Risk, Helsinki 2000 and the use of placebo in medical research

Abstract

There has been vigorous debate over the use of placebo controls in clinical trials in human subjects where active treatments are already in widespread use. The debate has extended from the use of placebo controls in trials of products for AIDS in developing countries to the use of placebos in trials in conditions such as mild hypertension, asthma, depression, chronic stable angina etc. Some have argued that placebos can never be justified where an active treatment exists. By contrast, we believe that minor levels of risk are justified in healthcare research under defined conditions provided there is full information and consent. The opportunities for altruism in research should neither be exploited nor prevented.