HUMAN RESEARCH PROGRAM (IRB)

The Olive View-UCLA Education & Research Institute (ERI) operates a centralized program to review all human subject research.  The ERI’s Board of Trustees have established an IRB, called the Institutional Review Board (IRB).  This IRB reviews projects in a wide range of medical, social and behavioral fields. 

The purpose of the IRB is to assure that the rights and welfare of human subjects are adequately protected in research.  To achieve this, the IRB advises investigators in designing research projects in a manner to minimize potential harm to human subjects, reviews all planned research involving human subjects prior to initiation of the research, approves research that meets established criteria for protection of human subjects, and monitors approved research to ascertain that human subjects are indeed protected.  Review also includes an evaluation of the science of the project to further ensure that the rights and welfare of human subjects are adequately protected.

The ERI has filed an assurance of compliance with the Department of Health and Human Services (DHHS) Office for Human Research Protection (OHRP).  The full text of the Federalwide Assurance is available on the web site. The ERI’s FWA number is FWA#00000495.  The FWA also covers research conducted by Olive View investigators at the following component health centers: Glendale Health Center, Mid-Valley Comprehensive Health Center, and San Fernando Health Center. 

 

IRBNet

Effective September 1, 2015, the ERI began using IRBNet for the management, submission, review and oversight of our research protocols.  Features of IRBNet include electronic document management, web-based protocol sharing and collaboration, automatic notifications, electronic submissions and reviews, integrated training and credential management, and important audit capabilities including electronic revision histories, electronic signatures and event tracking.

IRBNet is secure, web-based, and extremely intuitive and easy to use.  You may access IRBNet from virtually any computer using a web browser by visiting www.irbnet.org.  You may now self-register as part of the ERI’s community and immediately begin using these exciting new tools.  Please also contact our office for a copy of one of the IRBNet Training Energizers and information about other training and assistance to help you get started.

The ERI will begin accepting electronic protocol submissions via IRBNet for beginning September 1, 2015.  As of this date, all protocols (including revisions and renewals) must be submitted electronically via IRBNet, and all review decision letters will be issued electronically via IRBNet.

For additional information please contact ERI at (747) 210-3434 - OV-IRB@ovuclaeri.com with any questions.

All studies being submitted to the IRB must be submitted electronically through IRBNet.  All forms and templates are located in the IRBNet system.  IRBNet is one of the industry’s leading Institutional Review Board (human subject research) software programs, and provides electronic protocol management, on-line submissions and many other important features to the research community.  In addition to being an intuitive system, IRBNet’s secure web-based solution is accessible anytime, anywhere. 

 

Following are links to useful tools to using the online system:

 

 

Video Tutorials

To view video tutorials, go here: www.irbnetresources.org/tresources/training

 

CERTIFICATION (CITI TRAINING)

The Collaborative Institutional Training Initiative (CITI Program) at the University of Miami is a leading provider of research education content.  Their web-based training materials serve millions of learners at academic institutions, government agencies, and commercial organization in the U.S. and around the world.  The ERI has chosen to subscribe to the CITI Program for all its online research based training. 

See the CITI Training tab for further information and instructions.

 

IRB RESOURCES

Belmont Report

IRB Committee List

Common Rule

FDA Information Sheets