RESEARCH AND ETHICS IN EMERGENCY-MEDICINE

Prerequisites for experimental study designs are extremely difficult t o realise under prehospital emergency conditions. Results obtained in animal experiments always need validation with prehospital or inhospit al patient studies. Investigations related to emergency medicine are, however, an ethical obligation on behalf of the patient. A retrospecti ve analysis of the available literature should be considered a prerequ isite for prospective randomised and controlled studies. Frequently, a pilot study or feasibility trial needs to precede the actual study. I nformed consent must be obtained for all patient studies. However, und er emergency conditions informed consent cannot always be obtained due to unconsciousness, etc. Nevertheless, the following principles shoul d be observed: (a) randomised studies are essential, even in emergency medicine; (b) they are ethically acceptable if the treatment provided for the study group is at least equivalent to the therapy for the con trol group; (c) only these preconditions guarantee that the patient al ways receives treatment in accordance with the standard of treatment. If the patient is unconscious or otherwise unable to give informed con sent, the principle of deferred consent is acceptable. The deferred co nsent principle should be carefully documented. A prospective randomiz ed study represents the gold standard for an investigation, even under emergency conditions. There are different principles of randomization : telephone or telefax randomisation, etc. Emergency medicine investig ations need to be completed within a reasonable time frame which shoul d, as a rule, not exceed 2 years. Otherwise, too many items might chan ge without being noted. Curative treatment and the intention to treat are terms employed by ethics committees. If an investigation does not bear in itself additional risk factors, it does not necessarily have t o be brought before the ethics committee. If, however, for example, th e effect of obtaining blood samples is investigated separately for res earch purposes, the patient needs to be informed and sign the respecti ve agreement. In Germany the ethics committees have agreed to accept t heir respective decisions. For multicentre and multinational studies, however, the ethics committees also need to accept decisions made by n on-German ethics committees. Not all therapeutic principles can serve as the basis of prospective randomized studies because they need to be considered the present standard of care (e.g., endotracheal intubatio n, etc.). Nevertheless, the feasibility of a study should be assessed according to the 1-3 rating proposed by the American Heart Association . In principle, the overall emergency physician protocol does not fulf ill scientific requirements. For all studies, particularly in the preh ospital setting, an independent observer should be involved for docume ntation purposes. Scores can be of importance for investigating differ ent treatment regimens. Biases in emergency medicine studies focus on the variability of EMS, personnel qualifications, etc. This is in part why it is extremely difficult to prove efficacy and efficiency in eme rgency medicine. The results of emergency medicine investigations shou ld be published in suitable journals, i.e., journals with a reasonable rating.