communicating risk in the United Kingdom

Mazur describes how in the United States clinicians are changing their practices in accordance with what the law demands. In the United Kingdom the medical profession should take the credit for the changes in clinical practice that have driven the law on informed consent. Within certain limits, it is the clinician who decides how and what to impart and, unless there is an adverse outcome, patients are unlikely to complain and cannot sue about inadequate information.

A report by the chief medical officer for England on clinical negligence acknowledges that communication and information sharing has to be improved.¹ Exchange and provision of information is at the core of an open and honest relationship between healthcare professionals and patients.² Mazur questions whether relatives should be informed when the patient does not want to know. Although this may be prudent, a relative still cannot give consent on behalf of a living patient. However, recent inquiries in the United Kingdom (Royal Liverpool Children's Hospital and the Isaacs reports) have emphasised the need to communicate fully with the next of kin to obtain consent for organ retention from deceased children and adults.

Figure 1.

Royal Courts of Justice, London

Credit: ANDY DRYSDALE/REX

Bolam test

Adequacy of information in law is assessed by the Bolam test—that is, whether the act or omission complained of accorded with what a responsible body of professionals would have done at the material time. As Mazur reminds us, the United States adopted the concept of a “reasonable person” standard in 1972. This approach was rejected by the House of Lords in 1985 (Lord Scarman dissenting). Their lordships reiterated the applicability of the Bolam test to issues of consent, although they included the caveat that disclosure of risk in some circumstances was so obviously necessary to a patient's informed choice that no reasonably prudent doctor would fail to make it.³

By 1997, the medical profession had effectively introduced its own “reasonable person” standard. The Royal College of Surgeons reminded surgeons that they must convey sufficient information “in detail required by a reasonable person in the circumstances of the patient to make a relevant and informed judgment.”⁴ In the case of Bolitho, the House of Lords said that even though a responsible body of medical opinion (the “Bolam” test) might hold something to be reasonable, this opinion was susceptible to destruction by logical analysis⁵: an unreasonable failure to disclose may now render a clinician liable in damages whatever his colleagues declare to be responsible practice. The finer the balance between benefit and risk, the more clinicians need to be attentive to informing the patient fully.

Clinical research

For consent in clinical research, Mazur espouses a “reasonable volunteer” standard. No such standard exists in the United Kingdom. Although we can agree on the need for more emphasis on “explicit detailing of information” in obtaining consent, the principles remain the same provided there is a potential therapeutic benefit to the individual volunteer. When genetic tissue can be stored for future research programmes Mazur sees the burdens on clinicians increasing still further in order to satisfy US data protection legislation; this is also true in the United Kingdom. Although therapeutic research may provide a benefit to balance against any risk to the volunteer, non-therapeutic research, by definition, cannot, and even when volunteers have the capacity to consent there are tight moral and absolute legal limitations. Incapacity makes consent to non-therapeutic research unobtainable, but in the few cases where it can be “convincingly shown” that a therapeutic research procedure is in the “best interests” of an incapable patient,⁶ the clinician in an emergency (and the court when time permits) can ensure that the balance between humanity and human autonomy is maintained.