Do I need IRB Approval?

Does Your Study Need IRB Review?

Faculty, staff, and students at the University of Massachusetts Amherst proposing research that involves intervention or interaction with individuals, or involves obtaining information about individuals, should seek a determination.

The Determination process asks researchers to provide just enough information for our office to apply the federal regulations to the project and decide whether the project falls under the auspices of the IRB or not. For more information about the regulatory framework for making determinations please visit Determining Whether IRB Review is Required for an Activity.

Determination Submission

If there is any ambiguity as to whether your project should be reviewed by the IRB, your first step should be to submit a Determination Form in Kuali.  

The process is the same as submitting an IRB Protocol:

  • Log in to the Kuali Protocols module and click the “+New Protocol” button located on the upper right-hand side of the screen.
  • Select “IRB” from the drop-down menu that will appear.
  • Complete the General Information fields (Principal Investigator, Department, and Protocol Title)
  • Click “Next” on the right-hand side of the screen.
  • Complete the questions regarding project type (Biomedical or Social Behavioral) and Community Engagement. 
  • The final question on this page will be “Are you seeking to determine whether or not your project requires IRB review?” Answering “YES” to this question and clicking "Next" on the right-hand side of the screen will open the Determination form.

Determination Process in Kuali - FAQs