Principles of research

Research has burgeoned in the last decades. It is recognized that clinical investigation is only acceptable if informed consent to this activity is granted by the patient. Informed consent was first defined in the Nuremberg code as 'the voluntary consent of the human subject is absolutely essential'. This means that the person involved should have the legal capacity to give consent, should be so situated as to exercise free power of choice, without the intervention of an element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion, and should have sufficient knowledge and comprehension of the elements of the subject matter involved to enable him or her to make an informed and enlightened decision. Informed consent therefore requires the following:

1. disclosure of information;

2. legal competency;

3. voluntariness and freedom of choice;

4. understanding by the patient;

5. decision-making capacity.

These principles grew up as a result of the revulsion felt universally to the practices in so-called 'research' carried out by the Nazi regime on concentration camp victims in the Second World War. This set of principles has been reaffirmed repeatedly in the declaration of the World Medical Association (Tokyo 1964: revised in Helsinki 1975) and in guidelines issued by the World Health Organization. The idea that research could be justified on the grounds of 'good of society' should never prevail over the interests and welfare of any particular human being ( Lemaire.etal 1997).

These principles have made it essential that all research is scrutinized by a research ethics committee empowered to give or deny consent for research. The need to recognize patient autonomy and to control medical investigation is intended to protect the concerned individuals who, in the case of intensive care, may be in no position to look after their own interests.

The vast majority of patients in intensive care are unable to give consent as defined above. Even when they appear to be conscious, they may be not be competent as a result of either disease causing confusion or the effects of drugs given for sedation. Judgment as to the competency of patients in intensive care to give consent is usually made by the attending intensive care doctors. It is recommended that there be a separation of duties between the responsible ICU physician and the investigator, and that they should not be the same individual. Clearly there are situations where consent cannot be obtained, for example research into treatment of cardiac arrest where consent cannot be asked from the patient. Intensive care specialists strongly believe that there is an ethical obligation to undertake research in these situations to improve patient care and outcome. Various solutions have been proposed to the problem of obtaining consent in the emergency situation and/or intensive care.

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