IRB Submission Tips for Researchers

Would you like to help speed up the review process?  If you follow these tips and avoid the common mistakes mentioned below you will prevent your submission from being returned to you for revisions during the initial pre-review. This saves valuable time!

SUBMISSION TIPS

For a successful application you will:

  • Use the latest version of all IRB applications and templates found on the Mentor App. Your application will be returned for revision if older forms are used.                                           
  • Ensure all research personnel (PI, Co-PIs, Research Assistants, etc.) have completed the CITI Training on human subject research. The CITI system and Fordham’s Mentor app sync with each other so your completion certificates will automatically appear in Mentor. However, if any research personnel are not affiliated with Fordham, you must upload their CITI certificates into Mentor as you do with any other supplemental documents.
  • Make sure your Faculty Advisor has reviewed and approved your protocol before submitting it into Mentor. After submission there is a place in Mentor for the Faculty Advisor to officially accept your protocol.  If they have already reviewed your protocol, they can immediately accept it which saves time. Review of your submission cannot begin until the protocol has been accepted.
  • Answer all applicable questions on the Mentor IRB Info page when creating a new protocol.
  • Ensure that the information you enter in Mentor is consistent with the information in your application. If you state in Mentor that the review type you are applying for is expedited, make sure you use the expedited application form and not the form for exemptions. If you select certain expedited categories in Mentor, make sure they are correct and match the categories you select on your application.
  • Answer every question on the IRB application completely and correctly. If a question is not applicable, write N/A so it is clear the question was not missed.
  • Use simple, jargon-free or lay language in all writing on the application - including forms written for the participants. When writing your purpose imagine explaining your purpose to someone with no background knowledge of your subject.
  • Provide thorough methods information and ensure that procedures are explained in detail. Again, write in simple, lay language.
  • For exempt applications, choose at least one exempt category and provide the short justification. If applicable, more than one exempt category can be chosen.
  • Upload ALL participant-facing materials with your submission (as separate attachments) including:
    • Recruitment and screening materials
      • Any materials being used to recruit participants must be uploaded as individual attachments - your flyers (8 x 11 only), verbal scripts, social media posts, email templates.
      • Any materials used to screen participants such as written or verbal scripts and questions must be uploaded as individual attachments.
  • Informed consent
    • The Adult Informed Consent form must be uploaded as an individual attachment.
    • If consent forms related to minor participants will be needed, they must also be uploaded as individual attachments - the Parent/Guardian Consent form and the Minor Assent form (written form and/or oral script).
    • Is consent being waived? If so, make sure that the application includes either a Waiver of Consent or Waiver of Documentation of Informed Consent uploaded as individual attachments.
    • Are you doing research in NYC schools? If so, the NYC Department of Education Consent and Assent forms must be used, and then uploaded as individual attachments.
  • Detailed study procedure and data collection materials                                                                 This section should provide clear details on how data will be collected from participants.
    • If surveys (Qualtrics, Prolific or any other platform), focus groups, and/or interviews will be conducted the demographic questions, surveys, questionnaires, focus group questions and interview scripts should each be uploaded as individual attachments.
    • If psychological testing will be used the measures should either be included as part of the survey content or uploaded as individual attachments.
    • If participants will receive task instructions, then written task descriptions should also be uploaded as an individual attachment.
    • We need to know exactly what will be recorded (written down) during the observations. An observation data collection sheet may be uploaded as an individual attachment or may also be embedded in the protocol.
    • If intervention materials will be provided - such as presentations for an educational study - these must also be uploaded as individual attachments.
  • Remove any instructions to researchers and/or template language from consent forms. They are provided for your information only.
  • Carefully check your application and all supplemental materials for inconsistencies before submitting. When there are discrepancies, the application will be returned for revisions which extends the review process. All materials should have consistent information.
    • Common inconsistences; estimated time for participation, age ranges for participation, the use of “anonymous vs confidential,” inclusion/exclusion criteria.
  • Ensure that the application form and ALL supplemental materials are checked for spelling and typographical errors.

 

COMMON MISTAKES TO AVOID

  • Discrepancies between information entered in Mentor and the application – especially stating a certain review type but submitting a different application form.
  • Using too much jargon in the purpose, throughout the application and consent form.
  • Leaving questions blank. Mark each one N/A if they don’t apply.
  • Answering questions incorrectly – read them carefully first.
  • Providing inconsistent information among different sections of the application, or between the application and supplemental materials. Every detail matters, and everything must match.
  • Leaving instructions and/or sample language for researchers in the final version of your documents.
  • Not uploading all of the required materials – see the reminders above.
  • Not uploading required materials as separate attachments from the application.
  • Not applying for expedited review category 6 when audio and video recording is involved in the research.
  • Uploading the recruitment flyers in a smaller or larger size than 8x11