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Education & Quality Improvement Program

What is 'EQUIP'?

'EQUIP' is the Education and Quality Improvement Program, initiated by the Human Research Protections (HRP) unit in the Office of Research. UCI's Human Research Protections Policies and Procedures states that the 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 laws, UCI IRB policies and procedures and UCI's Federalwide Assurance with the Office for Human Research Protections (OHRP).

Periodic Study Monitoring

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.

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.

Preparing for an EQUIP Review

Notification of a Periodic Review

Notification of an EQUIP periodic study monitoring visit is sent by email to the Lead Researcher and Faculty Sponsor (if applicable). HRP staff will work with the researcher to establish a monitoring visit usually within 45 days of notification. Researchers have the option of a one-time request to defer their review to the following quarter, should their particular schedule be impacted.

The periodic study monitoring visits, while required, are meant to be collegial and educational, both for the research team and HRP Staff. The EQUIP team works with researchers to ensure that are in compliance with federal regulations, state laws, and institutional policies and procedures, to identify education/training needs, and to provide other necessary resources in areas that may need improvement.

How Often Do Reviews Occur?

The EQUIP team will conduct approximately one periodic study monitoring visit per month.

Organizing for a Periodic Review

Refer to the EQUIP Expectations for Researchers document(s) for specific information on what specific documents researchers should maintain.

Suggested Study Documentation:

To ensure that study documentation is complete and includes all transactions submitted to the IRB, the EQUIP team recommends that researchers maintain a complete accounting of the study documentation submitted for IRB review such as the electronic new study application (APP), electronic modification requests (MODs), electronic continuing protocol applications (CPAs), and Adverse Events / Unanticipated Problems reports (AE/ UPs).

Note: The following document maintenance process is recommended as a "best practice." The EQUIP team suggests that researchers group copies of all documents submitted for IRB approval with the corresponding IRB approval letter and IRB-approved stamped versions for each submission. At a minimum, the EQUIP team will expect to see copies of all IRB approved documents, for each transaction.

For example, MOD #1234 involves a change to the Protocol Narrative and Consent Form, researchers should maintain the following in one section of the study file (or in one sub-folder maintained electronically):

  • A copy of the MOD #1234 application, submitted to the IRB for review
  • A copy of the Protocol Narrative with track changes inserted (reflecting the proposed changes being submitted to the IRB for approval)
  • A copy of the Consent Form with track changes inserted (reflecting the proposed changes being submitted to the IRB for approval)
  • A copy of the IRB approval letter for MOD# 1234
  • A copy of the IRB approved Protocol Narrative (with the IRB stamp in the footer (containing the UCI seal and current approval period))
  • A copy of the IRB approved Consent Form (with the IRB stamp in the footer (containing the UCI seal and current approval period))

The above method of maintaining documentation is especially useful should the IRB not approve all of the requested revisions as submitted per a modification request or to track removal of research personnel per a continuing review application.

IRB recordkeeping is the responsibility of the Lead Researcher. For more information about recordkeeping responsibilities of the Lead Researcher, please refer to the Lead Researcher Recordkeeping Responsibilities web page.

Consent Documentation Recommendations:

Per OHRP, obtaining and documenting the informed consent process is a researcher responsibility. Documentation may include the following:

  • Identification of all persons involved in the consenting process,
  • A discussion of the protocol, risks, benefits and alternatives to research,
  • Evaluation that the prospective subject exhibited the necessary competency to provide informed consent,)
  • Subject was provided an opportunity to ask and have answered questions,
  • Subject voluntarily agreed to participate in research by providing her / his informed consent or declined participation (including reason) and
  • Subject was provided a copy of the signed informed consent and HIPAA Research Authorization Form (as applicable)

Refer to the "EQUIP Tools" section of this page to view the "Study Visit Log Template",  which may be used, among other purposes, as a mechanism for documentation of the consent process.

Outline of the EQUIP Review Process

When preparing for an EQUIP review, refer to the document titled, "EQUIP Review Prep & Timeline" for an understanding of the process.

EQUIP Tools

The following tools are being provided to aid in the research study documentation process. Please feel free to download and use as applicable. In addition to the following tools, note the preparatory documents which will aid you in organizing for an EQUIP review.

Additional EQUIP Responsibilities

Verification from Other Sources

The IRB can require verification that no unapproved changes in an IRB-approved study have occurred since the previous IRB review. The scope and extent of such an independent assessment is determined on a case-by-case basis. Sources for such outside information could include:

  1. Compliance review from the EQUIP team or designee;
  2. Corroboration from School Deans, Department Chairs, Sponsors, other Clinical Research Organizations and other IRBs at collaborating institutions;
  3. Copies of FDA Audits
  4. Literature searches conducted by clinical librarians;
  5. Reports from subjects or study staff; or
  6. Directed audit at the direction of the IRB Committee or the RP Director or designee.

Examples of when verification from other sources may be requested include, but are not limited to:

  1. When the study is complex in design and the project involves unusual types of risk to subjects (e.g., multiple groups, rapid titration schedule to obtain maximum tolerated dose, novel and unique medical device investigations);
  2. When the study is conducted by researchers who previously have failed to comply with the requirements of the DHHS regulations or the requirements or determinations of the IRB; or
  3. When concerns are raised, based upon information provided in continuing review reports or from other sources, about possible material changes occurring without IRB approval.

For Cause Investigations

In addition, EQUIP will also respond to a request for a directed (for cause) investigation of human subjects research, indirect monitoring of unanticipated problems involving risk to research participants or others, participant outreach and management of participant complaints and concerns. For cause investigations may occur at the direction of the IRB or the Research Protections (RP) Director or designee.

Internal Quality Improvement

EQUIP includes ongoing internal quality improvement (QI) activities to ensure consistency and compliance within such as:

  • Minutes QI Review
  • Informed COnsent QI Review
  • Review of IRB Protocols
  • HRP Benchmark Targets
  • IRB/HRP Survey

Reporting of Monitoring Results

The results of any monitoring activity or audit activity by the HRP EQUIP team are reported in writing to the Director of RP or designee and the full IRB Committee. The Director of RP or designee follows the campus policy for resolving allegations of non-compliance in cooperation with the IRB when allegations of or incident(s) of non-compliance are reported.

If the monitoring or auditing activity finds that a human subject participating in a research project has been exposed to unexpected serious harm, the HRP EQUIP team or designee will promptly report such findings to the Director of RP or designee. The Lead Researcher will be required to submit an Adverse Event/Unanticipated Problems report and the IRB Chairperson will determine the need for full IRB Committee review.

If the information gained during the monitoring, auditing, or review process indicates that human subjects of a research project were exposed to unexpected serious risk or harm, or that the policies of the IRB were not met, the IRB may suspend or terminate the research.

Other Research Compliance Monitoring Entities at UCI

UCI School of Medicine Office of Research Oversight conducts post approval monitoring reviews and directed audits of IRB-approved studies when the Lead Researcher is School of Medicine personnel (i.e., faculty, staff, or student) and/or when the research is conducted at UCI Medical Center (UCIMC).

Chao Cancer Center Quality Assurance (QA) Unit conducts post-approval monitoring and faculty and staff education of cancer-related studies to ensure the Cancer Center maintains compliance with applicable sponsor, Federal, state and institutional requirements for research.

Internal Audit Services (IAS) is charged with the task of assisting University management and the Board of Regents in the discharge of their oversight, management, and operating responsibilities. IAS from time to time may conduct its own review of human subject research activities.

EQUIP Contact Information:

Laverne Estanol, MS, CHRC, CIP, CCRP
Assistant Director
Human Research Protections
949-824-4704
Lestanol@uci.edu

Jessica Sheldon, CIP
EQUIP Administrator
Human Research Protections
949-824-3831
jessica.sheldon@uci.edu

Vickie Langille
EQUIP Senior Analyst
Research Protections
949-824-6927
vickie.langille@uci.edu  

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