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Guidance Information

 Preparing an IRB Application

  1. Use language that is understandable to an unfamiliar reader. Do not use acronyms, abbreviations, or language specific to your discipline.
  2. List all personnel involved in the human subjects research on the application. Be sure all researchers listed on the application have up to date CITI training or approved equivalent for non-MU affiliates.
  3. Make sure to prepare the right type of consent for your study. Use the templates provided on the IRB website under “IRB Resources.” Consents must specify all procedures listed in the protocol.
  4. A single protocol must only represent one study. A single study may have multiple conditions or phases, but a protocol should not describe multiple studies or versions of studies.
  5. Always err on the side of giving us more detail about what you are doing with participants (you can go light on the background/literature review). Thoroughly explain procedures in a detailed, step-by-step fashion.
  6. For every recruitment method mentioned in the protocol, be sure to upload the associated material (script, flyer, etc.) Information about what to include on recruitment materials can be found under the help button in section 7.7 of the IRB application.
  7. The IRB generally needs to see everything a participant will see over the course of study participation. Supporting Documents can include: survey instruments, interview guides, images/video clips, letters of support, relevant permission/approval letters, training documents for any external personnel, certificates of translation, and debriefing forms.
  8. Double check all portions of the application, attachments, and consents for consistency (description of the procedures, duration of the procedure, risks, benefits, etc.).

Please contact the IRB office if you have any questions or need specific guidance.  You can email irb@misericordia or click here.

Turn Around Time

  • Every project is reviewed on its own merit!
  • There are many factors that impact how long it takes for a study to get approved:
    • IRB work load
    • Type of IRB review
    • Involvement of vulnerable populations
    • Procedures that require the use of a consultant
    • Submission quality
    • Reliance Agreements (IRB Authorization Agreements, Individual Investigator Agreements, etc.)
    • Etc.