IRB Updates

Beginning December 21, 2018 , the IRB will no longer accept Initial Applications for non-exempt research that do not include the most current versions of the protocol and consent form templates. This is to ensure that all new studies will be in compliance with the newly revised Code of Federal...

NIH has updated its policy regarding Certificates of Confidentiality in order to implement Section 2012 of the 21st Century Cures Act, enacted December 13, 2016. Effective October 1, 2017, NIH funded (partially or wholly) research studies that are collecting identifiable, sensitive information will automatically be issued a Certificate of Confidentiality...

The IRB has posted updated guidance documents regarding Classroom Research/Course Projects, and the use of Focus Group Procedures. Check out the Guidance Documents page to see these new guides!

The IRB has posted updated guidance documents regarding Research in Public Schools, IRB Authorization Agreements, and the use of Deception and Incomplete Disclosure in Research. Check out the Guidance Documents page to see these new guides.

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.). Click the title above for more...

This past April, the IRB welcomed a new Panel Coordinator, Misty White. Misty, a Certified IRB Professional, comes to us from, most recently, LSU Health Sciences Center in New Orleans, and her previous IRB experience includes several years at the University of Alabama at Birmingham. Here, she will coordinate all biomedical protocols and the convened IRB meetings. Please join us in welcoming Misty to the CU Boulder family!

In an effort to better serve our research community and streamline the review process, the IRB will change its procedures for all protocol submissions that require full board review. Starting June 23, 2016, all submissions requiring full board review will undergo an administrative pre-review before they will be scheduled for review at a convened meeting. The pre-review will ensure that only submissions that are complete and free of errors will go before the board. The change will affect how investigators determine timelines for submitting items to the IRB for review. Click the title above for more information.

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. When first accessing the eRA Portal, the system will present you with the campus dropdown field without requiring an additional login...

The IRB has recently updated the HRP-211 Initial Application Form and Protocol Template to include questions specifically geared to assessing the data security requirements for all human research studies. This follows coordination with the CU Boulder Office of Information Security (OIS), which manages all data security activities on the Boulder...