Introduction Clinical trial is biomedical or health related research studies in human being that follow a pre-defined protocol. Research is an activity designed to test a hypothesis that helps in concluding and developing knowledge. It is a protocol that has an objectives and procedures to reach those objectives (1). There are two types of clinical studies. One is interventional studies in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Second is an observational study in which individuals are observed and their outcomes are measured by the investigators. The first clinical trial of a novel therapy was conducted unintentionally by the Renaissance surgeon Ambroise Parè in 1537. He used a concoction of turpentine, rose oil and egg yolk to prevent the infection of battlefield wounds, noting that the new treatment was much more effective than the traditional formula. The first trial using properly randomized treatment and control groups was carried out in 1948 by the Medical Research Council, and involved the use of streptomycin to treat pulmonary tuberculosis. This trial also featured blind assessment (2). In December 1946, the War Crimes Tribunal at Nuremberg indicted 20 Nazi physicians and 3 administrators for their willing participation in carrying out the harmful research on unwilling human subjects. Thus, Nuremberg code was the first international code for the ethics to be followed during human subject research. It was permissible medical experiments implemented in August 1947. The code also provides few directives for clinical trials (3). Syphilis study at Tuskegee in 1974 was the most influential event that led to the HHS Policy for Protecti... ... middle of paper ... ...genome. A brief history of clinical trials. [http://genome.wellcome.ac.uk/doc_wtd020948.html.] Accessed 2011 Apr. 15 3) Protecting Human Research Participants. [http://phrp.nihtraining.com/history/04_history.php.] Accessed 2011 Apr. 15 4) Beauchamp, T. and Childress, J. Principles of Biomedical Ethics. Oxford Press, 6th edition, 2009 5) Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3): 141-145 6) http://www.bioethics.nih.gov/hsrc 7) Jenkins J., Hubbard S. History of clinical trials. Semin Oncol Nurs. 1991; 7(4): 228-234 8) Paul J., Seib R., Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res. 2005; 7(1):e5 9) Tunis S., Stryer D., Clancy C. Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy. JAMA. 2003;290(12): 1624-1632
Southam’s practice, beginning with the Code’s number 1 rule, “The voluntary consent of the human subject is absolutely essential.” Other rules under the Nuremberg Code were broken as well, however all of these egregious behaviors of researchers, more so than just Southam, have influenced the tight research protocols in place today. As Dr. Hardy shared information on research protocols, she consistently referred back to a strict system of regulations that, at times, may seem a little extreme. The alternative, a system permitting researchers like Southam, would be a far harder bullet to bite. In the end, I am glad these systems are in place to try to ensure a trust between patients and
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.
"Nazi Medical Experimentation: The Ethics Of Using Medical Data From Nazi Experiments." The Ethics Of Using Medical Data From Nazi Experiments. N.p., n.d. Web. 09 Dec. 2013.
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?
Polly Beam, J. S. (n.d.). Levy Library. Evidence Based Medicine Tutorial. 1.3 What’s Best: The Evidence Hierarchy. Retrieved April 9, 2014, from http://libguides.mssm.edu/hierarchy
Yarmolinsky, Adam. "The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation." The New England Journal of Medicine. N.p., 13 May 1993. Web. 05 Jan. 2014. .
Sidebotham, P. (2012). What do serious case reviews achieve?. British Medical Journal . 97 (3), 189-192.
The world of ethics and moral understanding of medicine was turned inside out as human rights were disregarded in an attempt to understand the anatomy of the human body, as well as its various responses to different drugs and environments. Human experimentation and subject research were of little interest to society before the 20th century (“Human Experimentation, Plutonium, and Colonel Stafford Warren”). The onset of the Holocaust heightened the popularity of that medical field. Experimentation using human subjects has drastically changed from the 20th to 21st century regarding the consent and state of the subject, the intent of the experiments, and the laws and policies passed.
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
When caring for patients it is fundamentally important to have a good selection of up to date evidence Based Practice clinical articles to support research strategies, this allows professionals to assemble the most resent and accurate information known which enables them to make decisions tailored to the individual’s plan of care. It is essential to have clinical expertise and have the involvement from the individual patient, they must have full engagement and incorporation in order to have the accurate evaluation.
Turner, B. J., Newschaffer, C. J., Zhang, D., Fanning, T., & Hauck, W. W. (1999). Translating clinical trial results into practice. Annals of Internal Medicine, 130(12), 979-986.
...obert J.. Ethics and regulation of clinical research. 2nd ed. Baltimore: Urban & Schwarzenberg, 1986. Print.
McGee, Glenn and Arthur L. Caplan. "Medical Ethics." Microsoft® Encarta® 98 Encyclopedia. © 1993-1997: Microsoft Corporation. CD-ROM.
Clinical drug trials are tests on drugs to find out if the outcome is a cure to the disease or not. In other words, clinical drug trials are done to figure out the effectiveness of the drug. Clinical drug trials are ethical because the scientists are trying to find hope and cures to diseases that may be taking over a person’s life. Chase, who has fragile X syndrome, showed signs that the drug he took in a clinical drug trial, minocycline, was working when he began to develop the abilities to understand things and respond to others. Also, clinical drug trials started back since the start of civilization and now the 20th century has advance much more in medicine. These clinical drug trial are being done for humans, are for people’s benefit, and can give to someone a better future. Therefore, clinical drug trials are ethical to be used on humans.