Assent from a surrogate

In these situations of emergency research, although according to British law relatives cannot give consent, it is always wise to obtain their assent to the research process if at all possible. The Declaration of Helsinki admitted the possibility of assent being given by a surrogate in a case of physical or mental incapacity. The ethical basis for surrogate consent is a concept of substituted judgment where the surrogate is supposed to act as the patient would have done him- or herself. It is suggested that surrogate consent is better than no consent at all. Perhaps the most important advantage of surrogate consent is that it allows the possibility that the surrogate may refuse consent to the research on the basis of their knowledge of the patient's attitudes. There are obviously problems regarding who can act as a surrogate for patients. In some countries there is a hierarchy of relatives, but in modern life many people may regard their next of kin as somebody who is not a relative at all. Another problem about surrogates is that it may prove very difficult to find the surrogate to allow research under such emergency situations.

Another idea that has been proposed as a solution to this problem of consent of the incapacitated patient in intensive care is the idea of deferred consent ( Abra.m.s.o..n...

etal: 1986), ie. obtaining consent to research after the procedure has already started. My own view is that this is not a very satisfactory solution because there is no element of informed consent at the start to either the patient or any surrogate or relative.

In this time of patient autonomy and increasing information patients, particularly in the United States, often have living wills, and a proviso of the living will may be a consent to research or otherwise in the intensive care situation. Perhaps a more useful concept, as practised in the United States although rarely, as yet, in Europe, is the idea of a durable power of attorney which the patient gives to a nominated representative to consent or otherwise to medical procedures if he or she is incapacitated. This would provide a very useful legal basis for consent in the emergency intensive care situation, although again it would suffer from the defect of time delay in finding the person who holds the power of attorney, as in the case of any other surrogate; in these situations time is often of the essence. The Council of Europe, through its Steering Committee on Bioethics, has stated in Article 6, Section 3: 'where according to law an adult does not have the capacity to consent to an intervention because of a mental disability or disease or for similar reasons, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided by law (Co.uncil...°i.Europe 1996). Article 8 of the same document states that when because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerned. Therefore it seems that the European regulations would permit research in intensive care without consent of the patient provided that all the safeguards were maintained.

In the United States a consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers noted that when the critical nature of the illness or injury, or the need to apply an investigation therapy rapidly, precludes prospective consent for participation in emergency research, patients are vulnerable not only to research risks but also to being denied potentially beneficial therapy for their life-threatening condition. They set out recommendations to resolve some of the problems surrounding research in the emergency situation (Biros e£al.i 1995).

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