The Ethical Implication in Human Research
Amanda K. Robertson
Fort Hays State University
The Ethical Implications in Human Research
Medical research using human subjects has been going on for years, however ethical standards in research with the use of human subjects is a new concept relative to time. Today IRBs or Institutional Review Boards must be consulted before research can begin when human subjects will be used. The formation of Institutional Review Boards were a result of some very unethical human research over a period of many years with the beginning of the ethical changes coming from the infamous Nuremberg Trials following World War II. These were the trials of many doctors and military leaders from the Nazi regime for crimes against humanity. This led to a formation of ten principles to be used and considered before any research with the use of human subjects is to begin. These principles were formed by the American judges that were among those that tried these doctors and former members of the Nazi regime; these principles were titled the Nuremberg Code (Shuster, 1997).
The ten principles known as the Nuremberg Code were developed during the trials in Nuremberg; these principles were based on ethical ideals that were explored for the trial with regard to ethics in research (Shuster, 1997). There were three distinct principles or ethical outcomes that have been a repetitive feature in other reports that followed in regards to human research; informed consent, benefits must always outweigh any risks that would be involved, and no unnecessary suffering on the part of the participant should occur (Fischer, 2005). Each of these principles have ideals that have been found in studies and reports following the trials in Nuremberg, and each have important ethical implications for research studies involving the use of human subjects. The first and most important principle of research using human subjects is that each participant must give full consent to being a participant after all the risks of the research has been disclosed (Shuster, 1997). The ethical implications of informed consent is based in autonomy of the patient to decide what happens to his or her body and not be coerced to participate or undergo any procedure, however, there is also legal implications to informed consent, because without permission to proceed, just merely touching the patient can be considered battery (Satyanarayana Rao, 2008). By definition battery is “the unlawful touching of another without consent, justification, or excuse” (Venes, 2009, p. 250). In the aspect of informed consent is also the ability of the participant or patient to revoke their consent at any time; which is also another principle found in the Nuremberg Code (Satyanarayana Rao, 2008). A second principle that is of great importance in relation to ethics in human research is that the benefits of the research must always outweigh any risks that could be involved in the actual research study (Fischer, 2005). There have been many studies that brought about this ethical implication in the field of human research due to the inhumane treatment of many individuals in the history of medical research. There will always be instances in which participants that have given full consent and are harmed in the course of the research study, however inhumane treatment cannot occur, and the benefits and risks of the actual research must be analyzed prior to the start of the study (Fischer, 2005). There are many studies that have brought about great strides in medical science and pharmacology through human research even though there were great risks involved.
The third principle is that no unnecessary suffering should occur to the individual involved in the study (Fischer, 2005). This falls under the broad terminology of nonmaleficence, which by definition means “the principle of not doing something that causes harm” (Venes, 2009, p. 1594). This principle is...
References: Definition of Autonomy. (n.d.). Retrieved 21 February 2015, from http://www.merriam-webster.com/dictionary/autonomy
Enfield, K., & Truwit, J. (2008). The purpose, composition, and function of an institutional review board: Balancing priorities. Respiratory Care, 10(53), 1331-1332. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/18811996
Fischer, B. (2005). A summary of important documents in the field of research ethics. Schizophrenia Bulletin, 32(1), 69–80. doi:10.1093/schbul/sbj005
Satyanarayana Rao, K. (2008). Informed consent: An ethical obligation or legal compulsion? Journal of Cutaneous and Aesthetic Surgery, 1(1). doi:10.4103/0974-2077.41159
Shuster, E. (1997). Fifty years later: The significance of the Nuremberg Code. New England Journal of Medicine, 337(20), 1436–1440. doi:10.1056/nejm199711133372006
Tyson, P. (2001, March 27). The Hippocratic Oath today. Retrieved 21 February 2015, from http://www.pbs.org/wgbh/nova/body/hippocratic-oath-today.html
Venes, D. (Ed.). (2009). Taber’s Cyclopedic Medical Dictionary (21st ed.) (pp. 250, 1594). United States: F. A. Davis Company.
Please join StudyMode to read the full document