study that does not take into account all the ethical aspects will be conducted. Finally the 2013 declaration gives the ethical possibility to the physician to use an unproven method if he believes that this will be for the benefit of the patient and after the informed consent is given.
References
1. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 2013
2. WMA Declaration of Helsinki, Recommendations guiding physicians in biomedical research involving human subjects, October 1996
The IRB is an administrative body which has been established to make sure research participants' rights are protected. IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and informed adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised.
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
Since the inception of this mode of research, peoples’ perception of what constitutes moral behavior towards patients and specifically harvesting cells from patients has changed. Over time, other doctors would take cells from patients without patient consent and use them for research. Coming from this, people began to think about how ethical this was, and especially if the potential for scientific or medical advances outweighs the injustices imposed by the lack of obtaining patient consent. One could argue that in the area of ethical behavior and medical advances, it might be necessary and acceptable to take cells or tissue samples without patient consent. And even though these cells and the research of these cells might not affect the patient, what advantages and disadvantages could come from obtaining or not obtaining patient consent?
Truog, Robert D., Walter Robinson, Adrienne Randolph, and Alan Morris. "Is Informed Consent Always Necessary For Randomized, Controlled Trials?" The New England Journal of Medicine 340, (March 1999): 804-807.
1. Capp, Marshall B. "Ethical and Legal Issues in Research Involving Human Subjects: Do You Want a Piece of Me? -- Kapp 59 (4): 335 -- Journal of Clinical Pathology." BMJ Journals. J Clin Pathol, 18 Jan. 2006. Web. 11 Feb. 2012.
Steinbock, Bonnie, Alex J. London, and John D. Arras. "The Principles Approach." Ethical Issues in Modern Medicine. Contemporary Readings in Bioethics. 8th ed. New York: McGraw-Hill, 2013. 36-37. Print.
Plecas, D., McCormick, A. V., Levine, J., Neal, P., & Cohen, I. M. (2011). Evidence-based
Ethics refers to the values and customs of a community at a particular point in time. At present, the term ethics is guided by the moral principles that guide our everyday actions. These moral principles guide the researcher into deciding what is ‘right’ or ‘wrong’. The foundation of medical ethics is governed by two philosophical frameworks that are deontology, and utilitarianism. However ultimately the ethics committees need to balance the risks, and benefits for the participants and the community associated with the particular research proposal. This balance is quite important as the well being of participants is at risk.7
JAMA: Journal of the American Medical Association. 14 Nov. 2001: 2322. Academic Search Complete. Web.
The first article is entitled “of mice but not men: problems of randomized clinical trials,” is written by Samuel Hellman and Deborah S. Hellman discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized because according to the article trust is very valuable in medicine especially when a patient’s life is at risk. A Kantian and a Utilitarian view of randomized clinical trials are debated but the authors clearly steers towards a Kantian point of view.
Informed consent is a very serious decision a patient has to make when it comes to their health and consenting to procedures that are believed to cure or treat their current health status. It is important to address the effectiveness of the role a physician play in the informed consent process assuring that the patient has given truly informed consent and what safeguards can be put in place to assure the patient is exercising informed consent. Informed consent is based on the fact that the person consenting is a rational individual that is aware of the action to which he/she is consenting. Allen and McNamara (2011) notes that "On the standard understanding, the important elements of informed consent are the provision of information, the voluntariness of the choice and the competence of the chooser to make the choice— so the potential research participant should be provided with information relevant to the decision to participate, they should be able to choose freely about their participation and they should be competent to decide.
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3): 141-145
Following the ethical codes and getting approval from the Institutional Review Board (if the study has human subjects) can really decrease the possibility of any harm being done to the participants. A perfect example of a research study that had lots of things unethical practices was the Tuskegee Syphilis study:
The article titled “Contemporary Ethical Analyses: A Shortfall in Scientific Knowledge” describes the ethics through the public’s eye. One of the major ethical issues brought up is informed consent.
Every year, millions of animals experience painful, suffering and death due to results of scientific research as the effects of drugs, medical procedures, food additives, cosmetics and other chemical products. Basically, animal experimentation has played a dominant role in leading with new findings and human advantages. Animal research has had a main function in many scientific and medical advances in the past decade and is helping in the understanding of several diseases. While most people believe than animal testing is necessary, others are worried about the excessive suffering of this innocent’s creatures. The balance between the rights of animals and their use in medical research is a delicate issue with huge societal assumptions. Nowadays people are trying to understand and take in consideration these social implications based in animals rights. Even though, many people tend to disregard animals that have suffered permanent damage during experimentation time. Many people try to misunderstand the nature of life that animals just have, and are unable to consider the actual laboratory procedures and techniques that these creatures tend to be submitted. Animal experimentation must be excluded because it is an inhumane way of treat animals, it is unethical, and exist safer ways to test products without painful test.