Welcome to the CU-Boulder's Institutional Review Board (IRB) website. On this website you will find everything you need to submit a human subjects research study for ethical review.
The Getting Started section is a practical checklist to reference when submitting new research for review, go to the Forms & Templates section to download any of the IRB templates, guidance for drafting submission documents is located under the Guidance Documents section, and the Submit for IRB Review section is where you can find tutorials for using the electronic submission system, eRA. If you need technical support, check the Common Questions section to see if your issue is listed.
The IRB has posted Guidance for Investigational Device Studies on the Guidance Documents page. This guidance provides information for investigators to follow in determining whether a study falls under FDA Device Regulations for IRB review and oversight.
The IRB is changing the way study personnel Roles function in eRA. Starting Wednesday, July 25, 2016, the following changes will take effect:
- Individuals listed on studies in eRA with Co-Investigator with Edit and Research Coordinator roles will have the ability to view study documents and to create and submit study submissions such as Amendments and Continuing Reviews on behalf of a PI.
- A new role, Research Assistant, will be included in eRA. Personnel who may not have a direct role in the science of a research study but need to access and download documents from eRA for study activities can be assigned this role (Undergraduate and Graduate Research Assistants, etc.).
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Logging into the eRA application is about to get easier! Click through for more. Beginning Saturday, February 6, the process for logging into the InfoEd eRA portal will change.
eRA will be unavailable Saturday, April 11, 2015 from 9:00 PM until Sunday, April 12, 2015 11:00 AM.