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Informed Consent? Not really!

How regulations for consent might be undermining patient safety.

A friend of mine has recently had to undergo treatment for cancer. The friend is knowledgable about medical research and has previously taken part in studies. The friend was then asked to take part in a study. Helpfully the consent form was produced. Pages and pages of small print. The friend signed. But had to confess to not reading the form in full.

How could this happen?

Cancer treatments are often exhausting. Chemotherapy, radiotherapy, immunotherapy all contribute to the tiredness and loss of energy that many patients report already prior to being diagnosed with cancer. The tiredness can at times be crippling. It becomes one of the most common complaints about the disease and the treatment.

Reading when being tired is a problem (ask any of my colleagues who are preparing for exams. Even the news paper can be a serious challenge. But surely a simple consent form should be possible. And this is the crux: there is no such thing as a simple consent form.

The representative template for informed consent from Oxford University is 10 pages long. It has over 4000 words. And the Welsh guidance for researchers in relation to informed consent goes of no less than 195 pages.

Why is consent needed?

The consent process should explain benefits and risks of an intervention. Consent should be voluntary, informed and the person should understand the information. But the capacity to consent is situation specific. How much can someone who is well rested and has plenty of time understand. And what can someone who is faced with a life-threatening illness, and is completely exhausted understand.

Very few patients who are seriously ill and exhausted will be able to understand the information in most consent forms. While the consent is a legal requirement to protect patients, at current it probably protects only the organisation where someone is undergoing treatment: "we provided detailed information and the patient signed".

The UK's equality strategy is available in an 'easy read' version. I have yet to see a consent form for a new treatment or invasive test in 'easy read'.

How about you?

I would love to hear whether other have found easy read version of consent? And how you feel that the current consent process undermines patient safety, choice and the meaning of the process?

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