science

Quality Assurance/Quality Improvement Projects

Projects conducted solely for quality assurance or quality improvement (QA/QI) purposes are not considered to be human subject research at Tufts Medicine / Tufts University. 

However, in some cases QA/QI activities meet the definition of research (45 CFR 46.102(d)), and in these cases the regulations for the protection of subjects in research may apply.

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. In addition, many journals and/or national organizations require a formal determination from the IRB in order to submit a manuscript or abstract.

Non-research QA/QI projects:

  • Are designed to improve or assess internal practices, programs, or systems AND
  • Are NOT designed to contribute to generalizable knowledge* AND
  • Are NOT reasonably able to be replicated in other settings

*Generalizable knowledge is not explicitly defined by HHS but is understood to refer to information that can 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 non-research QA/QI initiative:

Do I need to submit to the IRB?

If you think that the project you are planning to conduct might be considered a non-research QA/QI project, fill out our Self-Assessment Tool to find out whether your project needs to be submitted.

If you get a message at the end stating that you do not need to submit to the IRB, please follow the instructions to save a PDF copy of your responses and that message. If you want to publish the results, or if you’re ever asked whether the project received IRB approval, you will need that PDF.

If the tool indicates that you do need to submit to the IRB, follow the instructions below:

What do I need to submit?

If the Self-Assessment Tool instructs you to submit the project to the IRB, create a new study in eIRB following the instructions on the Step-by-Step Guide to Submitting a New Study.

Note: Question #5 in the eIRB smart form is: “Will an external IRB act as the IRB of record for this study?” Choose No, even if another IRB has reviewed and approved the research. This question is asking whether Tufts will need to formally cede review to another IRB with a reliance agreement. If Tufts’ involvement is Not Human Subjects Research, a reliance agreement will not be necessary.

  1. In place of a Protocol, complete Form 13: Non-Research Projects to describe your project.
  2. Letter of Support Form – Permission to Conduct Research at Another Institution – Required if this project is being performed at another institution/organization.
  3. Letter of Support Form – Permission to Recruit Employees or Students – Required if you will directly target employees, residents, students, interns and/or fellows for recruitment.
  4. If you are prospectively collecting specimens/blood for the purposes of QA/QI, you will need to provide project participants with an Information Sheet. We have created a template for you here: QA/QI Information Sheet Template.
  5. Include any additional supporting documents (e.g., data collection forms, surveys, questionnaires).