The patient's perspective on the need for informed consent for minimal risk studies: Development of a survey-based measure

ABSTRACTBackground: Recent efforts to study quality improvement (QI) efforts to improve the effectiveness and efficiency of healthcare have raised important questions about ethical boundaries for waiving informed consent. Confusion exists because similar projects can be undertaken for research or QI purposes, a distinction currently used to define Institutional Review Board oversight. However, patients are not aware of such distinctions. We sought to evaluate patients' views of waiving consent for non-invasive projects to improve healthcare quality and delivery. Methods: We developed a 32-item measure of patient thresholds for waiving consent for different types of QI interventions, including those involving changes to: 1) the hospital environment; 2) hospital policies or procedures; 3) objects used by patients; 4) medications or devices; and 5) use of patient information. In a sample of 200 hospitalized patients, we tested and confirmed the reliability and validity of subscales representing each of the 5...