The role of the clinical trial nurse in the informed consent process.

The purpose of this descriptive study was to elicit information about the current practice of clinical trial nurses in the informed consent process. A 50-item self-administered anonymous questionnaire was completed by a sample of 95 nurses from hospitals affiliated with McGill University in Montreal, Quebec, Canada, who were members of a clinical trial research team whose principal investigator was a physician and whose research participants were competent adults. The nurses were all members of the provincial nurses' association. Clinical trial nurses were found to have an important role in the informed consent process and to experience conflict of interest and other ethical dilemmas as members of clinical trial research teams. There is a need to develop specific practical and ethical guidelines for nurses involved with clinical trial research and to develop educational programs for nurses working in clinical research.