Trial design and informed consent for a clinic-based study with a treatment as usual control arm

Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using TAU as a control condition and the difficulty in designing high-quality research in a community-based setting.