ABSTRACT

The purpose of research is to gain knowledge and understanding through original investigation. Health professionals have an increasingly active role in research in order to develop new knowledge and to create a larger evidence base to inform their practice. The legal principles apply when seeking consent from patients for research purposes as when seeking consent for investigations or treatment. The court was satisfied that the proposed treatment was consistent with the philosophy underpinning the Bolam test, i.e. there was a responsible body of medical opinion which supported the innovative treatment. If the treatment being offered is of an experimental nature, but not actually part of a research trial, this fact must be clearly explained to patients before their consent is sought, along with information about standard alternatives. Overall responsibility for all elements of research activity, including gaining consent, rests with the lead researcher, although each individual member of the research team is responsible for their own specific actions.