Annex A > Chapter 17 - Communication Between Healthcare Professionals and Patients > National, regional or local guidelines

National, regional or local guidelines

4 General advice and guidance to healthcare professionals on communication with patients (and their parents in the case of children) and on obtaining consent before treatment can be found in a number of documents. These guidance documents were issued by (a) the Department of Health (DoH) and (b) professional and related bodies. Some of these documents have model consent forms.

5 In 1971 the Department of Health and Social Security (DHSS) discussed model consent forms with the British Medical Association (BMA), the Medical Defence Union (MDU), the Medical Protection Society (MPS) and the Medical and Dental Defence Union of Scotland (MDUS). As a result of this, agreement was reached on standard consent forms for use in the case of surgical operations: D.S. 30/71 `Consent Forms for Operations', [1] dated 2 February 1971.

6 This guidance included the following:

`It is important that the question of obtaining a signature to a consent form should not be allowed to become an end in itself. The most important aspect of any consent procedure must always be the duty to explain to a patient or relative the nature and purpose of the proposed operation and to obtain a fully informed consent.' [2]

7 In 1990 the DoH issued new guidance on consent: [3] HC(90) `A Guide to Consent for Examination or Treatment'. [4] In Chapter 1 it stated:

`A patient has the right under common law to give or withhold consent prior to examination or treatment ... This is one of the basic principles of health care.' [5]

It went on:

`Patients are entitled to receive sufficient information in a way that they can understand about the proposed treatments, the possible alternatives and any substantial risks, so that they can make a balanced judgement. Patients must be allowed to decide whether they will agree to the treatment, and they may refuse treatment or withdraw consent to treatment at any time.' [6]

8 The 1990 Guidance stated further:

`Where a choice of treatment might reasonably be offered the health professional may always advise the patient of his/her recommendations together with reasons for selecting a particular course of action. Enough information must normally be given to ensure that they understand the nature, consequences and any substantial risks of the treatment proposed so that they are able to take a decision based on that information. Though it should be assumed that most patients will wish to be well informed, account should be taken of those who may find this distressing.' [7]

9 The Guidance also advised that the patient's ability to appreciate the significance of the information should be assessed, [8] in the case, for example, of patients who might be shocked, distressed or have difficulty in understanding English. It further stated that:

`A doctor will have to exercise his or her professional skill and judgement in deciding what risks the patient should be warned of and the terms in which the warning should be given. However, a doctor has a duty to warn patients of substantial or unusual risks inherent in any proposed treatment. This is especially so with surgery but may apply to other procedures including drug therapy and radiation treatment.' [9]

10 The 1990 Guidance stated that: [10]

`The standard of care required of the doctor concerned in all cases is laid down in Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, namely, that he or she must act in accordance with a responsible body of relevant professional opinion.' [11]

11 It further stated:

`Guidance on the amount of information and warnings of risk to be given to patients can be found in the judgement of the House of Lords decision in Sidaway v Gov of Bethlem Royal Hospital [1985] AC 871.' [12]

12 The 1990 Guidance stated that consent may be implied or express. It then gave guidance on when written consent should be obtained:

`Written consent should be obtained for any procedure or treatment carrying any substantial risk or substantial side effect ... written consent should always be obtained for general anaesthesia, surgery, certain forms of drug therapy ...' [13]

It went on:

`Oral or written consent should be recorded in the patient's notes with relevant details of the health professional's explanation. Where written consent is obtained it should be incorporated into the notes.' [14]

13 As regards written consent, it stated:

`The main purpose of written consent is to provide documentary evidence that an explanation of the proposed procedure or treatment was given and that consent was sought and obtained.' [15]

14 The 1990 Guidance cautioned:

`Where a patient has not been given appropriate information then consent may not always have been obtained despite the signature on the form.' [16]

15 The Guidance emphasised the importance of discussing treatment with the multidisciplinary team and other doctors. These discussions, it stated, should also be documented in the clinical case notes. [17]

16 In 1991 the DoH issued guidance entitled, `Welfare of Children and Young People in Hospital' [18] which stated:

`Districts and provider hospitals should ensure that good practices are followed on seeking consent to the treatment of children. A guide to consent for examination and treatment published by the NHS Management Executive in August 1990 [19] will be of assistance here.' [20]

17 The 1991 Guidance gave advice on `Parental Attendance and Involvement': [21]

`District and provider hospitals are advised to agree service specifications which:

• `recognise that parents and members of the immediate family are not visitors and encourage and assist them to be with their child at all times unless the interests of the child preclude this
• `enable parents to give continuous love, care, comfort, and support to their child and, especially, be together with their child at the most stressful times - e.g. during and after treatment, anaesthesia, investigations and x-rays
• `help parents themselves to undertake many familiar tasks helpful to the care of their child (e.g. dressing and undressing) and, where appropriate, learn any clinical procedures which will enable them to care for their child at home after discharge
• `provide maximum help and advice to parents to enable them to play a part in the care of their children and to continue the care following the child's discharge from hospital
• `ensure that, exceptionally, when consideration is given to advising a parent on medical grounds not to visit a particular child, the decision is taken by the consultant in charge only after full consultation with other professional staff (the reason for the decisions will need to be recorded in the child's medical records)...' [22]

18 On 28 July 1992 the NHS Management Executive (NHSME) issued Guideline HSG(92)32, entitled `Patient Consent to Examination or Treatment'. [23] It superseded the 1990 Guidance:

`Following discussion with representatives of the medical profession, the Department has revised the model consent forms ... This should remove some of the misunderstandings that have arisen since HC(90)22 was introduced.' [24]

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Footnotes

[1] DOH 0014 0046; `Consent Forms For Operations', D.S. 30.71

[2] DOH 0014 0046; `Consent Forms For Operations', D.S. 30.71

[3] This appears to be the first guidance that addresses the position of the law on consent

[4] HOME 0004 0018 - 0034 ; `A Guide to Consent or Treatment', HC(90)

[5] HOME 0004 0020;`A Guide to Consent or Treatment', HC(90)

[6] HOME 0004 0020; `A Guide to Consent or Treatment', HC(90)

[7] HOME 0004 0021;`A Guide to Consent or Treatment', HC(90)

[8] HOME 0004 0021; `A Guide to Consent or Treatment', HC(90)

[9] HOME 0004 0021; `A Guide to Consent or Treatment', HC(90)

[10] See further the analysis of the law on consent in the Interim Report: BRI Inquiry Interim Report, `Removal and retention of human material', p. 20-34 and at Annex B of the Interim Report, particularly at p. 68-9

[11] HOME 0004 0028; `A Guide to Consent or Treatment', HC(90)

[12] HOME 0004 0021; `A Guide to Consent or Treatment', HC(90)

[13] HOME 0004 0022; `A Guide to Consent or Treatment', HC(90)

[14] HOME 0004 0022; `A Guide to Consent or Treatment', HC(90)

[15] HOME 0004 0022; `A Guide to Consent or Treatment', HC(90)

[16] HOME 0004 0022; `A Guide to Consent or Treatment', HC(90)

[17] HOME 0004 0028; `A Guide to Consent or Treatment', HC(90)

[18] HOME 0002 0001; `Welfare of Children and Young People in Hospital', DOH 1991

[19] HOME 0004 0018 - 0034 ; `A Guide to Consent or Treatment', HC(90)

[20] HOME 0002 0013; `Welfare of Children and Young People in Hospital', DOH 1991

[21] HOME 0002 0024; `Welfare of Children and Young People in Hospital', DOH 1991

[22] HOME 0002 0024; `Welfare of Children and Young People in Hospital', DOH 1991 (emphasis in original)

[23] DOH 0014 0037 - 0044 ; `Patient Consent to Examination or Treatment', HSG(92)32

[24] DOH 0014 0037; `Patient Consent to Examination or Treatment', HSG(92)32