Home / How to Submit / NHSR/Engagement Determinations Submission Requirements / Quality Assurance/Quality Improvement Projects
Projects conducted for the purposes of quality assurance or quality improvement (QA/QI) purposes are not considered to be human subject research at Tufts Medical Center/Tufts University.
Note: The Principal Investigator should not make the final determination as to whether a project constitutes human subject research or not; that determination may only be made by the IRB.
Quality assurance/quality improvement initiatives:
*Generalizable knowledge is not explicitly defined by HHS but is understood to refer to information that is intended to be applied outside of the program, process or system being studied.
Please refer to the following resources to help you determine whether your project might qualify as a quality assurance or quality improvement initiative:
1. Cover letter that includes:
2. If this project is being performed on behalf of another institution/organization, include a letter of support attesting that the project activities are being performed for QA/QI purposes.
3. Any additional supporting documents (e.g., data collection forms, surveys, questionnaires)