Ethics of randomized clinical trials and the 'ALARA' approach

A balanced discussion on the ethics of randomized clinical trials should no t be based on a single ethical aspect such as respect for the patient's aut onomy. Rather, the analysis should consider the four ethical principles-res pect for autonomy, non-maleficence, beneficence, and justice-as applicable to ail groups of persons concerned. We present the ethical benefits and cos ts of the present practice of randomized clinical trials for four groups: p atients involved in clinical trials, patients not involved in trials, parti cipating physicians and society. The ALARA (As Low As Reasonably Achievable ) approach is then introduced and practical measures to achieve a positive balance beta een ethical benefits and costs of randomized trials are propos ed.