Common Challenges with IRB Apps

• Make sure that:
  • You are not missing any attachments and 
  • Attachments that are submitted are filled out completely and in the correct format. 
• Confirm you have submitted all required information. Review the Common IRB Forms Explained document for guidance.

At the time of submission, your application should be polished and thorough – not  in rough draft format (Pro Tip: portions of a well-written application may be useful in jumpstarting the manuscript writing process). Some pitfalls to avoid when writing your application:

• Spelling/grammatical errors
• Partial sentences
• Missing title
• Missing version number (on each page of attachments)
• Leaving out investigators
• Mismatch between hypothesis and goals/aims across various submitted forms
• Missing information (e.g. expected time to complete surveys; number of patients the researchers plan to enroll; enrollment timeframe; where intervention drugs will be stored; steps for HIPAA protection)

Your study should be methodologically, logically, and ethically sound. GME Research Staff are happy to guide you through the research development process, but be sure to bring them a well-thought-out idea and list of questions to maximize everyone’s time. Some common mistakes to avoid:

• Issues around consent
  • Be sure to provide details on the informed consent process to both English and non-English speaking patients, including: who will consent patients, where consent forms will be stored, and how verbal consent will be documented. For specific questions, consult the GME Research FAQs and the CMH Institutional Review Board website.
• Issues around HIPAA authorization
  • You will need to obtain a written HIPAA Authorization from the subject(s) whose PHI you are using for research. For more information, consult the CMH Institutional Review Board website and the Common IRB Forms Explained guide.
    • A helpful primer on HIPAA in Research can be found here and a more comprehensive resource can be found here.
• Potential risks not properly outlined. For more information, see Understanding Risk.
• Not appropriately accounting for the Research Study Team members.
• Leading a randomized control trial will likely not be feasible during your residency due to resource constraints.