Patient consent—decision or assumption?
Authors: Glyn Elwyn
Journal: BMJ (2008)

The process of obtaining consent from patients for procedures such as surgical operations has been described as “the modern clinical ritual of trust,”1 although its real meaning and performance are still debatable.2 Last week, the General Medical Council released new guidance on the subject, Consent: Patients and Doctors Making Decisions Together, that will be implemented in June 2008.3

To caricature, obtaining consent often involves a junior member of the clinical team being charged with obtaining a signed piece of paper declaring that the patient has understood the nature of the procedure and its consequences. Consent is often completed a few hours before the intended procedure, and patients seldom have time to read, never mind reflect on, information about possible harms and benefits—rare or otherwise.

Although the consent discourse has hardly been studied in depth, many clinicians report the process of obtaining consent from patients as a perfunctory chore—to be accomplished in a superficial albeit efficient way—to ensure a smooth transition from preoperative assessment to preparation for the operating theatre. In the real world of rapid throughputs and turnaround times, consent is—and often has to be—assumed. Evidence shows that patients want to be given more relevant information about risks and consequences.4 This emphasises the fundamental aim of informed consent—that patients should be neither coerced nor deceived.2

The new GMC guidance urges doctors to re-think their approach.3 It advocates the communication of risks; it advises what should be done when patients refuse treatment; and it notes changes in the law, including the new legal safeguards for patients who lack capacity to make their own decisions. It encourages doctors and patients to be actively engaged in discussions about investigations and treatment, to enable patients to make informed decisions that are tailored to their individual circumstances and beliefs. The guidance stresses that obtaining and giving consent should not be a “tick the box” exercise but should be based around nine fundamental points (box).3


Fundamental points of the consent process

Consent should be obtained at a time and in a place that enables patients to best retain information


Allow time for reflection before and after decisions


Tailor the approach to individual wishes, making no assumptions about information needs, levels of understanding, or about the importance patients attach to different outcomes


Use clear, simple, and consistent language


Give information about risk in a balanced way, avoiding bias


Provide the likelihoods and uncertainties of benefits, risks, and the side effects of each option


Tell patients about serious adverse outcomes, even if likelihoods are very small


Use written material and visual aids—accurate and up to date—and refer to other sources


Check that patients understand the information they are given





So what are the implications for what clinicians do in practice? At first reading, the guidance seems radical and seems to signal a cultural change in how informed consent should be achieved. Yet closer reading reveals broad brushstrokes—details are sparse and the advice remains non-specific. For example, the guidance provides no detail about suggested risk thresholds for specifying the probability of harm; in addition, it makes no suggestions on how to achieve balance, how to tailor information, or how to explore personal preferences.

Considerable progress has been achieved in many of these areas in the related fields of risk communication, shared decision making, and decision support.5 Guidance on how to communicate risk—using graphics, negative framing, and positive framing; describing both absolute (baseline) and relative risk estimates; and deploying natural frequencies rather than percentages—have been published.6 Although the GMC’s guidance looks like a manifesto for shared decision making,7 it stops short of describing how clinicians could achieve these challenges in busy clinical settings.8 The lack of detail might prevent many clinicians from making major changes to their practice, perhaps just introducing patient information material, which may be of dubious quality.9 Nevertheless, the arrival of new guidance signals the need for an overhaul of how informed consent needs to be achieved for clinicians who are keen to make improvements.

What needs to happen before the guidance can be implemented? Systemic and cultural change is needed to move shared decision making beyond interactions between health professionals and patients into the realm of becoming a requirement at the organisational level, integrated into the way multidisciplinary teams are set up to provide care. Rather than remain a bureaucratic task, consent would become a step-wise conversation conducted over numerous contacts.10 Information would be provided early, preferably as soon as intervention is a possibility. The task of obtaining consent would be a distributed responsibility, conducted and documented by a series of clinicians working to a common goal. The process would become a consent pathway, with clear steps where information and patient preference would be considered and documented.

A signature on a consent form would no longer be sufficient evidence that the patient had been given accurate and tailored information. New materials will be needed that contain data about the intervention being considered, the likely outcomes, and their probabilities, complete with guidance on how to clarify patients’ preferences and deliberate about options. Generating these materials will require considerable investment and expertise, both in the synthesis of evidence and in the presentation of the information. There is, however, much experience in producing such tools—decision support technologies, also known as decision aids, are on the increase.11

The international patient decision aids standards collaboration is working to ensure that quality assurance criteria exist.12 These tools did not originate as methods to ensure informed consent—they were devised to help patients consider tough decisions, where clinical equipoise exists. However, as consent becomes increasingly regarded as a form of choice that involves a deliberated decision rather than just acceptance of professional advice, the shift to adopt decision support technologies as a means of achieving informed consent seems not only necessary, but inevitable.