There are 4 examples of IRB applications that were accepted without requiring additional information

  • Reviewing Form 1 in each of these studies will assist you in addressing each area in Form 1 and also provide good examples of types supporting documents that were included as needed.
  • As you review notice the level of detail to each section. Their responses were clear and detailed so the reviewer had a clear understanding of what was being asked of the participants and what was being done to the data to maintain confidentiality.
  • All identifying information related to the research team and PI have been deleted to maintain confidentiality.

Study 1: Example #001 Form 1

  • Provides a good example for describing the procedure, see this section of this application and notice how it provides a step-by-step process for conducting this study. The debriefing paragraph is well written and descriptive.
  • Notice the detail to section titled: Procedures for Attaining Consent or Assent, it is very descriptive and clear.

Study 2: Example #002 Form 1

  • This application is clear and very easy to read and follow.
  • The section titled: Possible Risks to Subjects and Precautions Taken To Avoid Risks is well written and detailed.

Study 3: Example #003 Form 1

  • The Procedure section is clear and well written, notice the details in this section.
  • Form 8 Request to Waive Consent provides a nice justification for waiving informed consent and describe how debriefing will occur.

Study 4: Example #004 Form 1

  • Well written, clear, and detailed.
  • The section titled: How Will Subjects be Selected and Recruited is well written and offers nice details to mitigate coercion.
  • This application provides a nice description of each instrument used in the study.