- Federal Regulations and UC Policy
- Standard Consent Form Wording
- Industry Sponsors' Wording
- Implementation, Reporting and Questions
Federal Regulations and UC Policy
Both OHRP and FDA require that if research-related injury is possible in research that is more than minimal risk, the consent form must include an explanation of whatever voluntary compensation and treatment will be provided.
Standard Consent Form Wording
The UCSF IRB, in consultation with campus Legal Counsel, formulated a standard statement to describe the UC policy.
Alternate versions of the statement are available for the following scenarios:
(1) the Sponsor requests MMSEA 111 Language
(2) this is a clinical trial of a COVID-19 countermeasure and the PREP Act applies.
(3) this is a SFVAHCS study or this consent form will be used at a SFVSHCS site (for UCSF/VA studies)
(4) the Sponsor chooses to remain silent on this point, and/or the sponsor is the NIH
A Treatment and Compensation for Injury statement is required in consent forms for greater than minimal risk studies (also called “full committee” studies) and for Department of Veterans Affairs studies.
Either the standard statement or one of the alternate statements below must be used without any changes to the wording. The IRB office is not in the position to negotiate indemnification agreements.
Sponsoring companies often request that their own wording be used for the treatment and compensation for injury policy statement or that minor changes be made in the UC statement. These requests cannot be honored. The wording of the statement was formulated with the advice of legal counsel with the intent of adhering to the requirements of the federal regulation, and conveying the basic, necessary information to the subject.
Industry sponsors have two — and only two — options regarding provisions for treatment and compensation for injury in the consent form:
- The sponsor may include its name in the UCSF statement as written above.
- The sponsor may remain silent on this point, in which case all reference to the sponsor should be omitted from the above statement.
No other changes may be made to the UCSF statement.
The IRB office is not in the position to negotiate indemnification agreements. This occurs through the Industry Contracts Division of the Office of Innovation, Technology and Alliances as part of the initial clinical research contract negotiations.
Implementation, Reporting and Questions
There are two major aspects of the UC policy: (1) treatment for injury and (2) compensation for injury. These two must be clearly distinguished in considering the University policy and the UCSF statement regarding that policy.
Appropriate treatment should be available to any subject injured as a result of participating in a research project. Treatment should be considered an ethical obligation rather than any admission of liability. Consent forms should indicate within the Risks section the nature of available treatment for any possible serious side effects.
Reporting: All reports of possible injury must be reported immediately to the IRB and to Risk Management and Insurance Services using standard UCSF Adverse Event or Protocol Violation/Incident Reporting forms. Minor incidents of anticipated side effects may be reported at the time of continuing review or at termination of the study if it is not to be continued.
Questions: Contact the office of Risk Management and Insurance Services at 415-476-4171 with questions about whether any serious adverse event, illness or other medical concern is potentially compensable under the University policy, or with questions about the process for filing a research-related injury claim.