Presumed consent or waiver of consent

Research in emergency life-threatening situations requiring immediate treatment in patients who are unable to communicate and where there is not time to look for relatives or any legal representatives can be conducted without consent under certain conditions ( Biros.etal 1995). The United States Federal Drug Administration allows physicians to carry out research with a waiver of informed consent under certain specified conditions ( US D.®p§rtm,§ni.oLH,§.§Jih.,...a.Od H,ymaD,„.S.®ryic®siiJi995).

1. This situation assumes that the research will benefit the patient him- or herself. In these circumstances it is obviously very important that the research must have been planned in advance and approved by a reputable independent ethics committee who should examine not only the ethics of the research but also critically scrutinize the scientific content.

2. The research should not involve significant risk.

The concept of risk in patients who are critically ill is difficult in that the risk for them is very different to the kind of risk that might be acceptable in a well person.

1. Patients or surrogates will be given full information after recovery and, if needed, proper informed consent will be sought when the patient regains consciousness.

In this kind of critical emergency situation the doctor has to act in the best interest of his or her patient according to a concept of presumed consent. There is a danger with current legislation that it may prove more difficult to carry out research on unconscious patients in intensive care if the general rules for research are overlegislated and thus preclude patients from the benefits that research can give.

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