What is the application process for submitting an Expedited Category Review research project?

Expedited Category Review | What is Expedited Review | What are the Criteria | What is the definition of minimal riskWho decides whether or not a project has “minimal risk” | What Research Categories fall under Expedited Category Review | What is the application process | How will I know that a Protocol has been approved | Who receives these IRB Action Notices | What happens if my Expedited Review does not qualify

When submitting your Expedited research to the Office of Research Compliance, please submit 2 complete, collated packets with the following information contained within EACH packet.

(1) IRB Expedited Review Application Form (with original PI signature)

(2) Protocol Synopsis

(3) Informed Consent Form (if applicable)

(4) Conflict of Interest Form for all key personnel listed on the project

(5) CITI Human Subject Research Training Certificates for all key personnel listed on the project

If applicable;

(6) Recruitment Materials (flyers, emails, advertisements, etc.)

(7) Surveys/Questionnaires

(8) Telephone scripts/oral scripts

(9) Assent Forms/Parental Permission Forms

(10) Research Agreements

(11) Letters of permission or cooperation, and/or approvals from other IRBs

(12) HIPAA Research Waiver

In order for the OReC and the IRB Chair to make a timely and appropriate determination of the project, the documents and materials you submit must be thorough, clear and complete. If the application packet is missing some critical information or is otherwise incomplete, your entire set of IRB review documents and materials will be sent immediately back to you.

Please ensure that the needed information (listed above) is submitted in each packet for a more streamlined “speedy” review of your research project.

In addition, please keep in mind that the review process takes time, and research may not be initiated until the application has been approved.

In most cases, Expedited Review can be completed within 5 – 7 working days, unless needed information is missing or incomplete.