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
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