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THE COMMITTEE ON HUMAN RESEARCH (CHR)

GENERAL CONDITIONS OF APPROVAL

EXPIRATION DATE:

An expiration date is clearly listed on the approval letter. Although the office of the Committee on Human Research (CHR) will, as a courtesy, send a reminder about eight weeks in advance of the expiration date, it is the investigator's responsibility to keep track of the expiration date and initiate the renewal process sufficiently early. The Department of Health and Human Services (DHHS), the Food and Drug Administration (FDA) and the University of California require at least annual review of all projects involving humans as subjects. It currently takes approximately six weeks, though often longer during busy periods and the holidays, from the time the CHR office receives a renewal application until an approval letter is sent out.

APPROVED VERSIONS OF CONSENT DOCUMENTS:

Beginning April 2002 the CHR identifies approved consent documents in the body of the CHR approval letter. The CHR no longer includes an approval stamp on the consent forms themselves as it had previously. Investigators are required to include a version date in a footer on each page of the consent documents so the documents can be identified in the CHR approval letter. If multiple consent documents are used for the study, a short identifier should be included in the footer to distinguish between the various documents.

MODIFICATIONS:

Prior CHR approval is required before implementing any changes in the approved consent documents, recruitment materials, or protocol. Please see Modification Application of the CHR Guidelines for more information on modifications

ADVERSE EVENT REPORTING:

All problems having to do with subject safety must be reported to the CHR within ten working days. All deaths, whether or not they are directly related to study procedures, must be reported. Please review Adverse Event Reporting of the CHR Guidelines for more information.

PAYMENT OF SUBJECTS:

Research subject payment is processed in the Accounts Payable Section of the University Accounting Office. In order for subjects to be paid in a timely manner, the paperwork to pay subjects should be started as soon as the CHR Approval Letter is received. An Accounts Payable Guideline which provides detailed information about subject payment is included as Accounts Payable Guidelines For Research Subject Payments in the CHR Guidelines. Information on how to fill out the subject payment forms can be obtained by calling Accounts Payable at 476-2126 and asking for the Research Subject Payment Desk.

Subjects may be paid by a Check Request (Form 5) or via petty cash (for on-site payments of $100 or less a visit). Please note, however, that the Form 5 must include the subject's name and address for mailing as well as the subject's social security number. Because the use of names and social security numbers increases the risk of loss of confidentiality and may be a cause for concern for some subjects, both the protocol and the consent form should address this issue in writing.

CHANGES IN FINANCIAL INTEREST

Any changes in the financial relationship between the study sponsor and any of the investigators on the study and/or any new potential conflicts of interest must be reported immediately to the Conflict of Interest Advisory Committee (COIAC) Office. If these changes affect the conduct of the study or result in a change in the required wording of the approved consent form, then these changes must also be reported to the CHR Office in the form of a request to modify the study.