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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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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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