Purpose | To test a hypothesis, advance a scientific body of knowledge, OR establish practice standards where none are accepted | To assess or promptly improve a program, or system OR improve performance as judged by accepted/established standards |
Benefits | Designed to contribute to generalizable knowledge and may or may not benefit subjects | Designed to promptly benefit a process, program, or system and may or may not benefit participants |
Risks/Burdens | May place subjects at risk and stated as such | By design, does not increase participant risk more than negligibly, with exception of possible privacy/confidentiality concerns |
Testing/Analysis | Statistically prove or disprove a hypothesis or in the case of qualitative research, establish scientific evidence to support an understanding of reasons, opinions, and motivations which supports the construction of a hypothesis | Compare a program/process/system to an established set of standards |
Requirements and Oversight | Research projects must meet IRB requirements for protection of human subjects Researchers conducting research must also meet HIPAA requirements regarding authorization to use or disclose protected health information Researchers conducting research must also meet FERPA requirements regarding access and use of student records | Quality Improvement projects are not covered by IRB requirements. IU physicians are allowed by HIPAA to use protected health information for Quality Improvement projects without patient authorization |
Characteristics | One of the main goals of the project is to advance general knowledge in the academic, scientific, or professional community The project will have a specific hypothesis or research question The project involves an organized review of relevant literature The project will be conducted using a research design that will lead to scientifically valid findings. Elements of a research design include control groups, random selection of subjects, statistical tests, sample design, etc. Most of the participants are not expected to derive a personal benefit from the knowledge gained One goal of the project is to generate, evaluate or confirm an explanatory theory or conclusion and invite critical appraisal of that conclusion by peers through presentation and debate in public forums | The project identifies specific services, protocols, practices, or processes or outcomes within a department, program or facility for improvement The project team may review available literature and comparative data, or programs, practices or protocols at other institutions in order to design improvement plan, but may not plan a full scientific literature review The project design uses established quality improvement methods (such as PDSA cycle) aimed at producing change within a program The project design does not include sufficient research design elements to support a scientifically valid finding Most of the participants in the project are expected to benefit from the knowledge gained The project does not impose any risk or burden on the participants The main goal of the project is to improve patient care, a program or service |