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International Clinical Trials

Choice Words

I recently came across an article on The Guardian website in which a doctor argued that "being health literate lies at the heart of better health. It means being able to process basic health information and use it to navigate decisions" (1). It got me thinking about an issue of interest to all involved in clinical trials: informed consent.

This is the process whereby the treating healthcare provider discloses appropriate information to a competent patient, so they can make a voluntary choice to accept or refuse treatment. It originates from the legal and ethical right the patient has to direct what happens to his or her body, and from the ethical duty of the physician to involve the patient in their own healthcare. A clinical researcher must ask a research participant before enrolling that person into a trial. The patient’s right of self-decision can be effectively exercised only if they possess enough information to enable an informed choice.

The physician's obligation is to present the medical facts accurately to the patient or the individual responsible for the patient’s care, and to make recommendations for management in accordance with Good Medical Practice. There is also an ethical and legal obligation to help the patient make choices from among the therapeutic alternatives.

Informed consent is a basic policy in both ethics and law that physicians must honour, unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent. But, while it may all sound fairly straightforward, this is not necessarily so.

Physicians the world over are not good at explaining their procedures in terms readily understood by lay people. In many cases where patients are being treated for serious diseases, the stress of the disease and the environment in which the informed consent is sought make understanding that much more difficult. The phenomenon of 'white coat hypertension' – patient anxiety heightening their blood pressure when taken – is well-known: something similar might apply here in the form of 'white coat incomprehension'.

In a clinical trial situation, CenterWatch says the rights of the participant include:
  • To be told the purpose of the trial
  • To be told about all the risks, side-effects or discomforts that might be reasonably expected
  • To be told any benefits that can be reasonably expected
  • To be told what will happen in the study and whether any procedures, drugs or devices are different than those used in standard medical treatment
  • To be told about all options available, and how they are better or worse than being in a clinical trial
  • To be allowed to ask any questions about the trial prior to consenting and/or at any time during the course of the trial
  • To be allowed ample time, without pressure, to decide whether or not to consent to participate
  • To refuse to participate, for any reason, before and after the trial has started
  • To receive a signed and dated copy of the informed consent form
  • To be told of any medical treatments available if complications occur during the trial
However, there are many contentious issues that can arise here – particularly when it comes to terms such as 'all', 'reasonably' and 'any'. In addition, it would be usual to inform the patient about the conditions pertaining to the continuation of the experimental treatment if it turns out to be successful. The list is rather like the oath in court – “the truth, the whole truth and nothing but the truth”.

The informed consent procedure will usually be assessed by an ethics committee (EC) – but the more experienced the EC, the less likely it is to be objective about 'all', 'reasonably' and 'any'. Moreover, it was recently reported that ECs themselves commonly provide text for informed consent forms that falls short of their own readability standards. At the same time, a recent poll by a UK cancer charity found one in five women mistakenly believed that gynaecological cancer was caused by promiscuity. Another survey found fewer than two out of three patients were able to say which of their organs had been operated on.

It all makes me wonder if truly informed consent can ever be obtained – even in reasonably well-educated Western society, let alone in developing countries where illiteracy is more of a problem.


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