RISCS - Risks in spinal consenting for surgery
Research type
Research Study
Full title
RISCS Trial – Risks In Spinal Consenting for Surgery.
IRAS ID
200953
Contact name
Paul Thorpe
Contact email
Sponsor organisation
Taunton & Somerset NHS Foundation Trust
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
This trial will address the research question of whether there are increase rates of consent withdraw for patients receiving spinal injections when using a legal centred consent form compared to a medical centred consent form. A recent legal case means that doctors should no longer decide how much and what information a patient should be given by their doctor prior to a procedure; all information may be relevant to the patient should something go wrong. This change in the consenting process has not been widely adopted by the surgical profession mainly due to a concern of over burdening a patient with incredibly rare risks.
This single centre trial will randomise patients having elective spinal injections to have either a standard ‘medical centred’ consent form (control) or a trial ‘legal centred’ consent form (intervention), the latter having 5 times as many risks stated on it. The primary end point is rates of consent withdraw, with the trial of 220 patients (110 per group) expected to last 6 1/2 months.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
16/SC/0510
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion