Policy responses and statements
- Name of organisation:
- General Medical Council
- Name of policy document:
- Consent: Patients and doctors making decisions together
- Deadline for response:
- 20 August 2007
Background: The GMC's existing guidance on consent, 'Seeking patients’ consent: the ethical considerations' was published in 1998. In January 2006, the Standards and Ethics Committee of the GMC decided that it was time to review this guidance booklet to make sure the guidance on consent was up to date and reflected the changing nature of the doctor-patient relationship.
A Working Group, consisting of members of the Standards and Ethics Committee, the GMC’s Patient and Public Reference Group (PPRG) and external members were established to take this project forward. They produced new draft guidance, which was approved by the SEC for consultation.
The new guidance is broader in scope than its predecessor, placing greater emphasis on how doctors and patients work together to make good decisions, and providing a framework that will apply to the range of situations that doctors face in practice.
The new guidance also reflects changes in the law, including the new mental capacity legislation and case law that requires doctors to explain the range of risks associated with a proposed intervention. For the first time, the GMC provides advice for doctors on how to assess and communicate risk, covering issues such as the content, presentation and timing of discussions with patients and how to handle difficulties such as uncertainty over the level or nature of risk.
COMMENTS ON
GENERAL MEDICAL COUNCIL
A CONSULTATION ON GUIDANCE FOR DOCTORS – CONSENT: PATIENTS AND DOCTORS MAKING DECISIONS TOGETHER
The Royal College of Physicians of Edinburgh is pleased to respond to the General Medical Council on its consultation on Consent: Patients and doctors making decisions together.
1 Is the guidance relevant to the range of situations that doctors and patients will face when making decisions about investigations and treatment?
Yes.
2 Are the principles set out in Part 1 the right ones?
Yes.
3 Does the draft accurately reflect the different roles of the doctor and the patient in the process of making medical decisions?
Yes.
Comment:
There is a tension between the language of partnership, which suggests a meeting of equals, and the distinct roles which the guidance assigns to doctor (giver of information) and patient (decision-maker). In 4(a), patients and doctors make an assessment together. In (b) and (c), however, a more legalistic or even consumerist tone separates them: doctors ‘offer … options’, and patients ‘decide’ and ‘choose’. Clearly, the GMC is properly anxious to avoid any accusation of old-fashioned medical paternalism, and also to state what the law requires. But in (b) and (c) doctors and patients are characterised in ways which reflect the adversarial context of the court rather than the ‘openness, trust and good communication’ of the proposed ‘partnership’ between patients and doctors in the clinical context. The portrayal of patients who ‘decide what weight to give ...’ and who ‘exercise their autonomy to choose ...’, moreover, suggests individuals whose judgement is unaffected by illness or anxiety and thus leaves out of account an essential dimension of many patient-doctor relationships. If the GMC is serious about the importance of ‘partnership’, and ‘making decisions together’, its ‘basic model’ needs to reflect, not only legal principles, but also the practicalities of communication with people who often are vulnerable patients as well as legal persons.
While paragraph 4 (c) (Partnership) is clearly right, it could be misleading in implying that the doctor’s responsibility ends if the patient chooses to refuse treatment apparently irrationally. We suggest adding a sentence such as, "However, the doctor should remain aware that an apparently irrational decision may reflect ineffective or misinterpreted advice or unrecognised impairment of capacity (part 3, para.58 t0 71)".
4 Does the guidance clearly express doctors’ obligations to provide this information?
Yes.
Comments:
It may be that there is a hidden judgment underlying the word “choice”. Does the guidance require doctors to tell patients about treatment available in other countries? Or other parts of this country? Or only those available within a range of options over which the patient can exercise “choice”?
5 Is this a reasonable obligation to impose on doctors?
Yes.
6 Is this a reasonable test for doctors to apply when deciding when they should tell patients about such treatments?
Yes.
Comments:
As for 4 above.
7 Are there any other circumstances when doctors should tell patients about treatments not available in the organisation providing care?
Yes.
Comments:
Patients should be told about treatments that are as effective as those available in the organisation providing care but differing in terms of cost or waiting time or coming under the description of alternative therapy.
8 Does paragraph 10 accurately reflect doctors’ obligations to answer patients’ questions?
Yes.
Comments:
However, the tension with paragraph 17 should be noted: there may be circumstances where the doctor judges that disclosure of information would cause the patient “serious harm”.
9 Is this guidance helpful?
Yes.
Comments:
Paragraph 12 is particularly important and could be placed before paragraph 11.
10 Is it clear that paragraph 14 is intended to cover all of these issues?
No.
Comments:
The thrust of the guidance is to emphasise mental or psychological barriers to communication and so the reader might overlook physical support.
11 Is there anything missing from paragraph 14?
Yes.
Comments:
The guidance should include the examples (provision of interpreters, signers, translations of information) indicated in the introduction to the consultation question.
12 Do paragraphs 15 and 16 strike the right balance between the need to respect patients’ wishes and the need for doctors to provide certain information?
No.
Comments:
In the previous (1998) guidance the relevant statement in the corresponding paragraph 11 read: ‘If they insist they do not want to know in detail about their condition and its treatment, you should still provide basic information about the treatment’. The new paragraph 16 reads: ‘If a patient insists that they do not want to know in detail about their condition or its treatment, you should respect their wishes, as far as is possible, but you must still provide basic information about what the treatment aims to achieve, and what it will involve.’ This appears to state the problem rather than offer helpful guidance. The key issue seems to be that between basic and detailed information and it might be helpful to focus more clearly on that distinction in the paragraph.
13 Is the guidance in paragraphs 19 and 20 clear?
No.
Comments:
While it is important in the guidance to recognise the constraints of time and resources, there is the danger that this could be used too often as an excuse for lack of consultation. Paragraph 19 could be strengthened by starting “In exceptional circumstances, it is difficult….”
14 Is this guidance helpful in practice?
Yes.
15 Is the guidance on risk clearly expressed?
Yes.
16 Does this paragraph make clear when doctors should tell patients about potential risks of proposed investigations and treatments?
Yes.
Comments:
Particularly when combined with the following paragraphs which indicate how this should be interpreted in certain circumstances.
17 Is the guidance on how doctors should approach discussions with patients about risks helpful?
Yes.
18 Is there anything missing from this section?
No.
19 Is it helpful for the GMC to provide guidance for doctors on discussing advance care planning with patients?
Yes.
20 Is there any other guidance we should give on this issue?
No.
21 Is the terminology we use in this section clear?
No.
Comment:
The following points are insufficiently clear:
(a) where the patient's capacity fluctuates then the assessment often needs to be repeated, and it is the patient's ability to understand and take decisions at their best level of functioning that is crucial.
(b) the doctor should make every reasonable effort to overcome potential barriers to capacity - such as by ensuring a deaf patient has a functioning hearing aid or by encouraging non-verbal communication with a patient who cannot speak.
(c) capacity is a continuum. There will be patients who are considered to retain capacity that have diminished understanding and patients who are considered to lack capacity who will have residual understanding. For these reasons it is important to ensure that the patient's supporters are involved in decision making where the capacitated patient wishes this and conversely the incapacitated patient's residual wishes are centre stage when the doctor is seeking consent from their family.
22 Does the guidance cover the situations doctors may face when making decisions with patients whose capacity is impaired?
Yes.
23 Is this guidance helpful?
Yes.
24 Does this section clearly set out doctors’ professional obligations when making decisions about patients who lack capacity?
Yes.
25 Is there anything missing from this section of the guidance?
No.
26 Is the guidance on assessing capacity helpful?
Yes.
27 Is there anything missing from this section of the guidance?
Yes.
Comments:
See comments on question 21, particularly section (b).
28 Is this guidance helpful?
Yes.
29 Does the guidance accurately reflect the legal and organisational environment in which you work or live?
No.
Comments:
In paragraph 53(b), the information is not accurate for Scotland. In Scotland, there is no doubt that a 16 year old can refuse any and all treatment.
30 Do you think the Legal Annex is helpful?
Yes.
31 Is there anything that could usefully be added to the Legal Annex?
No.
32 Are the standards set in the draft reasonable and achievable?
Yes.
33 Are there any paragraphs that you feel are not relevant to the majority of registered doctors?
No.
34 Have any key principles, duties or issues been omitted from the guidance?
No.
35 Do you have any comments on the structure of the draft, or on the headings or subheadings?
Yes.
Comments:
In a couple of places, a paragraph is modified by following paragraphs and it would be helpful to make that clear, viz. paragraphs 10, followed by 11-14, and paragraph 28, followed by 29-32.
36 Are there any other sources of guidance, or useful links that you think we should include?
Yes.
Comments:
There is a stark sentence at the end of the introduction - "serious or persistent failure to follow this guidance will put your registration at risk". This may be a statement of fact but it is also a threat. Further guidance and illustration from the GMC would be helpful with examples of - a) what would be deemed serious or persistent failures and b) where it is valid and appropriate to "use your judgement to apply the principles" (two paragraphs above). By providing the doctor with examples of acceptable and unacceptable deviations the GMC would add useful information that might reduce the likelihood of serious failure - and the anxiety of doctors.
37 Do you have any comments on the title of the guidance?
No.
38 Do you have any other comments on the draft guidance?
Yes.
Comments:
Although the guidance acknowledges that there are times when care is combined with research (paragraph 6g), this situation is not uncommon and the combination involves additional issues and responsibilities for the doctor. Separate consideration should be given to “combined clinical care and research” either in this document or in a separate one.
Paragraph 44 is important in noting that “implied” consent should not mean that information is not required. This paragraph should be strengthened.
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[22 August 2007] |
