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).

About EQUIP

IRB-E: 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.

EQUIP: 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.

IRB-E: Non-Compliances

Unanticipated Problems EQUIP:

Subject Complaints New Information Reports

Human Research

Protections (hrp)

Educational Workshops, Listserv Announcements

EQUIP staff are available to provide

educational workshops to undergraduate and

graduate courses, and for departmental and

academic units. Listserv announcements are

also published regularly, to ensure the

research community are informed on new

policies and processes.

Federal Award-to-Protocol Congruence

QA of ClinicalTrials.Gov Registrations

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/s (e.g., IRB and 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/s.

The HRP-EQUIP Unit also has oversight for

the registration process of applicable clinical

trials (ACTs), as well as the monitoring (QA) of

the registered ACTs that occur at UC Irvine.

Bruce Morgan Associate Vice Chancellor for Research Administration

Research Protections Executive Director (vacant) Laverne Estanol, M.S., CIP, CHRC, MRQA Assistant Director, Research Protections Supervisor, EQUIP Unit Jessica Sheldon, CIP EQUIP Principal Analyst II Vickie Langille EQUIP Principal Analyst I Edith Avila EQUIP Student Assistant

Office of Research

141 Innovation Dr, Suite 250 Irvine, CA 92697-7600

Phone: (949) 824-4704

Fax: (949) 824-3400

Web: http://www.research.uci.edu/

compliance/human-research-

protections/researchers/equip.html

https://escholarship.org/uc/hrp_equip

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.

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.

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.

Within the EQUIP

program, a Post-Approval

Investigator

Responsibilities (PAIR)

initiative was developed

to facilitate regulatory compliance by educating

randomly selected investigator-initiated protocols

on post-approval responsibilities, either at the

beginning of a new study or at the time of

continuing submission.

Investigator-initiated greater than minimal

risk studies with less experienced lead

researchers will be offered training

on record-keeping requirements and

regulatory submissions such as modification

submissions, adverse event/unanticipated

problems submissions, and continuing

protocol submissions.

Investigator-initiated minimal risk studies

with less experienced lead researchers will be

offered an opportunity to complete a self-

evaluation of their record-keeping

requirements and post-approval

responsibilities at the time of their continuing

application submission.

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.

Post-Approval

Monitoring

(PAM)

Post-Approval

Investigator

Responsibilities

(PAIR)

Internal

Quality Assurance

(QA)

Routine Reviews, and

For-Cause Reviews

HPS / ERA / OIT

In collaboration with OIT and ERA, develop

configurations and programming, and perform

continuous quality assurance and quality

control of the HPS applications and database,

to address changes to UCI and federal policies.

CITI TRAINING

EQUIP ensures that CITI Training modules

are regularly updated to align with regulatory

requirements.

REGULATORY

EQUIP performs deep dives into

regulations and policies, authors guidance

materials, and operationalize processes.