General Considerations

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  • This guidance is comprehensive to include aspects of research from varying disciplines. Do not be overwhelmed by the length of this guidance document.
  • Not all points will apply to all research.
  • The IRB will consider what is appropriate to the proposed research.
  • For each section, this guidance includes a description of why the information is important for IRB review (in italics).
  • The approved Research Plan must be submitted with the initial application, each continuing review.
  • The Research Plan will need to be updated via an Amendment Application to reflect any proposed changes and submitted with all other applicable protocol materials.
  • There is no minimum or maximum length requirement.
  • A list of commonly used human subjects definitions can be found on our website.

NOTE: See the Research Compliance Services (RCS) website for additional topical guidance. Be sure to incorporate relevant information from relevant guidance into the Research Plan.