Is Informed Consent Always Necessary for Randomized, Controlled Trials?

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 ex...

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... be in the patient’s best interest and getting the best results for the trial.

When the treatment can be found inside and outside of the trial, then no consent is needed. Since they cannot anticipate how the drug will react in the trial and preform unsatisfactory results, they still need the patient consent. A treatment cannot have more risks than an alternative. The treatments in the trial must be balanced to achieve the most precise data. If this is not the case then the patients might choose one treatment over another just because of the effects of treatment, indirect effects of treatment, or bias nature of the patient (Truog et al. 1999).

Works Cited

Truog, Robert D., Walter Robinson, Adrienne Randolph, and Alan Morris. "Is Informed Consent Always Necessary For Randomized, Controlled Trials?" The New England Journal of Medicine 340, (March 1999): 804-807.