How to Prepare and Submit your Application for IRB Review

[NOTE: Where this document refers to contacting the IRB, such contacts should usually be done via the CAP system unless an urgent situation requires immediate attention by the IRB Chair or the Assistant Director for Research Compliance.]

Preparing your Initial Review Application

• Prepare your research materials
  The IRB must review any materials that you will use as part of your research. This includes all materials used in recruitment (letters, phone scripts, flyers, etc.), consent forms, surveys or questionnaires, interview schedules, intervention tools, etc. Prepare these materials first before you fill out your application.  Having these materials already created when you begin writing your application will make answering the application questions easier.

  When preparing your consent form the IRB advises Investigators to use the IRB Template Consent Form when developing Informed Consent Forms.  Please also see the IRB's guidance on the Informed Consent process.

• Determine which Review Mechanism is Appropriate for your project
  The IRB reviews initial applications for research through three different review mechanisms:

  1. Exempt Review
  2. Expedited Review
  3. Full Board Review

  For help determining which IRB review mechanism is appropriate for your research please review the IRB's Guidance for Determining the Appropriate Review Mechanism.
• Fill out either the Application for Exemption or the Application for IRB Review
  When you fill out your application, remember to answer each question and all of its parts completely and in detail. The IRB must understand exactly what you are doing, step by step, in order to approve your research.  The clearer and more precise your IRB answers to the application questions are the easier it will be for the IRB to review your application.

  In general it is better to err on the side of providing too much information regarding recruitment, consent procedures, methodology, etc., as the lack of sufficient information in an application is the most common reason why the IRB Conditionally Approves or Tables protocols. The IRB cannot approve research based on a guess of what the Investigator intends to do. If an application is not clear enough and/or if the application does not contain enough details about how the research will be carried out approval will be delayed until the IRB has been provided with sufficient information.

• Edit your Application
  Editing your IRB application is an important step in the process. Read over your application and all of your research materials. Are your answers clear? Does your response to each application question provide sufficient details? Are your responses in your application consistent with the information in your research materials? Ask a colleague to read over your application and tell you whether any information is unclear.
  
  

  Please also remember that the materials you will distribute to participants are both a reflection of you and Loyola. It is unprofessional to have grammatical, spelling, or formatting errors in these materials. Since the applications available for download deactivates the spelling and grammar checking option in Microsoft Word, many investigators find it convenient to compose responses in a separate document and then paste them into to the IRB application form.

Additionally, if you are a student:

• Submit your IRB Application to your Faculty Sponsor for review.
• Ask your Faculty Sponsor to provide you with feedback regarding your application and research materials.
• After your Faculty Sponsor has reviewed your application and all materials, ask your Faculty Sponsor to type his/her name in the Faculty Sponsor Assurance section of the IRB Application to indicate his/her approval of your Application. Your Faculty Sponsor should then email the IRB your Application with all of your supporting materials.

How, Where and When to Submit your Initial Review Application

• What do you need to submit?
  You should submit a completed Exempt Application or Application for IRB Review and an attachment with all recruitment materials, consent forms, surveys, instruments, questionnaires, interview schedules, letters of cooperation, etc. All Consent Forms should be submitted to the IRB as a Word document (.doc).

  If you are a student and are completing the project for the purpose of a degree:

  • A scanned copy of your Ballot for the Approval of a Thesis/Dissertation Proposal that has been signed by your committee.

  If you are a Faculty Member submitting a project for external funding:

  • A scanned copy of the grant proposal
• How should you organize your initial application materials?
  Ideally, you should submit all of your appendixes in one Word document. If you have hard copies of materials (such as questionnaires, letters of cooperation, etc.) these should be scanned and submitted as one PDF document.The IRB will NOT accept submissions where each appendix is saved as a separate file.

  Note: All Consent Forms must be submitted as Word documents.

• When should you submit your application for review?

  Applications submitted for Exempt Review or Expedited Review are reviewed on a rolling basis. The IRB will begin the review of your application as soon as you submit it for review.

  Applications submitted for Full Board Review are reviewed at IRB Full Board Meetings that are held once a month. Applications for Full Board Review must generally be received by the Office of Research Services two weeks before the Full Board Meeting Date. Please review the IRB's current Full Board Meeting and Submission Schedule for the submission deadlines and meeting dates for the current term.

• How should you submit your application?
  All Applications must be submitted to the IRB through the online Compliance Approval Portal (CAP) system by a Faculty Member.If you are a student, your Faculty Sponsor must submit your application on your behalf.

  After you have submitted your initial review application to the IRB, the IRB will send you an email notifying you that your application was received. The IRB will then review your application to verify whether your application satisfies the criteria for IRB Approval. Once the IRB has completed the initial review of your application, you will be notified by email of the initial review outcome.

• When should you expect to be notified of the outcome of an initial review by the IRB?

  Exempt and Expedited Reviews:

  The IRB is generally able to notify Investigators of the outcome of their Exempt or Expedited review within 15 business days of receiving an application. Investigators are notified of the outcome of their review by email.
  
  

  Full Board Reviews:

  The IRB is generally able to notify Investigators of the outcome of their Full Board review within one week of the Full Board meeting the Protocol was reviewed at.