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Randomized Control Trial Pros And Cons

486 Words2 Pages

When designing a study, it is important researcher consider the potential risk of the study. After all, minimal risk should have considered when designing a randomized control trial. The fact that there is no clear understanding of what can the high-fiber supplement do to the subjects proves that this research is not ready to be piloted. A study was conducted to clarify the rules related to randomized control trials. The study concluded that,
Participation in a randomized, controlled trial may pose no more than minimal risk when: 1) genuine clinical equipoise exists; 2) all of the treatment options included in the research study fall within the current standard of care; 3) there is no currently available treatment with a more favorable risk-benefit …show more content…

If the risk factors are defined, and participants sing an inform consent of acceptance to the risk involved with the study, then there should be no problem. It is like joining the military, there are pros and cons, but those who chose to help us stay safe did it for a purpose, and some say they did it to help their country, to fight for their rights, and for everyone’s freedom. Regardless of the reason, the fact is that they took a considerable risk to serve and protect all of us. Those veterans have been exposed to so much to save humanity. Is that ethical? With that said, those who choose to participate in research studies do it so that one day there could be a cure for the intended disease, and their children or the coming generation would not have to suffer. However, it does not mean that researcher should ignore the fact that there could be potential for psychological and physical negative impact on the participants and their families (Nelson, & Morris, 2007). With that understanding, every precaution must be taken so that minimal risk is associated with any randomized control

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I personally would not have condoned the study if I was a nurse in the 1930s and was asked to be involved. As a nurse, I could not subject someone to a medical condition knowing that they would not receive treatment and eventually pass away. It is our responsibility as nurses to assist patients in recovering, not to exacerbate their illness. Another study that violated ethical standards was the Jewish Chronic Disease Hospital Study of 1962–1963 was unethical because Chester M. Southam, the supervising physician, gave live cancer cells without the patients' written agreement to twenty-two chronically sick, non-cancer patients. By saying that he "did not wish to stir up any unnecessary anxieties in the patients" who had "phobia and ignorance" about cancer, Southam sought to defend his conduct (not telling his patients).

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Secondly, the report discuses that safety must be kept in mind. Scientific advancement cannot happen unless the experiments are safe. Thirdly, participants have to be chosen fairly, not from populations who could be coerced into participating, such as prisoners or institutionalized children. And, of course, consent is

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In the context of medical research, informed consent provides individuals with the opportunity to accept or decline involvement in research, and thereby adheres to their right to choose. Obtaining consent from donors is not limited to simply seeking permission, but involves explaining the nature and consequences of research in an honest and understandable manner. When this aspect of informed consent is ignored, unethical research ensues. For example, during the infamous Tuskegee Syphilis Experiments, US Public Health researchers studied the progression of syphilis in African American men, under the false pretense of curing their “bad blood”. Though a treatment of penicillin was available at the time, researchers idly observed as subjects died painful, preventable deaths.

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Fear can cause some patients to feel “ treated as mere "experimental model(s)" for the studies, while others refuse to take part because of historical evidences of clinical trial fraud and misconducts known to them” (Nijhawan 134). Preconceived patient perceptions lead patients to “believe that, trials will put extra burden on them. They assume that the conventional treatment is best and they are afraid of the unknown side-effects of new treatment. Convincing and receiving an informed consent from such patient is most difficult. In some case disclosing too much information of the potential side-effects may unnecessarily scare the patient away from a potentially life-saving or life-enhancing surgery or procedure”(Nijhawan 134).

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First of all, the investigators should have respected the people they were going to conduct by obtaining an informed consent, letting the men decide if they want to be a participant after all. Second of all, medical researchers should not have lied to the people about how long this study was going to last. Third of all, both the risks and the benefits of it should have been stated to them so that the men could decide if this experiment is any beneficial to them or not. Lastly, the participants should have been randomly assigned to the control or experimental group without considering their race, class, and gender. Also, the medical researchers should not have the right to give the favored participants the helpful treatment rather than the riskier

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Consequently, patients did not have a proper informed consent or the required to skills or tools to make an educated decision to either continue with the research or to quit. The study went to great extent to prevent its participants from actually obtaining information about the purpose of the study and treatment when it became available. One of the examples in the study paper explains how the draft during World War II was abandoned specifically as it related to the Tuskegee participants. (cite) Patients were misled by coercion into accepting participation without a choice to make an educated decision to continue with the study that provided no

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Foremost, the respect for persons that each individual should be treated with autonomy was ignored. There was a lack of respect for autonomy since there was no documented informed consent and the study used a vulnerable group of subjects. Patients were also deceived in that they were getting a skin test. The study “withhold information necessary to make a considered judgment” (Department of Health, Education, and Welfare, 1979, p. 4). No one should consent to be a research participant without being informed of the risks and benefits of that involvement, and in this case, the risks and the benefits of the procedure were explained to the patients.

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With the expansion and development of modern medicine, randomized-controlled trials are becoming more significant to statistics. Medical discovery and advancements over the past decades are leading down the pathway of stronger statistical studies using randomized-controlled trials. This technique was first used by the Medical Research Council in the 1940s to study whooping cough and was the solution to a statistical nightmare. The problem at the time was that if a publisher “wanted to rig the results to prove a treatment worked, he or she could preferentially give the treatment to the patients who were less sick, or give the older treatment to patients who were more sick” (5). Although there are significant limitations to RCTs, the concept of randomizing and controlling trials has several essential advantages that allow studies to pinpoint variables, apply to the real-world, and show stronger results.

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