Research-Related Activity Policies & Guidelines — DCT V2

The purpose of this policy is to delineate policies and procedures for the processing and/or manufacturing and/or release of cellular therapies for clinical trials at UC Irvine.

Cellular therapies, especially those involving genetically modified cells, offer the potential for customized treatments that target the unique genetic makeup of individual patients and are already driving meaningful benefits for some patients living with blood cancer and those with solid tumors and autoimmune diseases. The cellular therapy market is growing rapidly, as are clinical trials investigating the safety and efficacy of these cellular products.

To ensure quality and compliance with regulations in these products' manufacturing, storage, release and administration, please read the policy.

READ CELLULAR THERAPIES POLICY

The purpose of this policy is to facilitate efficient, compliant and ethical clinical research study conduct and management. All clinical research studies covered by the scope of this policy are required to be coordinated and facilitated through one of the central research coordinating units. Oversight by the coordinating units does not in any way reduce or eliminate the Investigator’s responsibility for the conduct, billing, and reporting of clinical studies or data obtained through clinical trial investigations.

READ INTERVENTIONAL CLINICAL TRIALS POLICY

UC Irvine School of Medicine requires all clinical research teams to use OnCore, the university's official clinical trial management system, to record and track study activities. This ensures that research using UCI Health facilities, services, or staff is accurately documented — supporting billing compliance, patient safety, and institutional planning.

Study teams are responsible for keeping records up to date within 24 hours of any changes, helping UCI maintain transparency and accountability across its clinical research programs.

For questions or concerns, please contact clinicalresearch@hs.uci.edu.

View OnCore Utilization Policy

OnCore Support Documents can be accessed by all health system accounts. If you are a campus user and need access, please reach out to OnCore Support at oncoresupport@hs.uci.edu.

Effective July 1, 2025, the UC Irvine Disclosing, Reviewing and Approving Engagements Involving Countries of Concern policy will apply to new engagements involving countries of concern and substantive changes to currently active engagements. This policy will help ensure UC Irvine remains eligible for federal funding to support its research enterprise. It also creates transparency around countries of concern engagements so that the UC Irvine Office of Research can provide advisory and support services to the research community and help foster responsible engagements.

READ POLICY PDF

view Countries of Concern Engagements webpage

Environmental Health & Safety (EH&S) provides campus-wide support for training, monitoring, and ensuring a safe and healthy environment supporting academic and research excellence at UCI.

EH&S Policies and Programs provides a host of resources for biosafety, environmental management, fire safety, general safety, health inspections, laboratory and research safety, occupational health safety, and radiation safety.

EH&S also provides personal protective equipment (PPE) based on assessment of the hazards associated with various research activities.

EH&S has developed standard operating procedures (SOPs) related to specific operations and experiments and provided training regarding unique hazards and processes encountered in specific work units.

Ensuring Global Compliance

As part of a leading research institution, UC Irvine researchers create and have access to sensitive technologies controlled by U.S. export laws for national security, economic and foreign policy reasons. Export controls are federal laws designed to regulate the shipment or transfer of controlled items, software, technology or services outside the United States. These laws also restrict the release of certain information to foreign nationals within the U.S., known as a "deemed export."

International Shipping: Compliance Essentials

Does your lab ship internationally?

Before shipping, consult the UC Irvine Office of Research website devoted to international shipping.

Learn About International Shipping

Key considerations for international shipments:

• Decentralized Shipping: UC Irvine lacks a central shipping hub. Regulations vary by item, destination and use.
• Prevent Delays & Violations: Submit a Shipment Review Form to the Export Control Office before shipping internationally. 
• Review for Export License: The review determines if an export license is required.
• Include Hand-Carried Items: International shipments include items hand-carried or packed in baggage. 

Download Shipment Review Form

Email your Shipment Review Form to the Export Control Office.

Comprehensive Export Controls Overview

UC Irvine Office of Research

At UC Irvine, our export control program supports and facilitates our faculty's scholarly and creative activities while ensuring strict compliance with U.S. export control regulations. To ensure compliance, university personnel must identify when their activities may trigger export controls.

Please visit the Office of Research's Export Controls webpage for detailed information on all aspects of UC Irvine's export control policy, including training resources.

• UC Irvine Office of Research Export Controls
• Training Courses

Have questions? Wondering if you are compliant? Email Export Control for general inquiries or contact Export Control Officer Brian McCurdy. 

Guidance from the federal government highlights the importance of disclosing financial interests, affiliations, activities and relationships with foreign entities. At UC Irvine, international collaboration is essential. However, it is also important to be aware of disclosure requirements and compliance procedures UC Irvine has in place to protect faculty members. Among the issues that are often problematic are:

• Conflict of Commitment not filed annually 
• Conflict of Interest not filed when needed 
• “Other Support” reporting is incomplete 
• Funding agencies are not updated on new foreign engagements 
• Lack of awareness of regulations regarding international collaboration and possible threats 

fOREIGN AFFILIATIONS WEBPAGE

Human Research Protections (HRP) is responsible for managing the University's human research protections program. The HRP staff provides administrative support to UC Irvine's four Institutional Review Boards (IRB). Research involving human subjects must undergo review by the IRB. For more information, please visit the UC Irvine Office of Research Human Research Protections website.

The Compliance and Privacy Office maintains a comprehensive set of research compliance policies and procedures designed to promote ethical conduct, regulatory adherence and high-quality clinical research. These policies address key areas such as investigational product management, research billing compliance, documentation standards and more.

• Clinical Research Billing Compliance 
• Control of Investigational Devices 
• FDA Inspections of Clinical Investigators
• Research Compliance Program 
• Research Documentation in the EMR 

For additional information and access to these resources, please visit the UCI Health Compliance and Privacy SharePoint. Please note: To access the UCI Health SharePoint, you must have a health sciences email account.

For questions related to research compliance resources, training or guidance, please email the Research Compliance team at researchcompliance@hs.uci.edu.

UC Irvine School of Medicine is committed to the Responsible Conduct of Research (RCR), which denotes good citizenship in research conduct. Faculty, students and staff who report their work honestly, accurately and objectively promote public trust in research and model ethical research practices for future generations of scholars.

responsible Conduct of Research Webpage

In recent years, there has been a growing awareness of the need for rigorously designed published preclinical studies to ensure that research findings can be faithfully replicated. In response to this need, the National Institutes of Health (NIH) has established a formal initiative aimed at improving research reproducibility and they implement significant changes to their policies, grant applications and peer-review process, which took effect Jan. 25, 2016.

UC Irvine School of Medicine is committed to upholding the highest standards of conducting biomedical research.

rigor & Responsibility Webpage

The UCI Health Compliance & Privacy Office oversees ethical and legal compliance across the UCI Health enterprise. All UCI Health employees, including researchers within the UC Irvine School of Medicine, must stay up to date on guidelines and follow the regulations enforced by the Compliance & Privacy Office.

COMPLIANCE & PRIVACY OFFICE WEBPAGE

The UC Irvine Office of Administrative Policies and Procedures supports the university's research and academic missions by overseeing institution-wide policies, authority delegations, conflict-of-interest reporting and organizational structures.

Administrative Policies and Procedures

The UC Irvine Office of Research Policy Library is a collection of policy and guidance documents dedicated to the administration, execution and conduct of research at UC Irvine. Some of the policy topic areas include research eligibility, sponsored projects, export control and stem cell research.

POLICY LIBRARY

Bio Sci 199

Bio Sci 199 is an opportunity for undergraduate students to perform supervised undergraduate research alongside a mentor while earning graded research units.

Bio scI 199 webpage

Scientific Clinical Research Internship Program (SCRIP)

Scientific Clinical Research Internship Program (SCRIP) offers a volunteer, non-credit course administered by departments within UCI Health and UC Irvine School of Medicine. Students can participate and gain hands-on experience in biomedical research settings.

SCRIP Webpage

The designation of “School Center” was established by the UC Irvine Office of Research as a means of offering flexibility for faculty, predominantly within a particular school, to create research units that suit their needs and areas of expertise. The UC Irvine School of Medicine, with a faculty of wide-ranging and diverse expertise, encourages its faculty to form partnerships within the School of Medicine for the purpose of pursuing a research initiative that can be strengthened by the establishment of a School Center.

Center Guidelines Webpage

In order to protect the interests of all involved, the department or unit that will facilitate a vendor coming to campus (by reserving a space or making other arrangements) must fill out a UC Irvine School of Medicine Hosting Vendor Form. This form will notify the UC Irvine School of Medicine Office of Research of your plans so we can facilitate as appropriate.

VENDOR POLICY WEBPAGE

VENDOR GUIDE (PDF)