Research Compliance

The Office of Compliance and Privacy supports human subject research excellence through the adoption and implementation of policies and procedures that promote the safe, legal, and ethical conduct of research. The Office of Compliance and Privacy works across the research community to achieve best practices and to retain core values of the University of California, San Diego.

Fostering a culture, and expectation, of responsible and ethical conduct of research is a critical component in the advancement of knowledge through research and scholarship. It is also a key element in the maintenance of public trust in the research enterprise.

In order to ensure the quality and integrity of research at UC San Diego Health Sciences, the Office of Compliance and Privacy provides education to faculty, staff, and students conducting human subject research so that they may better understand and meet Federal, State, and UC San Diego regulatory compliance requirements. In addition, the Office of Compliance and Privacy may perform routine or for-cause compliance audits and recommend institutional responses to ensure regulatory compliance in the conduct of research.

High-Risk Areas of Research

In order to protect the rights, welfare, and wellbeing of human subjects involved in research at UC San Diego Health Sciences, the Office of Compliance and Privacy, in collaboration with numerous other departments, help research staff navigate many of the high-risk areas of research, such as:

Human Subjects Protections
Research Privacy and Security
Conflicts of Interest and Financial Disclosure
Conflict of Commitment
Research Misconduct
Fraud, Waste, and Abuse
Grant Management
Export Controls
Biosafety
Stem Cell Research
Investigational Drug and Device Storage
Data and Records Retention
Research Billing

Research Resources

If you have any questions related to research compliance you may contact the Office of Compliance and Privacy.

Audits & Monitoring

Clinical trials and research are subject to audit by internal or external authorities. Below are the types of audits conducted by the UCSDHS Office of Compliance and Privacy.

Audits Not for Cause

The purpose of the audit is for quality assurance and to confirm the study is being conducted in accordance with the general concepts of Good Clinical Practices (GCP), the IRB approved research protocol and study documents, institutional policies, and all applicable state and federal laws and regulations.

If you receive an email notification of a Compliance regulatory audit, there is no need to prepare. The main purpose of the audit is to assist the research unit in identifying opportunities for process improvement, provide targeted training and education, and to identify trends in the conduct of research conducted at UCSD.

If you would like to request a regulatory audit of your research study, please contact the Office of Compliance and Privacy via email and include the study IRB number, reason for the audit, and contact information.

Audits for Cause

Compliance is responsible for conducting for-cause audits or investigations related to research compliance concerns. These include concerns escalated by the UCSD IRB, internal or external committees, or University leadership. A for-cause audit is an in-depth examination of all components of a research study and may include observations of processes, interviews with research staff, as well as a review of the research study documentation and research data.

For-cause audits do not include concerns discovered through regulatory research audits conducted randomly or requested by a research unit.

Clinical Research Billing Audits

In order to comply with University policies, state and federal laws and regulations, any human subject research study in which clinical services are provided must adhere to UC San Diego Health Policies (UCSDHP) 342.2, Clinical Research Billing.

Compliance conducts random and for-cause billing audits in order to provide quality assurance, quality improvement, and education pursuant to research financial compliance and clinical research billing. Clinical research billing audits are initiated based on risk level, high enrollment, mixed billing, extensive services, case rates, etc.

Additionally, a for-cause audit will be initiated if significant issues of non-compliance are identified during the auditing process or the study has been escalated due to concerns raised by internal or external committees, the UCSD IRB, or University leadership.

Please contact the Office of Compliance and Privacy for your questions about the Audit and Monitoring processes.