The Ethics Of Equipoise

There are various moral considerations that support the adoption of clinical equipoise as a requirement for clinical trials. One of them being that clinical equipoise is based on the research which allows for

Shared decision-making involves an open and honest conversation between the clinician and the patient. It is a collaboration that takes into account treatment options and the patient’s values and preferences. It gives a patient a voice in their own care. Therefore, pure placebo-prescribing is ethical when the patient has a say – which can foster a placebo effect within the patient. Not from the pill “itself, but rather from the relationship between [the] healer and [the] patient, and the latter’s own capacity for self-healing” (Brody, 1982, 117). In other words, the context in which the pure placebo is prescribed can influence its positive results. Contrastingly, when patients are left out of the decision-making process, there is no room for the clinician’s and patient’s relationship to grow. It also raises the possibility of deception – a concept appearing in almost all of the medical literature on placebo-prescribing in clinical practice.

The study selected by this author centers around ethical and oversight issues concerning standard of care interventions received by participants in research studies. So as to address recently arisen concerns regarding key aspects of regulation and oversight of standard of care interventions executed during trials, the office for human research protections (OHRP) solicited comments from experts on what has been termed as “Draft Guidance” (Institute of Medicine [IOM], 2015, pp. 1-3).

In the US, the initial system concentrated on physician knowledge about an intervention and not the patient requirement, i.e., the physician was to decide the best practice as well as information to disclose to a patient. However, there was a recognizable trend towards the informed consent (Culhane et al., 2012). A case between Salgo and Leland Stanfors Jr. University Board of Trustees clearly provided a clear indication of the court resistance and struggle to adopt the autonomous approach rather than the physician paternalism (Culhane et al., 2012). The jury argued that the patient has the right to information of any risk associated with a practice. However, they argued for the physician in the sense that he/she is placed in a position to make choices that protect the patient.

All actions taken by the researchers and their constituents (the pharmaceutical co-sponsoring the study, Healthy People Pharmaceutical) should evaluated according to the principles set about by Rawlsian justice and from a deontological perspective that is concerned with the moral obligations one has to the betterment of society as a whole and the morality of individual action. Through this essay, I seek to prove that the conducted research was unethical and a clear violation of human rights. Thus, further examination has revealed clear violations of the principles of Rawlsian Justice from a deontological perspective, and a multitude of internationally recognized legal principles that directly address cases of human research subject injustice that were observed in the past were also

The trial I chose to explore for this discussion is the Risperidone Trials that occurred in India. For this trial, psychiatric patients were lied to by being told that their specific anti-psychotic drugs were no longer available, and then were given a drug called risperidone or just a placebo (SOMO Briefing Paper, 2008). This was unethical because the patients were lied to and informed consent was not obtained from the individuals who participated in this clinical trial. All of the participants receiving the placebo were unaware that they were not being provided legitimate anti-psychotic medications. Providing placebos instead of medications to these individuals was a dangerous decision, especially since these individuals depended on these drugs in order to maintain a semblance of sanity. An ethical principle that this violates is known as beneficence, which is the idea that if we can, we ought to do good (or what is right) in any given

If informed consent is not collected, how well the patients know if they are getting the treatment in the trial that best suits their wishes? The author states “If the

As any other clinical research study different ethical issues could arise while conducting my practicum experience. Providing an effective informed consent process is an important ethical aspect that will be thoroughly managed during research design and while recruiting the 150 participants. Respect for potential and enrolled subjects is another topic that will be considered to avoid having ethical problems that will prevent for this to happen. The risk-benefit ratio will also be studied for this to be favorable for the participants.

While noting that the ethical issue of deception exists, the significant benefits of placebos are revealed through studying some clinical cases and by determining the actual changes taking place in the brain and the body. Trust, found in the doctor-patient relationship, impacts the extent of the placebo effect. To possibly help solve the ethical issue of deception surrounding around the placebo effect, Kaptchuk points out that more research needs to be executed in order to carry out the placebo effect “with conformed consent” of the patient for the doctor to do what they believe is necessary for the patient’s well-being (9). This would eliminate the ethical issue of deception while still allowing “medicine’s goal to heal” to remain intact

to question whether it is ethical for clinicians to prescribe placebos as medication in clinical practice. Through defining placebo and placebo effect and determining whether placebos should be prescribed in clinical practice, I argue that in limited cases it is ethical for

The role of trust in successfully communicating informed consent is very important. Informed consent is necessary to make sure that the patient/subject is properly aware of all factors involved in his or her choice to proceed with any medical decision. All risks, side effects, steps or methods, and even intention should be disclosed at this time. If a patient does not receive full disclosure, it can lead to the perception of dishonesty on the doctor’s/researcher’s part. No one wants to feel lied to or misled by someone that was trusted to perform a specific task.

This study again demonstrates the need for informed participant consent. In this study participants were not provided with proper information regarding the study. Although the subjects consented to being part of the study they were not told of the true intent or purpose of the research. Participants did not receive the implied treatment they needed to survive the illness. The men involved in the study were in fact misled and were not presented with factual information to make an educated decision regarding their participation. Subsequently, the news media broke the story forty years later. Public uproar demanded an investigation. As a result the study ended immediately and a higher need for informed consent came to light once more (Centers for Disease Control and Prevention, 2017). The need for satisfactory moral and ethical laws was now at stake.

Phase I and consent discusses the issue of a patient that is terminally ill and a doctor that wants this patient to participate in a clinical trial. This study would not treat the patient’s disease, but it would allow the physician and the researchers to determine the toxicity of the medication Novamed. The patient understands that she is dying and she believes that she does not have anything to lose by doing the trial. The doctor wants to make sure the patient understands that Novamed will most likely no help her and the doctor would like her to be fully informed prior to her signing the consent. The moral issue of this case study is should a patient that is terminally ill participate in the Phase I trial of the study which will most

The movie the Constant Gardner and the commentary by Sonia Shah bring forward many moral principles that could be argued. The movie and the commentary bring to light the ethical and moral dilemmas pertaining to drug trials and the capitalist interests that create the moral dilemmas. I propose to argue only the moral principle that greed should dictate one’s actions with regards to the testing the effectiveness of new drugs. In theory the goal of doctors practicing medicine is to heal people. In theory the goal of the pharmaceutical industry should be creating drugs to cure diseases not creating wealth. When was the last time that a disease was actually cured, versus having to take medicine every day? It appears that pharmaceutical companies are motivated solely by profit and getting their new drugs to market rather than actually curing diseases. It appears that the primary motivation is profit and the secondary motivation is curing diseases. There is a rush to get new drugs to market purely for profit rather than perfect them to actually serve the purpose that they were created for, which is to cure diseases.

or not, rather than a true treatment eect. When we have randomised trials, the randomisation