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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:

  • Are intended to improve or assess internal practices, programs, or systems and
  • Are not designed to contribute to generalizable knowledge*
  • Are not intended to be replicated in other settings

*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:

What do I need to submit to the IRB?

If you think that the project you are planning to conduct might be considered a quality assurance or quality improvement initiative, submit the following in hard copy with original PI signature

1. Cover letter that includes:

    • Project Title
    • The funding source for the project, if any
    • The activities and intended purpose of the project
    • State whether there is intent/likelihood to produce generalizable knowledge from this project
    • What products (reports, presentations, etc.) will result from it, if any where they will be disseminated, and who is the intended audience
    • Whether data will be sent/shared outside of Tufts
    • Any other information you would like to convey about the project

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.

    • Please note: this letter must be from the appropriate person at the organization who has the authority to make this determination.

3. Any additional supporting documents (e.g., data collection forms, surveys, questionnaires)