Clinical trials: how to make informed consent more ethical

In conducting clinical trials, the researcher has to preserve patients’ autonomy by giving them enough information to make an autonomous decision. The researcher also has an ethical requirement to avoid unnecessarily harming patients. A recent study published in the BMJ Journal for Medical Ethics shows that the relatively recent discovery of so-called nocebo effects – a result of the patient’s expectation that the treatment will harm them – means that harm is being done by the way researchers inform patients about the trial in which they are taking part.

The study describes a multicentre randomized trial of aspirin versus sulfinpyrazone for treating unstable angina. Because of differences in individual hospital review processes, patients either received or did not receive a statement outlining possible gastrointestinal side-effects. This resulted in a sixfold increase in the number of people withdrawing from the study because of subjective, minor gastrointestinal symptoms, which suggests that the warning about side-effects may prompt patients to expect and subsequently experience them (nocebo effects).

How can researchers stop harming patients with nocebo effects while respecting their autonomy?

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