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IRB News & Updates

Electronic IRB System

CSUEB will be moving to an electronic IRB management system beginning Spring semester, 2020.   This system, offered by Cayuse, will allow all initial research protocol submissions, modification and renewal requests, and approvals to be handled electronically.   Configuration and deployment will be completed by the end of Fall semester, 2019.   Training materials for the Cayuse system will be posted on the IRB website, and in-person training sessions will be held beginning in Spring 2020.

Faculty research protocols may be submitted to the IRB via the Cayuse system from the beginning of Spring semester 2020, and the IRB encourages faculty to do so.   Faculty research protocols must be submitted via the Cayuse system beginning March 1, 2020

Student research protocols may continue to be submitted via email or hard copy until the beginning of Summer session 2020, after which, all protocols must be submitted via the Cayuse system.

Final Rule Provision

As of January 20, 2020, studies subject to the Revised Common Rule Cooperative Research Provision must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy – such as domestic, multisite career development (K) and fellowship (F) awards.

Final Rule News

The Common Rule, the set of regulations which have governed human subjects research in the U.S. since 1991, was replaced with the Final Rule on January 21, 2019.  For more information, please read below.

Notice Update: Delay of the Revisions to the Final Common Rule Revisions Effective July 19, 2018
Department of Health and Human Services (Press Release)
Federal Register Announcement

Human Subjects Research Training Required for Researchers doing Non-Exempt Research

Starting Fall 2008, researchers doing non-exempt research were required to complete a course in conducting research using Human Subjects before their research protocols could be approved by the IRB.  The IRB also strongly encourages researchers doing exempt research using human subjects to complete a course.  This requirement was approved by the Academic Senate in 2007-2008.  After submission of a research protocol, the IRB will make the determination as to the exempt status of the protocol and notify the researcher.

The training requirement must be fulfilled by taking the CITI (Collaborative Integrative Training Initiative) research training course in human subjects research ethics.  A certificate, valid for 3 years, will be issued on completion of the CITI courses. (An up-to-date NIH course completion certificate is also acceptable as proof of human subjects research training.)  The ORSP will maintain a database of the researchers who have completed the training.

Researchers working with human subjects must take either the social/behavioral/educational module, or in appropriate cases, the biomedical module of the CITI course. Each module contains 9-10 required sections needed to complete the course, along with optional sections for special interests. Elective sections include HIPAA, international research, and research with prisoners, among others. Instructors may demo the course from the home page.

To register for the courses go to CITI Program. Go directly to “New Users Register Here.” You will choose the human subjects courses in the process of registration. 

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