Gastroenterological Endoscopy. Группа авторов
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.
3.4 What Information Is Required?
For the reasons stated above, this is not simply a clinical question gauged by risk versus benefit. It includes an assessment of what information the patient might attach significance to, be it the risk of complications, alternative treatment, or the consequences of not providing treatment. The significance of a given risk to a patient (as opposed to the clinician), will reflect a variety of personal factors besides its magnitude: for example, its nature, his/her attitude to health and wellbeing, and the importance that the patient attaches to the benefits the treatment might bring. The information given should enable patients to make a decision based on what is important to them, which is not the same as a clinical judgment as to the benefits or otherwise of an intended procedure.
In endoscopy, the procedure will have been advised to establish or exclude a specific diagnosis, provide therapy, prevent an illness from arising, or undertake research, or it may be a combination of these. For screening or research, the patient will usually have already received an explanatory invitation; for diagnosis, therapy, or surveillance, an explanation will have been given by the referring clinician. However, it is the endoscopist’s responsibility to ensure that the patient is aware of his or her clinical condition, the reasons for the endoscopy, the potential complications and any alternative options that are available. Information must be provided indicating what the specific procedure will entail, and includes details of any preparation, dietary measures, or medication changes needed before the procedure. Sedation options should be included with an explanation of their advantages and disadvantages. The risk of complications must be clearly set out based preferably on local data. The written information should list possible side effects that might arise following the procedure and indicate any restrictions in activity or medication following the procedure.
Depending on local and regional customs and laws, the consent form should state who will perform the endoscopy, whether trainees will be involved, the cost, and whether tissue will be retrieved and stored and for what purpose, indicating specifically whether it might be used for research. If images or other recordings are to be made, it should state whether they might be used for teaching or publication.
If the patient is to be involved in a clinical trial, the consent protocol approved by an appropriate ethics committee must be used. If the endoscopy is to be part of a live teaching demonstration, it should conform to advice published by national or international endoscopy organizations.12
A consent form should be completed and signed by the patient. The person taking the consent should indicate that the above issues had been addressed and that the patient had given consent.
3.5 How Should the Information Be Provided?
Informed consent will be adequately obtained only if the information provided is comprehensible. The duty is not fulfilled by bombarding the patient with technical information, which they cannot reasonably be expected to grasp. If possible, patients should be provided with written information expressed in layman’s terms, and confirmation should be obtained that it has been read and understood by the patient. The process may involve other professionals such as trainee endoscopists or nursing staff but the principles remain the same. Those engaged in the consent procedure will require a full understanding of the patient’s medical condition, the intended procedure, its benefits, and the risks associated with treatment. This is because questions may well be asked which require an accurate and complete response. It is important that all of those involved in the consent process have received training and are aware of the medical and legal implications.
3.6 Where and When Should the Consent Be Taken?
Provided