Unlike physics or mathematics, medicine had been said to be a different science since it is not exact. As a result, medicine uses many principles. Although the principles are valid on many occasions, every patient is not the same as another patient. For example, an effective treatment for 85% of the population may not work for the other 15%. This imply that medicine is at best experimental. Even in situations involving the most widely accepted medical treatments, there is always need to carry out monitoring and evaluation to find out whether the medicine is effective for certain people and also patients in general. That is one of the processes involved in medical research. One of the other activities concerned with medical research is the development of new drugs for treatments. This is where activities like designing and organizing interventional drug trials are carried out. This is also an area where ethical conduct is highly required.
Since the setting up of the Nuremberg Code, the basic principles of ethics employed in clinical trials involving human participants are well established. Ethics is a very important component of human research. Currently, ethics is considered both as a practice and a discipline. According to Guraya, London, and Guraya (2014), some of the key aspects involved in ethical research of clinical trials involving human participants include privacy, informed consent, responsibility, confidentiality, and privileged communication. Consequently, anyone who is designing and organizing drug trials where human participants are expected to observe these key elements.
The National Institute of Health (NHI) has developed a set of principles for people who carries out activities such as those carrying out drug trials where human participants are involved. The principles include social and clinical value, respect for potential and enrolled subjects, scientific validity, informed consent, fair subject selection, independent review, and favorable risk-benefit ratio. The principle of fair selection of subjects state that the primary objective of selecting the human participants should be restricted to the goals of the study and not any other purpose. The principle further states that apart from maintaining consistency of the research to scientific purposes, human participants ought to be selected in such a way that it keeps the risks low and enhances benefits to not only the individuals but also the society at large (NIH, 2016). Indian Council of Medical Research (ICMR) require anyone carrying out activities such as designing and organizing drug trial involving human participants to adhere to the principle of informed consent. ICMR asserts that a researcher doing clinical trials must obtain informed consent from the individual before commencing the trials. In circumstances where the participant has no capacity to give informed consent, it is required that the guardian is sought to give informed consent on behalf of the participant (ICMR, 2006).
In the USA, the most important ethical values that need to be observed when carrying out research involving human participants are personal dignity, privacy of participant information, nonmaleficence, the fidelity of trust, autonomy to be informed, voluntary, and beneficence (Kapp, 2006). Physicians carrying out research involving human participants must ensure that they keep the respect the privacy and the confidentiality of the participant. They must undertake every precaution to protect the privacy of the human participants involved in the research as well as confidentiality regarding their personal information (WMA, 2013).
In the original Nuremberg Code, it is required that anyone performing a clinical trial using human participants must be ready to terminate further trials when there is a likelihood of injury, death, or disability of the participant. Further, the Nuremberg Code states that the benefits of carrying out the trial should outweigh the risks associated with the trial (Jarmusik, 2014). During the process of trial of drugs, the human participants should be at liberty to discontinue the trials if it has reached a mental or physical state where the participant seem it is no longer possible to continue with the trial. Also, it is required that proper preparations are conducted and adequate facilities ought to be provided so as to protect the human participant against even the slightest likelihood death, of injury or disability (CIRP, 2002). In these two cases, the researcher should not persuade, threaten, or use other means to stop the participant from withdrawing. The researcher must understand that this is a voluntary activity and that the voluntary participant can opt out anytime he or she wishes. Further, the researcher must take the greatest responsibility to care for the participants welfare. The researcher needs to be very keen to ensure that as he or she conducts the trials on the patient, he or she must observe the patient at all times to ensure that the participant is protected from possible harm or death arising from the trials. Health and Human Services added that the drug trials ought to be conducted in a way that avoids all unnecessary mental or physical injury or suffering to the participant (HHS, 2016).
One of the most important factors involved in the drug trials is the need to ensure that the process has been approved. The researcher should not proceed with the trials until the approving body has determined that is safe to continue. The approval process may involve checking the relevance of the trial, risks and benefits involved in the trial, consent procedure to be adopted, a protocol to be used, and quality of the facilities (Neal, n.d.). The approval process may further also check the trial design, suitability of the researcher, rewards or compensations, and justifications for including adults or minors who are not capable giving consent.
CIRP 2002, Nuremberg Code (1947): Permissible Medical Experiments. [Online]. Available at: http://www.cirp.org/library/ethics/nuremberg/ [accessed 13.12.2016]
Guraya, S.Y., London, N.J.M. and Guraya, S.S., 2014. Ethics in medical research. Journal of Microscopy and Ultrastructure, 2(3), pp.121-126.
Health and Human Services (HHS) 2016, Nuremberg Code: Directives for Human Experimentation. [Online]. Available at: www. ori.hhs.gov/chapter-3-The-Protection-of-Human-Subjects-nuremberg-code-directives-human-experimentation [accessed 13.12.2016]
Indian Council of Medical Research (ICMR), 2006. Ethical Guidelines for Biomedical Research Involving Human Participants. New Delhi: Director-General.
Jarmusik, N 2014, Nuremberg Code (1947). [Online]. Available at: http://www.imarcresearch.com/blog/bid/359393/Nuremberg-Code-1947 [accessed 13.12.2016]
Kapp, M.B., 2006. Ethical and legal issues in research involving human subjects: do you want a piece of me?. Journal of clinical pathology, 59(4), pp.335-339.
Neal, D n.d., Ethical review process for clinical trials in the European Union. [Online]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2010/06/WC500093372.pdf [accessed 13.12.2016]
National Institute of Health (NIH) 2016, Patient Recruitment: Ethics in Clinical Research. [Online]. Available at: www. clinicalcenter.nih.gov/recruit/ethics.html [accessed 13.12.2016]
World Medical Association (WMA) 2013, World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. [Online]. Available at: www.icf.uab.es/ca/pdf/recerca/assclin/helsinki.pdf [accessed 13.12.2016]
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