Objective: To review the literature on the involvement of patients in efforts to promote their own or others' safety while using health care services. Method: A total of 1933 reports were identified as potentially relevant and 745 of these were included in the review (437 descriptions of interventions, 299 comment or opinion pieces and 42 discussions or studies of patients' willingness and ability to adopt safety-promoting behaviours). Results: The rate of publication on these topics has increased, especially in the USA and UK. However, there is scant evidence of the impact of patient involvement initiatives on safety outcomes and there has been little exploration of patients' willingness and ability to adopt particular safety-oriented behaviours. We identified three broad routes by which patients' actions might contribute to their safety by helping to make sure that: their treatment is appropriate for them (informing the management plan); treatment is given as planned and according to appropriate protocols (monitoring and ensuring safe delivery of treatment); and problems and risks within health care systems are identified and reduced (informing systems improvements). Conclusions: An approach for appraising interventions intended to promote patient involvement in patient safety should involve: identification of the routes by which interventions assume patients' actions might contribute to their safety; identification of the conditions that would need to be met for patients to behave and contribute as the interventions (implicitly) assume; examination of the extent to which the intervention supports fulfilment of those conditions; and consideration of the potential negative effects of the intervention.