CLINICAL STUDIES

Definition of Clinical Study

The COIAC uses the following definition of “clinical study”. Please note that this definition differs from the definitions used by the Contracts and Grants Division of the Office of Sponsored Research (OSR), the Industry Contracts Division of OSR, the Committee on Human Research, the Budget Department, 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 in 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

A faculty member’s financial 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 participants or to manage the financial interest of investigators. As part of this review, the COIAC may place limitations on that faculty member’s participation in the clinical study and which 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 UCSF CHR for its review and management.

In addition to the below referenced requirements for federally sponsored and privately sponsored clinical studies, the principal investigator of a clinical study is required to complete the form entitled “CHR Financial Supplement: Disclosure of Investigators’ Financial Interests” and submit that form as part of the CHR application. Submit the original form to CHR. CHR will then give a copy to the COIAC for its review and action. The form is located at Forms, under the heading “Committee on Human Research Application.”

Federally Sponsored Clinical Studies

For federal disclosure requirements, please refer to the following:

• Federal Regulations



• Subcontracts



• Disclosure Requirements

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, the principal investigator 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.”

In addition to Form 700-U, the Principal Investigator must submit the “UCSF Supplement to Form 700-U for Privately Sponsored Clinical Studies” at the time of proposal submission.

Effective date: October, 21, 2004; Updated November 2004; Revised October 11, 2005