General Considerations [1]
- 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 [2]can be found on our website.
NOTE: See the Research Compliance Services (RCS) website [3] for additional topical guidance. Be sure to incorporate relevant information from relevant guidance into the Research Plan.