Common Challenges with IRB Apps

We polled your friendly GME Research Staff on the most common (and easily avoidable) hiccups during IRB submission. Their guidance falls into three categories:

Flawed Documents

Make sure that: a) you are not missing any attachments and b) attachments that are submitted are filled out completely and in the correct format.  Read the fine print!

Quality Control

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

  • 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)

Methodological Concerns

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 CMHS Institutional Review Board website.
  • Issues around HIPAA authorization
  • Potential risks not properly outlined. For more information, see Understanding Risk.
  • Research Study Team members are appropriately accounted for
  • Leading a randomized control trial will likely not be feasible during your residency due to resource constraints.
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