Protocol Application

Non-Exempt Research
If you plan to conduct a research project using human participants, you must complete and submit an Application and Research Protocol Form for IRB review and approval.  The protocol should:

• describe your research plan
• explain how the privacy and safety of the participants will be protected
• explain and document how informed consent from the participants will be obtained.  If you are carrying out research with minors (under age 18), you will need to explain how you will seek parental or legal guardian consent as well as the child's assent.

Request for Exemption
Some research projects using human participants raise no substantial risk to anyone.  These projects receive limited IRB review and, if approved, are exempted from further IRB oversight.  The criteria for requesting an exemption from further review are specified on the 2nd page of the Application and Research Protocol Form.  If you believe that your project meets these criteria

• request exemption on the cover page of the application form
• on the 2nd page of the form, specify the exemption criteria that apply
• answer only the questions requested in the instructions on the 2nd page

The Application and Research Protocol Form is a simple set of questions and requests for information about your project.  Each question should be answered in clear, self-explanatory language so that IRB reviewers who may not be familiar with your research will readily understand the proposed project.