Neuberger criteria: competence, information, understanding, voluntariness. All dubious!
New GMC guidance on consent (2008) – places it in context of process of discussion and decision-making. There is no “once size fits all” method. Starts with information being provided, in different formats. References advocacy services. Does not set threshold values for discussing risks: sensible, given how complex the communication of risk can be (see above). Acknowledges that some patients do not wish to go into detail about their condition. While doctors must respect their patients’ wishes, there is a minimum level of information that a patient is likely to need in order to give valid consent. Adults with Incapacity Act (Scotland 2000) and Mental Capacity Act (England 2005) establish mechanisms for incapacitated adults. Provides practical advice on assessing capacity.
In Scotland, legal age of consent is clearly defined as 16yrs (Age of Legal Capacity (Scotland) Act 1991). In England, Family Law Reform Act 1969 defines “child” as under 18yrs! This leads to some issues when it comes to competency.
Written consent – the law only requires written consent for a very few things, eg IVF, organ donation! But you must record the fact that you have gained consent in medical records. And it may just make everything easier to get it written anyway.
Proxy consent by parents can create conflict of interest eg handicapped child. Authorization a better concept (presumes right of child to take part in research)? Non-therapeutic research is not strictly legal, but usually accepted if minimal risk ie not significantly increased risk compared with standard care. Right of research enshrined in possibility of benefit outweighing possible risks. Alternative is therapeutic orphans, treated without good evidence of benefit. Failure to conduct research led to prophylactic sulphonamide disaster in 1950s (increased kernicterus). Research without consent not strictly legal but possibly acceptable for emergency situations, but retrospective consent should be sought (not really consent at all, of course) else assent (simplified consent) with later ratification, in stages if necessary.
Reasons for refusal in EURICON study: perceived risks/distress; distrust of research/researchers; dislike of the tone of approach of the doctor; shock and inability to decide; inconvenience of follow up. Hence communication skills essential. Information sheet should be given but should not be relied upon. As a minimum, parents must know that the treatment is being given as part of a trial, that their child may be receiving an experimental or unproven treatment, that they are free to say no and to opt for standard treatment. Check list should be provided. Involvement of independent committee should be highlighted. Feedback to parents should be encouraged.
Inability to give consent eg children, unconscious, learning difficulties does not mean research should not be done Â– indeed that would deprive patients and others of potential benefit. But should only be done if unable to do same study with patients who can give consent; risks should be minimal (for non-therapeutic research that means equivalent to everyday life or minimally invasive therapeutic interventions; assent should be sought from appropriate advocates eg relatives, who should be provided with the same information which would have been given to a competent patient; research should be explained after its completion to participants who have regained their competence subsequently (NOT retrospective consent, mind you).
Use of medical records without consent is a moral wrong Â– should be balanced against potential benefit. Patients should be informed of this potential use of their records and reassured about confidentiality. Only do if consent not praticable; research is of sufficient merit and has potential benefit; identifiers should be removed where possible; contact with patients is not anticipated; permission should be gained from responsible clinician.
How to get consent Â– Parents should feel they are being cared for, as well as their child. They should feel that they are being involved in the discussion of care. They should feel that they are being asked for their permission to enter the baby into a trial, not to defend the best interests of the baby. Parents hate the idea of their baby being a guinea pig, so emphasize background to study: importance, plausibility, etc. Acknowledge the pressure being put on parents to absorb and understand all the information. Invite questions and interruptions, reiterate key points. Accept that research has negative connotations. Randomization is difficult to understand (and if they do, computer allocation is seen as more appropriate than tossing a coin or drawing from a hat!)! DonÂ’t say what you would do. Beware strange comments/questions Â– suggest misunderstanding. Reinforce that whatever the decision, the best proven care will be given. DonÂ’t rush.