About the Program
UNLV’s Quality Assurance/Quality Improvement (QA/QI) Program is an independent, evidence-based initiative that provides assurance that all research activities under the Division of Research’s (DOR) Offices meet federal and state regulation, and institutional policy requirements. The QA/QI Program conducts systematic reviews of research compliance across all DOR Offices including but not limited to, human subjects research (IRB), animal care and use (IACUC), biosafety (IBC), radiation safety (RSC), conflict of interest (COI), export control, research misconduct, responsible conduct of research (RCR), research security, sponsored programs, research infrastructure, and clinical trials administration.
The DOR Office of Research Integrity (ORI) is committed to conducting routine, directed, and requested quality assurance reviews using consistent standard operating procedures. The QA/QI Program supports compliance monitoring, continuous improvement, and researcher education across all research compliance domains. Reviews identify compliance gaps before they result in reportable events, funding risk, or reputational harm.
Types of Quality Assurance Reviews
ORI conducts three types of research quality assurance reviews. Understanding each type helps researchers know what to expect during the audit process.
Routine Quality Assurance Reviews
Routine reviews are proactive, risk-based assessments of compliance across the full range of research compliance areas. These reviews help ensure compliance with regulatory and ethical standards, identify opportunities for improvement, and support researcher education.
Routine Review Process Overview
- Routine reviews are selected based on risk criteria by DOR-ORI.
- PI is notified 30 days before the review with the scope and how to prepare.
- Reviews may be fully remote, onsite at a laboratory or office.
- Reviewer(s) will examine records and may interview PI or research personnel.
- PI will be issued a written report of the review with documentation of any findings and recommendations for corrective actions, if needed.
Directed (For-Cause) Quality Assurance Reviews
Directed reviews are triggered by a specific concern, incident, complaint, or observation or noncompliance. These reviews evaluate compliance in response to the identified concern(s) and support UNLV’s obligation to investigate and remediate potential noncompliance, protect research participants and animals, safety of lab personnel and the public, and maintain research integrity.
Directed Review Process Overview
- Directed review is triggered by a specific concern, incident, complaint, or observation or noncompliance sent to the DOR.
- PI is notified within 5 business days of the review scope and how to prepare. Scope of the review may change if additional concerns are identified.
- Reviews may be fully remote, onsite at a laboratory or office.
- Reviewer(s) will examine records and may interview PI or research personnel.
- PI and, if applicable, requesting office, will be issued a written report of the review with documentation of any findings and recommendations for corrective actions, if needed.
Requested Quality Assurance Reviews
Requested reviews are voluntary audits requested by a PI, department, or office to proactively assess compliance and identify best practices. These reviews support researchers’ efforts to ensure compliance and prepare for potential sponsor or agency inspections or external audits.
Requested Review Process Overview
- Researchers may request a review at any time for a general review of best practices, identification of improvement opportunities, review of a new area of research, preparation for an upcoming sponsor or agency inspection, etc.
- A researcher or PI contacts the UNLV Research Integrity and Compliance Officer (RICO) to request a review and discuss scope.
- The RICO assesses availability and prioritizes relative to routine and directed reviews.
- RICO arranges timeframe and location with researcher or PI and what records to prepare.
- Reviews may be fully remote, onsite at a laboratory or office.
- Reviewer(s) will examine records and may interview PI or research personnel.
- PI will be issued a written report of the review with documentation of any findings and recommendations for corrective actions, if needed.
Corrective and Preventative Actions (CAPA) Process
When a QA review identifies findings, the PI or responsible individual may be required to develop and implement a Corrective and Preventative Action (CAPA) plan. A CAPA plan addresses the root cause of the finding and outlines steps to correct and prevent recurrence.
CAPA Plan Components
- Description of Finding
- Root Cause Analysis
- Corrective Action
- Preventative Action
- Timeline for Implementation
- Responsible Individual for Implementation
- Supporting Documentation for Completion
Audit Preparation Checklist for Researchers
Use the audit preparation checklist to prepare for routine, directed, or requested quality assurance review.