Ethical issues in patient safety research: a systematic review of the literature.
This systematic review of ethics in patient safety research identified several universal issues, including difficulty distinguishing between research and practice, the need for oversight, respect for privacy and confidentiality, and informed consent. A specific challenge for patient safety research is the duty to report any errors that are uncovered to patients and relevant authorities. The authors recommend specific ethical guidelines for patient safety research in order to assist investigators and institutional review boards in designing and reviewing studies.