Oversight of quality improvement: focusing on benefits and risks.

Quality improvement (QI) may substantially improve patient outcomes while posing little risk to subjects. However, the term quality improvement is used to refer to a broad range of projects, which vary widely in the potential benefits and risks to participants. Some projects raise ethical concerns. An explicit protocol for the ethical review of QI would benefit both patients and leaders of QI projects. If a project is considered research rather than QI, review by an institutional review board and informed consent from subjects may be required. In contrast, QI projects may require little oversight beyond what is already in place for clinical care. However, a monolithic approach to oversight of QI is inappropriate in light of the variation in benefits and risks of QI projects and their overlap with research. The key ethical issue is not the classification of a project as QI or research, but the balance of anticipated benefits and harms in the project. We propose a protocol for independent review of QI projects and patient consent that will protect subjects from serious harm while encouraging QI projects that will substantially benefit participants and pose only minimal risk.