Informed consent is an issue that has many facets. While the truism is that informed consent is generally good, there is some research which suggests that there is a limit to how much a patient should be informed…
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rug. Moreover, there is an issue with how much comprehension a participant may have of the risks that are dictated in the informed consent protocol. Not surprisingly, the forms must be readable in order for a patient to truly have considered himself “informed,” and the most important part of readability is to put the risks into layman’s terms. Studies have suggested that esoteric forms which are more difficult to read than complicated texts results in considerably less informed consent than forms which are not so. Therefore, it is important to pay attention to the level of language used in the consent forms and keep the audience in mind. If the person drafting these forms keeps in mind this golden rule, then other studies suggest that informed consent is extremely effective. The possible dangers of too much information conveyed Loftus & Fries (2008) theorize that informed consent may do more harm than good, at least when the risks that are presented to the patient consist of all potential risks that might occur, no matter how remote. They argue that the patient might imagine that he or she is experiencing the symptom because of the power of the mind, in that the mind can play tricks on people, and, if the patient knows that a certain risk is possible, then the patient may conjure this risk even though it is only remotely possible that the patient is actually experiencing the symptom. As proof of this, they point to the power of the placebo (Loftus & Fries, 2008, p. 217). To them, a patient is better off just knowing the general level of risk, ie, the symptoms that are likely to occur, and only provide patients the remote risks if the patient specifically asks for it. Therefore, the informed consent carries risks itself, and they “only ask that those whose task it is to formulate informed consent rituals pay some attention to the harm that may be caused by the ritual itself” (Loftus & Fries, 2008, p. 217). Loftus & Fries then cited a study that they performed that was unpublished. It involved patients at the Stanford University Medical School who were diagnosed with scleroderma and were treated with a drug cocktail consisting of propranolol and alpha-methyldopa. The patients were informed about the side effects of the drug cocktail, which included dizziness, headaches, upset stomach and tearfulness. Some patients received a standard informed consent form and some received a standard informed consent form plus a special message which explained the placebo effect, in that the patients who received the special message were informed of the phenomenon of experiencing symptoms simply because the symptoms were mentioned. Loftus & Fries found that all patients experienced “side effects,” even if the patient was given a placebo. They also found that those patients who received the special message experienced fewer side effects than those who did not (Loftus & Fries, 2008, p. 218). Therefore, their point about a patient knowing “too much” was validated. While Loftus & Fries concentrated on the placebo effect as a drawback for informed consent, at least informed consent that lists every possible side-effect, no matter how remote, Audrey et al. (2008) concentrated on the effect informed consent had on patients who want to undergo palliative chemotherapy. The issue that Audrey et al. focuses upon is
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