Barriers to informed consent in clinical trials.

Clinical trials are a type of scientific study conducted in human beings. They are designed to evaluate the safety and effectiveness of new drugs, procedures, or other means of treating, diagnosing, or preventing diseases. The ethical issues involved in clinical trials are nothing new, but because of the increased access to studies, they are steadily affecting more people. The sheer volume of clinical trials, as well as the number of patients and professionals involved in them, has increased in the past decade. Informed consent is a key element of clinical research. Meaningful informed consent requires that subjects weight the associated risks and benefits of an experimental intervention and then voluntarily give consent. One concern regarding informed consent in research is the confusion between therapeutic intervention and experimental treatment. This confusion could lead to barriers in informed consent. This column addresses this concern and includes a case study to illustrate the misunderstandings that might arise from the patient who is compelled to consent to clinical trials because of his sense of hopelessness from a chronic health condition and the traditional medical intervention he is receiving.