Office of Research Integrity and Assurance

Preparing for IRB Review

How to Prepare an IRB Submission

Step 1

The first step in preparing for IRB review is to determine whether IRB approval is even necessary.  See Do I Need IRB Review? for more information.  If you determine that IRB review is NOT required but would like a formal determination, you may submit a Not Human Subjects Research request via RAMP.

Step 2

Once you have determined that your project requires IRB review, the next step is to prepare for your IRB submission. Generally, a complete IRB submission includes the following:

  • A qualified Principal Investigator (see University Policy 402) Note: Students may not be listed as Principal Investigators
  • An application in RAMP
  • A completed study protocol
  • Completed CITI training for study team members
  • As needed:
    • Consent documents
    • Recruitment materials
    • Study instrumentation
    • Other supplemental materials (e.g., data use agreements, letters of support, drug/device information, etc).

Study Protocol

The IRB has developed a variety of protocol templates for use with IRB submissions.  You can access them here: IRB Templates. It is important to read the protocol instructions and complete the document clearly and completely.  The protocol is the primary source of information about the study, and the IRB uses it as the basis for determining whether the study meets the regulatory criteria for approval.  If you have any questions about selecting the appropriate protocol template, please contact the IRB.

Consent Documents

Most studies involving interactions and/or interventions with human participants require some form of consent. You can find a variety of consent templates and samples here: IRB Templates. As you draft the consent documents, remember that it is the primary method for communicating with study participants about the study. Consider length, content, and readability as they relate to the study population.

Recruitment Materials

Recruitment material is anything that is used to communicate the prospective study participants prior to enrollment.  Some examples are social media posts, email recruitment, survey platform posts, flyers, and phone scripts. These must be reviewed and approved by the IRB prior to their use.

CITI Training

All study team members must complete Human Subjects Research training in CITI.  See CITI Training for more information. Note: Completion certificates do not need to be submitted in RAMP, but the IRB will confirm completion during the review process.

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