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Education and Quality Improvement Program (EQUIP)

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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, UCI Office of Research Administration Mission Statement, UCI Chancellor’s Strategic Pillars (research, education, service), UCOP Mission Statement, and Huron’s High Performance HRPP Matrix (Organizational Components x Operational Outcomes).

EQUIP's Mission Statement:  Achieve regulatory compliance by providing regulatory education and training, and by performing continuous quality assurance (QA) reviews and quality control (QC).

Regulatory Education and Outreach Engagement

Pre-approval Expectations and Standards (PEAS)

IRB Navigator

In-Service to the Research Community

EQUIP staff are available to provide educational workshops to undergraduate and graduate courses, and for departmental and academic units. 

Contact EQUIP staff to coordinate an in-service for your course or your department/unit

HRP Listserv Announcements

Announcements are also published regularly to the HRP Listserv, to ensure the research community are informed on new regulations, policies, and processes.

To subscribe to HRP News & Announcements, send a blank email to:  or-irb-hrp-join@department-lists.uci.edu

Regulatory and Policy Guidance

EQUIP performs deep dives into regulations and policies, authors guidance materials, and operationalize processes. 

Regulatory guidance materials are published and updated regularly on the HRP webpage.

CITI Training

EQUIP ensures that CITI Training modules are regularly updated to align with regulatory requirements.

Post-Approval Investigator Responsibilities (PAIR)

Within the EQUIP program, a Post-Approval Investigator Responsibilities (PAIR) initiative was developed to facilitate regulatory compliance, by educating researchers on their post-approval responsibilities.

The PAIR Worksheet is available to any study team, for use in organizing and monitoring their post-approval regulatory responsibilities and daily project management tasks.

Regulatory Compliance and Quality Assurance (QA)

IRB E (Review of Serious and Continuing Noncompliance)

A committee of experienced IRB members review cases/activities of potential non-compliances (NC) and unanticipated problems (UP).  IRB-E considers whether cases/activities meet the definitions of non-compliance, serious non-compliance (SNC), and continuing non-compliance (CNC).  Activities that are determined to be SNC and/or CNC are reported to institutional officials and federal agencies, as appropriate, and corrective action plans are developed and implemented, where appropriate.

Subject Complaints and New Information Reports

Subject complaints and New Information Reports are initially assessed by EQUIP staff, through the appropriate IRB (A, B, C, Team-D) subcommittee.  Cases/activities that may potentially meet the definition of an UP, SNC, and/or CNC, are reviewed by the IRB-E Committee.

For-Cause Regulatory Reviews and Routine Regulatory Reviews of Human Subjects Research Protocols

Through EQUIP, HRP staff conduct periodic study monitoring, educational outreach, and other quality improvement activities in an effort to ensure that human subject research activities are conducted in accordance with regulations, laws and institutional policies regarding the protection of human subjects. This process is a requirement of UCI's Federalwide Assurance.

Periodic study monitoring reviews conducted by EQUIP may focus on both biomedical and social-behavioral research that involves greater than minimal risk, research that includes special and/or vulnerable populations, research that is investigator initiated and sponsored and/or research that involves collection of sensitive personal information; however, all types of research (including exempt and expedited research and research conducted at non-UCI sites) are subject to EQUIP review.

The PAIR Worksheet will help you to prepare for routine and for-cause reviews.

Outcomes from routine reviews are shared with the HRP staff and the IRB Committee members.

The IRB Committee (A, B, C, Team-D, E) may make a determination to perform a for-cause review, as well.

Post-Approval Monitoring (PAM)

In accordance with its charge, the IRB has procedures for observation of the informed consent process in ongoing research, when appropriate. As part of IRB oversight, the IRB may require an IRB Committee Member and/or EQUIP staff member observe the consenting of research participants to determine whether:

-  The informed consent process has been appropriately completed and documented;
-  The participant has had sufficient time to consider study participation;
-  No coercion has been used by the consenting staff; and
-  The information presented to the participant reflects the content of the consent form and is conveyed in understandable language.


Outcomes from these monitoring activities are shared with the HRP staff and the IRB Committee members.

Internal HRP QA

The EQUIP monitors and measures the effectiveness, efficiency and quality of UCI’s human research protections program.  IRB minutes, consent forms, and protocol narratives are reviewed for adherence to the regulatory requirements.  Outcomes from these reviews are shared with the HRP staff and the IRB Committee members.

HPS/ERA/OIT Liaison

In collaboration with OIT and ERA, the liaison develops configurations and programming, and performs continuous quality assurance and quality control of the HPS applications and database, to address changes to UCI policies and federal regulations.

Congruence Reviews for Federally-Supported Animal Research

The Office of Research (OR) is responsible for certifying that research procedures and activities supported by federal agencies and departments are authorized by the applicable regulatory committee (e.g., IACUC).  This certification process is done to protect both the institution and the investigator from inadvertently spending award dollars to perform unauthorized research procedures or to perform activities in violation of funding agreements and/or regulatory requirements.  Because UCI is subject to unannounced audits by federal regulatory and granting agencies, it is very important that the research supported by federal departments and agencies be approved by the applicable regulatory committee.

Ad-hoc congruence reviews of (federally-supported and non-federally supported) Human Subjects Research projects are also available by request.

QA of ClinicalTrials.gov Records

The HRP-EQUIP Unit has oversight for the registration process of applicable clinical trials (ACTs), as well as the monitoring (QA) of the registered ACTs for compliance with required updates to ACT records and results submission of completed ACTs.

External Audits

Any time an audit of study records is conducted by an external entity other than the UCI IRB, it is the responsibility of the Lead Researcher to inform the IRB promptly. If the Lead Researcher is given notice of an audit by an external entity, the IRB may send a representative to observe proceedings of any "exit interview" which may occur. Finally, the written report of any audit findings for a UCI study must be forwarded to the IRB for their records.


*** When UCI personnel receive notices about external audits (on-site and remote), they should immediately contact Internal Audit Services (IAS) at 949-824-7459 or 949-824-6757.  A copy of the Sponsor's audit notification letter should be sent to Loran Lerma (LLerma@uci.edu). ***

Resources

Contacts

 

Laverne Estanol, M.S., CHRC, CIP, CIM, MRQA
Editorial Board Member, Journal of Research Administration
Assistant Director, UCI Research Protections (RP)
949-824-4704
Lestanol@uci.edu


Jessica Sheldon, CIP
UCI Research Protections (RP)
Senior EQUIP Administrator (Principal Analyst II)
949-824-3831
Jessica.Sheldon@uci.edu


Vickie Langille
UCI Research Protections (RP)
EQUIP Administrator (Principal Analyst I)
949-824-6927
Vickie.Langille@uci.edu



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