Conclude that, as Mrs Conti does not have capacity, she should not be invited to take part in the research study?
Dr Ellis, a junior doctor on the cardiac team, decides that Mrs Conti might be eligible to take part in an approved clinical trial of a drug designed to treat her particular condition. Dr Ellis is discussing with Dr Abdullah, the senior clinician in charge of the project, whether to invite Mrs Conti to participate.
Mrs Conti, who is 80, has been diagnosed with heart failure. She has an appointment with a cardiac surgeon but before she can attend, there is a deterioration in her condition, and she is admitted to hospital because she is having difficult breathing.
Mrs Conti's quite a good candidate for this trial, in terms of the clinical picture at least. But I'm not entirely sure we would be able to secure consent. Her cardiac condition is exacerbated and the intermittent blood supply to her brain means her capacity is fluctuating. She's having trouble understanding what the cardiac team are trying to tell her about her treatment. Or at least, she understands, but doesn't remember for long and shows signs of confusion.
It sounds as though there is serious doubt about this lady's decision-making capacity. And I gather she's not very mobile? That's likely to make it difficult for her to attend follow-up appointments. We don't want to increase the drop-out rate of the study if we can avoid it.
It might do, I suppose. And she's very upset about being in hospital which isn't helping matters.
Raising the issue of research might just distress and confuse her even more. Don't you have other patients who fit the profile for the study? Perhaps someone younger and less vulnerable, who can understand more readily what's involved?
Dr Ellis asked Mrs Conti whether she would like to participate in the research project. She talked to Mrs Conti early in the day, when she was at her most alert, and gave her a patient leaflet so that she could talk the matter over with her son and his wife when they visited that afternoon. After talking to her family, Mrs Conti decided that she would like to be involved in the project, not only because the trial would provide an alternative to surgery but also because the research might help other people with the same condition.
81. You must start from the presumption that every adult patient has capacity to make decisions about their treatment and care. You must not assume a patient lacks capacity to make a decision solely because of their age, disability, appearance, behaviour, medical condition (including mental illness), beliefs, their apparent inability to communicate, or because they choose an option that you consider unwise.
83. A person has capacity if they can do all the following:
a. understand information relevant to the decision in question
b. retain that information
c. use the information to make their decision
d. communicate a decision.
(Decision making and consent, paragraphs 81 and 83)
27. Patients need relevant information (see paragraph 10) to be shared in a way they can understand and retain, so they can use it to make a decision. To help patients understand and retain relevant information you should:
a. share it in a place and at a time when they are most likely to understand and retain it
b. anticipate whether they are likely to find any of it distressing and, if so, be considerate when sharing it
c. accommodate a patient's wishes if they would like to record the discussion
d. accommodate a patient's wishes if they would like anyone else - a relative, partner, friend, carer or advocate - to be involved in discussions and/or help them make decisions
e. use an interpreter or translation1 service if they have difficulty understanding spoken English
f. share it in a format they prefer - written, audio, translated, pictures or other media or methods
g. give them time and opportunity to consider it before and after making a decision.
28. You should be alert to signs that patients may need support to understand and retain the relevant information, use it to make a decision, or communicate that decision to you.
29. You should make sure that reasonable adjustments are made so that patients with additional needs have enough time and support to understand relevant information and make a decision. In all cases, you must treat patients fairly and not discriminate against them.
30. You must check whether patients have understood the information they have been given, and if they would like more information before making a decision.
31. You must be clear about the scope of decisions so that patients understand exactly what they are consenting to. You must not exceed the scope of a patient's consent, except in an emergency.
Agreeing the scope of a patient's consent with them in advance is particularly important if:
a. treatment or care will be provided in stages with opportunities to review and adjust in between
b. different healthcare professionals will provide different parts of the treatment or care
c. there may be opportunity, once an intervention is underway and the patient's decision-making ability is compromised, to carry out another intervention
d. there is significant risk of a specific harm occurring during an intervention, which would present more than one way to proceed.
32. For some patients, there are foreseeable circumstances when they will have a choice of options at a time when they might find it more difficult to make decisions - for example because:
a. they may be in pain, confused or afraid
b. their capacity or insight may be impaired by their condition or the effects of an intervention
c. a decision may need to be made quickly so there will be less time for dialogue.
33. You should anticipate such circumstances and discuss them with patients in advance if practical, so that when a decision needs to be made patients have already had time and opportunity to consider the relevant information (see paragraph 10). Discussing a risk of serious harm will be easier to do in advance than in a time-pressured situation when the patient might be in pain, confused or afraid, and the mention of potential serious harm for the first time could be distressing.
34. Discussing options in advance doesn't remove the need to have a further dialogue immediately before providing treatment, and at regular intervals as treatment or care progresses. Even if there's a care plan in place, or the patient's made an advance decision, you should still talk to them about the options available in case the options have changed or the patient has changed their mind.
35. If a patient has a condition that is likely to impair their capacity as it progresses, you should sensitively encourage them to think about what they might want to happen if they become unable to make healthcare decisions. You should bear in mind that some patients may not be ready to talk about these issues. Such discussions might include:
a. the patient's wishes and fears, their preferences about future options for care, and the values and priorities that influence their decision making
b. any treatment or care the patient might want to refuse, and in what circumstances
c. any interventions that might become necessary in an emergency, such as cardiopulmonary resuscitation (CPR)
d. whether the patient would like anyone else - relatives, friends, carers or representatives - to be involved in decisions about their care.
36. A patient may want to nominate someone to make decisions on their behalf if they lose capacity or they may want to make an advance statement about refusing or requesting a particular treatment. In these circumstances, you should let patients know that there are ways to formalise their wishes and suggest that they seek support and independent advice about this.
37. You must record a summary of your discussion with the patient about their future care and any decisions they make, including as much detail as practical about the patient's wishes and fears, their preferences about future options for care, and the values and priorities that influence their decision making. If possible, you should make this record while the patient has capacity to review and understand it.
38. You should make sure the record of this discussion is flagged and made available to the patient and others involved in their care, so everyone is clear about what has been agreed. Any decision or preference should be easy to access and regularly reviewed.
39. If you are giving treatment or care to a patient who is nearing the end of their life, you must follow the guidance in Treatment and care towards the end of life: decision making.
(Decision making and consent, paragraphs 27 - 39)
You must make sure that decisions at all stages of research, especially for recruitment, are free from discrimination and respect participants' equality and diversity. You should take all reasonable steps to make sure that people eligible to participate in a project are given equal access to take part and the opportunity to benefit from the research.
Where appropriate, you should use patient and public involvement groups at all stages of the project to help make sure that the research is well designed and conducted.
(Good practice in research, paragraph 10)
Some adults with capacity may be vulnerable to pressure to take part in research. You should be aware that their health or social circumstances might make them vulnerable to pressure from others. Vulnerable adults may be, for example, living in care homes or other institutions, or have learning difficulties or mental illness. In these circumstances, it is particularly important that you check whether they need any additional support to understand information or to make a decision. You must make sure that they know they have the right to decline to participate in research, and that they are able to decline if they want to. The Royal College of Physicians of London provides further guidance on involving vulnerable groups in research.
(Consent to research, paragraph 21)