- 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.
1. The University of California will provide to any injured subject any and all medical treatment reasonably necessary for any injury or illness which a human subject suffers as a direct result of participation in an authorized University activity covered by University policy on the protection of human subjects in research, or reimburse the subject for the costs of such treatment, except when the injury or illness is a consequence of a medical research procedure which is designed to benefit the subject directly.
2. The obligation of the University undertaken in paragraph 1 shall be subject to the following conditions:
a. It must be demonstrated that the injury resulted directly from participation in the specified activity.
b. Written notification of any such injury is to be given to the University by the human subject within a reasonable time after discovery.
c. Any claim for reimbursement is to be supported by appropriate documentation.
3. It is the preference of the University that the medical treatment available under this policy be provided at a University of California medical facility.
4. Chancellors and other chief administrators, as appropriate, shall designate an individual or office as a contact for inquiries about implementation of this policy.
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.
Treatment and Compensation for Injury Statement (Standard)
If you get hurt because of this study, the University of California will give you medical treatment that you need. You might have to pay for this treatment, or your insurance might pay for it. It depends on different things. The University or the study sponsor might pay for the medical costs instead. But usually, they don't pay for other things besides medical care if you get hurt. If you want to know more, call the office of the Institutional Review Board at 415-476-1814.
Treatment and Compensation for Injury Statement (Alternate Versions)
Alternate statement #1- Use if Sponsor requests MMSEA 111 Language
If you get hurt because of this study, the University of California will give you medical treatment that you need. You might have to pay for this treatment, or your insurance might pay for it. It depends on different things. The University or the study sponsor might pay for the medical costs instead. But usually, they don't pay for other things besides medical care if you get hurt. If the sponsor pays for these costs they will need to know some information. This can include your name, birthdate, and Medicare Health Insurance Claim Number or Social Security Number. This information will be used to check to see if you receive Medicare. If you receive Medicare, the sponsor will notify Medicare about the payment. The sponsor will not use this information for any other purpose. If you want to know more, call the office of the Institutional Review Board at 415-476-1814.
Alternate statement #2- Use for studies of COVID-19 countermeasures that are covered by the PREP Act Declaration)
If you get hurt because of this study, the University of California will give you medical treatment that you need. You might have to pay for this treatment, or your insurance might pay for it. It depends on different things. Due to the coronavirus public health crisis, the federal government issued a Declaration under the Public Readiness and Emergency Preparedness (PREP) Act. If the Declaration applies, it limits your right to sue and recover for losses from the researchers, healthcare providers, any study sponsor or manufacturer or distributor involved with the study, including the University of California, while participating in this COVID-19 clinical study. However, the federal government has a program that may provide compensation to you or your family for certain claims if you experience serious physical injuries or death and these costs are not covered by other payors. To find out more about this “Countermeasures Injury Compensation Program” go to https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.
Alternate Statement #3- Use for SFVAHCS studies, or studies in which this consent form will be used at a VA site:
If you are having a medical emergency, call 9-1-1. If you get hurt or sick because of this study, the Department of Veterans Affairs (VA) give you medical treatment that you need. If you were following study instructions, the VA or the study sponsor will pay for the treatment. If you were NOT following study instructions, the costs of treatment might be billed to you or your insurer just like any other medical costs. It depends on different things. The VA and study sponsor usually do not pay for other things besides medical care if you get hurt. If you want to know more, call the study team at the number on page 1 of this form.
Alternate statement #4- Use for studies where the Sponsor chooses to remain silent, and/or the Sponsor is the NIH
If you get hurt because of this study, the University of California will give you medical treatment that you need. You might have to pay for this treatment, or your insurance might pay for it. It depends on different things. The University might pay for the medical costs instead. But usually, they don't pay for other things besides medical care if you get hurt. If you want to know more, call the office of the Institutional Review Board at 415-476-1814.
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.