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Is Informed Consent Always Necessary For Randomized, Controlled Trials?

1053 words - 4 pages

Is informed consent always necessary for randomized, controlled trials? The following sentences are different scenarios that answer the question. Informed consent should not be waived unless the treatment is offered inside and outside the trial. Treatment should not involve more than minimal risk compared to alternatives. Genuine clinic must value the treatments the same. No reasonable person should have a preference for one treatment or another (Truog et al. 1999).
If the treatments can be found in and outside of the trial, then you don't need the consent of the patient. “For example, a trial comparing a beta-blocker with an angiotensin-converting–enzyme inhibitor for treatment of hypertension should not be approved for a waiver of informed consent, because of the substantially different side effects of the two classes of drugs”(Truog et al. 1999). The information provided by the testing process when using multiple drugs could provide unsatisfactory results. Such as prior use of the common drug in return providing faulty results. If this were to happen, which isn't unheard of, then the consent of a patient should be wavered.
Patient consent is the law. Even though the test can provide unsatisfactory results they cannot anticipate the way the drugs will affect the present. This could lead to one patient favoring one treatment over another. The problem that comes from specific informed consent cannot be addressed solely by demanding more rigorous standard for research (Truog et al. 1999).
The treatments should not involve more risks compared to any of the alternatives (Truog et al. 1999). This means that if a treatment has more negative outcomes compared to an alternative treatment then you must obtain informed consent. “For example, if the patient were known to be allergic to one of the medications being studied” (Truog et al. 1999). In this example, it shows that the treatment that the patient is allergic to involve more risk compared to a different treatment that the patient is not allergic to. If the patient wants to use the treatment that he is allergic to then he must give informed consent because of the added risk.
The author states, “Should specific informed consent be sought from a patient enrolled in the study? If so, then what should be done if the patient chooses not to participate” (Truog et al. 1999)? In this scenario the patient does not give their consent to participate in the trial so the dilemma of what to do with the patient rises. Should no data be collected on the patient or should they be moved out of the program and if that happens, what was the point of having the trial in the first place? If you have to collect informed consent from patients in the trial it is going to make the data polls smaller and harder to collect.
Genuine clinical treatments must exist in balance when weigh against one another (Truog et al. 1999). That this is trying to explain is that when in a trial you cannot have a treatment that has more...

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