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Off Study Violation

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The regulation of off-study access presents a myriad of ethical dilemmas. Patients suffering from terminal illnesses face few options – either participating in a study, or facing certain death. The choice for most patients is simple: participate in the study, even at the risk of being given the placebo, because it is the only self-benefitting situation. If they refuse to participate in the study, they will surely die, but they are given a chance to live when through accessing the drugs in the study. This is beneficial to science and the population as a whole – though a small group of people will suffer as they are given a placebo, a greater number will benefit from the data collected from the research, as well as the future FDA approval, allowing …show more content…

Terminally ill patients are given two options: participate in a study or face certain death. However, participating in the study has its own pitfall: they may be given a placebo, in which case they are still facing death. Therefore, the options can be rewritten as accepting death, or putting their lives to chance, where a randomized sorting method decides their fate. Due to the will to live, patients will opt for their only chance at survival, which is participating in the study. However, the researchers violate the formula of humanity in two ways: the participants of the study are being treated merely as a means, and not as an end. The researchers are not looking out for the health or the safety of the terminally ill patients in this case – they are simply trying to further their own purpose and reach their goal. In order to treat the terminally ill sufferers as a means, but not merely as a means, the researchers and the patients must be in a consensual and mutually benefitting position – however, half of the participants of the study are receiving placebos, and the other half are under duress as they do not know if they are receiving treatment or a placebo. This raises the idea of a mortality salience in the participants – they are highly aware of their own death and ending because they are not sure if they are receiving treatment, so they are aware that any given moment, they are dying. As well, a key facet of scientific studies are in that they are voluntary – people give consent to participate without pressure. However, when the only other option available is facing certain death, there is a heavy pressure placed on participating in the study, and the choice is not made with full consent given. Therefore, the experiment itself is unethical. Opponents to my opinion may say that the participants sign up for a study willingly

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