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 Advisor.
Faculty Advisors are responsible for ensuring that student research is appropriately designed; fully, clearly, and accurately described in the documents submitted for review; and conducted in accordance with the documentation Approved by the IRB. For Initial Application Submissions, Faculty Advisors are required to complete and sign the Faculty Advisor Review Form unique to each student’s study. Students must upload this document with their Initial Application study materials in eRA.
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 POI in order to access eRA. If you have a POI and still cannot access eRA, contact for help.
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.
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 or Biomedical Research Investigators and Key Personnel.
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.
Develop study materials.
The IRB needs to review and approve final versions of everything you need to conduct research. This includes things that subjects will see (or hear) such as the consent form, recruitment materials, and assessment tools; as well as documents subjects will not see, like the protocol document. The first step in developing study materials for an Initial Application is to download blank templates from the IRB website.
Wait for IRB response.
The IRB review process takes time and the first response you receive from the IRB may not be an approval. See Review Timelines for information regarding how different review types are handled. A straightforward protocol that does not require review by a convened board could take up to 40 business days for approval. If the IRB requests additional information, see the Response page for your next steps.
Download approved documents from eRA.
After you have received an Approval letter from the IRB, The IRB approved versions of study documents are the “official” copies and you are required to use these versions to conduct your research. This means you must download the approved versions to use.
After you have downloaded the approved documents, you may begin your research as described in the approved protocol.
Manage ongoing research.
Through the course of your research, you may find that changes are needed (which will need IRB approval) or after a year, you will need to submit materials for continuing review. See below for a big-picture view of research that requires IRB review.
The Life of a Protocol
2. IRB Submission
Submit final version of all documents related to the study in eRA.
3. IRB Process
The submitted materials will be reviewed as Exempt or Expedited in the IRB Office, or referred to a convened board for review. Resulting determination will be Incomplete, Approved, Modifications Required, or Deferred.
4. Post Approval
Download approved documents from eRA and begin research. If changes to the research are needed, submit an amendment to the IRB. Report events when required.
5. Maintain Approval
IRB approval expires after one year. In order for the research to continue, and IRB approval to be maintained, submit a continuing review annually.
After all research-related procedures are complete and the data has been de-identified, close the study with the IRB by submitting a Final Report.