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...
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...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
Sidebotham, P. (2012). What do serious case reviews achieve?. British Medical Journal . 97 (3), 189-192.
Siegler, M., and W. Winslade. "Ethics in Medicine." Clinical Ethics. By A. R. Jonsen. 7th ed. N.p.:
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.
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 ...
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)
Those who were affected by the testing in hospitals, prisons, and mental health institutions were the patients/inmates as well as their families, Henrietta Lacks, the doctors performing the research and procedures, the actual institutions in which research was being held, and the human/health sciences field as a whole. Many ethical principles can be applied to these dilemmas: Reliance on Scientific Knowledge (1.01), Boundaries of Competence (1.02), Integrity (1.04), Professional and Scientific Relationships (1.05), Exploitative Relationships (1.07, a), Responsibility (2.02), Rights and Prerogatives of Clients (2.05), Maintaining Confidentiality (2.06), Maintaining Records (2.07), Disclosures (2.08), Treatment/Intervention Efficacy (2.09), Involving Clients in Planning and Consent (4.02), Promoting an Ethical Culture (7.01), Ethical Violations by Others and Risk of Harm (7.02), Avoiding False or Deceptive Statements (8.01), Conforming with Laws and Regulations (9.01), Characteristics of Responsible Research (9.02), Informed Consent (9.03), and Using Confidential Information for Didactic or Instructive Purposes (9.04), and Debriefing (9.05). These particular dilemmas were not really handled until much later when laws were passed that regulated the way human subjects could be used for research. Patients
The implementation of evidence-based programs is generally quite new in the field of medicine, and it is even more recent in the social sciences field. One point of interest in the development towards evidence-based programs was the foundation of the Food and Drug Administration that is in charge of testing the security and safety of medicinal treatments (Leff, Conley, & Hennessey, 2006). Another point of interest was in the utilization of randomized control studies. It was in 1948 that the first study occurred – examining the adequacy of streptomycin in treating tuberculosis. By the 1960s the quantity of randomized control experiments reached into the hundreds, and in the last ten (10) years there are tens of thousands happening each day (Dodge, 2006). In the field of psychology, which does not have a legislative body inspecting the adequacy of treatments, it is the obligation of those in the field to examine effective and compelling programs. It truly was not until the 1990s that this concept started to expand. The Alcohol, Drug Abuse and Mental Health Reorganization Act of 1992 assisted with the creation of the Substance Abuse and Mental Health Services Administration (SAMHSA), whose part was to help in disseminating research and viable programs/services in regards to issue practices. In 1999, the American Psychological
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
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.
AV. Pathways to human experimentation, 1933-1945: Germany, Japan, and the United States. In: Sachse C, Walker M, eds. Osiris, 2nd Series, Volume 20, Politics and Science in Wartime: Comparative International Perspectives on the Kaiser Wilhelm Institute. Chicago, IL: University of Chicago Press; 2005:205-231.
From 1946 to 1947, the Nuremberg War Crime Trials took place, withfifteen of twenty-three German physicians and research scientist-physicians found guilty of criminal human experimentation projects. The trial court attempted to establish a set of principles of human experimentation that could serve as a code of research ethics. The result was the Nuremberg Code, which attempted to provide a natural law-based set of universal ethical principles.
Randomized Controlled Trials can be used to in several types of evaluations, including new therapies (i.e. Cognitive behavioral therapy versus emotionally focused therapy when treating couples), community interventions, and diagnostic techniques (O'Brien, 2013). The RCT study design randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups is the outcome variable being studied (O'Brien, 2013).
Plecas, D., McCormick, A. V., Levine, J., Neal, P., & Cohen, I. M. (2011). Evidence-based
The dark history of human experimentation began with the clarification between experimentation and treatment. The larger public began to notice experimenters ethical neglect for their subjects in the early 1960s. Those charged with administering research funding took note of the public furor generated by the exposure of gross abuses in medical research. These included uncontrolled promotional distribution of thalidomide throughout the United States, labeled as an experimental drug; the administration of cancer cells to senile and debilitated patients at the Brooklyn Jewish Chronic Disease Hospital; and the uncontrolled distribution of LSD to children at Harvard Medical Center through Professors Alpert and Leary. Most important was Henry Beechers 1966 article in the New England Journal of Medicine, detaili...
Mitscherlich, Meilk Doctor of infamy: the story of the nazi medical crimes. New York: Schuman, 1949; xxii-xxv