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Informed consent
  1. G NEALE, Emeritus Lecturer in Medicine University of Cambridge
  1. 30 Bevin Square
  2. London SW17 7BB

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    At the beginning of 1999 the British Society of Gastroenterology (BSG) issued guidelines for informed consent for endoscopic procedures.1 This is the eleventh booklet in the Guidelines in Gastroenterology series, all of which contain excellent advice. But is there a down side? Is the practice of medicine becoming too prescriptive?

    Firstly, I must come clean. In 1995 I wrote the initial draft of the document on informed consent for endoscopic procedures at the request of Duncan Bell who told me that the BSG Council had commissioned the exercise some years previously, that those nominated had reneged and that the honour of East Anglian gastroenterologists was at stake. Duncan Bell and I aimed to keep the document short and tried to stress two central messages: firstly, the importance of speaking with patients and, secondly, the need for clinicians to devise their own method of ensuring that patients were guided wisely. In the ensuing three or four years the considerably expanded draft document shows all the signs of having been re-written in committee (on several occasions considering the length of gestation). Political correctness has taken over and the general guidelines of both the Department of Health and the General Medical Council are quoted at length and the legal position is clearly enunciated.

    In this issue Shepherd et al (see page 37) make a case for postal consent for upper gastrointestinal endoscopy. They claim that their study “…confirms that a specifically designed patient information booklet…improves the level of understanding (of the investigation)…(which is) an important component in delivering a quality service to patients.” Well, patient information booklets have been around for very many years and the BSG document quoted a previous suggestion that patients may prefer to sign a consent statement at home.2 To what extent does this help informed consent? Informed consent concerns empowering people who do not have pre-existing knowledge. In a sense it stems from the American Declaration of Independence (1776) in which it was stated that, “Governments…derive their just powers from the consent of the governed.” In the Middle Ages physicians in Europe and the Middle East sometimes made contracts with their patients but designed these to absolve them from responsibility from subsequent adverse events.3 Shades of the present!

    Be that as it may it seems that what we might recognise as informed consent first appeared about a century ago in a Prussian directive regarding human experimentation; and re-surfaced in a major way when the Nuremberg Code (1947) addressed the problem of voluntary consent again in respect of human experimentation.6 The question of informed consent in clinical practice arose from case law5 yet, in the United Kingdom, even today it is virtually impossible for a patient to succeed in suing in respect of being inadequately informed.6 Despite this, it is impossible to escape the implications of informed consent in an increasing range of clinical endeavour from using patients in teaching to undertaking human research. It includes agreeing all invasive procedures and associated problems in anaesthesia, the use of drugs and blood transfusion, the order “not to resuscitate”, medical interventions (or cessation of interventions) which may speed death, organ donation, screening for disease, and genetic testing.

    What is informed consent? Clearly, as Shepherd et al emphasise, it is not just a signature on a consent form. They quote the NHS Litigation Authority in stating that, “appropriate information provided to patients on the benefits and risks of proposed treatment” has its rationale in the observation that, “…complaint or litigation is less likely if patients understand to what they are consenting…”. This may be true but it does not necessarily make for good practice. For example, it is easy for a patient to read about the nature of endoscopic retrograde cholangiopancreatography (ERCP) and its attendant risks and then to sign a consent form. In which case if he/she undergoes ERCP and is permanently damaged by an attack of pancreatitis he/she is unlikely to sue.7 However, if the procedure has been performed simply as a means of diagnosing diarrhoea or unexplained abdominal pain, has the patient really understood the available options and the risk:benefit ratio of ERCP?

    The problem has been well explored by Meisel and Kuczewski8 who make a plea for the clinician to discuss therapeutic options rather than reach for the manual on informed consent. Informed consent is not about listing the risks, it does not mean that the patient should be provided with a comprehensive digest of information, nor does it mean that patients should be given information whether they want to hear it or not. Remember the root of the term doctor (L. docere - to teach). The gastroenterologist should not allow himself to become a technologist. He should first and foremost be a physician who is there to advise his patients. And he should strive to give the impression that he has time to talk. If this is not done the patient may build up resentment and if this happens no matter how much written information has been provided, he may become angry. And most plaintiffs are angry.

    Written information about endoscopic procedures is undoubtedly useful but it does not replace the over-riding need for doctors to speak with their patients about the options for further action. Shepherdet al suggest that written information delivers quality service (lovely “government speak”) but for those interested in the nature of the quality of consent I recommend reading a satirical editorial in theAmerican Journal of Medicine.9Advising patients about options is more important than obtaining informed consent.

    See article on page 37


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