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Compliance Program

Compliance Program

Standard 14 — Clinical Research

Integrity in research includes not just the avoidance of wrong doing, but also the rigor, carefulness, and accountability that are the hallmarks of good scholarship. University policies set forth expectations for high standards of ethical behavior for faculty, staff, and students involved in research. The rights of  research study participants and their well-being and privacy are protected by the University through compliance with ethical standards and all applicable University policies and federal and state regulation.

  • All members of the University community engaged in research are expected to conduct their
    research with integrity and intellectual honesty at all times and with appropriate regard for human subjects.

  • To protect the rights, well-being, and privacy of human subjects, all research involving human subjects is to be reviewed by institutional review boards.

  • The University prohibits research misconduct.  Personnel engaged in research are not to: fabricate data or results; change or knowingly omit data or results to misrepresent results in the research record; or intentionally misappropriate the ideas, writings, research, or findings of others.

  • All those engaged in research are expected to pursue the advancement of knowledge while meeting the highest standards of honesty, accuracy, and objectivity and to demonstrate accountability for sponsors' funds and to comply with specific terms and conditions of contracts and grants.

  • In accordance with University policy (UCOP Operating Requirement No. 95-5, "Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects"), the cost to perform clinical trials conducted for a private sponsor must always be fully funded by the sponsor and may not be supported in whole or in part by other funds, including third party insurance payments, gift or foundation funds, or charges to the subject.

  • Goods and services are procured in a competitive, fair and timely manner in compliance with OMB Circular A-110 and University policies.  Conflicts of interest are avoided.  Educational or research grants or other funds received from commercial entities are not permitted to influence procurement decisions.

  • Ongoing monitoring and auditing processes, with initiation of appropriate corrective action, ensure the University's clinical research programs are well managed.

  • The records retention program for clinical research ensures documents and other necessary supporting evidence are maintained for the appropriate length of time as required by federal and other regulations.  This program evaluates and verifies the effectiveness of the systems and internal procedures implemented.