Informed consent in the medical context is defined in the Oxford Dictionary as “permission from a patient for a medical professional to carry out treatment, with complete understanding of the possible risks and consequences.” In both medicine and surgery, clinicians take consent regularly for routine and emergency treatments and procedures. Ethically, we must take consent to respect patient autonomy. Legally, performing a procedure without consent is a criminal offence and the physician can be charged with battery.
In the post-Montgomery era, and in light of the updated guidelines from the General Medical Council (GMC) on consent there has never been a more appropriate time to review consent processes.1 The new guidance, in line with the Montgomery judgment,2 takes a firm step away from the previous patriarchal (“your doctor knows best”) approach and focuses instead on dialogue with the patient to identify the particular risks which that patient would need to understand before treatment, as well as emphasising the importance of discussing any levels of risk, including serious harm, even if such an occurrence is rare.
It is generally accepted that the best ethical and legal practice is to ensure valid written, signed consent is sought before starting treatments, procedures, or surgery. Taking written consent should follow a full discussion with the patient of the intended benefits and side effects of the treatment as well as any alternative treatments. Ideally patients should be given time to reflect before giving their consent. The GMC emphasises the importance of an understanding of individual patient priorities.1 While signing a consent form is not a substitute for a meaningful dialogue and discussion of treatment, it can help provide a focus for the discussion, a reference for side effects, and also documentation of part of the consent process which can also be used in court proceedings.
Across the UK, doctors are taking consent for the same procedures, but using different consent forms with different risks identified. An audit of the consent process for prostate radiotherapy indicated half of hospitals were annotating side effects by hand on a generic consent form, while the remainder had created their own pre-populated consent form.3 When comparing side effects included on pre-populated consent forms in different hospitals there was significant variation.3 While it is possible that there are regional differences in the level of risk from specific procedures this is less likely with highly protocolised treatments like radiotherapy. In any event, there are clear advantages in commonality in the consent process for a single procedure. Uniform consent documentation will simplify the training of healthcare professionals in obtaining consent and avoid confusion when they move between hospitals. If all doctors use the same forms and adopt similar approaches in the “dialogue” with patients, it will be easier for peer review to identify and support any doctors who are using sub-optimal methods to obtain consent. National forms will avoid duplication of effort in generating local consent forms. Where advances in medical knowledge mean that the risks or benefits of a procedure change, that learning can be disseminated nationally and simultaneously in a uniform way to all doctors by updating one form and not many. Most importantly, a national approach will reduce any unnecessary variation and ensure clarity for patients and relatives. If different risks are identified for a procedure in different hospitals, the more comprehensive forms may be used by litigators acting against those hospitals with less detailed forms, so a national approach will reduce time and resource spent litigating claims alleging a failure of consent.
We believe that clinical and surgical specialties should use national standardised consent forms for procedures and surgery to improve the consent process for patients and clinicians. The Royal College of Radiologists (RCR) developed national site specific consent forms for radiotherapy for curative and palliative treatments. The robust process which was followed led to the team being awarded cancer care team of the year at the BMJ awards in 2021.4 The first 10 radiotherapy consent forms were generated in 10 months involving 115 individuals, but most importantly with a strong focus on patient involvement. The protocol used could be followed by other specialties to develop national consent forms for procedures.56 The RCR forms are now used in the majority of UK cancer centres and have been downloaded more than 68 000 times, demonstrating the huge clinician support for such a project.
National standard consent forms designed by experts including patients and reviewed and approved by lawyers would put doctors in a stronger position both ethically and legally. We suggest other specialties follow this approach.