Human rights laws could prevent medical research

According to a clinical neuroscientist at the University of Edinburgh, European human rights legislation could prevent medical research into illness and injuries that leave people unconscious.

Charles Warlow, a physician, says new laws inspired by the European Human Rights Act change the requirement for patient consent. Regulations in the United States, and formerly in Europe, allow for so-called "waiver of consent," which permits certain interventions to be administered if the patient is unconscious.

Under new European regulations, if you want to do a randomised trial of a new treatment for stroke, head injury or cardiac arrest, you must get the patient's consent, or if unconscious, the consent of the next of kin.

There are problems however:

  • Often you can't find next of kin quickly enough.

  • A third of the cases in a recently published U.S. study on the cooling of head injuries employed waiver of consent.

  • A New England Journal of Medicine editorial pointed out this trial would never have happened if waiver of consent did not exist.

    Currently involved in a trial of a clot-busting drug on victims of sudden stroke, Warlow would probably not be able to recruit patients because they can't give consent.

    A study of the treatments paramedics give to heart attack victims, being conducted by cardiologist Stewart Cobb at Glasgow University, is particularly at risk. Speaking at the British Association Festival of Science, 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, "if you don't have waiver of consent, the trials will stop."

    Source: Damian Carrington, Human rights laws could prevent medical research, New Scientist, September 1, 2001.

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    FMF\18 September 2001
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