Establishing the threshold of material risk. Version 1

  • Research type

    Research Study

  • Full title

    Obtaining informed consent after Montgomery V Lanarkshire: Is it possible to establish a threshold of a material risk?

  • IRAS ID

    228405

  • Contact name

    Peter Douglas

  • Contact email

    pdouglas2@nhs.net

  • Sponsor organisation

    Clinical Research & Development, NHS Greater Glasgow and Clyde

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    A recent Supreme Court ruling has changed the amount of information that doctors are obliged to provide to patients when taking consent for treatment. Doctors are now expected to inform patients of any and all risks that the patient might think is important (known as a material risk). A further legal case attempted to establish a threshold of what constitutes a material risk, using the figure of 1 in 1000.
    Rather than doctors relying solely on legal rulings for advice, we plan to ask patients what level of detail they would wish to be informed of when giving consent for treatment.
    Participants will be asked how frequently a complication needs to be before they wish to be informed of it (and by extension how rare a complication needs to be before they would not wish to be informed about it). This would be repeated with a range of different complications, from minor to severe (the most severe being death).
    In addition, simple demographic information would be collected along with a few questions (5 or less) relating to factors which we believe might influence an individual's response.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    17/NE/0322

  • Date of REC Opinion

    12 Oct 2017

  • REC opinion

    Favourable Opinion