Popis: |
Misconceptions regarding quality improvement (QI) projects and their role within the human subjects research paradigm exist. Projects resulting in information applicable to local institutions with an emphasis on dissemination of the process implemented represent QI projects. Studies resulting in generalizable knowledge represent human subjects research. The chief misconception is that projects using experimental and quasi-experimental designs are not QI. Defining QI based on methodology is incorrect. Determination of whether a study is or is not QI lies in the study’s purpose. Nineteen study designs applicable to QI are presented. To assist faculty in determining whether a proposed study is considered human subjects research or QI, several tools are presented, and the IRB process in the context of QI is discussed. To ensure the rigor of QI, the SQUIRE guidelines are reviewed to provide guidance to faculty project directors. Finally, best practices for QI ethical considerations and human subjects research are emphasized. |