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Open Access Publications from the University of California

About

The University of California, Irvine (UCI) Institutional Review Board (IRB) is responsible for ensuring that all human subjects research conducted by faculty, staff, and students at UCI approved sites or using UCI’s name is conducted in compliance with federal regulations, state and local law as well as UCI IRB policies, procedures, and UCI’s Federalwide Assurance with OHRP, in order to preserve the rights and safety of research subjects, the quality of scholarly work and the integrity of the institution. In an effort to promote accountability and excellence, UCI HRP has developed the Education and Quality Improvement Program (EQUIP). EQUIP monitors and measures the effectiveness, efficiency and quality of UCI’s human research protection program. The primary purpose of the EQUIP is to provide education, training and post-approval monitoring, to assure that all human research protection operations support UCI’s mandate to protect the rights and welfare of research participants. This includes compliance with institutional policies and procedures, and applicable federal, state and local laws pertaining to the protection of human subjects in research.  EQUIP's aims are aligned with the UCI Office of Research Strategic Plan, the UCI Office of Research Administration Mission Statement, the UCI Chancellor's Strategic Pillars (research, education, service), the UCOP Mission Statement, and Huron's High Performance HRPP Matrix (Organizational Components x Operational Outcomes). 
 

Webpage: https://research.uci.edu/compliance/human-research-protections/researchers/equip.html

Human Research Protections (HRP), Education and Quality Improvement Program (EQUIP)

There are 5 publications in this collection, published between 2018 and 2019.
Education and Guidance Documents (5)

Post-Approval Investigator Responsibilities (PAIR) Worksheet

Worksheet and guidance to help researchers with their post-approval regulatory responsibilities and tools to ensure project management success

The Revised Federal Policy for the Protection of Human Subjects - A Summary, and an Implementation Roadmap and Matrix

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. The Final Rule will be effective January 21, 2019, with the exception of cooperative research (single IRB review) which will not be effective until January 20, 2020. The key revised elements of the federal policy are outlined in the table below.

  • 3 supplemental PDFs

Quality Improvement (QI) Project vs Quality Improvement (QI) Research

Regulatory guidance for determining QI Project Activities from QI Research Activities

2 more worksshow all