Issues of Ethics in Biomedical Trials

Clinical trials denotes to the practice where generation of new information for treatment, prevention and diagnosis through the research involves with human participants. Currently, the clinical trial or research refers to any study which performed on the human being themselves, biological materials or samples taken from them or utilization analysis of biological data with the goal to improve any existing treatment procedure with a new treatment procedure. However, the basis of ethical consideration under which a patient will enter in a randomised controlled trial is under debate amongst the medical professionals. Some medical professionals have the opinion which supports the idea of uncertainty principle in case of randomised controlled trial is acceptable, whereas some medical professionals are unsure of the best treatment method available for the patients. Essential ethical requirement for the clinical research or clinical trial requires a state of authentic uncertainty from the investigators of the clinical trials (Schneiderman et al., 2003). For example, if an investigator is uncovers that a particular treatment is superior in terms of therapeutic merits compared to other treatment methods, the investigator is obliged to convey the message and offer the treatment to the patient. Therefore, this essay will delve into the viewpoint forwarded by Benjamin Freedman regarding the ethical requirement necessary for performing a randomised controlled trial. Additionally, the viewpoint forwarded by Freedman will be also be critically analysed by the advancement made by Howard and Broody. Discussion regarding the above mentioned points is provided in the paragraph below.

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Clinical trials are scientific methods by which an investigator tested a novel treatment rigorously on human subjects to determine the fact that the treatment is safe and secure. Most common method of performing this kind of trial is Randomised Control Trials (RCT). Randomised Control Trials is a clinical trial in which a patients is chosen purely on the basis of chance for the various treatments he/ she might receive. The central moral dilemma for Randomised Control Trials is the uncertainty between the objective of research and objective of medical practice. This trails infers that a patient will randomly selected for a treatment irrespective of its efficacy and effectiveness. In direct contrast with this point, a medical professional’s first objective is to convey the information about the best possible treatment procedure available to him/ her (Kraemar et al., 2002). Thus, if an individual is randomly selected for a test, how can he/ she provide best possible treatment plan to his/her patient. This creates a fundamental conflict between responsibility as a medical professional and academic investigator as its neglect the fact that medical professions first job is to provide information about best possible treatment available to the patient. Additionally, all Randomised Control Trials involves procedures which are not related to the therapeutic procedures (like questionnaire, added x-rays or extra blood collection) whose sole purpose is to serve the scientific part of the study and not therapeutic part of the patient. This raises the concern about the risk of exposure for the subjects or patients. In his theory, Benjamin Freedman tried to solve this dilemma by proposing the theory of ‘Clinical Equipoise’ (Freedman, 1987). According to this theory of ‘Clinical Equipoise’ a medical professional or physician may only offer the choice of Randomised Control Trials only if he/ she is genuinely unsure about the fact that which is the best possible treatment for the patient. This theory have been critically criticized about its affectivity and practicality as it is very fragile to sustain. Any acquired information (little or substantial) about a treatment plan might throw the physician out of the randomised control trial because of ‘equipoise’. To tackle this situation, an idea proposed about ‘theoretical equipoise’ which Freedman believes to be both ethically and conceptually irrelevant (Freedman, 1987). According to the Freedman’s the theory of ‘Clinical Equipoise’, clinical equipoise must be present at all the research arm of a clinical research. If it is not present on the all the arm of research design, research design have to be modified or changed accordingly. Additionally, if the equipoise is disturbed or nullified during an experiment, the experiment has to be terminated and all the subjects receiving the treatments have to be enrolled in a superior treatment care. Along with that, although, the equipoise is mainly discussed with the context of randomised controlled trials, it can be applied to the every clinical controlled trials. The most common and similar problem raised by equipoise is that it might stop a physician from performing the investigation just because the physician might have reason to believe that one part of the research design is better than the other part. This will stop the investigation even before it is begins. To circumvent this technicality, physician might say that he/ she do not which experiment is better implies that no evidence is available to the investigator to lean for the side of an experiment. However, this actually means that no controlled study have been performed for these two experiment. Due to increasing number of research of clinical trial, the ethical issues become very much prominent in recent year and along with that the flaws and shortcomings of equipoise. As a rebuttal, Freedman has proposed the theory of ‘Clinical equipoise’ (Freedman, 1987). This clinical equipoise performs as a rational formulation for the ethics related to many studies. This approach does not change any things or discuss why a particular aspect act the way they are now. Nonetheless, this clinical equipoise helps to reformulate or clarify few topics related to research ethics. First of all, there no aid or support for a particular treatment within the medical community, then it will be unethical to perform that clinical trial. Second of all, this will stop all the investigation with narrowly developed conditions and hypothesis because according to the clinical equipoise, it will influence the clinical decisions raised in the experiment (Freedman, 1987).

Franklin Miller and Howard Brody have argued that the theory of clinical equipoise is founded on a therapeutic misconception in their published article (Miller & Brody, 2003). This therapeutic misconception is the merging of two sets information which is ethics of research and clinical practice. As pointed out by the authors, the main objective for both the clinical research and clinical practice differs from each other. The main aim of the clinical research is to generate information about a treatment method which will in turn benefit the patient, whereas the primary aim the clinical practice is to enhance the health of a particular individual (Miller & Brody, 2003). According to the Miller and Broody, the same moral rule cannot apply to the both activities as both the activities have different goal and objectives. They also mentioned that a physician’s primary duty or responsibilities is to provide care for their patients but it will grossly mistaken if someone considers that this is their only responsibility. In the view of that, the authors proposed that research ethics should recognise and built on the idea of ‘Frankly utilitarian purpose’ (Miller & Brody, 2003). In the point of view of the authors, the physician or investigator is obligated not exploit the subjects or patients unjustifiably and informed consent must be taken from them for their participation in the research. The author believes that this particular step will ensure to the patients or subjects that this not just and another form of therapy. However, Miller and Broody admitted that this approach might disinterest a person from participating in the research trials which is absolutely vital for development of new treatment procedures. To counter this flaw in their proposed model, Miller and Broody suggested that money can be offered to the subjects or patients who will willingly participate in the clinical research trials. This might increase the cost of a particular research treatment, but this will ensure amongst the patients or subjects that the intention of this research is not to be beneficial and only development of new treatment methods. Researchers and academics are divided between two different points of view regarding to the ethics in research. For example, Charles Weijer advocates the idea that the placebo controlled trials is ethically egregious. Miller and Broody argued that there is nothing ethically egregious about the placebo controlled trials (Miller & Brody, 2003).

Therefore, form the above discussion, it can be inferred that clinical research is in the rise currently and along with that the debate related to the ethics that should be considered during the randomised controlled trials. There is clear two divisions between the academics related to this subject. Freedman has proposed the theory of clinical equipoise as ethical standard for the randomised controlled trials. However, it has received much criticism being too fragile, simple and impractical. Thus, Miller and Broody provided an alternative instead of the clinical equipoise and argued that the clinical equipoise is based on the therapeutic misconception. After considering all the points of view related to the both theory, it can be said that theory proposed by Miller and Broody is much more compatible, effective and practical compared to theory proposed Freedman.

References

• Freedman, B. (1987). Equipoise and the ethics of clinical research. New England Journal of Medicine,(th July).
• Kraemer, H. C., Wilson, G. T., Fairburn, C. G., & Agras, W. S. (2002). Mediators and moderators of treatment effects in randomized clinical trials. Archives of general psychiatry, 59(10), 877-883.
• Miller, F. G., & Brody, H. (2003). A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials. Hastings Center Report, 33(3), 19-28.
• Schneiderman, L. J., Gilmer, T., Teetzel, H. D., Dugan, D. O., Blustein, J., Cranford, R., … & Young, E. W. (2003). Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial. Jama, 290(9), 1166-1172.