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Under certain specific circumstances, the IRB may determine that certain activities do not constitute human subjects research.

Projects conducted for the purposes of quality assurance or quality improvement (QA/QI) purposes are not considered to be human subjects 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 generalizeable knowledge*

*Generalizeable 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 fall into this category:

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/quality improvement initiative, please review the information below. The IRB considers these points in making its determination, so please ensure that the information covered below is addressed in your submission:

  • The intended purpose of the project and any products (reports, presentations, etc.) to result from it.
  • Where any and all study activities will take place.

Please provide the information requested above in a cover letter addressed to the IRB. Please ensure that any applicable supporting documents (i.e., IRB approval letters, letters from another institution regarding the study) are included in the submission.

In particular, for QA/QI projects being performed on behalf of another organization, please include a letter of support attesting that the project activities are being performed for QA/QI purposes. Please note: this letter must be from somebody at the organization who has the authority to make this determination. If you have questions about what documents and information should be included, please do not hesitate to call the IRB Office.