Definition of Clinical Study
The COIAC uses the following definition of “clinical study”. Please note that this definition may differ from the definitions used by the Contracts and Grants Division, the Industry Contracts Division, the Committees on Human Research, the Budget office, and the Accounting Office.
"A clinical study is defined as a research project undertaken to assess the safety, efficacy, benefits, costs, adverse reactions, and/or outcomes, if any, of a drug, device, regimen, or procedure involving human subjects whether the protocol is investigator-initiated or initiated by others. A clinical study evaluates prospectively or retrospectively the diagnostic, prophylactic, or therapeutic effect of a drug, device, regimen, or procedure used or intended ultimately for use in the practice of medicine or the prevention of disease. For purposes of conflict of interest review, the course of a clinical study is considered to comprise the entire period during which any CHR protocol for that study is active. The clinical study commences with the date of approval of the first CHR protocol for the study or the effective date of the contract, whichever is earlier, and ends with the date when the last CHR protocol for that study is closed, regardless of whether or not data analysis is being performed. Pre-clinical laboratory studies in animals are not included under the term clinical study and neither are projects designed to develop new compounds; such projects are reported in one of the other research categories.”
All Clinical Studies
An Investigator’s financial or other interests that are related to the clinical study being undertaken are carefully reviewed by the Conflict of Interest Advisory Committee (COIAC), and the COIAC will consider the effect of financial interests on the protection of human subjects or to manage the financial interest of Investigators. As part of this review, the COIAC may place limitations on that Investigator’s participation in the clinical study and may require that the financial relationship be stated in the human consent form. The COIAC’s concerns and requirements are communicated in writing to the person with the conflict and to the UCSF CHR for its review and management.
Federally Sponsored Clinical Studies
For federal disclosure requirements, please refer to the following COI webpages and chart:
Privately Sponsored Clinical Studies
Please refer to State Laws and Subcontracts for the disclosure requirements for clinical studies sponsored by private industry or non-governmental entities. For privately sponsored clinical studies, faculty must agree to follow item #11 of the UCSF clinical study policy:
“Faculty who have, or participate in, a privately sponsored clinical study shall not concurrently receive any compensation from the sponsor, including honoraria and consulting fees, during the course of the study. In addition, they shall not have any investment in, or serve in a decision making capacity for (such as serving on the Board of Directors or management committee), or be an officer or employee of the company sponsoring the study.”
Other investigators with conflicts will be reviewed by the COIAC on a case-by-case basis.