Clinical Trials: A Kantian and Utilitarian Point of View Essay

In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general

Misconception with equipoise will make the barrier between therapeutic and research null. Its goal in producing reliable and generalizable knowledge is coiled in with ethical difficulty. That’s why on an ethical standpoint, benefiting a collective group needs to be weighed with the rights of the participant patients in the clinical research. However, the goal of equipoise is beneficial since its main priority is extracting epistemic information from the randomized clinical trials. The useful information is needed since equipoise follows the principle of having “a state of genuine uncertainty.” This affects both theoretical and clinical. So, trials that are redundant can be marked out by taking equipoise into account since the trials have already been run where there is already certainty of the outcome. So, to detail what equipoise allows underneath the principle of “non-exploitation” is that there will be no exploitation of participants or patients with a needless trial that holds no useful outcome. Equipoise becomes a necessary condition in order for a trial to become ethical since trials must be reviewed to be deemed of value. But, there’s an underlying factor that equipoise’s uncertainty trials do not bring about and that is the health of the patients. Participant patients will undergo trials of uncertainty so there is a possibility that the patient may be harmed during the process. If the trial proceeds, then the health of the patients will be even more at risk, disregarded and exploited in order to grasp epistemic information. The moral principles between medical therapy and those that guide clinical research is different. Though, equipoise is valuable in a collective sense – it is exploitative of participant patients by failing to consider the balance with the subject and societal

A 35-year-old man named Paul, who has a supportive wife and two adventurous kids, has been diagnosed with a very severe case of bone cancer for 1 year now. Since this type of cancer is so severe, chemotherapy is starting to not work as well. Paul’s oncologist unfortunately had to suggest a final option for Paul to try which was a clinical research trial. Clinical research trials are experimental studies that deem whether or not a medical drug, treatment, surgery, or device is safe and beneficial for humans to use ("National Heart, Lung, and Blood Institute"). As explained in Marcia Angell’s Article, “The Ethics of Clinical Research in the Third World”, the Declaration of Helsinki of the World Health Organization (WHO) provides a guideline

In the field of medicine, clinical trials are known to be a reliable source of information. Although ethical issues do arise, to which the theory of equipoise was proposed, which states that there should be a balance of forces of interests (Weijer et al., 95). There are two types of equipoise; clinical and theoretical. Clinical equipoise is the assignment of multiple treatments to be tested on patients with the disagreement in the medical community in which medical professionals have differing views that one treatment is better than the others (Weijer et al., pg. 97). Theoretical equipoise is between a physician and researcher and the belief that the risks and benefits of the treatments are in perfect balance (Wiejer et al., 96). The differing factor of the two, being that clinical equipoise focuses on the difference in views of certain treatments involving much of the medical community to form an insightful conclusion on the procedure to which the evidence supporting each treatment does not have to be balanced, whereas theoretical equipoise focuses on the equal amount of risks and benefits within each treatment (Weijer et al., 97). With that being said I personally believe researchers must be in a state of clinical equipoise to run morally acceptable clinical trials.

Our country is one where every day, new medical treatments and medicines are being discovered and being approved to help Americans battle all of the different diseases and conditions that affect us. In order for us to be able to get access to those medications and treatments, many people agree to become part of clinical trials, they are the first to receive the treatments, this helps to understand how the body will be affected and if the medication will be effective. People who are part of these clinical trials, go through extensive medical testing, and they must be of sound mind and

Additionally human medical research studies often targeted those who came to public teaching institutions desperately seeking free medical treatment and who generally looked up to doctors and experimenters as experts in the field who were there to help them. While this motivation may seem logical, it is often faulty as many human medical research studies throughout history demonstrate that the motivation of medical researches is often not the care of those currently suffering from a particular condition but the future returns on the cures or medical treatments that may be discovered during the study (McKie). As with many such unethical studies, the participants often do not give consent and are not informed of known dangers to the procedure, medications or lack of treatment. The use of individuals who are poor, uneducated, and lack medical insurance in combination with prestigious university research institutions and the white coated, well-educated researchers motivated by discoveries of cures on the scientific frontier results in abuses of individuals.

Placebos have been used in clinical trials since the eighteenth century but did not become a research topic until the late twentieth century (van Haselen, 2013). Most often when using placebos in clinical trials it is to determine whether or not the active agent has more effect on a patient than the placebo by providing each to the same number of recipients. The trials are almost always double blinded, this means that both person giving the drug and the person receiving it are unaware whether or not it is active so that good care and relationships must be present in the recipients at all times (Tavel, 2014). Ovosi, Ibrahim, & Bello-Ovosi (2017) declared “The choice between placebo and active controls in clinical trials affects the quality of the result as well as the ethical and scientific acceptability by both the public and regulatory bodies. It has, therefore, continued to generate discuss among researchers” (para. 3). This goes against the autonomy of a patient which is the right for a person to

Clinical trials, or a test before a treatment is approved to be safe for human consumption, have been dated back to the biblical times. Recorded in the “Book of Daniel” a king and military leader performed the first known clinical trial (Evolution of Clinical Research). Although his experiment was nowhere near what we conduct in today's society scientist, doctors, and other researchers before them have learned through trial and error, and they have used clinical trials to study diseases. In 1774 James Lind followed through with the first clinical trial of the modern era studying scurvy.

In theory, "that evidence-based medicine (EBM), determined by the outcomes of clinical trials, would be an objective decision-making tool to help patients and their doctors make treatment decisions, once a patient has been diagnosed" (Torrey 2012:1). However, many problems exist with how the clinical trials that define evidence-based medicine are designed. Not all clinical research is created equal a small clinical trial with a homogeneous set of patients may not be applicable to the situation of Patient X. The psychological and social needs of patients are unique, and while scientific evidence must ground practice, each case must be evaluated on an individual basis. A sixty-five-year-old patient in the peak of health may not have the same health goals as one which is suffering from a chronic illness.

The greatest moral objection to the RCTs is that a physician has a duty to their patient to give them the best treatment possible. However, the physician does not truly know which drug is going to be better when they initiate the trial. During the trial, neither treatment is preferred over the other. This is an example of “individual equipoise” is the requirement that “investigator” him or herself be in a state of genuine uncertainty concerning the efficacy of treatments A and B. In clinical equipoise, there is a genuine uncertainty within the medical community about the merits of both treatments. Among physicians, there are some who may believe that a certain alternative treatment option is the best. However, even though there is a physician

• Ensure the human rights of the participants in emerging countries associated with the predictable risks

There are many ways in which a research trial can be unethical. Restating the obvious and what is already know for a research trial is unethical. You already have the knowledge and facts already, why do you need to have more research? A lack of clinical equipoise, which means a state of genuine uncertainty as to the advantages or disadvantages of each therapeutic arm in a clinical trial. If the question for the research is incapable of being answered then why is the research being conducted? If there is no outcome or end, why go on? Having bias during the research trial can make it unethical. Actions and procedures can be directed differently because of bias. Over-including a vulnerable population, such as, poor black men. Including people in a research trial whose ultimate benefits are unlikely to benefit them at all, they are just being used as the means to improve the well-being of others is unethical.

The first studies done on humans are phase one trials...The purpose of these earliest of trials is to determine if an experimental drug is safe for humans, and to figure out what dose is appropriate” (Eldridge). Basically, the first trials make sure that it won’t harm the body as a poison. After this, a drug can move onto phase two trials, which start to test the effectiveness of the drug on the intended disease. The amount of time spent in this phase can range from months to years. Finally, after passing this phase, the drug is then moved to phase three, which tests if the drug is more effective than current treatment available. Currently, the most common method of gaining access to these is through the involvement of a clinical trial (Eldridge). Overall, the possible pros of experimental drugs outweigh the cons for those with nothing to turn to. Experimental drugs can offer a possible cure to your disease, and even if it does not, it will provide research to help those after you. It also could be more effective and safe than current treatment publicly available. The only possible cons of experimental drugs are that they might have unpredicted side effects, not work, or prevent you from gaining access to another experimental drug in the future. However, if you are being given access to it in a clinical trial, there is a possibility you will be placed in the placebo group, with absolute

Contract research organizations run hundreds of clinical trials per year to evaluate new drugs for safety and efficacy. The phase 1 of these trials consists of testing the safety of a drug; therefore, it does not require the individual being tested to have the disease the drug is aiming to cure. However, it is important that an individual takes part of a single trial at one particular moment in time and that he refrains from participating in another trial prior to a washout period determined by his current trial participation. Unfortunately, people do not always follow the rules. In phase 1 trials, some people are lured by the monetary compensation offered in return for their participation. These people attempt to participate in more than

Whilst it is widely recognised that clinical trials are needed to develop new medicines, they also lead to an improvement in medical care more generally. The new regulation aims to remove the barriers to clinical research across Europe by-