Policies and Guidelines Environmental Health and Safety Human Research Foreign Affiliations School Center Guidelines Space Allocation Vendor Event Policy Responsible Conduct of Research Rigor and Responsibility Human Research Protections and the Institutional Review Board Home Research Office of Research Policies and Guidelines Human Research Human Research Protections (HRP) Human Research Protections (HRP) is responsible for managing the University's human research protections program. The HRP staff provides administrative support to UCI's four Institutional Review Boards (IRB). Research involving human subjects must undergo review by the IRB. The IRB is charged with the responsibility of reviewing human subjects research and ensuring compliance with federal regulations, state laws and UC/UCI policies. Institutional Review Boards The primary role of the IRB is to protect the safety and welfare of human subjects. UCI has four IRB committees: two review biomedical research (IRBs “A” and “B”), the third (IRB “C”) reviews social/behavioral research and the fourth (IRB “E”) reviews matters of alleged noncompliance. Each committee is composed of physicians, scientists, non-scientists and community members with varying backgrounds to promote complete and adequate review of the research activities conducted at UCI. Members are appointed by the Vice Chancellor for Research who is the UCI Official responsible for the human research protections program. In addition to working with the IRBs, HRP staff also work directly with investigators and their administrative staff to facilitate submission of the required IRB documentation. The UCI Office of Research provides ample resources for how to apply for IRB review, modify and maintain IRB approval and close protocols. Institutional Review Board Quality Improvement Program HRP has an Education and Quality Improvement Program (EQUIP) that provides education, training and quality improvement reviews to ensure compliance with federal and state regulations as well as UC/UCI policies. In addition, EQUIP is responsible for evaluating, tracking and monitoring the effectiveness of the UCI HRP to ensure the rights and welfare of human subjects and compliance with applicable laws. Other Human Research Review Committees Before the IRB can approve research, there may be other prerequisite UCI committee reviews that may be required. In some cases, there are UCI committee reviews that may be required prior to IRB review including: Cancer Related Protocols (PRMC) Research Revenue Integrity (RRI) Clinical Research Acceleration and Facilitation Team (CRAFT) Conflict of Interest Oversight Committee (COIOC) Environmental Health and Safety Epidemiology and Infection Prevention (EIP) Committee Institutional Biosafety Committee (IBC) Radiation Safety Committee Review DocuSign for Consent Process DocuSign is allowable as a consent process both per UCI policy and federal regulations (Office for Human Research Protections + FDA). In order to use DocuSign for this purpose, visit the UCI DocuSign website. Video tutorials on the DocuSign website will help with determining how to best use DocuSign.