Informed consent - can trusts ever meet the legal standard?

In 2002, the Department of Health tasked the NHS with radically improving the process and documentation surrounding consent to treatment. Clearer guidance was issued about who was qualified to take a consent in different circumstances and standard documentation was introduced, including a requirement to obtain confirmation of an earlier consent at the time of admission for the procedure.

At the time, some clinicians regarded this initiative as a bureaucratic imposition that would extend the time of consultations with disastrous consequences for productivity in the outpatient department.

This was especially so when implemented with a robust observance of the increasingly exacting requirements of the relevant standards in the clinical negligence scheme for trusts.

In the event, the impact on productivity, if it occurred at all, was small. Across the NHS, patients have benefited from a much more robust and disciplined process for ensuring their options for treatment (and the relevant consequences and risks) are properly explained to them by experienced professionals. Trusts and clinicians also have much clearer documentation of the process.

Although the NHS Litigation Authority reports a reduction in claims with a significant consent element in the three years since the new policies were put in place, there were still 150 such cases in 2006-07.

So what more can be done to avoid such claims and why, given the robustness of the new procedures, are there still some problems with consent that provoke legal action against trusts?

Real understanding

The answer takes us back to legal basics and the literal definition of the term 'informed consent'. Giving a patient masses of information and documenting that this has been done is not in itself sufficient to prove that the patient understood what they were being told.

Recent case law (Chester v Ashraf 2004) has shown that the courts can impose a high burden on trusts to demonstrate that the information given to patients before a procedure is tailored to their specific circumstances and not simply a regurgitation of a standard information pack.

This has prompted some debate in the legal press about what additional steps hospitals might take to demonstrate the nature and the quality of the consent discussion between the clinician and the patient.

One controversial suggestion is that consent discussions for more significant procedures should be audiotaped or videotaped as a matter of routine. These recordings could then be used for the benefit of the patient to help them recall the conservation away from the stressful environment of the hospital. They would also be available if required in any legal proceedings as evidence of the quality of the consent that was taken.

There are many practical difficulties to such recording (especially where this is done simply as a record for the hospital). The greatest of these will be the acceptability to many patients of such a process and their concerns about the security of the recordings.

In a climate where there is a serious ongoing discussion about the rights of patients to refuse to have their records communicated electronically, there is bound to be even greater controversy about audio/visual recording of such a profoundly private conversation.

Apart from the practical and legal concerns, many NHS clinicians (and patients) will doubtless begin to wonder if a move to tape consent discussions 'for the record' will corrupt an important part of the treatment process for which a great deal of mutual trust is necessary between the clinician and the patient.

Viewed from the perspective of enhancing rather than undermining the bond of trust between a clinician and a patient, any taping of the consent discussion should be confined to specific circumstances (multiple treatment options with potentially significant consequences) where the clinician and the patient agrees it would be helpful to assist the patient in reflecting on the discussion with the clinician before coming to a view about treatment options.

As to the problem of proving to the courts, on the basis of current processes, that the patient understood what they had been told, the best trusts can do is produce well-documented evidence that current guidance is faithfully observed (including evidence that patients are allowed free and convenient access to a range of relevant professionals such as specialist nurses and are encouraged to make use of this if they have questions).

In most cases, good documentary evidence that current guidance is fully and properly observed will be a sufficient defence. However, there will be occasions when the quality of consent is legally challenged (usually in relation to adverse consequences of treatment).

In some cases, a judge may be more sympathetic to the claimant's position regarding the adequacy or quality of information they were given on the grounds that the patient's recollection of a process that was personal to them (and that they have experienced only once) will be clearer and sharper than that of a professional recalling one case from hundreds (a further argument for exemplary documentation).

So, while the current consent process is not entirely risk free from a legal point of view, the risk is minimised where there is full and proper observance of current guidance. In my view, we do not need to introduce technology into a process that must be built on mutual trust between the clinician and the patient.