Education And Debate

Thrombolytic treatment for acute ischaemic stroke: consent can be ethical

BMJ 1998; 316 doi: (Published 28 March 1998) Cite this as: BMJ 1998;316:1005
  1. Richard I Lindley, part time senior lecturer
  1. Department of Clinical Neurosciences, Edinburgh University, Western General Hospital, Edinburgh EH4 2XU

    According to proposed guidelines by Len Doyal it is unethical to randomise patients who are not competent to give informed consent in a randomised controlled trial when the treatment risks are not “minimalin relation to the standard available treatment.”1 This would rule out trials of many forms of medical and surgical treatment for a wide range of disabling and life threatening conditions. Is it ethical to condemn millions of “mentallyincompetent” patients to no prospect of improving outcome? I believe a better guideline would be that such a trial is ethical if the treatment is promising but unproved provided that the potential risks are considered acceptable by the public. I illustrate my argument by discussing the role of thrombolytic treatment for acute ischaemic stroke.

    Summary points

    Recently suggested ethical guidelines would limit inclusion of mentally incompetent patients to trials of treatment that had only “minimalrisk”

    Some new treatments may have a substantial risk, but their potential for substantial benefit means that we should not exclude them from further evaluation

    The criterion of “minimalrisk” should be changed to “promisingbut unproved,” provided that the public agrees that the risk is worth taking

    A new type of card, the randomised controlled trial card, may help educate the public about trials

    With proper safeguards, it is ethical to randomise mentally incompetent patients into further trials of thrombolytic treatment for acute ischaemic stroke

    Ethical requirements for trials of thrombolytic treatment

    The box shows the major requirements that I consider necessary for further randomised controlled trials of early thrombolytic treatment for acute ischaemic stroke.

    Criteria needed to justify trials of thrombolytic treatment for acute stroke

    • Treatment promising but unproved

    • Patients would be prepared to risk early death in order to avoid the severe consequences of a stroke

    • Information overload at randomisation is reduced by local education programmes for those at risk of stroke

    • Lay people agree to and contribute to the trial design

    • Local ethics committee …

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