European human rights legislation could prevent medical research into illness and injuries that leave people unconscious, a doctor in Scotland has warned.
Charles Warlow, a clinical neuroscientist at the University of Edinburgh, says a new Scottish act, inspired by the European Human Rights Act, changes the requirements for patient consent. They key part of the Adults with Incapacity Act is about to be implemented.
鈥淣ow, if you want to do a randomised trial of a new treatment for stroke, head injury or cardiac arrest, you must get the patient鈥檚 consent, or, if he is unconscious, the consent of the next of kin 鈥� but you can鈥檛 find them quickly enough,鈥� says Warlow. 鈥淭he slogan for these conditions is 鈥榯ime is brain鈥�.鈥�
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Warlow says peer review and ethical approval of proposed research is essential and that consent is preferable. But for cases where urgent treatment is also essential, 鈥渋f you don鈥檛 have waiver of consent, the trials will stop. We won鈥檛 know how to treat people who are suddenly unconscious and unable to give consent.鈥�
The legal implications of the European Human Rights Act in England and Wales have not been resolved and Warlow says countries across the European Union will now be making their minds up.
Paramedic dilemma
Warlow is involved in a trial of a clot-busting drug on victims of sudden stroke. 鈥淲e are likely not to be able to recruit patients, because they can鈥檛 give consent,鈥� he says.
A study of the treatments paramedics give to heart attack victims, being conducted by cardiologist Stewart Cobb at Glasgow University, is particularly at risk. 鈥淚 can鈥檛 see how that can continue,鈥� says Warlow.
In contrast, a third of the cases in a recently published US study on the cooling of head injuries employed waiver of consent. The New England Journal of Medicine editorial pointed out this trial would never have happened if waiver of consent did not exist.
People are rightly sensitive about experiments being done without their consent, says Warlow. 鈥淏ut patients are going to be extraordinarily disadvantaged by the current obsession to get consent for everything. If the public knew what they were losing, I think they would object.鈥�
Warlow was speaking at the British Association Festival of Science in Glasgow.