Identifying possible depression in clinical research: ethical and outcome considerations for the investigator/clinician.

Most nurse researchers are aware of the ethical implications of research including the need to ensure confidentiality for research participants, as well as to provide full disclosure of the risks and benefits of the study. However, another consideration that can impact methodology from the perspective of the protection of human subjects from research risks includes the measurement of certain psychosocial variables such as depression and appropriate disclosure of such information to research participants. This issue has received little attention in the nursing literature. The intent of this article is to provide an overview of (1) the importance of informing participants about possible depression, (2) issues of identifying potential depression in clinical research including those related to depression measures, (3) strategies for the investigator/clinician to ensure protection of research participants and potential impact of those strategies, and (4) considerations in addressing depression in study design and analysis.