We polled your friendly GME Research Staff on the most common (and easily avoidable) hiccups during IRB submission. Their guidance falls into three categories:
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!
- Make sure you have submitted all required information. Review the Advice for Advancing Your IRB Application document for guidance.
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)
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
- 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 CMHS Institutional Review Board website and the Advice for Advancing Your IRB Application guide.
- 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.