Definition of adverse reactions in clinical trials of a behavioral intervention

An important tenet in the ethical conduct of research is to evaluate the risk–benefit ratio for each participant as part of obtaining informed consent [1]. Identifying potential adverse reactions to treatment has long been a major touchstone for risk assessment in drug efficacy trials and treatment. In the conduct of clinical drug trials, safety data, including adverse reactions, are carefully documented and have become an important part of the indication to use the drugs to treat people in the public health system. Trials of behavioral interventions, including interventions that assist individuals in reducing their r isk of contracting HIV, have the potential to confer not only benefits but also risks. Procedures are needed to systematically detect, monitor, and respond to adverse events in clinical trials of behavioral interventions.