Human Subjects

Individuals who are responsible for the design, analysis, conduct, or reporting of the results of research performed (or to be performed) under a human subjects protocol must disclose whether or not they have a financial interest in or association with the sponsor or the company supplying the materials, drugs, or devices for the project.

Procedures

Complete the Berkeley eProtocol application as per instructions from the Office for Protection of Human Subjects. If applicable, the Human Subjects Financial Conflict of Interest Form should then be completed and included in the Attachments section of the corresponding eProtocol application. Final CPHS approval will be contingent upon the disclosure and resolution of all financial conflicts of interest.

Procedures for UC IRB Reliance Registry

UC Berkeley utilizes the UC IRB Reliance Registry for all studies in which our investigators rely on another UC campus or Lawrence Berkeley National Lab for IRB review or vice versa. UC Berkeley asks that our Relying PIs provide, via the Registry, a signed and scanned copy of the CPHS Checklist for Financial Conflict of Interest Human Subjects Studies (Student investigators will need to have their faculty sponsor sign as well.) and an electronic copy of the PI’s CITI course training report.


Forms

NOTE: Please use Adobe Acrobat or Reader to fill out PDF forms. (If you have difficulty filling out a form, please download the form to a local computer before filling it out.)


Related Federal Policy and Guidelines

Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection