IRB

Guidance for Investigational Device Studies

Aug. 30, 2016

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.Read more »

Updates to Study Personnel Roles

July 27, 2016

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...Read more »

New IRB Staff Member Announcement

June 20, 2016

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!Read more »

Changes to Pre-review Process for Full Board Studies

June 20, 2016

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.Read more »

Changes are coming to the eRA Log-in Process

Feb. 5, 2016

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... Read more »

IRB Institutes Data Security Questionnaire for New Submissions

Aug. 28, 2015

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... Read more »

HRP-506: TEMPLATE - Pre-screening Consent Script

July 31, 2015

A new template for Pre-screening subjects, HRP-506: TEMPLATE - Pre-screening Consent Script, has been added to the Forms & Templates page. If you are obtaining information about potential participants before consent is obtained this document should be used.Read more »

HRP-502: TEMPLATE - Consent Document Updated

March 18, 2015

The HRP-502: TEMPLATE - Consent Document has been updated. Please ensure that you use this version moving forward. The new version is available to download in eRA and on the Forms & Templates page.Read more »

Changes to Panel 2 Submission Deadlines

Jan. 26, 2015

As of January 26, 2015 the submission deadline for Panel B full board review is 16 days prior to the convened meeting date.Read more »

New Research Ethics for CU Students Online Course Available

Jan. 12, 2015

A new online introduction to human research course is now available to all current CU students.Read more »

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