If you are new to human subjects research, the IRB process can be overwhelming. This checklist will help you get started and keep you on track for submitting an Initial Application to the IRB and what to do after approval.

  • ​ Are you a student? You will need a faculty member to be the Principal Investigator.
    CU Boulder students are not allowed to be Principal Investigators (PI) for human subjects research. A CU Boulder faculty member must be the PI; students can be listed as Co-Investigators.

  • ​​ Do you have access to eRA? If not, you may need a POI number. 
    All IRB-related documents are submitted through the Electronic Research Administration Portal (eRA). If you do not have a current employment relationship with CU Boulder, you will need a Person of Interest (POI) number to access eRA. If you have a POI and still cannot access eRA, contact erahelp@colorado.edu for assistance.

  • ​​ Complete DEPA.
    All faculty, and any other employee or student involved in the design, conduct and/or reporting of research are required to submit a Disclosure of External Professional Activities (DEPA) Form to the Office of Conflicts of Interest & Commitment in order to meet University and federal conflicts of interest and commitment reporting requirements. All study staff listed on a protocol must meet this requirement. 

  • ​​ Complete appropriate CITI training.
    All researchers involved with a protocol must complete the appropriate course for the research: Social Behavioral Research Investigators and Key Personnel (Basic Course) or Biomedical Research Investigators and Key Personnel (Basic Course). All study staff listed on a protocol must meet this requirement.

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

  • ​​ Decide level of review.
    There are two levels of review, Exempt and Non-Exempt, and each has its own set of required templates that are not interchangeable. The Exempt Self-Assessment can help you decide if your research qualifies for an Exempt Determination. Any research that does not meet Exempt requirements is Non-Exempt and will be reviewed using Expedited of Convened Board procedures. If you are still unsure after using the Exempt Self-Assessment, contact the IRB.  Note: The IRB reviewer will make the final decision regarding whether your research meets Exempt requirements.

  • ​​ Develop study materials.
    After determining if your research is Exempt or Non-Exempt, the next step is to download the corresponding required templates for Exempt or Non-Exempt Research from the IRB website. The IRB needs to review and approve final versions of everything you need to conduct research. This includes things that participants will see (or hear) such as the consent form, recruitment materials and assessment tools; as well as documents participants will not see, like the protocol document.

  • ​​ Create an Initial Application and submit materials in eRA.
    The Initial Application page provides helfpul information for what to include in your Initial Application. For step-by-step instructions on submitting materials to the eRA, see eRA Submission Guides. 

  • ​​ Wait for IRB response. 
    The IRB review process takes time and the first response you receive from the IRB may not be an approval. An Exempt protocol could take 20 business days for a final determination. Non-Exempt research will likely take more than 20 business days or even longer for research that requires convened Board review. If the IRB requests additional information, see the Response page for your next steps. 

  • ​​ Download approved documents from eRA.
    When completing the review process, the IRB will upload “official” approved versions of all study documents. After you have received an Exempt Determination or Approval letter from the IRB, you must download your study documents from eRA as you are required to use only these versions to conduct your research. 

  • ​​ Begin research.
    After you have downloaded the approved documents, you may begin your research as described in the approved protocol.

  • ​​ Manage ongoing research.
    Throughout the course of your research, you may find that changes are needed, which are submitted for review via Amendment. Non-Exempt research will have an annual Check-in or Continuing Review, depending on the risk level of the research. All research requires a Final Review to close the record when the research is complete.

 

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