3.1 Introduction

Informed consent for gastrointestinal endoscopy is an essential part of a quality endoscopy service. It empowers patients to determine their own medical management based on an understanding of their clinical condition and the potential risks, benefits, and alternatives to the proposed intervention. It also protects the endoscopist and the clinical institution providing the service from liability for complications arising outside their control. It therefore benefits all parties. This chapter considers the principles underlying informed consent in digestive endoscopy. It draws attention to the rights of the patient giving consent and discusses when and how consent should be taken and by whom. It sets out what information should be disclosed and considers those cases where consent may not be required or is undesirable. In particular, the chapter addresses the medicolegal issues that are evolving with the increasing burden of litigation that is influencing medical management in the 21st century.

Historically, the medical profession has adopted a paternalistic approach to patient management. Hippocrates said “… sometimes you will have to deftly comfort [your patient] without revealing the true progress of his illness because many patients take a turn for the worse when they find out about their condition and the prognosis.” ¹ A prototype of informed consent operated as long ago as the 14th century, but it was employed more to protect the doctor than to enable patient autonomy. ² Since the beginning of the 20th century, patients have been able to sue their surgeon successfully if their expressed wishes concerning an operation had been ignored, but there was no requirement for “informed consent” until late in that century. ² Following the Nuremberg trials, ethics relating to medical research came under scrutiny, but this did not have a major impact on medical practice in the United Kingdom. In 1967, Pappworth controversially published “Human guinea pigs”—a history. ³ , ⁴ This led to the adoption of local ethics committees and requirement of informed consent from patients recruited for research.

In 1994, the World Health Organization published a declaration of patients’ rights in Europe. ⁵ It stated:

Patients have the right to be fully informed about their health status, including the medical facts about their condition; about the proposed medical procedures, together with the potential risks and benefits of each procedure; about alternatives to the proposed procedures, including the effect of non-treatment; and about the diagnosis, prognosis and progress of treatment. The informed consent of the patient is a prerequisite for any medical intervention. A patient has the right to refuse or to halt a medical intervention. The implications of refusing or halting such an intervention must be carefully explained to the patient.

These are the principles that today underlie the concept of informed consent, but their application varies according to the legislation in individual countries. However, in spite of the general acceptance that informed consent in endoscopy is important, studies suggest that it is often poorly done and is sometimes neglected altogether. ⁶ , ⁷ This chapter is based on recent guidelines produced by National endoscopy societies, ⁸ , ⁹ and on case law.

3.2 What Is “Informed Consent”?

It is legally defined as follows:

… An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and his or her consent must be obtained before treatment interfering with that person’s bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any treatment, and of any reasonable alternative or variant treatments …. ¹⁰

The concept of informed consent requires the sharing of sufficient information between doctor and patient so as to protect the patient’s right of autonomy. Whether or not this duty is met will depend on: what information is provided; how it is provided; and where and when it is provided.

3.3 Clinician and Patient Relationship

The relationship between providers and recipients of clinical care lies at the heart of understanding the modern concept of informed consent. The starting point is a recognition that the relationship between the doctor and the patient is a partnership, involving a mutual understanding that medical treatment is uncertain of success and may involve risks. It is then that the patient is able to make decisions concerning their treatment and accept responsibility for taking those risks and living with their consequences.

Historically, the doctor/patient relationship was characterized very differently, one in which “the doctor knows best” and the patient is a passive and potentially reluctant recipient of medical care. This was the default position in the United Kingdom during the 1960s, when to tell a patient he or she had cancer was usually a sentence of death, and medical students were taught not to use the “C” word. Most therapy was ineffective and public understanding of medical matters was limited. To deprive a patient of all hope offended the first Hippocratic principal “Do no harm.” Furthermore, many patients preferred the doctor to do his/her best without wanting to know the details. Until the late 20th century, the common law accepted that the nature and extent of information to be provided by a doctor to a patient was primarily a matter of clinical judgment:

… a decision what degree of disclosure of risks is best calculated to assist a particular patient to make a rationale choice as to whether or not to undergo a particular treatment must primarily be a matter of clinical judgment. ¹¹

More recently, there has been a fundamental shift away from this paternalistic approach. Today, the internet generation is well-educated about medical matters and is aware that effective treatments are available for most conditions, that medicine has subspecialized, and that certain doctors and hospitals are better qualified to treat them than others. Patients and their relatives are also aware that if the advice given is inappropriate or if procedures go wrong, they have recourse to the court for compensation.