Whether you are a veteran or a novice researcher this section is designed to help you prepare your study for IRB review. In this section, you’ll find tools to help you understand who and what is involved when you conduct human subjects research. The tools and topics outline what is expected of you and your research team.

Follow the steps in the checklist below to aid with pre-submission preparation. (Note: ADA-compliant forms are available on the Forms & Templates page.)

Pre-Submission Steps

The IRB has purview to review and approve any research that meets the definition of human subjects research. Not all projects are considered research or human subjects research.

To confirm that your study meets the definition of human subjects research, download HRP-310: WORKSHEET - Human Research Determination. Consult the IRB Office via email at irbadmin@colorado.edu or by phone at (303) 735-3702 if you have questions. If you need a formal determination, you must submit your study via eRA for review.

The Investigator Manual is designed to guide you through policies and procedures related to the conduct of human research. This manual will answer many of your questions and will be a valuable reference throughout the lifetime of your study.

Feel free to download and print a copy of this manual to share with your research team:

Review the roles and responsibilities expected of you and your research team. Roles include principal investigators (PIs), co-investigators, and faculty advisors for student research.

Complete CITI training and obtain completion reports for you and your research team.

Learn about the different categories of IRB review in order to determine which study documents you should draft.

Review the eRA submission types and requirements.

See the submission timeline for an estimate of IRB review response.