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.
Procedure for IRB Reliance Requests
UC Berkeley requires documentation to be submitted to irb_reliance@berkeley.edu for collaborative projects in which our investigators would like to rely on another institution for IRB review. UC Berkeley asks that our Relying PIs provide a signed and scanned copy of the CPHS Checklist for Financial Conflict of Interest Human Subjects Studies along with an electronic copy of the PI’s CITI course training report.
Collaborative research projects are studies that involve more than one institution engaged in human subjects research. In the conduct of collaborative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with pertinent federal regulations, state regulations, and institutional policies. For collaborative research projects, institutions may choose to rely upon the review of another Institutional Review Board (IRB) to avoid duplication of effort. Reliance agreements for institutions or individual investigators may be executed upon the request of the investigator, the Committee for Protection of Human Subjects (CPHS)/Office for Protection of Human Subjects (OPHS), or the collaborating institution to document IRB review and engagement in human subjects research.
See the Collaborative Human Subjects Research page for more information.
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.)
- Human Subjects Financial Conflict of Interest Form
- CPHS Checklist for Financial Conflict of Interest Human Subjects Studies (reliance requests only)